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

• Status: No longer available
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Efavirenz

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