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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Page 1 of 10 (37 locations)

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