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

Further Study Details: 

Expected Total Enrollment:  158

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.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

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

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

Study chairs or principal investigators

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

Study ID Numbers:  ACTG A5170
Record last reviewed:  August 2004
Last Updated:  April 7, 2005
Record first received:  December 3, 2002
ClinicalTrials.gov Identifier:  NCT00050284
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08