An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children With HIV Infection
- Conditions
- HIV Infection
- Registration Number
- NCT00162227
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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 Sustiva capsules.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
Children'S Hospital
🇺🇸Boston, Massachusetts, United States
State University Of New York At Stony Brook
🇺🇸Stony Brook, New York, United States
Metro Health Medical Center
🇺🇸Cleveland, Ohio, United States
The Wellness Center
🇺🇸Las Vegas, Nevada, United States
St Luke'S-Roosevelt Hospital Center
🇺🇸New York, New York, United States
Harlem Hospital Center
🇺🇸New York, New York, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Bronx Municipal Hospital Center
🇺🇸Bronx, New York, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
Lac & Usc Medical Center
🇺🇸Los Angeles, California, United States
The Children'S Memorial Hospital
🇺🇸Chicago, Illinois, United States
Arnold Palmer Hospital For Children And Woman
🇺🇸Orlando, Florida, United States
Office Of John Montana
🇺🇸New York, New York, United States
Women And Childrens Care Center
🇺🇸New York, New York, United States
Umdnj - New Jersey Medical School
🇺🇸Newark, New Jersey, United States
Suny Upstate Medical University
🇺🇸Syracuse, New York, United States
University Of Chicago
🇺🇸Chicago, Illinois, United States
St Jude Children'S Research Hospital
🇺🇸Memphis, Tennessee, United States
Local Institution
🇵🇷San Juan, Puerto Rico
University Of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
Lsu Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Children'S Diagnostic Treatment Center
🇺🇸Fort Lauderdale, Florida, United States
Montefiore Medical Center/Aecom
🇺🇸Bronx, New York, United States
Schneider'S Childrens Hospital
🇺🇸New Hyde Park, New York, United States