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A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Infants and Children Infected With or at Risk for HIV Infection

NCT00000984 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2005-06-24

No results posted yet for this study

Summary

AMENDED: As of 10/19/90 only Children 0 to 3 months are being enrolled. Original design: To determine whether the experimental drug recombinant CD4 (rCD4), which is produced through genetic engineering technology, is safe and well-tolerated in children infected with or at risk for HIV infection.

rCD4 may be an effective treatment for HIV infection, based on its ability to block infection of human cells by HIV in laboratory tests. However, the activity of rCD4 still needs to be confirmed in clinical trials. It is hoped that these tests will show that rCD4 is both safe and effective in treating children who are infected with or who are at risk for infection with HIV.

Conditions

  • HIV Infections

Interventions

DRUG

CD4 Antigens

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • P Weintrub

Study Design

Purpose
TREATMENT
Masking
NONE

Eligibility

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

Timeline & Regulatory

Countries

  • United States

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 NCT00000984 on ClinicalTrials.gov