Long-term side effects, the expense of medications, and the difficulty of taking medications continuously for long periods of time are all problems with complicated anti-HIV drug regimens. The purpose of this study is to determine whether two drugs, atazanavir and ritonavir, will control HIV infection when taken together without any other anti-HIV drugs after 48 weeks of viral suppression.

Condition	Treatment or Intervention
HIV Infections	Drug: Atazanavir  Drug: Ritonavir

The expense, difficulty, and long-term adverse events associated with sustained adherence to combination antiretroviral therapy emphasize the need for simpler, alternative treatment strategies for HIV infection. Studies have shown that single protease inhibitor (PI) maintenance therapy may provide sufficient virologic suppression while reducing the risk of nucleoside reverse transcriptase inhibitor (NRTI)-associated metabolic complications. This study will determine whether simplified maintenance therapy with ritonavir-boosted atazanavir (ATV/RTV) after 48-week virologic suppression will increase the likelihood of virologic failure.

This study will last 54 weeks. Participants will undergo an electrocardiogram (EKG) at screening. At study start, participants will switch from their current PIs to ATV/RTV and stay on their current NRTIs until Week 6, when they will discontinue their NRTIs and remain on a maintenance regimen of ATV/RTV alone for the duration of the study. Study visits will take place at Weeks 3 and 6, then every 4 weeks until Week 30, then every 8 weeks until the end of the study at Week 54. Medication assessment, physical exam, and blood work will occur at each study visit.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• HIV infected
• On first antiretroviral regimen, including at least 2 NRTIs and 1 PI, for at least 48 weeks immediately prior to study entry
• CD4 count of 250 cells/mm3 or greater
• Viral load less than 50 copies/ml within 30 days prior to entry
• Willing to use acceptable methods of contraception

Exclusion Criteria:

• Current or prior use of an NNRTI
• Certain PI mutations
• Hepatitis B infection within 90 days prior to study entry
• Certain therapies or medications within 30 days prior to study entry
• Heartbeat abnormalities or symptoms potentially related to heart block, such as unexplained fainting, dizziness, or palpitations, occurring within 180 days prior to study entry
• Drug or alcohol use or dependence that would interfere with adherence to the study requirements
• Serious illness requiring systemic treatment or hospitalization until the participant either completes therapy or has been clinically stable on therapy for at least 14 days prior to study entry
• Allergy or sensitivity to study medications or their formulations
• Pregnant or breastfeeding
• Involuntarily incarcerated for treatment of either a mental or physical illness

California
      Stanford University, Stanford,  California,  94305-5107,  United States; Recruiting
Colorado
      Univ. of Colorado Health Sciences Center, Denver, Denver,  Colorado,  80262-3706,  United States; Recruiting
Hawaii
      University of Hawaii, Honolulu,  Hawaii,  96816-2396,  United States; Recruiting
Massachusetts
      Brigham and Womens Hospital, Boston,  Massachusetts,  02115,  United States; Recruiting
Minnesota
      University of Minnesota, Minneapolis,  Minnesota,  55455-0392,  United States; Recruiting
Missouri
      Washington University (St. Louis), St. Louis,  Missouri,  63108-2138,  United States; Recruiting
Nebraska
      Nebraska Health System, Omaha,  Nebraska,  68198-5130,  United States; Recruiting
New York
      The Cornell Clinical Trials Unit, New York,  New York,  10021,  United States; Recruiting
      Chelsea Clinic, New York,  New York,  10011,  United States; Recruiting
North Carolina
      University of North Carolina, Chapel Hill,  North Carolina,  27514,  United States; Recruiting
Pennsylvania
      University of Pittsburgh, Pittsburgh,  Pennsylvania,  15213-2582,  United States; Recruiting
Rhode Island
      The Miriam Hospital, Providence,  Rhode Island,  02906,  United States; Recruiting
      Rhode Island Hospital, Providence,  Rhode Island,  02906,  United States; Recruiting
      Stanley Street Treatment and Resource, Providence,  Rhode Island,  02906,  United States; Recruiting
Washington
      University of Washington (Seattle), Seattle,  Washington,  98104,  United States; Recruiting

Study chairs or principal investigators

Susan Swindells, MD,  Study Chair,  University of Nebraska   

Study ID Numbers:  ACTG A5201
Record last reviewed:  November 2004
Record first received:  June 4, 2004
ClinicalTrials.gov Identifier:  NCT00084019
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08