ACTG 247. Drug: increased caloric density infant formula. This trial will study a high calorie infant formula and its effects on the growth and nutritional status of HIV+ infants. The study coordinators would like to enroll the mothers before the infants are born. Non-study formula is allowed for the first 14 days after birth. Participants will be divided into two groups. One group will take the high calorie formula. The second group will take regular formula. The study will look at weight, length, weight for length, head circumference, and body composition at 28 weeks; tolerability; immunologic status; occurrence of opportunistic infections; and quality of life. Treatment will be discontinued if the: infant is unable to receive nutrition by mouth for more than 7 days; infant fails to grow; investigator decides continuing in study would be harmful to the child; child needs a treatment not allowed while on study. Neither the doctor nor the mother will know which treatment the infant is on. Total time on study is 28 weeks. To participate you must be an HIV+ mother with an infant1 to 14 days old and over 1.8 kg. You cannot be nursing and the infant cannot have Nursing mothers evidence of congenital anomalies or conditions that may result in infant mortality within 28 weeks (e.g., enencephaly, renal agenesis, pulmonary hypoplasia, etc.) and/or be unable to sustain growth by commencing oral feedings by 14 days of age (gastroschisis, omphalocele, esophageal atresia, diaphragmatic hernia, etc.). Contact: Gilberto Hinds, RN, Cornell Medical Center, New York, NY, (212) 746-3326; Karen Novita, MPA, Metropolitan Hospital Center, New York, NY, (212) 423-7103; Delia Calo, Harlem AIDS Treatment Group, New York, NY, (212) 939-4045; Mohan Ramnarine, MD, Kings County Hospital, Brooklyn, NY, (718) 467-4446. (added 8/20/97)

ACTG 254. Drug: atovaquone, azithromycin, Bactrim. This trial will compare different drugs for the prevention of PCP in children and adolescents. Participants will be divided into two groups. The first group will take Bactrim. The second group will take atovaquone and azithromycin in combination. Neither the participant nor the doctor will know which treatment is being taken. Participants can change treatment if serious side effects occur. If a bacterial infection or PCP breakthrough occurs, participants will change to the alternative treatment. Clinic visists are every 4 weeks for the first 4 months, then every 8 weeks. Contact: sites in New York, Great Neck, Rochester, Stony Brook, Syracuse, Valhalla, Baltimore and Philadelphia. Call The Network at (800) 734-7104 or ACTIS at 1-800-TRIALS-A for referral.

ACTG 299. IL-2 (aldesleukin). This trial will study IL-2 for the treatment of HIV infection in children. To participate, children 3-5 years old must have a T4 cell count of between 500 and 1000. Children 6 to 12 years old must have T4 cells counts between 200 and 500. Participants will be treated with intravenous IL-2 once a day for 5 days every 8 weeks for 3 cycles. IL-2 has been studied in adults but not children. Children treated with IL-2 outside of a study were able to tolerate IL-2. This trial will study different dose levels to determine which is the best treatment for children. Both the doctor and participant will know which treatment is being given. To participate the child must be HIV+ and 3 to 12 years old. The child must be recieving the best antiretroviral therapy for at least 1 month prior to entry. The child cannot be pregnant or nursing. The child cannot have taken antiretroviral treatment for more than 12 months, steroids or other immunosuppressive therapy, polyclonal or monoclonal antibody therapy, IVIG, or other immunomodulators. Total time on study is 24 weeks. Contact: Babette Tang, MD, Columbia Presbyterian Medical Center, New York , NY, (212) 305-7222; Carol Vincent, RN, Children's Hospital, Philadelphia, PA, (215) 590-2262. (added 4/2/97)

ACTG 321. Drug: abacavir (1592U89), AZT. This trial will study abacavir and AZT for the treatment of HIV infection in newborns. Abacavir is an antiretroviral in the same class as AZT made by Glaxo Wellcome. All participants will be treated with AZT and abacavir. The dose of abacavir will depend on the age of the infant. Follow up is for 4 weeks. Both the participant and the doctor will know which treatment is being given. To participate the mother must be HIV+ with estimated gestational age more than 37 weeks. The infant must be 0-72 hours old for parts 1A and 2, and 21-28 days old for Part 1B. The infant cannot have serious infections requiring treatment during study period. Mothers cannot be taking antiretrovirals such as protease inhibitors and non-nucleoside reverse transcriptase inhibitors (nucleosides allowed). Infants cannot be taking antiretroviral agents other than those on study, other investigational agents, HIV-1 vaccines, immunomodulators, glucocorticoids, drugs which have adverse interaction with AZT or 1592U89 in vivo or 1592U89 in serum or plasma, biological response modifiers, human growth hormone, probenecid, or I.V. pentamidine. Total time on study is 6 weeks. Contact: Patrice Edwards-Cihak MPH , Bronx Lebanon Hospital, Bronx, NY, (718) 960-1010. (added 4/2/97)

