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Clinical Trial: An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children with HIV Infection: Canada
This study is currently recruiting patients.
Verified by Bristol-Myers Squibb September 2005
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Purpose
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 of 3-16 who are failing or intolerant of thier current antiretrovival regimen and who are unable to swallow Sustive Capsules.
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infection | Drug: Oral Liquid Sustiva | Phase II |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Expanded Access Assignment, Safety Study
Official Title: Canadian Sustiva Oral Liquid Expanded Access Program: An Open-Label, Multicenter Expanded Access Study of The Liquid Formulation of Sustiva (Efavirenz, DMP266)
Further Study Details:
Primary Outcomes: Obtain information on the safety profile of the oral liquid solution.
Secondary Outcomes: Assess effect of treatment on HIV-1 RNA levels and CD4 cell counts in children.
Expected Total Enrollment: 400
Secondary Outcomes: Assess effect of treatment on HIV-1 RNA levels and CD4 cell counts in children.
Expected Total Enrollment: 400
Study start: May 2001
Eligibility
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 ARV regimen
- Limited available viable therapeutic options
- Inability to take capsules/tablets
Exclusion Criteria:
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00162188
BMS Call Center 1-866-892-1BMS Ext. 227
BMS Call Center Outside the US and Canada 1-215-347-4079 Ext. 227
BMS Call Center Outside the US and Canada 1-215-347-4079 Ext. 227
Canada, Alberta
Local Institution, Edmonton, Alberta, Canada; Not yet recruiting
Canada, British Columbia
Local Institution, Vancouver, British Columbia, Canada; Completed
Canada, Ontario
Local Institution, Toronto, Ontario, Canada; Recruiting
Canada, Quebec
Local Institution, Montreal, Quebec, Canada; Recruiting
Study chairs or principal investigators
Bristol Myers Squibb, Study Director, Bristol-Myers Squibb
More Information
Study ID Numbers: AI266-914
Last Updated: September 12, 2005
Record first received: September 9, 2005
ClinicalTrials.gov Identifier: NCT00162188
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 12, 2005
Record first received: September 9, 2005
ClinicalTrials.gov Identifier: NCT00162188
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-13
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