Introduction HIVNET Research Studies
HIVNET at the 12th World AIDS Conference HIVNET's specific goal is to evaluate the safety and efficacy of promising interventions to prevent sexual, perinatal, and parenteral transmission of HIV, using HIV seroincidence as the primary trial endpoint. The HIV epidemic continues to grow world-wide despite major advances in understanding the pathogenesis of HIV infection and in our ability to treat the disease. Control of the epidemic requires improved methods and strategies for preventing HIV infection. Development and testing of an HIV vaccine that is simple to administer, inexpensive and that induces long-lasting immunity to all known HIV strains would be the optimal preventive measure and is the highest priority of the HIVNET. Although promising HIV vaccine products are in various stages of development, an effective vaccine will not be available for several years. Therefore, other promising HIV prevention approaches need to be developed and evaluated for interrupting HIV transmission. Such approaches include topical microbicides, treatment of sexually transmitted diseases that are co-factors for HIV transmission, prophylaxis to prevent mother to child transmission, and behavioral risk reduction strategies. Even in the presence of an efficacious vaccine, control of the epidemic will probably require combinations of methods and strategies to protect individuals and the public against HIV infection. HIVNET's studies are often carried out in collaboration with other agencies that are involved in prevention research including the National Institute of Mental Health (NIMH), the National Institute on Drug Abuse (NIDA), the National Institute of Child Health and Human Development (NICHD), the National Institute on Alcohol and Alcohol Abuse (NIAAA), the Fogarty International Center (FIC), the Centers for Disease Control and Prevention (CDC), the Walter Reed Army Institute of Research (WRAIR), the U.S. Agency for International Development (USAID), the Population Council, the Contraceptive Research and Development Program (CONRAD), UNAIDS, and World Health Organization (WHO). HIVNET Research StudiesHIVNET research studies are carefully designed to take advantage of the diversity of populations from which HIVNET sites recruit participants. Studies are based on up-to-date knowledge of HIV prevention, and are designed to increase that knowledge. The Vaccine Preparedness Study (VPS) is evaluating strategies for conducting future HIV vaccines and other preventive measures in populations at greater risk for contracting HIV in the United States. Study questions include what motivates people to enroll in HIV prevention trials, and what prevents people who may be interested from enrolling. The VPS, which was completed in January 1998, had 4,892 participants from three groups at high risk for HIV: injection drug users, men who have anal intercourse (receptive or insertive) with other men, and women at high risk for HIV infection through heterosexual contact. In August 1997, an expansion of the VPS was launched with the recruitment of new groups of injection drug users at HIVNET sites in Philadelphia, PA and New York, NY. The expansion continued in February 1998 with the start of recruitment at five pre-existing and three new HIVNET sites, in Baltimore, MD, Los Angeles, CA, and the Bronx, NY, of participants from all three groups at high risk. These new sites will initially concentrate on vaccine preparedness. Additional studies have provided information on:
HIVNET Safety and Immune Response Trial of an HIV Vaccine In 1997, the HIVNET began a Phase II study to test the safety and immune response of two experimental HIV vaccines that had been studied previously among people at low risk for HIV infection. This study is designed to tell us how people at lower and higher risk for HIV infection react to these vaccines; that is, whether they are safe, and whether they produce an immune system response that may prevent infection. This study is being conducted in collaboration with the NIAID-sponsored AIDS Vaccine Evaluation Group (AVEG). The AVEG -- with six domestic sites, a statistical center, and two specialized central immunology laboratories -- has lead responsibility for design of this study and analysis of the results. Participants in the HIVNET study come from the populations for whom HIV vaccines are intended. Two hundred and fifty-five healthy, HIV-1 uninfected, adult men and women who are at increased risk of HIV infection are participating at HIVNET sites in Boston, Chicago, Denver, New York, Philadelphia, Pawtucket/Providence, San Francisco and Seattle. An additional 180 participants have joined the study at AVEG sites in Baltimore, Birmingham, Nashville, Rochester, Seattle and St. Louis. The participants recruited for the AVEG Phase I and II trials are mostly individuals at low risk of HIV infection. This study will not tell us whether the vaccines will actually prevent HIV infection or HIV-related disease - that will