57CL9802. Drug: calanolide A. This trial will study calanolide A for the treatment of HIV infection. Calanolide A is an experimental NNRTI anti-HIV drug derived from a Malaysian rain forest tree. Study participants will receive various doses of calanolide A, or a placebo for 14 days. After the 14 day period, all study participants will receive $1,000. In addition, the study sponsor will provide 6 months of an approved three drug anti-HIV combination for participants who do not have insurance or choose not to use their insurance. Required: To participate you must be HIV+, male or female, with a viral load over 10,000 and T4 cell count over 350. You must be negative for hepatitis B antigens and hepatitis C antibodies. Not allowed: You cannot have had any previous anti-HIV treatment, or use over-the-counter or prescription drugs during screening (except oral contraceptives). Contact: Lauren Birnhak, FNP, Beth Israel Medical Center, New York, (212) 420-4519. (added 2/9/99)

1193-219. Drug: Il-2. This trial will study subcutaneous injections of IL-2 for the treatment of HIV infection. All participants will be treated with IL-2. Participants will be taught to give themselves shots and will take IL-2 daily. All participants must remain on current antiretroviral for the length of the study. Antiretroviral can be AZT, ddI, ddC, d4T or 3TC, alone or in combination. Clinic visits for weekly physicals and labs are required. You must be 18 years or older with a T4 cell count of 200 to 500. You must be on antiretroviral therapy for more than one month. Contact: Elizabeth Jacobson, MD, New York Hospital/Cornell, New York, NY, (212) 746-4464.

2NN Study. This study will compares combination treatment with Viramune, Sustiva or both. Required: Participants can never have taken anti-HIV medications. Contact: Cornell Clinical Trials Unit, New York, NY, 746-4177 or 746-7206. (added 12/1/2000)

A5041. Drug: GM-CSF. This trial will study the effect on viral load when GM-CSF (sargramostim) is added to a potent antiviral regimen. Participants will be divided into two groups. One group will have sargramostim added to their current regimen, the second group will have a placebo added to their current regimen. Neither the doctor nor the participant will know which treatment they are getting. To participate your viral load must be 1500 copies or more and you must be on a stable anti-HIV medication regimen. Contact: Cornell Clinical Trials Unit, New York, NY, 212-746-7206. (added 1/6/2000)

ABT-378 CompUse. Drug: ABT-378 (new name: lopinavir). ABT-378 (new name: lopinavir) is a new anti-HIV protease inhibitor developed by Abbott Laboratories, the makers of the approved protease inhibitor Norvir (ritonavir). Early studies have shown that ABT-378 has a strong anti-HIV effect. It's also possible that ABT-378 will have some effect on HIV that has become resistant to other available protease inhibitors, although how strongly the drug can block resistant HIV is not yet known. Abbott is now starting a small "Early Access" program for ABT-378. This will be a very small program, allowing only 500-700 people in the US and Europe access to the drug. Required: over 10,000 copies HIV RNA or a recent opportunistic infection, less than 200 CD4+ cells within the past three months, intolerance to and/or failure (viral load increases) to at least two protease inhibitors, unable to construct a viable combination without ABT-378. To register patients in the program, physicians should call (888) 711-7193. In the US, the drug will be available through about 35 clinics, though you don't have to be receiving your medical care through those clinics to qualify for the program. (updated 1/13/2000)

ACTG A5039. Drug: hydroxyurea, Sustiva, ddI, d4T, Protease Inhibitors. This study will examine maintenance therapy. The study will see if there is a way to maintain viral suppression without the use of protease inhibitors. HIV+ people who have have maintained an undetectable viral load for at least a year on their initial therapy will be randomized into three groups. Group A will switch from their present combination to ddI/d4T/hydroxyurea, group B will switch to ddI/d4T/Sustiva and group C will stay on their present combination. If viral load becomes detectable in groups A or B, the participant will return to their combination therapy prior to study. Time on Drug: approx 3 years. Required: HIV+, Male or female, 13 years old, T4 cell count: > 200, viral load: undetectable, Abstinence/barrier birth control during and 30 daysafter, Chemoprophylaxis for pneumocystis carini pneumonia for all patients who have a CD4 count < 200, Viral load < 400 for a year and < 50, 60 days prior to entry. Not allowed: Pregnant or nursing mothers, Pancreatitis, Peripheral neuropathy > Grade 2, AIDS related malignancy that requires systemic chemotherapy (Minimal Kaposi's Sarcoma defined as no more than 5 cutaneous lesions and no visceral disease or tumor associated edemas is allowed). Drugs not allowed: Systemic corticosteroids for more than 21 days, Any therapy for CMV, toxoplasmosis, disseminated fungal infection, or other significant medical illness, Systemic anti-cancer agents, Intravenous pentamidine and ddI, Antiretoviral therapies not defined in study. Contact: Janet Forcht, RN, NYU Medical Center, New York NY, (212) 263-8726. (added 7/27/99)

ACTG 325. Drug: interleukin 12 (IL-12). This trial will study IL-12 for the treatment of HIV infection. IL-12 has been shown to enhance immune function. As a Phase I study, the primary goal of this trial is to determine dose levels related to toxicity of the treatment. Treatment is by subcutaneous injection. Participants will be divided into two groups. The first group will be treated with semi-weekly injections of IL-12 at different doses for 4 weeks. The second group will be treated with injections of placebo for 4 weeks. Neither the doctor nor the participant will know which treatment is being given. Mild fever and fatigue, malaise, muscle pain, nausea, anorexia, and mouth pain have been some of the side effects observed with IL-12 treatment. To participate you must be HIV+ and 18 years or older with a T4 cell count of under 50. You must have been taking combination antivirals for more than 4 weeks before study entry. You cannot be pregnant or nursing. You cannot have a serious ongoing opportunistic infection, a history of disseminated MAC infection, CMV end-organ disease, or invasive fungal disease (e.g. cryptococcosis, histoplasmosis, coccidiomycosis, etc.), or a history of severe hypersensitivity or toxic reactions to IL-2 or IL-12. You cannot have taken IL-12 within 24 weeks of study entry. Many drugs are not allowed while on this study. The study coordinator will go over the drug list with you. Total time on study is 4 weeks. Contact: Janet Forcht, RN, New York University Medical Center, New York, NY, (212) 263-8724. (updated 2/1/99)

ACTG 349. Drug: prednisone. This study evaluates the safety and efficacy of prednisone in elevating CD4 T cells and decreasing plasma HIV-1 RNA, from baseline, in HIV-1 infected patients. Patients are separated into two groups according to whether or not they are currently receiving a protease inhibitor as part of their antiretroviral therapy (PI vs. no PI therapy). Group A will receive current stable ARV therapy plus prednisone for 8 weeks, followed by 4 weeks at half the prior dose, then a two week taper. Group B will receive current stable ARV therapy plus a prednisone placebo for 12 weeks. Total time on treatment: 18 weeks. Required: HIV+, male or female, age: > 18 years, T4 cell count: 200-600, viral load: < 1,000. Not allowed: pregnant or nursing mothers, active alcohol or substance abuse, evidence of an active and symptomatic bacterial, protozoal, fungal, viral or other opportunistic infection not previously identified, febrile illness of unknown cause with a temperature > 38.5 within 7 days of study entry. Contact: Eileen Chusid, PhD, Mount Sinai Medical Center, New York NY, (212) 241-0433. (added 8/15/99)

