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

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00162227
First received: September 9, 2005
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
HIV Infection
Drug: Efavirenz

Study Type: Expanded Access     What is Expanded Access?
Official Title: US Sustiva Oral Liquid Expanded Access Program: an Open-label, Multicenter Expanded Access Study of the Liquid Formulation of Sustiva (Efavirenz, DMP 266)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Study Start Date: September 2000
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Efavirenz
    Oral Solution, Oral 200 - 600 mg (weight based), once daily. Until further treatment with Sustiva Oral Solution is not warranted.
    Other Names:
    • Sustiva
    • BMS-561525
  Eligibility

Ages Eligible for Study:   3 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162227

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

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00162227     History of Changes
Other Study ID Numbers: AI266-913
Study First Received: September 9, 2005
Last Updated: January 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on April 17, 2014