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

Canadian Sustiva Oral Liquid Expanded Access Program: An Open-Label, Multicenter Expanded Access Study of the Liquid Formulation of Sustiva (Efavirenz, DMP266)

Status

NO_LONGER_AVAILABLE

Phases

Unknown

Study type

Expanded Access

Source

ClinicalTrials.gov

Registry ID

NCT00162188

Enrollment

Unknown

Registered

2005-09-13

Start date

2001-05-31

Completion date

2010-12-31

Last updated

2014-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

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.

Interventions

DRUGEfavirenz

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

Eligibility

Sex/Gender

ALL

Age

3 Years to 16 Years

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026