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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00543530
• Other study ID #: 0831-908
• Secondary ID: MK0831-9082007_6
• Status: Completed
• Phase: Phase 3
• First received: October 5, 2007
• Last updated: November 26, 2015
• Start date: March 2001
• Est. completion date: December 2002

Study information

• Verified date: November 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2002
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 16 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• MK0831

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.