ACTG 326. Drug: ALVAC HIV vaccine. This trial will study the ALVAC HIV vaccine in children born to HIV-positive mothers whose HIV status is not yet known. The ALVAC vaccine is designed to help the immune system fight HIV by creating antibodies to HIV. Participating infants will be randomly divided into three groups. Groups one and two will receive different formulations of the ALVAC vaccine. Group three will receive a placebo vaccine. Total time on drug: 104 weeks. Required: women: Confirmed HIV+ status, infants: Born to HIV-infected women >37 weeks gestational age. Not allowed: different exclusions for children and mothers, such as use of Investigational agents, immune modulators or IVIG. Contact: Kathy Contello, RN, MSN, SUNY - Health Science Center, Syracuse NY, (315) 464-6331; Nagamah S. Deygoo, BN, NYU (Peds) Medical Center, New York NY, (212) 263-6426; Carol Vincent, RN, Children's Hospital, Philadelphia PA, (215) 590-2262. (added 8/19/99)

ACTG 331. Drug: AZT. This trial will study AZT for the treatment of premature infants who have been exposed to HIV. To participate, the mother must be HIV+ and the baby must be 1-5 days old. The infant will be entered into the study in the first 5 days of life. AZT will be give every 12 hours either intravenously or orally. Both the mother and the doctor will know the treatment being given the infant. The infant must be less than or equal to 34 weeks gestational age at birth and require AZT therapy in the opinion of the primary care physician. The infant cannot have a life threatening or severe illness, not be expected to survive 6 weeks, have hypotension and/or poor perfusion requiring treatment with volume expansion and/or vasopressors. The infant cannot have urine output less than 0.5 ml/kg/hr within 24 hours of study enrollment. NOTE: If exclusion criterion is present, but resolves within the first 5 days of life, the infant is eligible to be enrolled. The infant cannot have exchange transfusion within 24 hours of entry or be treated with granulocyte transfusion within 24 hours of entry. Total time on study is 12 weeks. Contact: Delia Calo, Harlem AIDS Treatment Group, New York, NY, (212) 939-4045; Liz Ahern, RN/Lynda Shand, RN, NY Medical College WCMC, Valhalla, NY, (914) 285-7898. (added 4/2/97)

ACTG 345. Drug: ritonavir, AZT, 3TC. This trial will study ritonavir with and without AZT and 3TC for the treatment of HIV infection in infants and children under 2 years old. Ritonavir is a protease inhibitor also known as Norvir. Participants will be divided into two groups. The first group will be treated with a single dose of ritonavir. The second group will be treated with the combination of AZT, 3TC and ritonavir. The child may be a participant if it is assumed HIV+ due to exposure. Both the guardians of the child and the doctor will know which treatment is being given. To participate the child must be 1 month to 2 years old, and either HIV+ or presumed HIV+ due to exposure. T4 cell count requirements vary depending on age. The child must weigh more than 3.5 kg. The child cannot have a known toxicity or intolerance to 3TC and/or AZT at the proposed dosages, or any significant acute or chronic infections requiring treatment during the study period. Contact: Delia Calo, Harlem AIDS Treatment Group, New York, NY, (212) 939-4045. (added 7/29/97)

