A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3

Phase 1

Completed

• Conditions: HIV Infections

• Registration Number: NCT00000779
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

PRIMARY: To compare the immunogenicity and safety of each of several HIV-1 derived immunogens versus control in HIV-infected individuals with CD4 counts greater than or equal to 500 cells/mm3.

SECONDARY: To determine whether significant advantages to any one vaccine exist.

Before large clinical trials of anti-HIV vaccines are undertaken, it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies.

Detailed Description

Before large clinical trials of anti-HIV vaccines are undertaken, it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies.

Patients are randomized to receive one of four vaccines or one of two placebo controls. The vaccines are: rgp 120/HIV-1IIIB, rgp 120/HIV-1MN, rgp 120/HIV-1SF, and env 2-3. The two control immunogens are aluminum hydroxide (alum) and BIOCINE Placebo Vaccine 2 (MF-59 adjuvant emulsion in citrate buffer). Patients are vaccinated at weeks 0, 4, 8, 12, 16, 20, 28, and 36. If significant benefit is seen among vaccine patients, then placebo patients may receive vaccination with one of the immunogens producing an immune response.

Study Timeline

• Study Completion: 1996-09
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (10)

UCLA CARE Center CRS; 🇺🇸 Los Angeles, California, United States

Santa Clara Valley Med. Ctr.; 🇺🇸 San Jose, California, United States

NY Univ. HIV/AIDS CRS; 🇺🇸 New York, New York, United States

Massachusetts General Hospital ACTG CRS; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Med. Ctr., ACTG CRS; 🇺🇸 Boston, Massachusetts, United States

Stanford CRS; 🇺🇸 Palo Alto, California, United States

Bmc Actg Crs; 🇺🇸 Boston, Massachusetts, United States

University of Colorado Hospital CRS; 🇺🇸 Aurora, Colorado, United States

University of Washington AIDS CRS; 🇺🇸 Seattle, Washington, United States

San Mateo County AIDS Program; 🇺🇸 San Mateo, California, United States