An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children With HIV Infection: Canada

Canadian Sustiva Oral Liquid Expanded Access Program: An Open-Label, Multicenter Expanded Access Study of the Liquid Formulation of Sustiva (Efavirenz, DMP266)

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.

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