The purpose of this study is to see if giving a vaccine (Remune) is effective in
HIV-positive patients who are also taking anti-HIV therapy.
Regular treatment of HIV-positive patients with anti-HIV drugs slows the multiplication of
the HIV virus in the body. A vaccine called Remune works to stop the virus infection by
"boosting" the body's immune cell defense against the HIV virus before the virus enters
cells. It also blocks the virus from entering the cells. This study will see whether Remune
will improve the immune cell natural defense in patients who are also taking anti-HIV drugs.
During primary HIV infection, after an initial burst in viral load, the body mounts an
immunologic response to viral antigens. It is thought that this initial immune response
plays an important role in determining early and long-term suppression of HIV. However,
limited information is available regarding the effect of early antiretroviral therapy on
immune responses. Therapeutic approaches such as Remune, which augment cell-mediated
immunologic responses, may prove to be beneficial in controlling the progression of HIV
infection, especially when used in combination with antiretroviral therapy in early
infection. Current antiviral drugs work by inhibiting the infection of new cells yet seem to
suppress early cell-mediated immune responses. The question is raised as to whether
immune-based therapies such as Remune may counteract the suppressive effects of
antiretrovirals and slow the progression of infection.
Patients receiving fully suppressive antiretroviral therapy are randomized to add either
Remune or an Incomplete Freund's Adjuvant (IFA) control. Vaccinations are administered on
Day 1, Week 12, and Week 24. Blood samples are collected at Day 1 and Weeks 4, 12, 16, 24,
and 28. Clinical assessment includes lymphocyte proliferative response, cytotoxic T
lymphocyte (CTL) memory cell activity, chemokine and cytokine measurements, CD4 count, and
viral load. Delayed-type hypersensitivity (DTH) skin tests are performed at Day 1 and Week
28. HIV-1 specific immunogenicity is coordinated with the response to antiretroviral
therapy in patients.
Patients may be eligible for this study if they:
- Are HIV-positive and started anti-HIV drugs soon after tests showed the presence of
- Have been on an anti-HIV drug combination that includes a protease inhibitor for at
least 3 months but no longer than 12 months.
- Have 2 consecutive viral loads of less than 50 copies/ml, at least 30 days apart,
within 90 days of study entry.
- Are at least 16 years old (consent of parent or guardian required if under 18 years).
- Agree to practice abstinence or use effective methods of birth control during the
Patients will not be eligible for this study if they:
- Are pregnant or breast-feeding.
- Currently abuse alcohol or drugs.
- Are currently being treated for some types of cancer.
- Have any illness or condition that might interfere with the study or put them at
- Have received a vaccination 6 weeks before study entry.
- Have previously received Remune.
- Are taking medications that affect the immune system within 30 days of study entry.