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A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection

NCT00000762 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-11-03

No results posted yet for this study

Summary

To determine the safety and immunogenicity of gp160 (MicroGeneSys), rgp120/HIV-1MN (Genentech), and rgp120/HIV-1SF2 (BIOCINE) and their adjuvants in HIV-infected children 1 month to 18 years of age.

The initiation of this immunotherapy trial will provide multiple benefits by assessing in asymptomatic HIV-infected children a therapy currently being tested in their adult counterparts, in the hope of forestalling the progression of HIV immunosuppression and clinical disease.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

rgp120/HIV-1MN

BIOLOGICAL

rgp120/HIV-1 SF-2

BIOLOGICAL

gp160 Vaccine (MicroGeneSys)

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • MicroGeneSys Inc (nka Protein Sciences Corporation)

    collaborator UNKNOWN

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Lambert JS

  • Katz S

Study Design

Purpose
TREATMENT
Masking
DOUBLE

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
1996-02-29

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 NCT00000762 on ClinicalTrials.gov