ACTG 371. Drugs: abacavir, amprenavir, AZT, 3TC. This is a study for people who have become infected with HIV in the recent past (within the last 6 months). Researchers call this acute or recent seroconversion. In this study, everyone will receive four approved anti-HIV drugs, abacavir (Ziagen), amprenavir (Agenerase), zidovudine (Retrovir), and lamivudine (Epivir). Contact The Network for more information about other studies for people who have become recently infected with HIV. Time on Drug: 52 weeks. Required: 16 years old HIV RNA > 2,000 and one of the following: negative ELISA < 7 days of entry, or positive ELISA but negative or indeterminate Western blot > 7 days of entry, or positive ELISA and Western blot < 7 days of entry but with documented negative ELISA or plasma RT-PCR < 2,000 30 days before entry. Not allowed: Intercurrent illness. Drugs not allowed: All antiretroviral therapies other than study medications, Chronic systemic corticosteroid use (more than 21 days), Systemic cytotoxic chemotherapy, Investigational drugs. Contact: Eileen Donaghy, RN, University of Pennsylvania, Philadelphia PA, (215) 349-8092; Maura Laverty, RN, NYU Medical Center, New York NY, (212) 263-6565; Lauren Birnhak, FNP, Beth Israel Medical Center, New York NY, (212) 420-4519. (added 7/27/99)

ACTG 387. Drug: indinavir, GM-CSF, IL-12, nevirapine, AZT (or d4T), 3TC. This trial will study combinations of anti-HIV drugs and immune modulators for the treatment of HIV infection. Participants will first be divided into two groups, A and B. Group A will start the study with a 72 hour stay in the clinic. During this 72 hour period, Group A will take one of four anti-HIV treatments: AZT/3TC (Combivir), nevirapine (Viramune) alone, indinavir (Crixivan) alone, or the combination of AZT, 3TC, Crixivan and Viramune. After this 72 hour period, everyone in Group A will start taking AZT, 3TC, Crixivan and Viramune. Group B will take AZT, 3TC, Crixivan and Viramune from the start of the study. Both groups have the option to use d4T (Zerit) if AZT side effects are a problem. After 7 days of the study, all participants will be randomly divided into three new groups. The first group will add a daily shot of GM-CSF to their anti-HIV drugs. The second group will add a shot of twice weekly shot of IL-12 to their anti-HIV drugs. The third group will not add immune modulators to their anti-HIV drugs. Both GM-CSF and IL-12 treatments will stopped after 14 weeks of the study. All participants will continue their anti-HIV drugs for the rest of the study. Both the doctor and participant will know which treatment is being taken. To participate in this study you must be HIV+ and 18 years or older with a T4 cell count over 300 and viral load over 20,000. You cannot be pregnant women and nursing mothers, have any active infection needing acute treatment within 30 days prior to study, or unexplained fever for more than 7 days within 30 days prior to study. You cannot be receiving systemic chemotherapy for cancer, or have been on any antiretroviral treatment for more than 7 days. The study coordinator will go over other drugs not allowed with you. Total time on study is 48 weeks. Contact: Rhonda Kost, MD, Aaron Diamond Research Ctr., New York, NY, (212) 448-5. (added 6/22/98)

ACTG 401. Drug: methadone, Fortovase, Norvir. This trial will study the effect of the combination of Fortovase (saquinavir) and Norvir (ritonavir) on the levels of methadone in people on methadone maintenance. Fortovase and Norvir are both protease inhibitors. Norvir and Fortovase are taken twice a day. This combination will be given for two weeks. Two 24 hours stays at the study site will be required for intensive blood sampling on days 1 and 16 of the study. A follow up visit is then required on the 30th day. A payment of $575 is paid to people who complete all study visits at Beth Israel. Time on Drug: 30 days. Required: HIV+, Male or Female, viral load: <100,000, On stable methadone dose (more than 2 weeks and not to change in 30 days), No protease inhibitor within past 4 weeks, Stable (more than 2 weeks) nucleoside analog therapy allowed, Within 40% of ideal body weight. Not allowed: Pregnant women or nursing mothers, Active opportunistic infections or other opportunistic diseases requiring medication within 14 days prior to study entry, Persistent diarrhea or other gastrointestinal conditions which would interfere with drug absorption. Drugs not allowed: Illicit drug/alcohol usage, Other drugs with potential interactions that the study coordinator will go over with you. Contact: Lauren Birnhak, FNP, Beth Israel Medical Center, New York NY, (212) 420-4519; Eileen Chusid, PhD, Mount Sinai Medical Center, New York NY, (212) 241-0433; Valery Hughes, NP, Cornell Medical Center, New York NY, (212) 746-4393. (added 7/27/99)

ACTG 5055. Can Crixivan + Norvir be used as a treatment option for people who have experienced treatment failure taking Agenerase, Viracept or Fortovase? Contact: Cornell Clinical Trials Unit, New York, NY, 746-4177 or 746-7206. (added 12/1/2000)

ACTG 5057. Drug: Remune. This trial will study the effects of a therapeutic vaccine when added to combination anti-HIV drugs. The goal of the study is to see if the vaccine helps keep HIV viral load under control for a longer period. The study will enroll people taking anti-HIV drugs who have had a viral load of less than 500 copies for at least 12 weeks. Participants in the study will be divided into two groups. Everyone in the study will keep taking their anti-HIV drugs. One group will take the Remune vaccine by shot under the skin every three months. The second group will take a placebo or dummy shot every three months. If the study finds that Remune helps keep viral load under control, all study participants will be eligible to receive the vaccine. Required: HIV+, male or female, age: > 13 yrs, on stable anti-HIV drugs for at least 12 weeks prior to study, viral load less than 500 for at least 12 weeks prior to study. Not allowed: pregnant women or nursing mothers, infection or acute illness within past 30 days, any symptomatic chronic infection other than HIV, malignancy requiring systemic therapy, history of lymph node irradiation. Drugs not allowed: use of any prior HIV vaccine, immunizations within past 30 days, hydroxyurea within past 30 days, any GM-CSF, G-CSF, M-CSF, IFN, IL-2 or other cytokine within past 30 days, any immunoenhancing or immunosuppressive drugs within 30 days prior to entry. Contact: Candy Talabucon, RN, NYU Medical Center, New York, NY, (212) 263-8708. (added 1/13/2000)

AD 378. Drug: ABT-378, Sustiva. This study will look the combination of the experimental protease inhibitor ABT-378^®, the NNRTI drug efavirenz (Sustiva), and two NRTI type drugs. Everyone in this study receives the ABT-378^® twice a day. The other drugs are taken once or twice a day. This is one of the few studies of experimental treatments that allow people who have had experience with at least two protease inhibitor combinations (for at least 12 weeks each). Required: HIV+, Male or Female, Age: > 18 years old, NNRTI naïve, viral load: > 1,000, Multiple PI experienced. Not allowed: Pregnant or nursing mothers. Drugs not allowed: Sustiva. Contact: Elizabeth Jones, CCRC, Aaron Diamond Aids Research Ctr., New York NY, (212) 448-5124. (added 7/28/99)

