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

N/ANo Longer AvailableNCT00162188

Bristol-Myers Squibb

Overview

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.

Study Type

EXPANDED_ACCESS

Conditions

HIV Infection

Interventions

EfavirenzDRUG

Oral Solution, Oral 200 - 600 mg (weight based), once daily. Until further treatment with Sustiva Oral Solution is not warranted.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (4)

Local Institution

Edmonton, Alberta, Canada

Local Institution

Vancouver, British Columbia, Canada

Local Institution

Toronto, Ontario, Canada

Local Institution

Montreal, Quebec, Canada

Data from ClinicalTrials.gov

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