Discontinuation of Antiretroviral Therapy in Patients With Asymptomatic HIV Infection

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00050284
First received: December 3, 2002
Last updated: November 5, 2010
Last verified: November 2010
  Purpose

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.


Condition
HIV Infections

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Predictors of Immunologic and Clinical Progression in Subjects With CD4+ Cell Counts Greater Than 350 Cells/mm3 Who Discontinue Antiretroviral Therapy

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 158
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00050284

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00050284     History of Changes
Other Study ID Numbers: ACTG A5170
Study First Received: December 3, 2002
Last Updated: November 5, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced
Disease Progression
Anti-HIV Agents
Treatment Interruption

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 16, 2014