Experimental Treatment Guide from the AIDS Treatment Data Network

vaccines

Contact numbers on these pages are for the New York area. Many of the trials are nationwide. For sites in your area, call the AIDS Clinical Trials Information Services (ACTIS) at 1-800-TRIALS-A.

For HIV-negative participants
Vaccines that are meant to prevent infection have to be tested in people who are HIV-negative.

VAX 004. AIDSVAX vaccine. This trial will study a vaccine for preventing HIV infection in HIV-negative people. The vaccine is called the AIDSVAX B/B vaccine. It is a copy of a protein on the coat of HIV called gp120. The vaccine is given by a shot under the skin. Participants will be divided into two groups. One group will receive AIDSVAX. The second group will receive a placebo vaccine. Both groups will receive shots at the start of the study, with additional shots at six month intervals for 30 months. The total number of shots given is seven. Total time on treatment is 3 years. Required: HIV-, Age: 18-60 yrs, Woman who had a documented sexually transmitted disease (Std) in the last 12 months, Men having sex with men (anal sex in the last 12 months). Not allowed: HIV-positive, Drug or Alcohol Abuse, IV drug use currently or in the past, Allergy to any of the vaccine components. Contact: Thomas Evans, University of Rochester Medical Center, Rochester NY, (716) 275-5871; Brenda Stamos, MA, Ed.M., Erie County Med Cntr/SUNY, Buffalo NY, (716) 898-4119; Dilcia Ortega, RN, Mount Sinai Medical Center, NY NY, (212) 241-6886; Joan Bono, ACRN, NJCRI, Newark NJ, (973) 483-3444, ext43; Melanie Smerkanich, RN, Philadelphia FIGHT, Philadelphia PA, (215) 985-4448. Contact: Tino Merced-Galindez, National Cancer Institute, Bethesda MD, (800) 772-5464 x562. (added 8/13/99)

CR 400-003-04. Vaccines for HIV negative people. This trial will test a new vaccine in HIV negative people. APL 400-003 is a DNA vaccine made from parts of the HIV genetic code. Apollon, Inc. which makes the vaccine states that the vaccine uses only a couple of pieces of the genetic code for the virus; it does not use live, dead or weakened HIV virus, and thus does not carry the risks of using live virus immunization. All participants receive the vaccine by intramuscular injection once a month for 3 months with a booster injection at 6 months. To participate you must be HIV-negative, healthy, and between 18 and 60 years old. You cannot have had a prior vaccination for HIV. Total time on study is 12 months. Contact: Kim Lacy, RN, University of Pennsylvania, Philadelphia, PA, (215) 662-2473; Grace Kelly, RN, National Institutes of Health, Bethesda, MD, (800) 772-5464 x 399.

NYU GCRC. Drug: VaxGen vaccine. This trial will study a vaccine developed by VaxGen, Inc. to prevent HIV infection. The vaccine cannot cause HIV infection. Participants will be divided into three groups. The first two groups will get the vaccine and the third group will get a placebo. Neither the participant nor the doctor will know which treatment is being given. All participants will be given a total of 7 treatments over 30 months and followed for an additional 6 months after the last treatment. To participate, you must be an HIV-negative man who has sex with men, or an HIV-negative woman at risk through heterosexual sex. You must be willing to practice safe sex during the study period. You cannot be an IV or injection drug user. Contact: Study Coordinator, New York University, New York, NY, (212) 263-0362. http://gcrc-www.med.nyu.edu/HIVvaccine/ (added 11/20/98)

For HIV+ participants
A newer kind of vaccine is a treatment vaccine, meant to boost or restore immune function in people who are HIV+.

94-C-159F. Vaccine: HUV. 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 two peptide vaccines for the treatment of HIV infection. Peptide vaccines contain fragments of genes that can prompt an immune response. Participants will be divided into three groups. Participants must have been on highly active antiretroviral therapy for at least 4 weeks. The study lasts 15 months during which time participants will be given a total of 6 vaccinations and monitored for two hours after each one. Check with study coordinator about T4 count history. Total time on treatment is one year. Required: HIV+, Male or Female, Age: 18 years or older, On HAART for at least 4 weeks. Not Allowed: Pregnant women or nursing mothers, Prior AIDS defining opportunistic infection; active life-threatening infection; actual or suspected allergies to any component of the vaccine; severe malabsorption; evidence of KS or other tumor likely to require anti-tumor treatment within 6 months. Drugs not allowed: Any growth factors, corticosteroids, interferons, other investigational agents including HIV drugs, therapies and/or vaccines Drugs with immunomodulating activity. Contact: Tino Merced-Galindez, National Cancer Institute, Bethesda MD, (800) 243-2732. (added 12/7/1999)

APL 400-047. Drug: DNA vaccine for HIV-positive people. This study will determine the safety and effectiveness of an experimental vaccine against HIV in people who are already HIV-positive. The vaccine being used is Genevax-HIV. This vaccine uses DNA genes which will show the cells in your body how to make protein molecules found on the surface of HIV. Researchers hope that the vaccine will help the immune system to fight HIV by stimulating cell-mediated immunity. Participants will make 19 visits over a year period. Total time on study is 12 months. To participate you must be HIV+, male or female, on stable anti-HIV treatment for the past three months, and have a T4 cell count over 400 and viral load of less than 1,000. Drugs not allowed: you cannot have been previously immunized with any HIV vaccine, or received an experimental drug within the last 30 days. Contact: Kim Lacy, RN, University of Pennsylvania, Philadelphia, PA, (215)662-6434 or 2473. (added 2/9/99)

trials page Network home page

Last modified: 12/7/1999 The Network copyright © 1999 The Network