Status:
COMPLETED
A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE1
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. SECOND...
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. ...
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
September 1 1996
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00000779
End Date
September 1 1996
Last Update
November 4 2021
Active Locations (10)
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1
UCLA CARE Center CRS
Los Angeles, California, United States
2
Stanford CRS
Palo Alto, California, United States, 94115
3
Santa Clara Valley Med. Ctr.
San Jose, California, United States, 951282699
4
San Mateo County AIDS Program
San Mateo, California, United States, 943055107