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Safety and Effectiveness of CD4-IgG2 in HIV-Positive Children

NCT00000876 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-11-03

No results posted yet for this study

Summary

CD4-IgG2 is a special man-made protein that was built to block the entrance of HIV into CD4 cells (cells of the immune system that fight infection). The purpose of this study is to see if giving CD4-IgG2 to HIV-infected children is safe and effective.

HIV attaches to CD4 cells and enters them. Inside, HIV makes copies of itself that will help the virus invade the body. CD4 cells are killed or disabled during this process of HIV replication. Decreases in CD4 cells lead to a weakened immune system. When CD4 cell counts become very low, the body is unable to defend itself, and HIV infection develops into AIDS. The protein used in this study, CD4-IgG2, may be able to attach to HIV and inactivate it so that it cannot enter CD4 cells. This is an early study to examine CD4-IgG2 as a possible treatment for HIV in children.

Conditions

  • HIV Infections

Interventions

DRUG

CD4-IgG2

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • William Shearer

  • Stuart Starr

Study Design

Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
2006-11-30

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 NCT00000876 on ClinicalTrials.gov