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

Phase 3

Completed

• Conditions: HIV Infections

• Registration Number: NCT00543530
• Lead Sponsor: Merck Sharp & Dohme LLC

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2001-03
• Primary Completion: 2002-12
• Study Completion: 2002-12
• Study First Submitted: 2007-10-05
• Study First Submitted QC: 2007-10-12
• Study First Posted: 2007-10-15
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-26
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP