Discontinuation of Antiretroviral Therapy in Patients With Asymptomatic HIV Infection
NCT ID: NCT00050284
Last Updated: 2010-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
158 participants
OBSERVATIONAL
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
13 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Daniel J. Skiest, M. D.
Role: STUDY_CHAIR
University of Texas Southwestern Medical Center
Locations
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Univ of Southern California
Los Angeles, California, United States
Univ of California, San Diego Antiviral Research Ctr
San Diego, California, United States
Univ of California San Francisco
San Francisco, California, United States
San Mateo County AIDS Program
Stanford, California, United States
Santa Clara Valley Med Ctr
Stanford, California, United States
Stanford Univ
Stanford, California, United States
Willow Clinic
Stanford, California, United States
Harbor General/UCLA
Torrance, California, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States
Univ of Hawaii
Honolulu, Hawaii, United States
Northwestern Univ
Chicago, Illinois, United States
Cook County Hosp Core Ctr
Chicago, Illinois, United States
Rush-Presbyterian / St.Lukes (Chicago)
Chicago, Illinois, United States
Indiana Univ Hosp
Indianapolis, Indiana, United States
Methodist Hosp of Indiana
Indianapolis, Indiana, United States
Wishard Hosp
Indianapolis, Indiana, United States
Univ of Minnesota
Minneapolis, Minnesota, United States
St. Louis Connect Care
St Louis, Missouri, United States
Washington Univ (St. Louis)
St Louis, Missouri, United States
Beth Israel Med Ctr
New York, New York, United States
NYU/Bellevue
New York, New York, United States
Chelsea Clinic
New York, New York, United States
The Cornell Clinical Trials Unit
New York, New York, United States
Univ of North Carolina
Chapel Hill, North Carolina, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Univ of Cincinnati
Cincinnati, Ohio, United States
Presbyterian Med Ctr- Univ of PA
Norristown, Pennsylvania, United States
Univ of Pennsylvania, Philadelphia
Philadelphia, Pennsylvania, United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, United States
Rhode Island Hosp
Providence, Rhode Island, United States
Stanley Street Treatment and Resource
Providence, Rhode Island, United States
The Miriam Hospital
Providence, Rhode Island, United States
Comprehensive Care Clinic
Nashville, Tennessee, United States
Univ of Texas, Southwestern Medical Ctr
Dallas, Texas, United States
Countries
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References
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Le Moing V, Chene G, Leport C, Lewden C, Duran S, Garre M, Masquelier B, Dupon M, Raffi F; Antiproteases Cohorte (APROCO) Study Group. Impact of discontinuation of initial protease inhibitor therapy on further virological response in a cohort of human immunodeficiency virus-infected patients. Clin Infect Dis. 2002 Jan 15;34(2):239-47. doi: 10.1086/324354. Epub 2001 Dec 4.
Mocroft A, Youle M, Moore A, Sabin CA, Madge S, Lepri AC, Tyrer M, Chaloner C, Wilson D, Loveday C, Johnson MA, Phillips AN. Reasons for modification and discontinuation of antiretrovirals: results from a single treatment centre. AIDS. 2001 Jan 26;15(2):185-94. doi: 10.1097/00002030-200101260-00007.
Deeks SG, Wrin T, Liegler T, Hoh R, Hayden M, Barbour JD, Hellmann NS, Petropoulos CJ, McCune JM, Hellerstein MK, Grant RM. Virologic and immunologic consequences of discontinuing combination antiretroviral-drug therapy in HIV-infected patients with detectable viremia. N Engl J Med. 2001 Feb 15;344(7):472-80. doi: 10.1056/NEJM200102153440702.
Daar ES, Bai J, Hausner MA, Majchrowicz M, Tamaddon M, Giorgi JV. Acute HIV syndrome after discontinuation of antiretroviral therapy in a patient treated before seroconversion. Ann Intern Med. 1998 May 15;128(10):827-9. doi: 10.7326/0003-4819-128-10-199805150-00005. No abstract available.
Robertson KR, Su Z, Margolis DM, Krambrink A, Havlir DV, Evans S, Skiest DJ; A5170 Study Team. Neurocognitive effects of treatment interruption in stable HIV-positive patients in an observational cohort. Neurology. 2010 Apr 20;74(16):1260-6. doi: 10.1212/WNL.0b013e3181d9ed09. Epub 2010 Mar 17.
Other Identifiers
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ACTG A5170
Identifier Type: -
Identifier Source: org_study_id