This study is being conducted to assess the safety and tolerability of an oral liquid solution of Sustiva for antiretroviral therapy-naive or therapy-experienced HIV-1 infected children between the ages 3-16 who are failing or intolerant of current antiretroviral regimen and who are unable to swallow Sustive Capsules.

Condition	Intervention	Phase
HIV Infection	Drug: Sustiva	Phase II

Further Study Details: 

Primary Outcomes: Obtain information on the safety profile of the oral liquid solution
Secondary Outcomes: Assess effect of treatment on HIV-1RNA levels and CD4 cell counts in children
Expected Total Enrollment:  400

Ages Eligible for Study:  3 Years   -   16 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Children 3-16 years of age
• Anti-retroviral naive or experienced
• Failing or intolerant to current Anti-retroviral regimen
• Limited available viable therapeutic options
• Inability to take capsules/tablets

Exclusion Criteria:

• Less than 10kg
• Failure on or concomitant use of other NNRTIs
• An active AIDS-defining opportunistic infection or disease
• More than two episodes of moderate to severe diarrhea or vomiting lasting more than four days within the past three months

Please refer to this study by ClinicalTrials.gov identifier  NCT00162227

BMS Call Center      1-866-892-1BMS  Ext. 190 
BMS Call Center Outside the US and Canada      1-215-347-4079  Ext. 190 

California
      Local Institution, Fresno,  California,  United States; Terminated
      Local Institution, La Jolla,  California,  United States; Terminated
      Local Institution, Los Angeles,  California,  United States; Terminated
      Local Institution, Oakland,  California,  United States; Terminated
      Local Institution, San Francisco,  California,  United States; Terminated
      Local Institution, San Jose,  California,  United States; Terminated
      Local Institution, Stanford,  California,  United States; Terminated
Colorado
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Connecticut
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District of Columbia
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Florida
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      Local Institution, Orlando,  Florida,  United States; Completed
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      Local Institution, St. Petersburg,  Florida,  United States; Terminated
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Georgia
      Local Institution, Atlanta,  Georgia,  United States; Terminated
Illinois
      Local Institution, Chicago,  Illinois,  United States; Recruiting
Indiana
      Local Institution, Indianapolis,  Indiana,  United States; Terminated
Louisiana
      Local Institution, New Orleans,  Louisiana,  United States; Terminated
Maryland
      Local Institution, Baltimore,  Maryland,  United States; Terminated
      Local Institution, Greenbelt,  Maryland,  United States; Terminated
Massachusetts
      Local Institution, Boston,  Massachusetts,  United States; Completed
      Local Institution, Harwich,  Massachusetts,  United States; Terminated
      Local Institution, Worchester,  Massachusetts,  United States; Terminated
Michigan
      Local Institution, Detroit,  Michigan,  United States; Terminated
Missouri
      Local Institution, St. Louis,  Missouri,  United States; Terminated
Nevada
      Local Institution, Las Vegas,  Nevada,  United States; Terminated
New Jersey
      Local Institution, Newark,  New Jersey,  United States; Recruiting
      Local Institution, Jersey City,  New Jersey,  United States; Terminated
      Local Institution, Patterson,  New Jersey,  United States; Terminated
New York
      Local Institution, Bronx,  New York,  United States; Recruiting
      Local Institution, New York,  New York,  United States; Recruiting
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      Local Institution, East Meadow,  New York,  United States; Terminated
      Local Institution, Great Neck,  New York,  United States; Terminated
      Local Institution, Jamaica,  New York,  United States; Terminated
      Local Institution, New Hyde Park,  New York,  United States; Completed
      Local Institution, Rochester,  New York,  United States; Terminated
      Local Institution, Staten Island,  New York,  United States; Terminated
      Local Institution, Valhalla,  New York,  United States; Terminated
North Carolina
      Local Institution, Winston Salem,  North Carolina,  United States; Terminated
Ohio
      Local Institution, Cleveland,  Ohio,  United States; Terminated
      Local Institution, Youngstown,  Ohio,  United States; Terminated
Pennsylvania
      Local Institution, Chester,  Pennsylvania,  United States; Terminated
Tennessee
      Local Institution, Memphis,  Tennessee,  United States; Recruiting
Texas
      Local Institution, Fort Worth,  Texas,  United States; Terminated
      Local Institution, Houston,  Texas,  United States; Terminated
      Local Institution, San Antonio,  Texas,  United States; Terminated
Virginia
      Local Institution, Richmond,  Virginia,  United States; Terminated
Puerto Rico
      Local Institution, Arecibo,  Puerto Rico; Recruiting
      Local Institution, Caguas,  Puerto Rico; Terminated
      Local Institution, Mayaquez,  Puerto Rico; Terminated
      Local Institution, San Juan,  Puerto Rico; Terminated

Study ID Numbers:  AI266-913
Last Updated:  September 12, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00162227
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13