ACTG 356. Drug: abacavir, nevirapine, AZT, 3TC. This trial will compare different drug combinations for the treatment of HIV infection in infants and children. Participants will be divided into two groups. The first group will take AZT, 3TC and nevirapine. The second group will take AZT, 3TC, nevirapine and abacavir. Abacavir, also known as 1592, is an antiretroviral in the same class as AZT made by Glaxo Wellcome. Neither the parent nor the doctor will know which combination the infant is taking. Study drugs will be provided in both pill and liquid form. To participate, the child must be HIV+ and 15 days to 2 years old. If the infant is under 3 months of age , the mother must have been pregnant for at least 34 weeks. T4 cell count depends on age. The child cannot have had more than 6 weeks of prior antiretroviral therapy, or any history of infant nevirapine use, or any history of maternal nevirapine use for more than 2 weeks. The study coordinator will go over other drugs not allowed while on study with you. Contact: Nagamah S. Deygoo, New York University Medical Center, New York, NY, (212) 263-6426; Delia Calo, Harlem AIDS Treatment Group, New York, NY, (212) 939-4045. (added 7/16/97)

ACTG 366. Drug: HAART. This trial will study combinations of anti-HIV drugs for treating children with rapidly progressing or advanced HIV Disease. The study drugs include Viracept, Norvir, Viramune, 3TC, d4T, ddC, ddI, and AZT. Study participants will take one or two nucleoside analogues. Participants will also be assigned to receive one of the following three combinations, depending on what they have taken in the past: Viramune plus Viracept, Viramune plus Norvir; Viramune plus Viracept plus Norvir, or Viracept plus Norvir. All study drugs are taken orally 2 or 3 times daily. Participants and doctors will know which medications they are taking. Study visits are once a month for the first 6 months, then every two months for the remainder. Total time on drug: 12 months or more. Required: HIV+, male or Female, age: Between 6 months and 21 years old, evidence of HIV disease progression or advanced disease while on at least 8 weeks of unchanged continuous antiretroviral therapy, must be able to take 2 never before taken drugs, one of which must be ritonavir, nevirapine, or nelfinavir, T4 cell count: <1500 for under 12 mos, viral load: >50,000. Not allowed: sSerious bacterial, viral, or opportunistic infection within 14 days of study entry, cancers requiring chemotherapy, pregnant females, prior pancreatitis or severe peripheral neuropathy, prior use of ritonavir and nelfinavir in combination. Contact: Delia Calo, Harlem Hospital Center, New York NY, (212) 939-4040; Robin Scudder, RN, NPC, New Brunswick UMDNJ, New Brunswick NJ, (908) 253-7066; Denise Swindell, Children's Medical Center of Brooklyn, Brooklyn NY, (718) 270-3185, Marie Donahue, CPNP, Columbia PMC/Pediatrics, New York NY, (212) 305-7222, Karen Novita, MPA, Metropolitan Hospital Center, New York NY, (212) 423-7103; Susan Laverty, University of Rochester, Rochester N, (716) 273-3828; Connie Colter, PNP, Schneider Children's Hospital, New Hyde Park NY, (718) 470-3318; Joanne Kazista, RN, St. Joseph's Hospital, O'Neill Center, Paterson NJ, (973) 754-2000 x2878; Kathy Contello, RN, MSN, SUNY - Health Science Center, Syracuse NY, (315) 464-6331; Gail Karas, RN, UConn GCR Center, Farmington CT, (860) 679-1636; Deborah Storm, PhD, RN, UMDNJ, Newark NJ, (973) 972-3118; Mary Jo Hoyt, RN, University Hospital, Newark NJ, (973)972-3118; Mary Ellen Adams, RN, Albany Medical Center Pediatrics, Albany NY, (518) 262-6888; Jean Sale, RN, MPH, NY Hospital, Cornell Medical Center, New York NY, (212) 746-3355. (added 8/19/99)

ACTG 381. Drug: HAART. Patients receive a HAART regimen of at least three drugs, including at least one protease inhibitor. The drug combinations are decided upon by the patient and their primary health care provider. Patients are followed for three years or until they demonstrate treatment failure. Total time on drug: 156 weeks. Required: HIV+, male or female, age: 8 to 22 years old, treatment naïve or AZT only. Not allowed: patients currently receiving HAART or combination therapy. Contact: Dina Monte, RN, Montefiore Medical Center, Bronx NY, (718) 882-0023; Carol Vincent, RN, Children's Hospital, Philadelphia PA, (215) 590-2262; Kathy Contello, RN, MSN, SUNY - Health Science Center, Syracuse NY, (315) 464-6331; Denise Swindell, Children's Medical Center of Brooklyn, Brooklyn NY, (718) 270-3185. (added 8/19/99)

