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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Study Start Date

2001-05-31

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00162227

HIV Infection

NO_LONGER_AVAILABLE

Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children

NCT00364793

HIV Infections

COMPLETED PHASE1/PHASE2

Pediatric Expanded Access Program-Oral Solution (0831-908)

NCT00543530

HIV Infections

COMPLETED PHASE3

Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen

NCT00135382

HIV Infections

COMPLETED PHASE3

A Pilot Study of the Immunologic Reconstitution in HIV-1 Infected Children Receiving Highly Active Antiretroviral Therapy With Combination Ritonavir, Nevirapine and Stavudine

NCT00001688

HIV Infection

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Efavirenz

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sustiva BMS-561525

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No