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

The Immune Response Corporation

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Biological: HIV-1 Immunogen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002359

092

806

Details and patient eligibility

About

To determine the effect of HIV-1 immunogen (Remune) on AIDS-free survival, defined as the time prior to development of an AIDS-defining condition or death.

Full description

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.