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

A Noncomparative,Open, Multisite Study to Monitor the Safety and Tolerability of Efavirenz Oral Solution Given in Combination Antiretroviral Therapy (ART) in ART-naive or Experienced HIV-1 Infected Patients Age 3 to 16 Years Who Have Failed Therapy or Are Intorerant to Their Current ART Regimen

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00543530

Enrollment

Unknown

Registered

2007-10-15

Start date

2001-03-31

Completion date

2002-12-31

Last updated

2015-11-30

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

Conditions

HIV Infections

Keywords

HIV, Treatment Experienced

Brief summary

Monitor the safety and tolerability of efavirenz oral solution in combination with Antiretroviral Therapy for the treatment of patients age 3 to 16 years who have failed therapy or who are intolerant to their current therapy. This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).

Interventions

DRUGMK0831

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 16 Years

Healthy volunteers

Inclusion criteria

* Not tolerating current ART regime laboratory status is stable * Able to take oral liquid medications but have difficulty swallowing capsules * Weigh at least 10 kg (22 lbs)

Exclusion criteria

* Has had more than 2 episodes of moderate to severe diarrhea or vomiting lasting more than 4 days within 3 months prior to taking study drug * Have taken another investigational drug 30 days before starting this study * Have a history of drug or alcohol abuse

Outcome results

None listed

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