ADRC 98. Drug: 3TC, Ziagen, Agenerase, Crixivan. This trial will study a combination of four anti-HIV drugs in people who have become infected in the last 90 days. Everyone in this study will receive 3TC (Epivir), Ziagen (abacavir), Agenerase (amprenavir) and Crixivan. Both the doctor and the participant will know which treatment is being taken. There are also other studies at this site for people who are about to start HIV treatment. People who have been recently infected, as well as those who are infected for many years but with high T4 cell counts and low viral loads are encouraged to contact this site as well. To participate you must be 15 years or older with HIV detected using Roche Amplicor or Chiron bDNA AND one of following: absent HIV-1 by ELISA, positive ELISA and evolving Western blot, clinical history consistent with HIV-1 infection within 90 days and a documented negative HIV-1 test within 120 days of screening. You must be antiretroviral naive and have had a negative serum pregnancy test within 30 days of day 1 of study. You cannot be pregnant or nursing, have radiation therapy within 30 days of Day 1, an AIDS diagnosis, excluding CD4+ counts under 200, pancreatitis or hepatitis within last 6 months, current alcohol or drug use that may result in non compliance, or a history of coagulopathy. You cannot have ever taken other investigational antiretroviral treatment. Contact: Rhonda Kost, MD, Aaron Diamond Research Ctr., New York NY, (212) 448-5030. (added 4/12/99>

AI424-007. Drug: BMS 232, Viracept, ddI, d4T. Different combinations of the experimental protease inhibitor, BMS 232, are being studied in this four group study. Everyone in the study will take ddI (Videx) once a day. Three groups in the study also take d4T (Zerit) twice a day, and different doses of the protease inhibitor. The fourth group takes Zerit and the protease inhibitor nelfinavir (Viracept). Required: HIV+, Male or Female, Age: >18 years old, T4 cell count: >100, viral load: 2,000-200,000, treatment naive, or less than 7 days or treatment. Not allowed: History of pancreatitis or hemophilia, suspected primary (acute) HIV infection. Drugs not allowed: Prior antiretroviral therapy with the exception of up to 7 days of nucleoside therapy, No nucleosides within 30 days of entry. Contact: Lauren Birnhak, FNP, Beth Israel Medical Center, New York NY, (212) 420-4519. (added 7/28/99)

AI454 152F. Drug: Enteric Coated ddI, d4T, nelfinavir. This study will give participants one of two doses of a newly formulated version of the drug ddI (Videx). The new ddI is enteric coated. It does not contain buffers that prevent the stomach acid from breaking it down. This might cause fewer cases of stomach upset and diarrhea. Everyone in this study will take the EC ddI, and the protease inhibitor Viracept and d4T (Zerit). Total time on drug: 48 weeks. Required: HIV+, Male or female, Age: > 12 years old, T4 cell count: > 200, viral load: > 2,000, treatment naïve or <4 weeks NRTI. Not allowed: Pregnant women, History of active or chronic pancreatitis, Active Ois. Drugs not allowed: > 4 weeks of NRTI use (AZT, ddI, 3TC, etc.), > 1 week Protease inhibitor use (Crixivan, Viracept, Norvir, etc.). Contact: Candy Tobin, ACRN, NJCRI, Newark NJ, (973) 483-3444, ext 44. (added 7/28/99)

AMD-3100. This study will examine the safety of a new kind of HIV drug given intravenously—by vein. The study drug is one of a new class of drugs, called entry inhibitors. A Community Forum on entry inhibitors will be held Jan. 10, 2001. Requires:: 12 day hospitalization, compensation provided. Contact: Cornell Clinical Trials Unit, New York, NY, 746-4177 or 746-7206. (added 12/1/2000)

COLA3003. Drug: amprenavir, Ziagen, 3TC. This study will give participants three drugs, taken twice a day. The drugs are amprenavir (Agenerase), abacavir (Ziagen) and lamivudine (Epivir). A tonsillar biopsy, a procedure during which a small piece of tissue is removed from the tonsils for examination, will be performed three times during this study. Participants will receive $100 for each biopsy. Required: HIV+, Male or Female, Age: > 18 years of age, T4 cell count: 200-500, viral load: >5,000, no NNRTI. Not allowed: diagnosis of AIDS, history of tonsillectomy. Drugs not allowed: More than one week of therapy with a protease inhibitor or 3TC, Over 4 weeks of therapy with NRTIs (AZT, ddI, etc.), Previous use of any NNRTI. Contact: Lauren Birnhak, FNP, Beth Israel Medical Center, New York NY, (212) 420-4519. (added 7/28/99)

COLA4005. Drug: Epivir, Zerit, Crixivan, Viracept. The purpose of this study is to see if Epivir (3TC) can be taken once a day instead of twice a day. Participants must currently be taking either Viracept or Crixivan along with d4T and 3TC. One group in the study will be given 300 mg of 3TC once a day. The other group will be given 150 mg of 3TC twice a day. Total time on drug: 6 months. Required: HIV+, Male or Female, Age: > 18 years old, T4 cell count: over 50, viral load: less than 400, PI stable for 6 months, Currently taking Epivir (3TC) and Zerit (d4T) and either Crixivan 800 mgs three times a day or Viracept 750 mg three times a day for at least six months. Not allowed: You cannot have taken any other first line treatment therapy besides the Crixivan or Viracept combination that you are currently taking. Contact: Jim O'Connor, RN, St. Lukes/Roosevelt Hospital Center, New York NY, (212) 523-6743; Joseph Kassous, St. Vincent's Hospital, New York NY, (212) 604-2684. (added 7/28/99)

CPCRA 046. Drug: indinaivr, ritonavir, saquinavir, AZT, 3TC, d4T. This trial will study the short-term effects of managing an antiretroviral treatment regimen based on genotypic antiretroviral resistance testing (GART) compared with managing an antiretroviral treatment regimen without GART. All participants must currently be on one of the following triple antiretroviral regimens for at least 16 weeks: 1. AZT/3TC/indinavir 2. AZT/3TC/saquinavir 3. AZT/3TC/ritonavir 4. d4t/3TC/indinavir. All participants will know which treatment theyr'e on and which treatment they are switched to. To participate you must be HIV+ and 13 years or older with a T4 cell count between 50 and 500 and a viral load of over 50,000. You must have had at least 18 months of antiretroviral treatment with documentation of a 3-fold rise in plasma HIV RNA level (using the same assay) or a previously documented plasma HIV RNA at an undetectable level while on your current antiretroviral regimen. You cannot have had an illness within 2 weeks prior to, or since, obtaining blood for screening, have access to previous genotypic or phenotypic resistance testing results, or be co-enrolled in a clinical trial with anti-HIV drugs. You cannot have had a vaccination within 2 weeks prior to, or since, obtaining blood for the screening HIV RNA measurement, be taking other agents with anti-HIV activity, initiate ttreatment with IL-2, interferon, or adefovir diplivoxil, or have had anti-influenza or other vaccines. Time on study is at least 8 weeks. Contacts: Barbara Standridge, Institute for Clinical Research, Washington, DC, (202) 745-8695; Victoria Taylor, RN, New Jersey Community Research Initiative, Newark, NJ, (201) 483-3444; Mary Ann LiVolsi, Southern New Jersey AIDS Clinical Trials, Camden, NJ, (609) 963-6890; uis Fuentes, Harlem AIDS Treatment Group, New York, NY, (212) 939-2957; Carol Graeber, Philadelphia Fight, Philadelphia, PA, 215) 985-4448. (added 8/20/97)

