An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children With HIV Infection
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 3 - 16 |
| Updated: | 1/1/2014 |
| Start Date: | September 2000 |
| End Date: | December 2010 |
| Contact: | For participation information at a USA site use a phone number below. For site information outside the USA please email: |
| Email: | Clinical.Trials@bms.com |
US Sustiva Oral Liquid Expanded Access Program: an Open-label, Multicenter Expanded Access Study of the Liquid Formulation of Sustiva (Efavirenz, DMP 266)
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.
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.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
27
sites
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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St Luke's - Roosevelt Hospital Center With 523 beds, Mount Sinai St. Luke's serves as...
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UMDNJ-New Jersey Medical School NJMS is committed to educating humanistic, culturally competent physicians who will...
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SUNY Upstate Medical University Hospital SUNY Upstate Medical University in Syracuse, NY, is the only...
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New York Medical College The College was founded in 1860 by a group of New...
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Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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225 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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