require a much larger and longer study. This study is designed to tell us whether the vaccines are safe, and whether the volunteers who receive the vaccines produce an immune system response that may prevent infection. We will also be able to see what strategies work best and should be used for future large trials, and we will be able to assess the impact of participation in a vaccine trial on the volunteer participants. In the study, participants receive injections of two different vaccines. One vaccine, called SF-2 rgp120, manufactured by Chiron Vaccines in San Francisco, contains a synthetic version of a substance found on the surface of the HIV particle. The other, called ALVAC-HIV vCP205, manufactured by Pasteur Merieux Connaught contains a canarypox virus that has been modified to contain some HIV genetic information. (Canarypox is a virus that causes disease only in canaries, and it cannot cause disease in humans. However, it will cause an immune response.) It is hoped that giving the two vaccines together will activate two parts of the immune system, antibodies and killer cells, that together will be effective in fighting off HIV. At the time of enrollment, each participant received two injections simultaneously in separate injection sites, one in each arm. Participants are assigned at random to one of three groups. The three groups are:
Three more injections are given 1 month, 3 months, and 6 months after the first injections. Follow-up continues with safety evaluations accompanied by risk reduction counseling at 9, 12, 18, and 24 months after the last injection, plus long-term check-ups at months 36 and 48. Measurements of the immune system's response to the vaccine will be done two weeks after the third and fourth injections. Screening and enrollment for the HIVNET began in July 1997, and vaccinations began in August 1997. Enrollment was completed in December 1997. Click here for Q & A on Phase II Prime-Boost HIV Vaccine Trial (AVEG 202/HIVNET 014). Safety Trial of Two HIV Vaccine Strategies in HIV-Negative Volunteers (HIVNET Protocol 014) Q & A on Phase II Prime-Boost HIV Vaccine Trial HIV-Exposed But Uninfected Study (HIVNET Protocol D01.3) Infected Participant Cohort (IPC) (HIVNET Protocols D01.1 and 019) HIV Vaccine Preparedness Study (VPS) (HIVNET Protocol D01) PMPA Gel Vaginal Microbicide Study (HIVNET Protocol 018) Phase 1 Rectal Microbicide Study (HIVNET Protocol 008) Vaginal Microbicide Study of Buffergel HIV Early Detection Study (HEDS) (HIVNET D01.2) Trial of a behavioral intervention for men who have sex with men (HIVNET Protocol 015, "EXPLORE") Application of Computer Technology to Assesment of Risk Behaviors Among Participants in the Vaccine Preparedness Study of HIVNET (HIVNET Protocol 005) For copies of our fact sheets detailing HIVNET research studies, contact the HIVNET site nearest you. Some Useful DefinitionsTopical Microbicides - A chemical that kills the germs ("microbes") that cause some sexually transmitted infections. Microbicides are things like gels or jellies, cream, suppositories, or film; they are put into the vagina some time before sexual intercourse. Microbicides are being studied that may kill HIV and bacterial sexually transmitted diseases such as gonorrhea and chlamydia. Some microbicides also kill sperm (are "spermicidal") and therefore can also be used as contraceptives. Risk Reduction - A form of counseling designed to assist individuals to learn how to utilize behavioral strategies that may help reduce their risk for being exposed to HIV. SF-2 rgp120 - rgp120 is a vaccine which contains a man-made protein that looks like a protein found on the outer surface or "envelope" of HIV. rgp120 was not made from live HIV. It does not contain all of the parts needed to make HIV. It cannot infect you with HIV or cause AIDS. ALVAC-HIV vCP205 - ALVAC-HIV vCP205 or vCP205 for short is made up of a weakened canarypox virus that has been altered to contain man-made copies of three genes from HIV. The canarypox virus vCP205 cannot grow or cause disease in humans. But the copies of the HIV genes inside the canarypox virus will make proteins that look like some of the proteins made by real HIV. Sexually Transmitted Diseases - Sexually transmitted diseases (STDs), also know as sexually transmitted infections (STIs), are either viral or bacterial infections transmitted or spread through sexual contact, including vaginal, anal, and oral. Some STDs can also be transmitted through touching and kissing. Prophylaxis - A treatment to prevent the onset of a particular disease. Related Websites12th World Conference
on AIDS 13th International
Conference on AIDS Durban 2000 HIVNET EXPLORE
Study Population Council
National Institute
of Allergy and Infectious Diseases (NIAID) Family Health
International Centers for
Disease Control and Prevention Sexuality Information
and Education Council of the United States (SIECUS) Division of
AIDS Vaccine Site Vaccine Information
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