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

• Status: Completed
• Trial end date: 1993-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Genentech, Inc.; Glaxo Wellcome
• Treatments: Vaccines; Zidovudine

Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.