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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000779

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

130

Expected to finish

1996-09-01

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…

• Concurrent Medication:
• Allowed:
• Short-term nonsteroidal anti-inflammatory therapy.
• Patients must have:
• HIV seropositivity.
• CD4 count >= 500 cells/mm3.
• Successful establishment of EBV-transformed B-cell lines at study entry.
• Consent of parent or guardian if < 18 years of age.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Suspected or known allergies to any vaccine components.
• Medical contraindication.
• Problem with compliance.
• Concurrent Medication:
• Excluded:
• Antiretroviral therapy (e.g., AZT, ddI, or ddC).
• Agents with putative immunomodulating activity (e.g., interferon, steroids, hematopoietin).
• Parenteral therapies (including SC allergy sensitization).
• Other investigational HIV drugs or therapies.
• Prior Medication:
• Excluded:
• Any prior vaccinations against HIV.
• Antiretroviral therapy (e.g., AZT, ddI, or ddC) within the past 6 months.
• Agents with putative immunomodulating activity (e.g., interferon, steroids, hematopoietin) within the past 3 months.
• Parenteral therapies (including SC allergy sensitization) within the past 3 months.
• Other investigational HIV drugs or therapies within the past 3 months.

Where it is running

• UCLA CARE Center CRS — Los Angeles, California, United States
• Stanford CRS — Palo Alto, California, United States
• Santa Clara Valley Med. Ctr. — San Jose, California, United States
• San Mateo County AIDS Program — San Mateo, 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 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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