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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00543530
Recruitment Status : Completed
First Posted : October 15, 2007
Last Update Posted : November 30, 2015
Sponsor:
Information provided by (Responsible Party):

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).


Condition or disease Intervention/treatment Phase
HIV Infections Drug: MK0831 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2001
Primary Completion Date : December 2002
Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00543530


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00543530     History of Changes
Other Study ID Numbers: 0831-908
MK0831-908
2007_626
First Posted: October 15, 2007    Key Record Dates
Last Update Posted: November 30, 2015
Last Verified: November 2015

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases