To compare the proportion of subjects with HIV-1 RNA viral load < 50 c/mL through Week 48 of the Maintenance Phase among HIV-infected subjects with an initial undetectable viral load following an Induction Phase with an ATV/RTV containing HAART regimen, when switched to ATV versus remaining on ATV/RTV, whilst continuing their previous NRTI backbone.

Condition	Intervention	Phase
HIV-1 infected treatment naive patients	Drug: atazanivir (sulfate)	Phase IV

Further Study Details: 

Primary Outcomes: The primary endpoint measure will be the proportion of subjects with viral load < 50 c/mL through Week 48 of the Maintenance Phase between the 2 treatment arms.
Secondary Outcomes: The % of subjects with viral load <400 c/mL and time to treatment failure through Maintenance Phase; changes in CD4 and lipids, frequency and severity of adverse events (AEs), and discontinuations for AEs through Induction and Maintenance Phases.
Expected Total Enrollment:  200

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

Criteria

Inclusion Criteria:

• Treatment naive HIV-1 infected subjects ( < 10 days of treatment with any ARV).
• Subjects who have an HIV-1 RNA level ≥ 5000 c/mL at screening.
• Subjects who have a CD4 count ≥ 50 cells/mm3.
• Men and women, ages 18 years of age or older (or minimum age as determined by local regulatory or as legal requirements dictate).
• Both females of child-bearing potential and males must utilize effective barrier contraception. Other contraception in addition to barrier methods is permitted; refer to the Investigator Brochure for details regarding potential interactions with ATV and some oral contraceptives

Exclusion Criteria:

• WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study.
• WOCBP using a prohibited contraceptive method. Caution is warranted with coadministration of oral contraceptives (ethinyl estradiol and norethindrone) - see Investigator Brochure for details
• Women who are pregnant or breastfeeding
• Women with a positive pregnancy test on enrollment or prior to study drug administration.
• Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment
• Primary HIV infection
• Subjects with known Gilbert’s syndrome
• Active alcohol or substance use sufficient, in the investigator’s opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis Physical and Laboratory Test Findings
• Screening laboratory values measured as follows:
• Grade IV glucose,
• Grade IV electrolytes,
• Grade IV transaminases,
• Grade IV hematology.
• Hypersensitivity to any component of the formulation of study drug
• Prior history of taking any ARV for more than 10 days
• Concomitant administration of tenofovir (TDF).
• Refer to Section 6.4.1 which details all prohibited therapies

Please refer to this study by ClinicalTrials.gov identifier  NCT00207142

BMS Call Center      1-866-892-1BMS 
BMS Call Center Outside the US & Canada      1-215-347-4079 

Estonia
      Local Institution, Tallinn,  Estonia
France
      Local Institution, Le Kremlin Bicetre 94,  France
      Local Institution, Orleans,  France
      Local Institution, Paris,  France
      Local Institution, Paris Cedex 12,  France
      Local Institution, Paris Cedex 20,  France
Ireland, Dublin
      Local Institution, Dublin 3,  Dublin,  Ireland
      Local Institution, Dublin 7,  Dublin,  Ireland
      Local Institution, Dublin 8,  Dublin,  Ireland
Italy
      Local Institution, Brescia,  Italy
      Local Institution, Milano,  Italy
      Local Institution, Napoli,  Italy
      Local Institution, Padova,  Italy
Latvia
      Local Institution, Riga,  Latvia
Russian Federation
      Local Institution, Moscow,  Russian Federation
      Local Institution, Smolensk,  Russian Federation
      Local Institution, St Petersburg,  Russian Federation
Spain
      Local Institution, Barcelona,  Spain
      Local Institution, Madrid,  Spain
      Local Institution, Valencia,  Spain
Spain, Alicante
      Local Institution, Elche,  Alicante,  Spain
United Kingdom, Avon
      Local Institution, Bristol,  Avon,  United Kingdom
United Kingdom, Central
      Local Institution, Edinburgh,  Central,  United Kingdom
United Kingdom, Greater London
      Local Institution, London,  Greater London,  United Kingdom
      Local Institution, London,  Greater London,  United Kingdom

Study chairs or principal investigators

Ghislaine Lelue, MD,  Study Director,  Bristol-Myers Squibb   

Study ID Numbers:  AI424-136
Last Updated:  September 20, 2005
Record first received:  September 16, 2005
ClinicalTrials.gov Identifier:  NCT00207142
Health Authority: France: Agence Francaise de Securite Sanitaire des Produits de Sante
ClinicalTrials.gov processed this record on 2005-09-27