CPCRA 057. Drug: Sustiva, protease inhibitor combinations. This trial will study different anti-HIV treatment strategies in people who have had their viral load go up while taking a protease inhibitor. The trial has two options. Option one is for participants who have not yet taken at least two nucleoside analogs. Participants in option one will be randomly assigned to either Sustiva + Fortovase (saquinavir), or Norvir (ritonavir) + Fortovase. Participants in this group will also be required to switch to take at least two new nucleoside analog drugs. Option two is for participants who have tried all, or all but one, of the available nucleoside analogs. Participants in option two who are currently taking Viracept (nelfinavir) will be randomly assigned to either Sustiva + Crixivan (indinavir), or Norvir + Fortovase + Sustiva. Participants in option two who are currently taking Norvir or Crixivan will be randomly assigned to either Sustiva + Viracept or Norvir + Fortovase + Sustiva. Participants in this group will also be required to switch to at least one nucleoside analog drug. Both the participant and the doctor will know which treatment is being taken. Total time on study is 12 months. To participate you must be HIV+ and 13 years or older with a viral load greater than or equal to 500 copies and a planned change in your anti-HIV treatment due to detectable viral load after 16 weeks in a row on a protease inhibitor. You cannot be pregnant or nursing, or have an active opportunistic infection. You cannot have taken an NNRTI for more than 1 week or nelfinavir for more than 2 weeks. You cannot have had a vacinnation within 2 weeks. Contact: Group Cheryl Guity, RN, Harlem AIDS Treatment Group, New York NY, (212) 939-2915; Barbara A. Gallagher, RN, Philadelphia FIGHT, Philadelphia PA, (215) 985-4448; Robert C. Sawyer, PhD, NJCRI, Newark NJ, (973) 483-3444, ext15. (added 3/14/99)

CPCRA 058. Drug: HAART (combination therapy). This study will find out what kind of antiretroviral treatment is best to start with in people who have not had prior treatment. HAART (Highly Active Anti-retroviral Therapy) is a drug regimen consisting of a combination of at least three different antiretroviral drugs. The participants will be divided into 3 groups, Group A will take one or two PIs with two NRTIs, Group B will take an NNRTI and two NRTIs and Group C will take both one PI, one NNRTI, and either one or two NRTIs. Participants will be given the option of choosing what group they will be in and what antiretrovirals they will be taking, or they may leave the choice up to the clinicians. Total time on drug: 60 months. Required: HIV+, Male or Female, Age: > 13 years old, Use of barrier contraceptives, PI and NNRTI naïve. Not allowed: Pregnant or Nursing Mothers, A cumulative total of > 4 weeks of NRTI use, including no more than 1 week of 3TC use, Any previous Protease Inhibitor or NNRTI use. Contact: Maryse Joseph, RN, Harlem AIDS Treatment Group, New York NY, (212) 939-2915. (added 7/28/99)

CPCRA 059. Drug: IL-2. This trial will study IL-2 injected under the skin (subcutaneously) for the treatment of HIV infection. All participants will need to be taking anti-HIV drugs. Study participants will be randomly divided into three groups. The first two groups will take different doses of subcutaneous IL-2, taken twice daily. The third group will receive no IL-2. To participate you must be 18 years or older with a T4 cell count over 350. Both the participant and the doctor will know which treatment and dose is being given. Total time on study is 12 months. You cannot be pregnant or nursing, have any CNS abnormality that requires treatment with antiseizure medication, Crohn's disease, psoriasis, or other autoimmune/inflammatory diseases with potentially life-threatening complications. You cannot have had prior rIL-2 therapy at any time or be on cytotoxic chemotherapy. Contact: Susan Caras, RN, Harlem AIDS Treatment Group, New York NY, (212) 939-2917; Cheryl Guity, RN, Harlem AIDS Treatment Group, New York NY, (212) 939-2915; Barbara A. Gallagher, RN, Philadelphia FIGHT, Philadelphia PA, (215) 985-4448; Robert C. Sawyer, PhD, NJCRI, Newark NJ, (973) 483-3444, ext15. (added 3/14/99)

DMP 266-049. Drug: Sustiva, Protease Inhibitors. This study will see if people with an undetectable viral load while taking their first anti-HIV treatment combination can maintain it when they switch to a combination without a protease inhibitor. Everyone in this study must currently be taking a one or two protease inhibitor combination and have a viral load below 50. The PI combination they are taking must be the first combination that they have tried. Participants will then be randomized to either continue whatever PI combination they are taking, or to receive the drug efavirenz (Sustiva) and whatever two NRTI drugs they are already taking. Total time on drug: 48 weeks. Required: HIV+, Male or Female, Age: > 18 years old, 2 consecutive undetectable HIV RNA's, Combination therapy containing at least one PI, viral load: <50, stable on PI(s). Not allowed: Prior use of NNRTI's, Cannot be using Saquinavir as a single protease inhibitor, Acute hepatitis, Lipodystrophy, Acute or chronic Pancreatitis, Malignancy requiring systemic therapy, Opportunistic infection, Interferon within 30 days of this study. Contact: Mary Catherine George, Bentley-Salick Med. Practice, New York NY, (212) 414-4624; Dr. Frechette, Howard Grossman,MD, New York NY, (212) 929-2629. (added 7/28/99)

GS-97-415. Drug: Preveon. The purpose of the study is to see if adding Preveon (adefovir) to an existing anti-HIV treatment combination will reduce viral load. Anti-HIV drug combinations are often called highly active anti-retroviral therapy, or HAART. Preveon is the first of a new class of anti-HIV drugs called nucleotide analogs. One group will take whatever HAART combination they are already on along with the Preveon. The other will take HAART and a placebo. L-carnitine will be taken by both groups because this supplement prevents kidney damage in people taking Preveon. Total time on drug: 48 Weeks. Required: HIV+, Male or female, Age: > 13 years old, T4 cell count: Over 50, viral load: > 50 and less than 400, Stable HAART therapy of 16 weeks (any regimen of three or more antiretroviral agents). Not allowed: Pregnant woman, Prior use of Preveon (adefovir), AIDS-defining event diagnosed within 4 weeks prior to beginning study Kidney problems or dysfunction. Contact: Mary Catherine George, Bentley-Salick Med. Practice, New York NY, (212) 414-4624; Dr. Frechette, Howard Grossman,MD, New York NY, (212) 929-2629; Eileen Chusid, PhD., Mount Sinai Medical Center , New York NY, (212) 241-0433; Trish Garton, Blick Medical Associates, Stamford CT, (203) 357-7800. (added 7/28/99)

