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Search / Trial NCT00000755

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of January 15, 2025

Completed

Keywords

Vaccines, Synthetic Hiv 1 Acquired Immunodeficiency Syndrome Aids Related Complex Zidovudine Hiv Envelope Protein Gp120 Aids Vaccines Hiv Therapeutic Vaccine

ClinConnect Summary

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.

Patients are randomized to receive rgp120/HIV-1MN vaccine or alum adjuvant placebo by intramuscular injection at weeks 0, 4, 8, 12, 16, and 20, with or without daily oral zidovudine (AZT) or their current stable dose of antiretroviral therapy. After completing the prima...

Gender

ALL

Eligibility 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.

Trial Officials

Schooley RT

Study Chair

Walker B

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Los Angeles, California, United States

Palo Alto, California, United States

San Francisco, California, United States

Aurora, Colorado, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

New York, New York, United States

Seattle, Washington, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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