An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children With HIV Infection

January 8, 2014 updated by: Bristol-Myers Squibb

US Sustiva Oral Liquid Expanded Access Program: an Open-label, Multicenter Expanded Access Study of the Liquid Formulation of Sustiva (Efavirenz, DMP 266)

This study is being conducted to assess the safety and tolerability of an oral liquid solution of Sustiva for antiretroviral therapy-naive or therapy-experienced HIV-1 infected children between the ages 3-16 who are failing or intolerant of current antiretroviral regimen and who are unable to swallow Sustiva capsules.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Arecibo, Puerto Rico, 00612
        • Local Institution
      • San Juan, Puerto Rico, 00936
        • Local Institution
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Local Institution
    • California
      • Los Angeles, California, United States, 90033
        • LAC & USC Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Local Institution
    • Florida
      • Fort Lauderdale, Florida, United States, 33301
        • Children'S Diagnostic Treatment Center
      • Orlando, Florida, United States, 32806
        • Arnold Palmer Hospital For Children And Woman
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60614
        • The Children's Memorial Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • LSU Health Sciences Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical School
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • The Wellness Center
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • UMDNJ - New Jersey Medical School
    • New York
      • Bronx, New York, United States, 10461
        • Bronx Municipal Hospital Center
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center/AECOM
      • New Hyde Park, New York, United States, 11042
        • Schneider'S Childrens Hospital
      • New York, New York, United States, 10037
        • Harlem Hospital Center
      • New York, New York, United States, 10011
        • Office Of John Montana
      • New York, New York, United States, 10025
        • St Luke's-Roosevelt Hospital Center
      • New York, New York, United States, 10032
        • Women And Childrens Care Center
      • Stony Brook, New York, United States, 11794
        • State University of New York at Stony Brook
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
      • Valhalla, New York, United States, 10595
        • New York Medical College
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Metro Health Medical Center
      • Youngstown, Ohio, United States, 44502
        • Local Institution
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St Jude Children's Research Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children 3-16 years of age
  • Anti-retroviral naive or experienced
  • Failing or intolerant to current Anti-retroviral regimen
  • Limited available viable therapeutic options
  • Inability to take capsules/tablets

Exclusion Criteria:

  • Less than 10kg
  • Failure on or concomitant use of other NNRTIs
  • An active AIDS-defining opportunistic infection or disease
  • More than two episodes of moderate to severe diarrhea or vomiting lasting more than four days within the past three months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

January 9, 2014

Last Update Submitted That Met QC Criteria

January 8, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI266-913

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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