M98-863. Drug: ABT-378, d4T, 3TC, Viracept, Norvir. This study will compare two different combinations of drugs. One group will get the experimental protease inhibitor ABT-378, along with a small amount of the drug ritonavir, also a protease inhibitor. The other group will receive Viracept (nelfinavir). Both of the groups of this study will receive d4T (Zerit) and 3TC (Epivir).To be in this study you must have never taken either d4T (Zerit) or 3TC (Epivir). You can have taken other nucleoside type treatments such as AZT or ddI, but not for more than 14 days. Total time on drug: 48 weeks. Required: HIV+, Male or female Age: >12 yrs, T4 cell count: >400, treatment naïve or <14 days. Not allowed: Pregnant women and nursing mothers, An active opportunistic infection (OI) within the last 30 days, although having had an OI in the past is okay. Drugs not allowed: Previous or current antiretroviral treatment. Contact: Michael Thorn, RN, SUNY at Stony Brook, Stony Brook NY, (516) 444-1659; Lauren Birnhak, FNP, Beth Israel Medical Center, New York NY, (212) 420-4519; Dr. Frechette, Howard Grossman,MD, New York NY, (212) 929-2629; Jim Fallon, St. Michael's Hospital, Newark NJ, (973) 877-2663; Todd Stroberg, RN, Cornell Medical Center, New York NY, (212) 746-7198. (added 7/28/99)

M98-888. Drug: ABT-378, Norvir, Viramune, hydroxyurea. The purpose of this study is to see how different treatment combinations work for people who are already taking a protease inhibitor. You must currently be taking one protease inhibitor and two NRTI drugs for 12 weeks. NRTI type drugs include AZT,d4T, 3TC, ddI,ddC, and abacavir. Group One will receive one or two protease inhibitors, Viramune (nevirapine), and two NRTIs. The double protease combinations that are allowed in this study are RTV/SQV, RTV/IDV or NLF/SQV. Group Two will receive ABT-378, Viramune and two NRTIs. One of the NRTI drugs must be one that you have never taken before. Hydroxyurea may be added at the investigators' discretion. Total time on drug: 48 weeks. Required: HIV+, Male or female, Age: >12 yrs, viral load: 1,000-100,000, one protease, no NNRTI. Not allowed: Pregnant women and nursing mothers, An active opportunistic infection (OI) within the last 30 days, although having had an OI in the past is okay. Drugs not allowed: Previous Sustiva, Viramune or Rescriptor use, ddC (Hivid), or abacavir (Ziagen) as part of the treatment combination, Previous use of ritonavir (Norvir) is okay. A small amount of the drug ritonavir is added to the ABT-378 pill because it increases the amount of drug that gets into the body. Contact: Jim Fallon, St. Michael's Hospital, Newark NJ, (973) 877-2663; Michael Thorn, RN, SUNY at Stony Brook, Stony Brook NY, (516) 444-1659; Lauren Birnhak, FNP, Beth Israel Medical Center, New York NY, (212) 420-4519; Valerie Hughes, NP, Cornell Medical Center, New York NY, (212) 746-4393. (added 7/28/99)

Merck 079-02. Drug: Crixivan, Viracept, d4T, 3TC. This is an open label study that compares two combinations of drugs. The first group will take Crixivan (indinavir) and 3TC (Epivir) and d4T (Zerit). The second group will take twice daily Crixivan and Viracept (nelfinavir) along with 3TC and d4T. Both participants and the study coordinators will know what drug combination is being taken. Total time on study is 24 weeks. To participate you must be HIV+ and 16 years or older with a T4 greater than or equal to 100 and a viral load over 10,000. You must be clinically stable and on the same medications for at least 14 days. You cannot be pregant or breast feeding, or have acute hepatitis of any kind. Chronic hepatitis B is not an exclusion. Drugs Not Allowed: Prior use of a protease inhibitor or 3TC, any investigational drug, including hydroxuyrea. Contact: Robert C. Sawyer, PhD, NJCRI, Newark, NJ, (973) 483-3444, ext15. (added 2/9/99)

Merck 094. Drug: Crixivan, Ritonavir, d4T, 3TC. This study will see if Crixivan is safe when taken twice a day with ritonavir. Crixivan is currently prescribed as a three times a day drug. Previous studies demonstrated that taking Crixivan twice a day with two NRTIs did not work well, but other studies of Crixivan with different drugs are ongoing. Everyone in this study will also take 3TC and d4T. Total time on drug: 24 weeks. Required: HIV+, Male or Female, Age: > 16 years old, T4 cell count: >75, viral load: >5,000, PI and 3TC naïve. Not allowed: Previous use of 3TC, protease inhibitors or abacavir. Contact: Rose M. Tirelli, CNP, Liberty Medical, New York NY, (212) 691-7261 ext 18; Israel Lowy, MD, Mount Sinai Medical Center, New York NY, (212) 241-1562; Tricia Driscoll, RN, Children's Med. Ctr of Brooklyn, Brooklyn NY, (718) 270-4487. (added 8/2/99)

MKC 304. Drug: MKC-442. This trial will study MKC-442, an NNRTI, for the treatment of HIV infection in people whose protease inhibitor treatment has failed. Participants in this study will be screened using resistance testing to see if there are at least two drugs of the available approved antiretrovirals which will work against their HIV. Study participants will then take these selected drugs along with MKC-442. There are no viral load or T4 cell count requirements for this study. Medical evaluations, protocol related laboratory tests, viral load and CD4 tests are provided by the site, as is the MKC-442. Both the participant and the doctor will know which treatment is being taken. To participate, you must be HIV+ and 18 years or older. Your protease inhibitor regimen must not longer be working, as shown by a rising viral load while on therapy). You cannot have taken an NNRTI such as delavirdine or nevirpine. Contact: Rhonda Kost, MD, Aaron Diamond Research Ctr., New York NY, (212) 448-5030; Pam O'Byrne, RN, North Shore University Hospital, Manhasset NY, (516) 562-4280. (added 3/14/99)

MKC 305. Drug: MKC-442, d4T, ddI, hydroxyurea. This trial will study different combinations of drugs for the treatment of HIV infection in people whose protease inhibitor treatment has failed. Participants entering the study with viral loads between 5,000 and 50,000 will be randomly placed into one of two groups. One group will receive MKC-442 (an NNRTI) with d4T (Zerit), ddI (Videx), and hydroxyurea. The second group will receive d4T, ddI, hydroxyurea, and a placebo. Participants entering the study with a viral load over 50,000 will receive MKC-442, d4T, ddI, and hydroxyurea. All participants must have previously taken a protease inhibitor-containing combination, but cannot have taken an NNRTI (Viramune, Rescriptor, Sustiva). Neither the doctor nor the participant will know which treatment is being taken. Total time on study is 48 weeks. To participate you must be HIV+ and 18 years or older who has had previous treatment with a protease inhibitor but no previous NNRTI treatment. You must have a viral load over 5,000. You cannot be pregnant or nursing. Contact: Pam O'Byrne, RN, North Shore University Hospital, Manhasset NY, (516) 562-4280; Rose M. Tirelli, Liberty Medical Associates, New York NY, (212) 682-4711. (added 3/14/99)

