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

• Conditions: HIV Infection

• Registration Number: NCT00162188
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-05
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-13
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-08
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

Local Institution; 🇨🇦 Montreal, Quebec, Canada