NCT00543530

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2001

Shorter than P25 for phase_3 hiv-infections

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2007

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 15, 2007

Completed
Last Updated

November 30, 2015

Status Verified

November 1, 2015

Enrollment Period

1.8 years

First QC Date

October 5, 2007

Last Update Submit

November 26, 2015

Conditions

HIV Infections

Keywords

HIVTreatment Experienced

Interventions

MK0831DRUG

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2007

First Posted

October 15, 2007

Study Start

March 1, 2001

Primary Completion

December 1, 2002

Study Completion

December 1, 2002

Last Updated

November 30, 2015

Record last verified: 2015-11