ACTG 391. Drug: VZV vaccine. This is a vaccine study for children 2 to 18 years old with previous varicella (chicken pox) and no prior history of zoster(herpes). This will look at the usefulness of a live attenuated varicella-zoster vaccine to boost immunity to varicella-zoster in HIV+ children previously infected with chicken pox. There will be a pilot study with 10 participants for 12 weeks before the full study begins. Total time on drug: 2 years. Required: HIV+, age: 2 years to 18 years, prior history of varicella, participants must be receiving stable antiretroviral therapy for at least three months with no projected change in therapy, no previous history of zoster. Contact: Kathy Contello, RN, MSN, SUNY - Health Science Center, Syracuse NY, (315) 464-6331; Nagamah S. Deygoo, BN, NYU (Peds) Medical Center, New York NY, (212) 263-6426; Delia Calo, Harlem Hospital Center, New York NY, (212) 939-4040; Connie Colter, PNP, Schneider Children's Hospital, New Hyde Park NY, (718) 470-3318. (added 8/19/99)

ACTG 397. Drug: Fortovase, Viracept. This trial will study combinations of anti-HIV drugs for the treatment of HIV infection in children. Children between the ages of 3 and 16 will be given one of two combinations of anti-HIV drugs. The study will also look at how well, if at all, the drug combinations increase T4 cell numbers, and immune system function. One group will receive the protease inhibitor Fortovase (the soft gel capsule of the drug saquinavir) plus two nucleoside analog type drugs(AZT, ddI, ddC, d4T, 3TC) of their choice. The other arm of the study will take the Fortovase with one or two of the nucleoside type drugs, along with the protease inhibitor Viracept(nelfinavir). Prior use of a protease inhibitor is allowed. All the drugs in this study are taken by mouth. Total time on drug: 48 weeks. Required: HIV+, male or female, age: 3 to 16 years of age prior to study entry, naive to at least one designated nucleoside analog, viral load: >10,000. Not allowed: pregnant women or nursing mothers, current acute opportunistic infection, > 2 episodes of diarrhea/vomiting, prior treatment with saquinavir/nelfinavir. Drugs not allowed: investigational drugs, immunomodulators, chemotherapy. Contact: Marie Donahue, CPNP, Columbia PMC/Pediatrics, New York NY, (212) 305-7222; Lourdes Rodriguez, CPNP, North Shore /NYU School of Medicine, Manhasset NY, (516) 662-5085; Carol Vincent, RN, Children's Hospital, Philadelphia PA, (215) 590-2262; Jean Sale, RN, MPH, NY Hospital, Cornell Medical Center, New York NY, (212) 746-3355; Joanne Kazista, RN, St. Joseph's Hospital, O'Neill Center, Paterson NJ, (973) 754-2000 x2878; Mary O'Mahony, Bronx Lebanon Hospital Center, Bronx NY, (718) 960-1010; Deborah Storm, PhD, RN, UMDNJ, Newark NJ, (973) 972-3118; Nagamah S. Deygoo, BN, NYU (Peds) Medical Center, New York NY, (212) 263-6426; Mary Ellen Adams, RN, Albany Medical Center Pediatrics, Albany NY, (518) 262-6888; Debra Hickey, CPNP, SUNY at Stony Brook, Stony Brook NY, (516) 444-7809; Mary Jo Hoyt, RN, University Hospital, Newark NJ, (973)972-3118. (added 8/19/99)

