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

Expanded access is currently available for this treatment.
Verified October 2012 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00162188
First received: September 9, 2005
Last updated: October 24, 2012
Last verified: October 2012
History of Changes
  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 of 3-16 who are failing or intolerant of their 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: Canadian Sustiva Oral Liquid Expanded Access Program: An Open-Label, Multicenter Expanded Access Study of the Liquid Formulation of Sustiva (Efavirenz, DMP266)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Efavirenz
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Study Start Date: May 2001
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 (ARV) regimen
  • Limited available viable therapeutic options
  • Inability to take capsules/tablets

Exclusion Criteria:

  • Weighs less than 10 kg
  • Failure on or concomitant use of other non-nucleoside reverse transcriptase inhibitors (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: NCT00162188

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations
Canada, Alberta
Local Institution
Edmonton, Alberta, Canada, T6G 2J3
Contact: Site 003            
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada, V6H 3N1
Contact: Site 004            
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5G 1X8
Contact: Site 002            
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, H3T 1C5
Contact: Site 001            
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00162188     History of Changes
Other Study ID Numbers: AI266-914
Study First Received: September 9, 2005
Last Updated: October 24, 2012
Health Authority: Canada: Health Canada

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 May 21, 2013