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

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 Regardless of Concomitant HIV Therapies

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002359

Enrollment

3000

Registered

2001-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Vaccines, Synthetic, Viral Vaccines, HIV-1, AIDS-Related Complex, AIDS Vaccines, Salk HIV Immunogen

Brief summary

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.

Detailed description

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

Interventions

BIOLOGICALHIV-1 Immunogen

Study design

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026