ACTG 403. Drug: ddI, d4T, Viracept, Viramune, Ritonavir. This is a trial for children who are HIV positive who have already been taking some kind of anti-retrovirals and still have a viral load above 4,000. It seems that it is harder to get a child's viral load down to undetectable. Researchers want to find out if there are other combinations that can help children get their viral load down. In this study children will be put into different groups according to their age and what drugs they have already taken. Blood samples will be taken at weeks 2,4 and then every 4 weeks after that to measure the viral load. Children must currently be on same continuous antiretroviral therapy for the 16 weeks before the study starts. Total time on drug: 48 weeks. Required: HIV+, male or female, age: > 4 months < 21 years, CD4 count: > 750 for patients under 12 months of age, > 500 for 1 to 5 years of age, > 200 for 6 years of age or older within the last four months, or a CD4 percent of 15 percent or greater within the last four months, viral load: >4,000, received the same continuous antiretroviral therapy for the past 16 weeks. Not allowed: gGrade 3 or 4 clinical or laboratory toxicity, active OI's and/or serious bacterial infection, diagnosis of malignancy. Drugs not allowed: therapy with any other anti HIV -1 agents , biologic response modifier, or human growth hormone, continuous use of systematic corticosteroids for 14 days or longer unless discussed with the lead investigator, probenecid or daily I.V. pentamidine, terfenadine, astemizole, cisapride, rifampin, triazolim, midazolim, ergot derivatives, amiodarone, and quinidine. Contact: Connie Colter, PNP, Schneider Children's Hospital, New Hyde Park NY, (718) 470-3318; Marie Donahue, CPNP, Columbia PMC/Pediatrics, New York NY, (212) 305-7222; Karen Novita, MPA, Metropolitan Hospital Center, New York NY, (212) 423-7103; Joanne Kazista, RN, St. Joseph's Hospital, O'Neill Center, Paterson NJ, (973) 754-2000 x2878; Kathy Contello, RN, MSN, SUNY - Health Science Center, Syracuse NY, (315) 464-6331; Deborah Storm, PhD, RN, UMDNJ, Newark NJ, (973) 972-3118; Nagamah S. Deygoo, BN, NYU (Peds) Medical Center, New York NY, (212) 263-6426; Delia Calo, Harlem Hospital Center, New York NY, (212) 939-4040; Michelle Davi, RN,PNP, SUNY at Stony Brook, Stony Brook NY, (516) 444-7809; Mary Jo Hoyt, RN, University Hospital, Newark NJ, (973)972-3118. (added 8/19/99)

NCI 93-C-0207. Drug: cyclophosphamide, methotrexate, ara-c, G-CSF. This study is being done at the National Cancer Institute in Bethesda, MD. The NCI will pay for airfare for every visit except the first. This trial is for the treatment of non-Hodgkin's lymphoma and is open to both HIV infected children and those children with a congenital immunodeficiency. For HIV-infected children, antiretroviral therapy (AZT and ddI) will be added to their treatment. Participants with brain lymphomas will also be given radiation therapy. If there is a relapse or persistent disease at the end of the study, ifosfamide and cytarabine will be added. Required: HIV+, male or female, age: 3 months to 18 years, acquired or congenital immunodeficiency Proven B-cell non-Hodgkin's lymphoma or have failed a trial of alpha-interferon/IVIG, sufficiently stable to go on chemotherapy. Not allowed: active OI requiring treatment(may be eligible after treatment of the OI), pregnant women or nursing mothers. Drugs not allowed: any other conditions or drugs which are not allowed will be explained by the coordinator. Contact: Susan Sandelli, RN, National Cancer Institute, Bethesda MD, (301) 402-1391. (added 8/19/99)

NCI 95-C-0144. Drug: all-trans-retinoic acid, alpha interferon. This study is being done at the National Cancer Institute in Bethesda, MD. The NCI will pay for airfare for every visit except the first. This trial is primarily for HIV infected children, but children with lymphoproliferative disorders caused by other immune deficiencies may also be eligible. The trial is in two parts. The first part is an observation period. The second part is treatment with all-trans-retinoic acid and alpha interferon. All-trans-retinoic acid is a retinoid. Retinoids are based on Vitamin A. All children with HIV infection must also take approved antiretroviral therapy. Children will be seen at the beginning of the study, then 12 weeks before starting treatment. Tissue biopsy is required at entry and after 12 weeks of treatment and may require hospitalization. Total time on drug: six months. Required: HIV+ or HIV-, male or female, age: under 18 years old, acquired or congenital immunodeficiency and a lymphoproliferative disorder, able to swallow capsules, children with HIV infection must be receiving approved antiretroviral therapy. Not allowed: pregnant or nursing women, active OI requiring treatment, rapidly progressing malignant lymphoma, critically ill or clinically unstable. Drugs not allowed: within 30 days prior to entry no use of: immunomodulating agents(interleukin 2, interferons, IGF-1), cytolytic chemotherapeutic agents, radiation therapy. Study coordinator will go over with you other drugs not allowed while on study. Contact: Susan Sandelli, RN, National Cancer Institute, Bethesda MD, (301) 402-1391. (added 8/19/99)

