A Comparison of Two Anti-HIV Treatment Plans

September 28, 2013 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

A Randomized Study of a Prescribed 4-Month Structured Treatment Interruption (STI) Followed by Initiation of a New Antiretroviral Regimen Versus Immediate Initiation of a New Antiretroviral Regimen in HIV-Infected Patients With Multidrug Resistant (MDR) Virus

The purpose of this study is to compare 2 treatment plans to try to increase the effects of anti-HIV drugs in patients who are resistant to the drug effects.

Sometimes the increase in a patient's viral load (the level of HIV in the blood) can be slowed or stopped by taking anti-HIV drugs. This does not always happen. Sometimes anti-HIV drugs work at first but then stop working. When most of the usual anti-HIV drugs no longer seem to work, the virus is called multidrug-resistant (MDR). This study will compare 2 treatment plans to try to increase the effects of anti-HIV drugs in patients with MDR virus.

Study Overview

Status

Completed

Conditions

Detailed Description

An increasing number of patients are developing multidrug-resistant (MDR) virus, as determined by genotypic antiretroviral resistance testing (GART), due to treatment failure to suppress viral replication after several rounds of combination antiretroviral therapy. The best therapeutic strategy for these patients is uncertain. Two strategies currently being used are (1) STI followed by a new antiretroviral regimen and (2) immediate initiation of a new antiretroviral regimen.

Patients are screened for the presence of MDR virus and a plasma HIV RNA level greater than 10,000 [AS PER AMENDMENT 07/03/01: greater than 5,000] copies/ml. Eligible patients attend a baseline visit [AS PER AMENDMENT 07/03/01: and a subsequent randomization visit] where the qualifying GART results are provided. Patients who consent to participate have phenotypic antiretroviral resistance testing (PART) done on a specimen from the same blood draw that was used for the GART evaluation. After PART results are available, patients are randomized [AS PER AMENDMENT 07/03/01: If the predicted sensitivities are not available for some or all drugs included in the PART, the patient may still be randomized.] to either a 4-month STI followed by a new antiretroviral regimen or an immediate new antiretroviral regimen. The antiretroviral regimens chosen are based on the patients' history and both GART and PART results. [AS PER AMENDMENT 07/03/01: Additional GART and PART may be requested after at least 4 months of antiretroviral treatment.] Patients have the follow-up data collection done at Months 1-8 and every 4 months thereafter. Changes in antiretroviral therapy, Grade 4 adverse experiences, progression of disease, and deaths are reported as they occur. Patients are seen for clinical management as often as deemed necessary. All patients are followed to a common closing date estimated to be 24 months after the last patient is randomized. Some patients may participate in a Point Mutation Substudy [AS PER AMENDMENT 07/03/01: Plasma Point Mutation Substudy and PBMC Point Mutation Substudy].

Study Type

Observational

Enrollment

480

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 / UCSF
      • San francisco, California, United States, 94110
        • Lawrence Goldyn, MD
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver CPCRA / Denver Public Hlth
      • Denver, Colorado, United States, 80204
        • Univ Hosp Infectious Disease
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Washington Reg AIDS Prog / Dept of Infect Dis
    • 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
      • New Orleans, Louisiana, United States, 70112
        • Our Lady of the Lake Regional Med Ctr
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hosp
      • Detroit, Michigan, United States, 48201
        • Wayne State Univ - WSU/DMC / Univ Hlth Ctr
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Southern New Jersey AIDS Clinical Trials
      • Newark, New Jersey, United States, 07103
        • North Jersey Community Research Initiative
    • New York
      • Bronx, New York, United States, 10453
        • Bronx-Lebanon Hosp Ctr
      • New York, New York, United States, 10037
        • Harlem AIDS Treatment Grp / Harlem Hosp Ctr
    • Oregon
      • Portland, Oregon, United States, 97210
        • The Research and Education Group
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Philadelphia FIGHT
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Veterans Administration Med Ctr
      • Houston, Texas, United States, 77006
        • Montrose Clinic
      • Houston, Texas, United States, 77030
        • Univ TX Health Science Ctr
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Richmond AIDS Consortium / Div of Infect Diseases

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 (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients may be eligible if they:

  • Have proof of MDR virus from a blood test.
  • Have a viral load above 5,000 copies/ml from the same blood sample showing MDR virus.
  • Intend to start a new anti-HIV treatment around the time of the study.
  • Have been on a stable anti-HIV treatment between 14 days prior to the blood test mentioned above and when they are randomly assigned to a treatment.
  • Are at least 13 years old (consent of parent or guardian required if under 18).
  • (This protocol has been changed to reflect new criteria.)

Exclusion Criteria

Patients will not be eligible if they:

  • Have received a vaccine or had an illness that might affect viral load within 14 days before the blood test showing MDR virus.
  • Have received IL-2 within 4 months of the above-mentioned blood test or plan to take IL-2 during the study.
  • Have an opportunistic (AIDS-related) infection requiring treatment.
  • Are pregnant or breast-feeding.
  • Are currently participating in CPCRA 057 (PIP study).

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?

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: Jody Lawrence

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 Major Dates

Study Completion (ACTUAL)

June 1, 2004

Study Registration Dates

First Submitted

June 15, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (ESTIMATE)

August 31, 2001

Study Record Updates

Last Update Posted (ESTIMATE)

October 1, 2013

Last Update Submitted That Met QC Criteria

September 28, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPCRA 064
  • 11619 (DAIDS ES)

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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