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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00543530
First received: October 5, 2007
Last updated: December 16, 2014
Last verified: December 2014
  Purpose

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).


Condition Intervention Phase
HIV Infections
Drug: MK0831
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Study Start Date: March 2001
Study Completion Date: December 2002
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   3 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543530

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00543530     History of Changes
Other Study ID Numbers: 0831-908, MK0831-908, 2007_626
Study First Received: October 5, 2007
Last Updated: December 16, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Merck Sharp & Dohme Corp.:
HIV
Treatment Experienced

ClinicalTrials.gov processed this record on June 02, 2015