NCI 95-C-0172. Drug: Remune (HIV-immunogen, Salk vaccine). This trial will study a therapeutic vaccine called Remune for the treatment of HIV infection in children. Remune is a vaccine made from the HIV virus. The HIV virus is killed (also called inactivated) and used as a vaccine to create a specific immune response to the HIV virus. All children who have not been immunized for hepatitis B, or who have no history of hepatitis B, will also get the Hepatitis B vaccine. Total time on drug: 24 weeks. Required: HIV+, male or female, age: 3 months to 18 years old, asymptomatic or mild symptoms, normal to moderate immune suppression, call the study coordinator for age-specific T4 cell count requirements. Not allowed: pregnant women or nursing mothers, critically ill or clinically unstable, active infection requiring acute intervention (therapy for chronic infections may be permitted). Certain other clinical conditions which the study coordinator will go over with you. Drugs not allowed: chemotherapeutic or immunomodulating agents. Contact: Susan Sandelli, RN, National Cancer Institute, Bethesda MD, (301) 402-1391. (added 8/19/99)

NCI 95-C-0183. Drug: IL-2, AZT, ddI. This study is being done at the National Cancer Institute in Bethesda, MD. The NCI will pay for airfare for every visit except the first. This trial will study IL-2 (interleukin-2) in combination with AZT and ddI. For the first eight weeks of the study, all participants will take AZT with ddI. After eight weeks, all participants take IL-2. IL-2 is an immune system chemical that controls the growth and function of many types of cells. Side effects can be fever, chills, and an overall sick feeling. IL-2 is given by an injection under the skin. All participants will be required to stay in the hospital for the first IL-2 cycle. A cycle of IL-2 lasts for five days and will take place once every other month. Both AZT and ddI are pills. IL-2 will be given through an IV. All participants will take the three drugs in this trial. Required: HIV+, male or female, age: 2 to 21 years, progressive weight loss, 2-5 years old : > 500 and < 1000 T4 cells, 6-21 years old: > 200 and < 500 T4 cells. Not allowed: pregnant women or nursing mothers, critically ill or unstable; disease progression on current antiretroviral therapy; allergic reactions to AZT or ddI; neurologic disease; retinal depigmentation; concurrent malignancy or significant autoimmune disease, active acute or chronic pancreatitis, active OI requiring treatment at time of entry. Drugs not allowed: previous therapy with IL-2, chemotherapy, corticosteroids, G-CSF/GM-CSF, or interferons within 4 weeks prior to study, other investigational or immunomodulating drugs within 4 weeks prior to study entry, concurrent participation in HIV vaccine trial. Contact: Susan Sandelli, RN, National Cancer Institute, Bethesda MD, (301) 402-1391. (added 8/19/99)

NCI 97-C-0119. Drug: lodenosine. This study is being done at the National Cancer Institute in Bethesda, MD. The NCI will pay for airfare for every visit except the first. This trial will study a nucleoside analog called lodenosine (F-ddA). Lodenosine is similar to the approved anti-HIV drug ddI (Videx), but does not have to be administered with buffers. The buffers in ddI pills can make the drug difficult to take. In the test tube, lodenosine is active against HIV that is resistant to ddI. On the 1st day, participants are given a single intravenous dose of lodenosine. On the 2nd day, participants take a single oral dose. Then, for the remainder of the 3 months, participants take oral doses twice daily, either 1 hour before or 1 1/2 hours after meals. After the first 3 months participants will be followed for an additional 6 months on standard antiretroviral therapy. Time on drug: 9 months. Required: HIV+, male or female, age: 6 months to 18 years old, previously untreated or minimally treated (less than 6 weeks of therapy) OR previously treated at least 12 weeks with intolerance/toxicity to treatment/progressive clinical/immunological deterioration. Not allowed: active opportunistic infections requiring acute intervention, pregnant women or nursing mothers, treated for an acute infection less than 7 days prior to entry, history of pancreatitis, retinal depigmentation, cardiomyopathy or cardiac arrhythmia, radiation therapy within past year. Drugs not allowed: chemotherapeutic agents; foscarnet and ganciclovir; immunomodulating agents within 30 days of entry: GCSF, corticosteroid administration, IVIG, radiation therapy. Contact: Susan Sandelli, RN, National Cancer Institute, Bethesda MD, (301) 402-1391. (added 8/19/99)

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