Despite antibody and cytotoxic T lymphocyte responses, HIV infection does not stimulate an effective immune response. Further, although plasma viral burden may be substantially suppressed by antiretroviral therapy, it is unlikely that the immune system can be reconstituted solely by antiretroviral therapy. Current antiviral drugs work by inhibiting the infection of new cells after the virus is internalized into the cells. Immune-based therapies may inhibit infection by increasing immune responses to infected cells as well as inhibiting viral entry by increasing cells secreting the appropriate chemokines. Thus, the combination of antivirals and an HIV immunogen may act synergistically in controlling the progression of HIV infection. Specifically, the induction of novel immune responses by an HIV immunogen might be enhanced if viral replication is substantially inhibited with highly active antiretroviral therapy (HAART). The hypothesis of this study is, therefore, that the administration of HIV-1 Immunogen (REMUNE) will induce new immune responses against HIV antigen that were not stimulated by the infection, and that the development of these new immune responses will be greater in subjects in whom HIV replication has been suppressed by HAART. This study is designed to evaluate HIV-1 specific immunologic responses following treatment with REMUNE in combination with indinavir / zidovudine / lamivudine compared to indinavir / zidovudine / lamivudine alone. It is a phase II, two arm, randomized, double blind, placebo controlled trial. A total of 150 HIV-1-infected patients with CD4 counts >350 cells/pL will be enrolled through participation of 6 centers.
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