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

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

MK0831

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, Treatment Experienced

Eligibility Criteria

3 Years - 16 Years (Child)All SexesDoes not accept 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

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

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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