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

Bristol-Myers Squibb (BMS)

Status

Conditions: HIV Infection

Treatments: Drug: Efavirenz

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT00162188

AI266-914

Details and patient eligibility

About

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.

Sex: All

Ages: 3 to 16 years old

Volunteers: No Healthy Volunteers

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