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Home > "D" Clinical Trials Conditions > Discontinuation of Antiretroviral Therapy in Patients With Asymptomatic HIV Infection  Discontinuation of Antiretroviral Therapy in Patients With Asymptomatic HIV Infection
Discontinuation of Antiretroviral Therapy in Patients With Asymptomatic HIV Infection
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type: Observational, Screening, Longitudinal, Defined Population, Prospective Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 158
Location and Contact Information:
Overall Study Official:
DanielSkiest, Study Chair, University of Texas Southwestern Medical Center
The Cornell Clinical Trials Unit
New York City, New York, 10021
United States
Wishard Hosp
Indianapolis, Indiana, 46202
United States
NYU/Bellevue
New York City, New York, 10016-6481
United States
Univ of Southern California
Los Angeles, California, 90033-1079
United States
Chelsea Clinic
New York City, New York, 1001
United States
Willow Clinic
Stanford, California, 94305
United States
Stanford Univ
Stanford, California, 94305
United States
Stanley Street Treatment and Resource
Providence, Rhode Island, 02906
United States
Cook County Hosp Core Ctr
Chicago, Illinois, 60612
United States
Univ of Cincinnati
Cincinnati, Ohio, 45267-0405
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213-2582
United States
Rush-Presbyterian / St.Lukes (Chicago)
Chicago, Illinois, 60612
United States
Methodist Hosp of Indiana
Indianapolis, Indiana, 46202
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Univ of California San Francisco
San Francisco, California, 94110
United States
Univ of California, San Diego Antiviral Research Ctr
San Diego, California, 92103
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
St. Louis Connect Care
St. Louis, Missouri, 63108-2138
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455-0392
United States
Harbor General/UCLA
Torrance, California, 90502-2052
United States
Univ of Texas, Southwestern Medical Ctr
Dallas, Texas, 75235
United States
Indiana Univ Hosp
Indianapolis, Indiana, 46202
United States
Comprehensive Care Clinic
Nashville, Tennessee, 37203
United States
Northwestern Univ
Chicago, Illinois, 60611-3015
United States
Presbyterian Med Ctr- Univ of PA
Norristown, Pennsylvania, 19401
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Santa Clara Valley Med Ctr
Stanford, California, 94305
United States
Washington Univ (St. Louis)
St. Louis, Missouri, 63108-2138
United States
San Mateo County AIDS Program
Stanford, California, 94305
United States
Univ of North Carolina
Chapel Hill, North Carolina, 27514
United States
Rhode Island Hosp
Providence, Rhode Island, 02906
United States
Univ of Pennsylvania, Philadelphia
Philadelphia, Pennsylvania, 19104
United States
The Miriam Hospital
Providence, Rhode Island, 02906
United States
Additional Information:
Study ID Numbers: ACTG A5170;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00050284
Other Hiv Infections Studies:
1. A Study on the Effect of Chemotherapy Combined with Anti-HIV Drugs in HIV-Positive Patients
2. A Phase I/II Study of Recombinant Interleukin-4 in AIDS and Kaposi's Sarcoma
3. A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group
4. A Multicenter, Exploratory Study to Evaluate the Effects of Antiretroviral Cessation on Plasma Associated HIV-1 RNA
5. A Study of Zidovudine Plus Acyclovir in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Ohio Clinical Trials
Other Cincinnati Clinical Trials
Discontinuation of Antiretroviral Therapy in Patients With Asymptomatic HIV Infection
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