Status:
COMPLETED
A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Genentech, Inc.
Biocine
Conditions:
HIV Infections
HIV Seronegativity
Eligibility:
All Genders
1-3 years
Phase:
PHASE1
Brief Summary
PRIMARY: To determine the safety of envelope recombinant proteins rgp120/HIV-1MN (Genentech) and rgp120/HIV-1SF2 (Chiron/Biocine) in infants who are of indeterminate HIV status born to HIV-infected wo...
Detailed Description
Only 30-50 percent of HIV-infected infants have detectable virus at birth. Successful early sensitization to HIV envelope epitopes may help prevent infection or, alternatively, may enhance HIV-specifi...
Eligibility Criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
- Antiretroviral therapy.
- Coenrollment in a therapeutic protocol if begun at least 30 days following the week 20 immunization.
- Routine immunizations if given more than 1 week before or after study vaccine.
Patients must be:
- > 37 weeks gestation and < 72 hours of age born to HIV-infected women.
- NOT born to women who received either passive or active immunotherapy during pregnancy.
- NOT breast-fed.
- NOT born to women who are hepatitis B surface antigen positive.
- Receiving AZT at study entry (except infants enrolled in ACTG 076).
NOTE:
- Parent or guardian must provide informed consent and be willing to comply with study requirements.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Documented or suspected serious bacterial infection, metabolic illness, or other immediate life-threatening conditions.
Concurrent Medication:
Excluded:
- Passive or active HIV-specific immunotherapy other than the study candidate vaccines.
- Investigational medications.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 1999
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00000774
End Date
January 1 1999
Last Update
November 4 2021
Active Locations (37)
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1
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90801
2
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States, 900951752
3
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, United States, 920930672
4
San Francisco Gen. Hosp.
San Francisco, California, United States, 94110