Discontinuation of Antiretroviral Therapy in Patients With Asymptomatic HIV Infection

November 5, 2010 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Predictors of Immunologic and Clinical Progression in Subjects With CD4+ Cell Counts Greater Than 350 Cells/mm3 Who Discontinue Antiretroviral Therapy

The purpose of this study is to determine whether patients who have asymptomatic HIV infection can discontinue antiretroviral therapy (ART) without adverse clinical, virologic, or immunologic consequences. This study will also assess the virologic, immunologic, and clinical outcomes in any patients who restart ART.

Study Overview

Status

Completed

Conditions

Detailed Description

Patients who can discontinue ART without a significant loss of virologic or immunologic control and without an increase in clinical events may be spared the expense and adverse effects of treatment. However, the consequences of treatment discontinuation in patients with asymptomatic HIV infections are not well understood. This study will follow the clinical and immunologic progression of HIV infection in patients who have low HIV viral load and preserved CD4+ cell counts at the time ART is stopped.

Patients will fast for at least 8 hours prior to the first study visit. At this visit, blood will be drawn and body measurements will be taken. Patients will then discontinue their ART. Patients taking nonnucleoside reverse transcriptase inhibitors (NNRTIs) will stop taking NNRTIs 48 hours before withdrawing their other ART drugs. Study visits will occur every 4 to 8 weeks for the first year, then every 12 weeks for the second year. Blood will be taken at most visits, and patients will be asked to fast for at least 8 hours prior to Week 12 and 24 visits and again every 6 months. Patients who reinitiate ART for any reason will be registered to Step 2 and followed for 24 weeks.

Study Type

Observational

Enrollment

158

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
      • Los Angeles, California, United States, 90033-1079
        • Univ of Southern California
      • San Diego, California, United States, 92103
        • Univ of California, San Diego Antiviral Research Ctr
      • San Francisco, California, United States, 94110
        • Univ of California San Francisco
      • Stanford, California, United States, 94305
        • San Mateo County AIDS Program
      • Stanford, California, United States, 94305
        • Stanford Univ
      • Stanford, California, United States, 94305
        • Willow Clinic
      • Stanford, California, United States, 94305
        • Santa Clara Valley Med Ctr
      • Torrance, California, United States, 90502-2052
        • Harbor General/UCLA
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown Univ Med Ctr
    • Hawaii
      • Honolulu, Hawaii, United States, 96816
        • Univ of Hawaii
    • Illinois
      • Chicago, Illinois, United States, 60611-3015
        • Northwestern Univ
      • Chicago, Illinois, United States, 60612
        • Cook County Hosp Core Ctr
      • Chicago, Illinois, United States, 60612
        • Rush-Presbyterian / St.Lukes (Chicago)
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Wishard Hosp
      • Indianapolis, Indiana, United States, 46202
        • Methodist Hosp of Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Univ Hosp
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455-0392
        • Univ of Minnesota
    • Missouri
      • St. Louis, Missouri, United States, 63108-2138
        • St. Louis Connect Care
      • St. Louis, Missouri, United States, 63108-2138
        • Washington Univ (St. Louis)
    • New York
      • New York, New York, United States, 10003
        • Beth Israel Med Ctr
      • New York, New York, United States, 10021
        • The Cornell Clinical Trials Unit
      • New York, New York, United States, 10016-6481
        • NYU/Bellevue
      • New York, New York, United States, 1001
        • Chelsea Clinic
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Univ of North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Univ Med Ctr
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0405
        • Univ of Cincinnati
    • Pennsylvania
      • Norristown, Pennsylvania, United States, 19401
        • Presbyterian Med Ctr- Univ of PA
      • Philadelphia, Pennsylvania, United States, 19104
        • Univ of Pennsylvania, Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15213-2582
        • Univ of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hospital
      • Providence, Rhode Island, United States, 02906
        • Stanley Street Treatment and Resource
      • Providence, Rhode Island, United States, 02906
        • Rhode Island Hosp
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Comprehensive Care Clinic
    • Texas
      • Dallas, Texas, United States, 75235
        • Univ of Texas, Southwestern Medical Ctr

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:

  • HIV infection
  • ART with 2 or more drugs for 6 or more months
  • CD4+ cell count(s) > 350 cells/mm3 immediately prior to initiation of first ART
  • CD4+ cell count > 350 cells/mm3 within 45 days prior to study entry
  • Plasma viral load < 55,000 copies/ml within 45 days prior to study entry
  • Willingness to discontinue ART at study entry
  • Negative serum or urine pregnancy test within 14 days prior to study entry

Exclusion Criteria:

  • Pregnancy or breast-feeding
  • Systemic cancer chemotherapy, systemic investigational agents, or immunomodulators within 30 days prior to study entry
  • Drug or alcohol use or dependence that would interfere with adherence to study requirements
  • Illness requiring systemic treatment and/or hospitalization until the patient either completes therapy or has been clinically stable on therapy for at least 30 days prior to study entry
  • Chronic medical condition that would have a negative impact on the participation of the patient or would be expected to result in significant use of the medical care system
  • History of an HIV-related illness or complication in CDC categories B and C
  • Nonadherence to ART
  • Active infection with hepatitis B and currently taking adefovir at doses > 10 mg or 3TC and/or TDF

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: Daniel J. Skiest, M. D., University of Texas Southwestern Medical Center

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

December 3, 2002

First Submitted That Met QC Criteria

December 3, 2002

First Posted (Estimate)

December 4, 2002

Study Record Updates

Last Update Posted (Estimate)

November 9, 2010

Last Update Submitted That Met QC Criteria

November 5, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG A5170

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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