Status:
NO_LONGER_AVAILABLE
An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children With HIV Infection: Canada
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 (ARV) regimen
- Limited available viable therapeutic options
- Inability to take capsules/tablets
Exclusion
- Weighs less than 10 kg
- Failure on or concomitant use of other non-nucleoside reverse transcriptase inhibitors (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 :
May 1 2001
Trial Type :
EXPANDED_ACCESS
End Date :
December 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00162188
Start Date
May 1 2001
End Date
December 1 2010
Last Update
January 9 2014
Active Locations (4)
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1
Local Institution
Edmonton, Alberta, Canada, T6G 2J3
2
Local Institution
Vancouver, British Columbia, Canada, V6H 3N1
3
Local Institution
Toronto, Ontario, Canada, M5G 1X8
4
Local Institution
Montreal, Quebec, Canada, H3T 1C5