NIAID 00-1-0020. Drug: intermittent vs. continuous HAART. This study is being done at the National Institutes of Health in Bethesda, MD. The NIH will pay for airfare for every visit except the first. This trial will study intermittent vs. continuous of combination anti-HIV drugs (Highly Active AntiRetroviral Therapy or HAART). To enroll in the study you must currently be taking HAART and have a viral load of less than 50 copies. Study participants will be divided into two groups. One group will continue taking HAART on an ongoing basis. The second group will take HAART intermittently. In this study, intermittently means taking a month-long break followed by two months on HAART again. These cycles of one month off/two months on HAART will be repeated throughout the course of the study. The study will look at whether taking breaks from HAART helps boost the immune system's response to HIV. The study will also investigate whether taking breaks from HAART helps lessen side effects and improves quality of life. Monthly visits are required for blood drawing and monitoring. Required: HIV+, male or female, age: > 18 yrs, receiving combination anti-HIV treatment with at least 2 NRTIs and one NNRTI or PI (HAART), viral load: < 50 copies. Not allowed: pregnant women or nursing mothers, chronic hepatitis B infection, nmo maligancy or other illness requiring chemotherapy, no symptomatic HIV-related infections apart from kaposi's sarcoma on the skin, no significant cardiac, pulmonary, kidney, rheumatologic, gastrointestinal, or CNS disease. Drugs not allowed: no use of experimental anti-HIV drugs less than 6 months before joining the study, no current or previous use of IL-2. Contact: Christian Yoder, RN, MD, National Inst. of Health, Bethesda, MD, (800) 772-5464 x57745. (added 1/13/2000)

NIAID 97 I-082. Drug: AZT, 3TC, indinavir, nevirapine. This study is being done at the National Institutes of Health in Bethesda, MD. The NIH will pay for airfare for every visit except the first. This trial will study the amount of HIV in the body. Viral load tests only measure the amount of virus in the blood. This trial will study other parts of the body where HIV may be making more virus as well. Participants will recieve AZT, 3TC, indinavir and nevirapine for at least twelve months. All participants will have viral load tests, 4 leukophereses (removal of white cells from the blood), 3 lymph node biopsies and 3 lumbar punctures. Participants with less than 300 T4 cells will have 3 bone marrow biopsies. Five participants with counts greater than 400 will receive a steroid intravenously for 5 days to see if that helps lower total body viral load faster. To participate you must be HIV+ and 18 years or older with a T4 cell count over 500 or under 300 and a viral load of over 10,000. If your count is over 500, you must be asymptomatic and have had no prior antiretroviral treatment. If your count is under 300, you must have no active infections and no prior use of 3TC, nevirapine or protease inhibitors. You cannot be pregnant or nursing, be taking systemic corticosteroids, or have taken experimental medication or chemotherapy in the previous six months. Contact: Christian Yoder, RN, NIH, Bethesda, MD, (800) 772-5464 x 399. (added 4/17/97)

NIH 991. Drug: protease inhibitors and NNRTIs. This trial is being done at the National Institutes of Health in Bethesda, MD. The NIH will pay for airfare for every visit except the first. This study is for people who have had their viral load go up above 500 while taking a protease inhibitor based therapy. This study will look at how the newly approved protease inhibitor amprenavir (Agenerase) is affected by using either nelfinavir (Viracept) or ritonavir (Norvir). All participants will also take efavirenz (Sustiva). Although the main purpose of this study is to see how different drugs at different doses interact with each other, researchers will also be looking at the safety and tolerability of the different combinations. Participants may have prior experience with nelfinavir or ritonavir. A viral load test will be given at screening. Time on drug: 1 year. Required: HIV+, Male or Female, Age: >18 years old, viral load: >500 while taking a PI as part of combination therapy, Treatment with a PI for preceding 20 weeks with no change or interruption for more than 3 days in the last 12 weeks. Not allowed: Pregnant or nursing mothers, Intolerance of ritonavir or nelfinivar, Prior use of Ziagen, amprenavir, or Sustiva, Use of foscarnet, investigational antivirals or vaccines other than those being studied, active opportunistic infections or lymphoma within the past five years, GI absorption abnormalities, Recent use of steroids, chemotherapy, interleukins, interferons, or radiation therapy except local treatment of Kaposi's sarcoma. Contact: Christine Bechtel, RN, National Inst. of Health, Bethesda MD, (800) 772-5464 x401. (added 8/2/99)

NIH ILTNF. Drug: IL-2 (Proleukin), prednisone. This study is being done at the National Institutes of Health in Bethesda, MD. The NIH will pay for airfare for every visit except the first. This trial will study the drug IL-2 (Interleukin-2) alone, or with the corticosteroid prednisone, to treat HIV. Everyone in the study must take a protease inhibitor containing anti-HIV combination during the study. The side effects of IL-2 can be fever, chills, and an overall sick feeling. The corticosteroid drug prednisone may make IL-2 more tolerable. Participants will be divided into four groups. The first group will take anti-HIV treatment with IL-2 . The second group will take anti-HIV treatment with IL-2 and prednisone. The third group will take anti-HIV treatment and prednisone. The fourth group will take just anti-HIV treatment. Neither the doctor nor the participant will know which treatment is being taken. Total time on treatment: up to one year. Required: HIV+, male or female, age: >18 years, current antiretroviral treatment that includes a protease inhibitor for at least 4 weeks, T4 cell count: over 350, intravenous catheter placement. Not allowed: pregnant women or nursing mothers, malignancy other than KS, history of AIDS defining opportunistic infection, significant cardiac, pulmonary, rheumatologic, thyroid, kidney, GI or CNS disease. Drugs not allowed: Corticosteroids, chemotherapy, pentoxifylline, thalidomide, insulin, experimental therapy in prior 4 weeks, history of systemic therapy for KS. Contact: Barbara Hahn, RN, National Inst. of Health, Bethesda MD, (800) 772-5464 x426. (added 8/15/99)

NIH ONO. Drug: IL-2, HAART. This trial is being done at the National Institutes of Health in Bethesda, MD. The NIH will pay for airfare for every visit except the first. Patients will be divided into two groups. Group A will receive HAART therapy (D4T, 3TC, Crixivan and Sustiva). Group B will receive the same HAART therapy plus an IL-2 injection twice a day for five days every eight weeks. Required: HIV + within the last six months, male or female, age: >18 years old T4 cell count over 300. Not allowed: pregnant or breast feeding, past or current autoimmune disease, taking antiseizure or chemotherapy medication, active substance abuse, past or current opportunistic infections or AIDS defining conditions. Contact: Cheryl Perry, RN, BSN, National Inst. of Health, Bethesda MD, (800) 772-5464 x723. (added 8/15/99)

NIH RCT. Receptor cell therapy for twins (gene therapy). This trial is being done at the National Institutes of Health in Bethesda, MD. The NIH will pay for airfare for every visit except the first. This trial will study a treatment using blood from an HIV-negative identical twin that is treated and then given to the HIV+ identical twin. Healthy CD4+ lymphocytes (T4 cells) will be obtained from the blood of the HIV-negative twins using a procedure called apheresis. All donor cells will be modified to include a gene that allows the cells to be monitored. Cells will also be modified to include two anti-HIV genes. The modified cells will then be given to the HIV+ twin through an intravenous infusion done as an outpatient. After the infusion the HIV+ twin will be monitored weekly for 12 weeks. The process may be repeated up to four times. Total time on treatment: 1 year. Required: male or female, age: 18 years or older, identical twins, one HIV+, one HIV-negative, healthy enough to take care of self and travel, CD4 count must be currently or in the past under 100. If CD4 count is < 500 copies participants must be willing to take antiretrovirals. Not allowed: pregnant women and nursing mothers. Donor Twin: unstable medical conditions, CMV or EBV positive if recipient is negative, active or suspected hepatitis B or C. Recipient Twin: history of lymphoma, acute or progressing disease process, Kaposi's sarcoma beyond the skin or mucous membranes, radiation/chemotherapy in the past 4 weeks or anticipated need in the next 4 months. Contact: Christine Bechtel, RN, National Inst. of Health, Bethesda MD, (800) 772-5464 x401. (added 8/15/99)

