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A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers

NCT00000774 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2021-11-04

No results posted yet for this study

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 women. To evaluate changes in viral load in infants proven to be infected and absolute CD4 counts in all immunized infants.

SECONDARY: To evaluate the immunogenicity of these envelope recombinant proteins in infants of indeterminate HIV status born to HIV-infected women.

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-specific immune function to alter HIV replication and disease progression.

Conditions

  • HIV Infections
  • HIV Seronegativity

Interventions

BIOLOGICAL

rgp120/HIV-1MN

Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.

BIOLOGICAL

rgp120/HIV-1 SF-2

Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.

BIOLOGICAL

Placebo version of rgp120/HIV-1MN

Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.

BIOLOGICAL

Placebo version of rgp120/HIV-1SF2

Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Biocine

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Borkowsky W · NYU MEDICAL CENTER

  • Wara DW · UCSF Moffit Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
3 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Completion
1999-01-31

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000774 on ClinicalTrials.gov