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

June 23, 2005 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

A Randomized Study of the Clinical Effects of Initiating or Changing Antiretroviral Therapy Based on Plasma HIV RNA Quantitation Compared With Initiating or Changing Therapy Based on Current Clinical Practice Alone

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.

Study Overview

Status

Terminated

Conditions

Detailed Description

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.

Patients are randomized to a decision making strategy for initiating or changing therapy based on current clinical practice alone vs. decision making based on plasma HIV RNA quantitation in addition to current clinical practice in patients with <= 300 CD4+ cells/mm3. All patients in the RNA arm as well as a subset (n = 183) of those in the CCP arm will have a plasma HIV RNA quantitation drawn every 4 months. The results of these quantitations will be blinded until the end of the study. CD4 counts will be obtained at least every 4 months if the previous count was > 20 cells/mm3. The remaining patients in the CCP arm will have CD4 counts obtained according to their clinicians' current clinical practices. Medications, clinical status, and changes in antiretroviral therapy will be recorded for all patients in the study. Patients are stratified by CD4+ cell count (<100 cells/mm3 [200 patients] vs. 100-300 cells/mm3 [900 patients]).

Study Type

Observational

Enrollment

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • Community Consortium of San Francisco
    • Colorado
      • Denver, Colorado, United States, 802044507
        • Denver CPCRA / Denver Public Hlth
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Veterans Administration Med Ctr / Regional AIDS Program
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium of Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60657
        • AIDS Research Alliance - Chicago
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Baltimore Trials
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hosp
      • Detroit, Michigan, United States, 48201
        • Comprehensive AIDS Alliance of Detroit
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Southern New Jersey AIDS Cln Trials / Dept of Med
      • Newark, New Jersey, United States, 071032842
        • North Jersey Community Research Initiative
    • New Mexico
      • Albuquerque, New Mexico, United States, 871315271
        • Partners Research
    • New York
      • New York, New York, United States, 10037
        • Harlem AIDS Treatment Group / Harlem Hosp Ctr
    • Oregon
      • Portland, Oregon, United States, 97210
        • The Research and Education Group
      • Portland, Oregon, United States, 972109951
        • Portland Veterans Adm Med Ctr / Rsch & Education Grp
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Philadelphia FIGHT
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Richmond AIDS Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients must have:

  • HIV infection.
  • CD4 count <= 300 cells/mm3.
  • NO stage 2 or worse AIDS dementia complex.
  • Life expectancy of at least 6 months.
  • Reasonably good health.
  • age >= 13yrs.
  • signed informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Disorders or conditions that may prevent adequate compliance with study requirements.

Patients with the following prior conditions are excluded:

  • Stage 2 >= AIDS dementia complex.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Perez G
  • Study Chair: Thompson M

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

January 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPCRA 036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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