Overview

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