NR15520E. Drug: Fortovase, Viracept . This trial will study different combinations of drugs for the treatment of HIV infection. Study participants will be randomly divided into three groups. The first group will receive Fortovase (at a dose of 1200mg three times a day) along with two nucleoside analogs. The second group will receive Fortovase (at a dose of 1,600 mg twice a day) along with two nucleoside analogs. The third group will receive Fortovase (at a dose of 1200 mg twice a day), Viracept (nelfinavir) at a dose of 1,250 mg twice a day and one nucleoside analog. For people who have never taken anti-HIV drugs before, the nucleoside analogs will be d4T (or AZT) and 3TC. People that have taken anti-HIV drugs before will take nucleoside analogs that they have not yet tried, or have not taken for a long time. Total time on study is 48 weeks. To participate, you must be HIV+, male or female, 16 years or older, with a T4 cell count over 100 and viral load over 5,000. If you've had anti-HIV treatment, it must be for more than 3 months with antiretrovirals other than NNRTIs and/or PIs, or more than 2 weeks with PIs or NNRTIs. No previous antiretroviral treatment is defined as less than 2 weeks total time on drug. You cannot be pregnant or nursing, have a history of malabsorption syndrome or use of alcohol, narcotics, barbituates, benzodiazepines, phenothiazines, crack cocaine or other CNS active agents that could affect study adherence. You cannot have any active OIs requiring acute therapy, severe hepatic impairment, or hypersensitivity to saquinavir. Drugs not allowed: fifamycins, astemizole, cisapride, midazolam, terfenadine, triazolam or ergot derivatives. Contact: Patricia Driscoll, RN, Children's Medical Center of Brooklyn, Brooklyn, NY, (718) 270-3185; Kate O'Keefe, FNP, Cornell Medical Center, New York, NY, (212) 746-3318; Barbara A. Gallagher, RN, Philadelphia FIGHT, Philadelphia, PA, (215) 985-4448; Robert C. Sawyer, PhD. NJCRI, Newark, NJ, (973) 483-3444, ext15. (added 2/9/99)

NYH 1193-219. Drug: protease inhibitor (indinavir, Crixivan), IL-2, AZT, 3TC. This trial will study IL-2 for the treatment of HIV infection. IL-2 is given by an injection under the skin. Participants will be taught to give themselves shots and will take IL-2 daily. All participants must take indinavir, AZT and 3TC for the length of the study. Monthly clinic visits are required to monitor T4 cell count and viral load. Both the participant and the doctor will know which treatment is being given. To participate you must be HIV+ and 18 years or older with a T4 cell count between 200 and 500. You cannot be pregnant or nursing. The study coordinator will go over other conditions and drugs not allowed. Call one of the 3 doctors listed here. A package will be mailed to those interested describing the study. Those still interested will be scheduled for more detailed screening. Subjects will be considered based on initial phone contact order. Total time on study is 12 months. Contact: Mary Lind Veloso, MD, Cornell Medical Center, New York, NY, (212) 746-4464; Roger Emert, MD, Cornell Medical Center, New York, NY, (212) 746-4464; Elizabeth Jacobson, MD, Cornell Medical Center, New York, NY, (212) 746-4464. (updated 11/25/96)

PRO20005. Drug: amprenavir, Crixivan, nelfinavir, 3TC. This study is being done at the National Institutes of Health in Bethesda, MD. The NIH will pay for airfare for every visit except the first. This study will look at the newly approved protease inhibitor amprenavir (Agenerase) in people who have already taken other protease inhibitors. Participants must have taken either indinavir (Crixivan) or nelfinavir (Viracept) for at least twelve weeks, and have experienced an increase in their viral load to between 1,000 and 50,000. Participants will be switched from one of these combinations to the other. Participants who are taking Viracept will be switched to Crixivan. Participants who are taking Crixivan will be switched to Viracept. Everyone in the study will also take abacavir (Ziagen), lamivudine (Epivir) and amprenavir (Agenerase). Total time on drug: 12 weeks. Required: HIV+, male or female, age: > 13 years old, viral load: 1,000 to 50,000, PI experienced: on either Crixivan or Viracept for at least 12 weeks, experience of viralogic failure while receiving above therapy. Not allowed: history of clinically relevant hepatitis within last 6 months, Active AIDS defining opportunistic infection or disease that precludes participation (determination by investigator). Drugs not allowed: Prior use of abacavir, amprenavir or any NNRTIs, use of immunomodualeting agents, radiation therapy, or investigational agents in the 30 days before study. Contact: Mary Catherine George, Bentley-Salick Med. Practice, New York NY, (212) 414-4624; Susan Vogel, RN, BSN, National Inst. of Health, Bethesda MD, (800) 772-5464 x404. (added 8/2/99)

RCK TH1. Drug: thalidomide, HAART. The purpose of this study is to see if thalidomide can increase the body's production of IL-2 and IL-12, two immune system chemicals that are believed to be involved in restoring the immune system. One group will receive thalidomide, and the other group will receive a placebo. After the first week of the study, everyone will receive immunizations (similar to vaccines). Two weeks later all study medications will be stopped. Tests will then be done over an 8 week period to see how the immune system is responding to the vaccines. Everyone in the study will have a brief stay at the clinical research center. Compensation of $400 is offered to volunteers. Women of childbearing potential who are sexually active are not permitted to enroll in this study, even if employing a barrier and hormonal form of contraception. The reason, researchers state, is that potential interactions between the newer anti-HIV drugs and hormonal contraceptives are not yet known. Neither the participant nor the doctor will know which treatment is being given. Total time on study is 11 to 14 weeks. To participate you must be HIV+ and 19 or older with a T cell count between 300 and 500. You must be on stable, effective antiretroviral therapy (HAART) for at least past 3 mos. You cannot have had an adverse reaction to thalidomide treatment, hypersensitivty to vaccine treatment, allergy to seafood, peripheral neuropathy or Grade 2 or higher, or an active opportunistic infection. You cannot be taking immundolatory drugs (e.g., gluctoricoids, hematopoictins, interleukin-2, interferon or pentoxyfylline. Contact: Laura Fleischer,CSW, Rockefeller University, New York NY, (212) 327-8415. (added 4/12/99>

RIGHT 702. Drug: hydroxyurea, ddI, d4T. This study will give everyone a three drug combination of hydroxyurea, d4T and ddI. Participants will be randomized to receive one of nine different regimens. Hydroxyurea is given at 600, 900 or 1,200 mg either once a day, twice a day, or three times a day. Total time on drug: 52 weeks. Required: HIV+, male or female, age > 18 years old, viral load: 5,000 to 10,000, PI naïve, if prior antiretroviral therapy, there must be a 28 day washout period. Not allowed: prior opportunistic infections, red blood cell transfusions within 60 days, history of pancreatitis, history of peripheral neuropathy, virological failure with d4T, prior malignancies, treatment with any colony stimulating factors. Contact: Colleen Dascenzo, CRA, Thomas Jefferson University, Philadelphia PA, (215) 955-2639; Eileen Donaghy, RN, University of Pennsylvania, Philadelphia PA, (215) 349-8092; Trish Garton, Blick Medical Associates, Stamford CT, (203) 357-7800. (updated 8/14/99)

