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The Effects of Anti-HIV Drugs in HIV-Infected Patients Who Do Not Have AIDS

NCT00001024 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-11-01

No results posted yet for this study

Summary

Immunopathogenesis objectives: To compare and quantitatively determine HIV burden and HIV replication in peripheral blood (PB) and lymphoid tissue (LT). To determine the degree to which antiretroviral therapy alters HIV replication in LT.

Clinical objectives: To gain insight into the degree of correlation between immunologic surrogate markers for HIV disease (e.g., CD4, beta-2 microglobulin) as compared to measures of HIV replication in PB and LT. To assess changes in PB and LT viral burden after antiretroviral therapy and to determine its ability to predict an antiviral response.

One of the major problems in defining the immunopathogenic changes in HIV infections has been the inability to correlate the extent of loss of immunologic function with the number of HIV-infected CD4+ cells in the peripheral blood. Few studies exist that measure viral burden in lymph nodes of HIV-infected individuals. Researchers hope to find out whether the amount of HIV virus or markers for the virus in the body's lymph tissue is a better measure of disease progression than the amount of virus or markers for the virus in the blood.

Conditions

  • HIV Infections

Interventions

DRUG

Zidovudine

DRUG

Didanosine

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Glaxo Wellcome

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • J Cohn

  • M Niu

Study Design

Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
2002-06-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00001024 on ClinicalTrials.gov