Status:
NO_LONGER_AVAILABLE
An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children With HIV Infection
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
HIV Infection
Eligibility:
All Genders
3-16 years
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 ag...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2000
Trial Type :
EXPANDED_ACCESS
End Date :
December 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00162227
Start Date
September 1 2000
End Date
December 1 2010
Last Update
January 9 2014
Active Locations (29)
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1
Local Institution
Phoenix, Arizona, United States, 85016
2
Lac & Usc Medical Center
Los Angeles, California, United States, 90033
3
Local Institution
Washington D.C., District of Columbia, United States, 20010
4
Children'S Diagnostic Treatment Center
Fort Lauderdale, Florida, United States, 33301