Pediatric Expanded Access Program-Oral Solution (0831-908)
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0831
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, Treatment Experienced
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00543530
First Posted
October 5, 2007
Last Updated
November 26, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00543530
Brief Title
Pediatric Expanded Access Program-Oral Solution (0831-908)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
December 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Treatment Experienced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0831
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Pediatric Expanded Access Program-Oral Solution (0831-908)
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