SILCAAT. Drug: IL-2. The drug commonly known as IL-2 is made by several different companies. There are many studies of Il-2 currently taking place. Different studies are testing different doses of the drug taken for different different periods of time. In this study, recombinant, human Interleukin-2 (rIL-2), made by Chiron Therapeutics, is being tested. Study participants are randomized to one of two arms. People in the IL-2 group will take 2 shots of IL-2 a day (4.5 million units) for five straight days, every 8 weeks, along with their current HAART therapy. The other group will take only their current HAART regimen. The point of the study is to see if people taking anti-HIV drug combinations along with IL-2 will live longer and develop fewer AIDS-related illnesses than people who take HAART by itself. Everyone in the study will have their CD4 counts and viral load measured every two months for the first year of the study. Total time on study: 4 to 6 years. Required: HIV+, male or female, age: >18 years old, viral load less than 10,000 when measured at least two times, less than two weeks apartwithin two months of entering the study CD4 count greater than or equal to 50 and less than 300 when measured two times within two months of entering the study, four months of HIV therapy with at least three drugs. Not allowed: an AIDS defining illness now or anytime in the past, except for KS that did not require systemic therapy. Contact: Janet Forcht, RN, NYU Medical Center, New York NY, (212) 263-8726; Lauren Birnhak, FNP, Beth Israel Medical Center, New York NY, (212) 420-4519. (added 8/15/99)

T1249-101. Drug: T1249. This is the first study to test T1249 in people. T1249 is a newer version of the drug T-20, which is a fusion inhibitor. It is hoped that T1249 will be active against HIV that has become resistant to the parent drug, T-20, and will have broader activity against different strains of HIV. Five different doses of the drug will be given to study participants. First, one group of people will given shots four times a day. If no unexpected side effects occur, the next group of participants will be given higher dose shots. Like many experimental anti- HIV drugs now being studied, the first studies of this drug in people will look at what effect the drug has on CD4 cell counts and viral load. Total time on drug: six to seven weeks. Required: HIV+, Male or female, Viral load over 5,000. Not allowed: An active opportunistic infection, use of anti-HIV treatments within the last two weeks. Contact: Karen Cavanagh, RN, NYU Medical Center, New York NY, (212) 263-8707. (added 8/2/99)

T20-206. Drug: T20, amprenavir, abacavir, Sustiva. Everyone in this study will receive the combination of efavirenz (Sustiva), amprenavir (Agenerase) and abacavir (Ziagen). It is hoped that the other drug used in this study, a fusion inhibitor called T-20, has a potent effect against strains of HIV that have already become resistant to the common first line therapies. Three of the four groups in this study will receive different dose shots of T-20 twice a day to see how well this combination of drugs works, and how well the drugs combine with each other. The fourth group will not receive T-20, although there is no placebo used in this trial. T-20 (pentafuside) is an experimental drug that belongs to a new class of anti-HIV drugs called fusion inhibitors. Although the company that makes T-20 is already testing an improved version of this drug, they have decided to continue testing it to improve treatment options for people who need salvage therapy. Total time on drug: 52 weeks. Required: HIV+, Male or Female, Age:>18, viral load: 400 to 100,000, Taking at least one protease inhibitor for at least 16 weeks prior to study, NNRTI naïve. Not allowed: Active opportunistic infections, Chronic diarrhea, Prior exposure to Abacavir (Ziagen), amprenavir or Sustiva, chemotherapy. Contact: Karen Cavanagh, RN, NYU Medical Center, New York NY, (212) 263-8707. (added 8/2/99)

UP 0016. Drug: tipranavir, Ritonavir, saquinavir. This study is for people who have clinically failed their first protease inhibitor combination, and are currently taking a second protease inhibitor combination that they have been on for at least six months. This study will determine safe and effective doses of Tipranavir, a new type of protease inhibitor, when taken with or without a small dose of ritonavir (Norvir) and two new NRTI type of drugs. Although participants can't have taken any investigational drugs within 30 days of starting the study, they can be taking Preveon or Agenerase. There are four arms to this study, one gets tipranavir alone, two get TPV and RTV, the other gets SQV/RTV, all will receive two NRTIs. Time on drug: 24 weeks, or longer. Required: HIV+, Male or Female, Age: >18 years old, T4 cell count: >50, viral load: >5,000, protease inhibitor experienced, participants can have taken NNRTI type drugs (Sustiva, Rescriptor or Viramune), but cannot have taken either saquinavir (Fortovase) or ritonavir (Norvir) in the past. Previous use of Agenerase as first time PI is okay. The NRTI drugs taken in this study can include abacavir (Ziagen) and adefovir (Preveon). Contact: Jim O'Connor, RN, St. Lukes/Roosevelt Hospital Center, New York NY, (212) 523-6743. (added 8/2/99)

UP 006. Drug: Tipranavir, ritonavir. Tipranavir, a newly developed, "non-peptide" type of protease inhibitor, is being studied in people who have used at least two protease inhibitors. One group will get Tipranavir at 1200 mg, twice a day, along with 100 mg of ritonavir (Norvir) twice a day. The other group will get 2400 mg of Tipranavir and 200 mg of ritonavir, twice a day. In addition, both groups will take one new NRTI and one new NNRTI type of drug. Previous studies suggest that adding ritonavir to this drug increases blood levels. This study will also help to determine safe and effective doses of Tipranavir taken with ritonavir. Total time on drug: 24 weeks, or longer. Required: HiV+, male or female, T4 cell count: >50, viral load: >5,000, on a stable PI regimen for at least 2 months prior to joining the study, experience taking 2 or more PIs for at least seven months total, participants must have the option of taking one NRTI and one NNRTI drug that is new to them. Not allowed: Pregnant women or nursing mothers, current alcohol or drug abuse that may result in noncompliance. Contact: Elizabeth Jones, CCRC, Aaron Diamond Aids Research Ctr., New York NY, (212) 448-5124; Jim O'Connor, RN, St. Lukes/Roosevelt Hospital Center, New York NY, (212) 523-6743; Dilcia Ortega, RN, Mount Sinai Medical Center, New York NY, (212) 241-6886. (added 8/2/99)

UP 72. Drug: Rescriptor, Crixivan, AZT. This trial will compare the combination of Crixivan (indinavir), Rescriptor (delavirdine) and Retrovir (zidovudine) taken twice a day, to a combination of the same drugs taken three times a day. All the drugs used in this study are approved, although not at these dosages. The point of this study is to see if the widely used protease inhibitor Crixivan can be taken only twice a day if taken with Rescriptor and Retrovir. Studies have shown that Rescriptor can increase the amount of time that Crixivan stays in the bloodstream. This may keep blood levels of the drug high enough so that it can be taken fewer times a day. Total time on drug: 24-48 weeks. Required: HIV+, male or female, age: 18 years or older, T4 cell count: over 50, viral load: >20,000, treatment naïve or less than one month AZT. Not allowed: pregnant women or nursing mothers. Drugs not allowed: more than one month treatment with AZT; prior treatment with NNRTIs, NRTIs, or protease inhibitors, other than less than one month of AZT. Contact: Jim O'Connor, RN, St. Lukes/Roosevelt Hospital Center, New York NY, (212) 523-6743. (added 8/2/99)