Moss RB, Jensen FC, Ferre F, Trauger RJ, Daigle AE, Richieri SP, Carlo DJ; Conference on Advances in AIDS Vaccine Development; National Cooperative Vaccine Development Groups for AIDS. Meeting.

Conf Adv AIDS Vaccine Dev Natl Coop Vaccine Dev Groups AIDS Meet 8th 1996 Bethesda Md. 1996 Feb 11-15; 133 [Poster 13].

The Immune Response Corporation, Carlsbad, CA.

Multiple studies are planned to test the clinical utility of a gp120-depleted, inactivated HIV-1 virus in Incomplete Freund's Adjuvant (HIV-1 Immunogen) in the treatment of HIV-1 infection. The clinical development plan for the HIV-1 Immunogen will be discussed in detail. A double-blind, adjuvant-controlled study is planned for approximately 2500 HIV-1 seropositive adult subjects with CD4 T lymphocyte counts of 300-549 cells/microliter to examine the impact of the HIV-1 Immunogen on clinical progression to AIDS, regardless of concomitant antiviral drug therapy usage. Also throughout this trial, collection of PBMCs and plasma will allow examination of the relationship between viral load and clinical disease progression. Other planned clinical trials will test whether the HIV-1 Immunogen and a specific regimen of antiviral drugs can act synergistically to affect surrogate markers, including cell-mediated immunity (CMI), virus load, CD4 counts and percent, and drug resistance. In addition, the first pediatric trial of the HIV-1 Immunogen has been designed to examine safety, immunogenicity, and effect on virus load in infants and children. Finally, studies will be initiated in Thailand, where type E viral isolates may predominate. Large-scale efficacy testing of the HIV-1 Immunogen in various subject populations will determine its impact on surrogate markers and clinical disease progression, thereby defining the clinical utility of this approach.

Publication Types:

• Meeting Abstracts

Keywords:

• Adult
• Antiviral Agents
• CD4 Lymphocyte Count
• CD4-Positive T-Lymphocytes
• Child
• Disease Progression
• Double-Blind Method
• Freund's Adjuvant
• HIV Envelope Protein gp120
• HIV Infections
• HIV-1
• Humans
• Immunity, Cellular
• Infant
• Thailand
• Viral Load
• immunology
• incomplete Freund's adjuvant

Other ID:

• 97920707

UI: 102222846

From Meeting Abstracts