An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children With HIV Infection: Canada
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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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Ages Eligible for Study:
3 Years to 16 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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