Pediatric Expanded Access Program-Oral Solution

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00543530
First received: October 5, 2007
Last updated: September 23, 2009
Last verified: September 2009

October 5, 2007
September 23, 2009
April 2001
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Complete list of historical versions of study NCT00543530 on ClinicalTrials.gov Archive Site
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Pediatric Expanded Access Program-Oral Solution
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

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: MK0831
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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January 2003
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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
Both
3 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00543530
2007_626, MK0831-908
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Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP