A Multicenter, Double-Blind, Phase III, Adjuvant-Controlled Study of the Effect of 10 Units of HIV-1 Immunogen (Remune) Compared to Incomplete Freund's Adjuvant (IFA) Alone Every 12 Weeks on AIDS-Free Survival in Subjects With HIV Infection and CD4 T-Lymphocytes Between 300 and 549 Cells/microL Rega

Launched by THE IMMUNE RESPONSE CORPORATION · Aug 30, 2001

Keywords

ClinConnect Summary

Patients receive 10 units of HIV-1 immunogen in IFA or IFA alone every 12 weeks, then are followed for 104-148 weeks.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Antiretrovirals if on a stable dose for at least the past 3 months.
• Patients must have:
• • HIV-1 infection with CD4 count 300-549 cells/mm3.
• • No AIDS-defining condition.
• • Been on a stable dose of antiretroviral for the past 3 months, if taking antiretrovirals.
• NOTE:
• • KS is permitted if not requiring systemic therapy.
• Prior Medication:
• Allowed:
• • Prior antiretrovirals.
• • Exclusion Criteria
• Concurrent Medication:
• Excluded:
• • Systemic chemotherapy for KS.
• • Treatment for malignancy other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
• Patients with the following prior conditions are excluded:
• • History of any illness that would interfere with study.
• • Acute infection requiring prescription therapy within the past month, other than genital herpes and oral or vaginal candidiasis.
• Prior Medication:
• Excluded:
• • Prior HIV-1 Immunogen. Unwilling to use effective safe sex practices. Active substance abuse.