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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Drug: MK0831

Study type: Interventional

Funder types: Industry

Identifiers

NCT00543530

2007_626

MK0831-908

0831-908

Details and patient eligibility

About

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).

Sex: All

Ages: 3 to 16 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)