Evaluation of HIV-1 Immunogen, an Immunologic Modifier, Administered to Patients Infected With HIV Having 300 to 549 × 106/L CD4 Cell Counts: A Randomized Controlled Trial
2000
ContextDespite enormous improvements achieved through the use of antiretroviral
therapies (ARTs), the risk for eventual human immunodeficiency virus (HIV)
disease progression remains high. Agents that enhance the immunologic mechanism
for viral recognition might reduce disease progression.ObjectiveTo determine whether the addition of HIV-1 Immunogen would confer added
clinical efficacy to that achievable by ARTs.Design and SettingMulticenter, double-blind, placebo-controlled, randomized trial beginning
March 1996 and ending May 1999 conducted at 77 centers in the United States
providing primary care or referral care for persons infected with HIV.PatientsAdults infected with HIV who have baseline CD4 cell counts between 300
× 106/L and 549 × 106/L without prior acquired
immunodeficiency syndrome–defining conditions receiving stable ART (or
no therapy) were screened and 2527 were randomized.InterventionsTen units of HIV-1 Immunogen, derived from a Zairian HIV isolate, inactivated
and formulated with incomplete Freund adjuvant, was administered intramuscularly
every 12 weeks. The placebo was incomplete Freund adjuvant. Changes in ARTs
were allowed.Main Outcome MeasuresHIV progression-free survival; secondary end points included overall
survival, changes in HIV RNA, CD4 cell counts, CD4 percentage, body weight,
and immunogenicity.ResultsThe overall event rate was 1.8 per 100 person-years of follow-up. Fifty-three
subjects developed clinical progression in each treatment group (relative
risk [RR], 0.97; 95% confidence interval [CI], 0.66-1.42; P = .89). There were 19 and 23 deaths in the placebo and HIV-1 Immunogen
groups, respectively (RR, 0.81; 95% CI, 0.44-1.48; P
= .49). There were no statistically significant differences between the groups
with respect to changes in HIV RNA (P = .59), CD4
percentage (P = .63), or body weight (P = .89). Subjects in the HIV-1 Immunogen group had an increase in
average CD4 cell count of approximately 10 × 106/L greater
than the placebo group (P = .02).ConclusionHIV-1 Immunogen with unrestricted ART failed to demonstrate an increase
in HIV progression-free survival.
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