A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 14, 2025
Completed
Keywords
ClinConnect Summary
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.
Patients are randomized to receive one of four vaccines or one of two placebo controls. The vaccines are: rgp 120/HIV-1IIIB, rgp 120/HIV-1MN, rgp 120/HIV-1SF, and env 2-3. The two control immunogens are aluminum hydroxide (alum) and BIOCINE Placebo Vaccine 2 (MF-59 adjuvant emulsion in citrate buffer). Patients are vaccinated at weeks 0, 4, 8, 12, 16, 20, 28, and 36. If significant benefit is s...
Gender
ALL
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.
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Palo Alto, California, United States
San Jose, California, United States
San Mateo, California, United States
Aurora, Colorado, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
New York, New York, United States
Seattle, Washington, United States
Patients applied
Trial Officials
Schooley RT
Study Chair
Walker B
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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