A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3

Completed · Phase 1

Conditions studied: HIV Infections

In brief

To examine the response of HIV-1 infected patients to vaccination with gp120/HIV-1MN antigen. To determine the effect of antiretroviral therapy on vaccine responsiveness. Fifty percent of HIV-1 infected individuals remain symptom free for 8-12 years. It has been hypothesized that HIV-specific immune responses are responsible for the period of relative quiescence of viral replication. Recent studies suggest that these immune functions can be augmented by vaccination with HIV-derived antigens.

Key facts

Study ID

NCT00000755

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

168

Expected to finish

1993-03-01

Last updated by the study team

2021-11-04

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Required immediately prior to study entry:
• A minimum of 2 and a maximum of 12 months of AZT therapy at 500-600 mg/day (does not apply to the pilot group patients receiving vaccine only and to patients with CD4 counts of 50-199 cells/mm3).
• Concurrent Medication:
• Allowed:
• PCP prophylaxis.
• Rifabutin and clarithromycin (in patients with CD4 counts of 50-199 cells/mm3 only).
• Short-term nonsteroidal anti-inflammatory therapy for acute conditions.
• Short intermittent cycles of acyclovir.
• Patients must have:
• HIV infection, with CD4 count of 50-500 cells/mm3.
• No active opportunistic infection (patients with CD4 counts of 50-199 cells/mm3 may have a history of an opportunistic infection).
• Consent of parent, guardian, or person with power of attorney, if less than 18 years of age.
• B-cell lines established in order to be vaccinated.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Known or suspected allergies to any vaccine components.
• Concurrent Medication:
• Excluded:
• Agents with immunosuppressive activity.
• Antiretroviral therapies other than AZT (except in patients with CD4 counts of 50-199 cells/mm3).
• Interferon.
• Parenteral therapies (including SC allergy medications and chemotherapy for Kaposi's sarcoma).
• Steroids.
• Hematopoietins.
• Prior Medication:
• Excluded within 12 weeks prior to study entry:
• Agents with immunosuppressive activity.
• Antiretroviral therapies other than AZT (except in patients with CD4 counts of 50-349 cells/mm3).
• Interferon.
• Parenteral therapies (including SC allergy medications and chemotherapy for Kaposi's sarcoma).
• Steroids.
• Hematopoietins.
• Active drug abuse.

Where it is running

• UCLA CARE Center CRS — Los Angeles, California, United States
• Stanford CRS — Palo Alto, California, United States
• Ucsf Aids Crs — San Francisco, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Massachusetts General Hospital ACTG CRS — Boston, Massachusetts, United States
• Bmc Actg Crs — Boston, Massachusetts, United States
• Beth Israel Deaconess - East Campus A0102 CRS — Boston, Massachusetts, United States
• Beth Israel Deaconess Med. Ctr., ACTG CRS — Boston, Massachusetts, United States
• NY Univ. HIV/AIDS CRS — New York, New York, United States
• University of Washington AIDS CRS — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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