Discontinuation of Antiretroviral Therapy in Patients With Asymptomatic HIV Infection - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00050284

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:	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:

MedlinePlus related topics: AIDS

U.S. FDA Resources

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

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Locations

United States, California
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
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
Harbor General/UCLA
Torrance, California, United States, 90502-2052
Willow Clinic
Stanford, California, United States, 94305
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
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
Univ of North Carolina
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Univ of Cincinnati
Cincinnati, Ohio, United States, 45267-0405
United States, Pennsylvania
Univ of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213-2582
Univ of Pennsylvania, Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Presbyterian Med Ctr- Univ of PA
Norristown, Pennsylvania, United States, 19401
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

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:

Daniel J. Skiest, M. D.

University of Texas Southwestern Medical Center

More Information

Additional Information:

Haga clic aquí para ver información sobre este ensayo clínico en español. This link exits the ClinicalTrials.gov site

Publications:

Le Moing V, Chene G, Leport C, Lewden C, Duran S, Garre M, Masquelier B, Dupon M, Raffi F. 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.

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.

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.

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. No abstract available.

Study ID Numbers:	ACTG A5170
Study First Received:	December 3, 2002
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00050284 History of Changes
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:

Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection

Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 25, 2009