An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children With HIV Infection: Canada
Expanded access is currently available for this treatment.
Verified October 2012 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00162188
First received: September 9, 2005
Last updated: October 24, 2012
Last verified: October 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 9, 2005 | ||||||||
| Last Updated Date | October 24, 2012 | ||||||||
| Start Date ICMJE | May 2001 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE |
Obtain information on the safety profile of the oral liquid solution. | ||||||||
| Change History | Complete list of historical versions of study NCT00162188 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE |
Assess effect of treatment on HIV-1 RNA levels and CD4 cell counts in children. | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children With HIV Infection: Canada | ||||||||
| Official Title ICMJE | Canadian Sustiva Oral Liquid Expanded Access Program: An Open-Label, Multicenter Expanded Access Study of the Liquid Formulation of Sustiva (Efavirenz, DMP266) | ||||||||
| 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 of 3-16 who are failing or intolerant of their current antiretroviral regimen and who are unable to swallow Sustiva capsules. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Expanded Access | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Not Provided | ||||||||
| Condition ICMJE | HIV Infection | ||||||||
| Intervention ICMJE | Drug: Efavirenz
Oral Solution, Oral 200 - 600 mg (weight based), once daily. Until further treatment with Sustiva Oral Solution is not warranted.
Other Names:
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Available | ||||||||
| Enrollment ICMJE | Not Provided | ||||||||
| Estimated Completion Date | December 2010 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 3 Years to 16 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00162188 | ||||||||
| Other Study ID Numbers ICMJE | AI266-914 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Bristol-Myers Squibb | ||||||||
| Study Sponsor ICMJE | Bristol-Myers Squibb | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Bristol-Myers Squibb | ||||||||
| Verification Date | October 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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