This phase-II, three-arm, randomized, double-blind, placebo-controlled study will measure HIV-1-specific immunogenicity in response to one of three treatment regimens: 1) REMUNE* in combination with indinavir/ ZDV/3TC, 2) IFA and indinavir/ZDV/3TC, or 3) REMUNE* and oral placebo. Recipients will be HIV-1-infected subjects with CD4 cell counts >400 cells/uL and plasma HIV RNA levels <12,000 copies/mL upon entry into the study. The primary endpoint will be lymphocyte proliferation responses to HIV-1 antigen stimulation in vitro. Cytokine and chemokine responses to antigen stimulation in vitro, gag CTL activity, and changes in CD4 T lymphocytes (cell count and percentage) will also be examined. Subjects will also be monitored for safety parameters and disease progression. The induction by REMUNE* of new immune responses to HIV in the absence and presence of active HIV replication will be compared, as will the development of these immune responses as a consequence of the suppression of HIV replication in the absence or presence of REMUNE*.

Project Start
1997-12-01
Project End
1998-11-30
Budget Start
1997-10-01
Budget End
1998-09-30
Support Year
37
Fiscal Year
1998
Total Cost
Indirect Cost
Name
New York University
Department
Type
DUNS #
City
New York
State
NY
Country
United States
Zip Code
10016
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