An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children With HIV Infection: Canada
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infection
Intervention: Efavirenz (Drug)
Phase: N/A
Status: Available
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s):
Bristol Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
Overall 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
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.
Clinical Details
Official title: Canadian Sustiva Oral Liquid Expanded Access Program: An Open-Label, Multicenter Expanded Access Study of the Liquid Formulation of Sustiva (Efavirenz, DMP266)
Study design: N/A
Eligibility
Minimum age: 3 Years.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
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
Local Institution, Edmonton, Alberta T6G 2J3, Canada
Local Institution, Toronto, Ontario M5G 1X8, Canada
Local Institution, Montreal, Quebec H3T 1C5, Canada
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Starting date: May 2001
Ending date: December 2010
Last updated: September 22, 2009
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