This study is being conducted to assess the safety and tolerability of an oral liquidsolution of Sustiva for antiretroviral therapy-naive or therapy-experienced HIV-1infected children between the ages 3-16 who are failing or intolerant of currentantiretroviral regimen and who are unable to swallow Sustiva capsules.
Not Provided
Drug: Efavirenz
Oral Solution, Oral 200 - 600 mg (weight based), once daily. Until further treatment with
Sustiva Oral Solution is not warranted.
Other Name: Sustiva,BMS-561525
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
Local Institution
Phoenix, Arizona, United States
Lac & Usc Medical Center
Los Angeles, California, United States
Local Institution
Washington, District of Columbia, United States
Children'S Diagnostic Treatment Center
Fort Lauderdale, Florida, United States
Arnold Palmer Hospital For Children And Woman
Orlando, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
The Children'S Memorial Hospital
Chicago, Illinois, United States
University Of Chicago
Chicago, Illinois, United States
Lsu Health Sciences Center
New Orleans, Louisiana, United States
Children'S Hospital
Boston, Massachusetts, United States
University Of Massachusetts Medical School
Worcester, Massachusetts, United States
The Wellness Center
Las Vegas, Nevada, United States
Umdnj - New Jersey Medical School
Newark, New Jersey, United States
Bronx Municipal Hospital Center
Bronx, New York, United States
Montefiore Medical Center/Aecom
Bronx, New York, United States
Schneider'S Childrens Hospital
New Hyde Park, New York, United States
Office Of John Montana
New York, New York, United States
St Luke'S-Roosevelt Hospital Center
New York, New York, United States
Women And Childrens Care Center
New York, New York, United States
Harlem Hospital Center
New York, New York, United States
State University Of New York At Stony Brook
Stony Brook, New York, United States
Suny Upstate Medical University
Syracuse, New York, United States
New York Medical College
Valhalla, New York, United States
Metro Health Medical Center
Cleveland, Ohio, United States
Local Institution
Youngstown, Ohio, United States
St Jude Children'S Research Hospital
Memphis, Tennessee, United States
Local Institution
Houston, Texas, United States
Local Institution
Arecibo, Puerto Rico
Local Institution
San Juan, Puerto Rico
Bristol-Myers Squibb, Study Director
Bristol-Myers Squibb