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A Study of Two Methods of Determining When to Begin or Change Anti-HIV Treatment

NCT00001069 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1100

Last updated 2005-06-24

No results posted yet for this study

Summary

PRIMARY: To compare the clinical efficacy of two decision making strategies for initiating or changing antiretroviral therapy: decision making based on current clinical practice alone (i.e., initiating or changing therapy based on CD4 count decline and/or clinical progression) versus decision making based on plasma HIV RNA quantitation in addition to current clinical practice.

SECONDARY: To evaluate toxicity, biological markers, and patient management in the two arms.

Although changing therapies is a common strategy in the treatment of HIV disease, guidelines are needed to help clinicians and patients decide when a change in antiretroviral therapy is indicated. The technology of measuring HIV RNA in plasma has been suggested as a tool for monitoring clinical drug efficacy. However, uncertainty remains about whether aggressive antiretroviral treatment to lower HIV RNA and maintain low levels for as long as possible will confer clinical benefit in comparison with management based on monitoring CD4 counts and HIV-related symptoms.

Conditions

  • HIV Infections

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Thompson M

  • Perez G

Eligibility

Min Age
13 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 NCT00001069 on ClinicalTrials.gov