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

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00162188
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 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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162188

Locations
Canada, Alberta
Local Institution
Edmonton, Alberta, Canada, T6G 2J3
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada, V6H 3N1
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, H3T 1C5
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: NCT00162188     History of Changes
Other Study ID Numbers: AI266-914
Study First Received: September 9, 2005
Last Updated: January 8, 2014
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on October 30, 2014