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Clinical Trials

MainTitle

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
Bristol-Myers Squibb


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
History of Changes
Purpose

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)

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)

Eligibility

Eligibility

Ages Eligible for Study: 3 Years to 16 Years  
Sexes Eligible for Study: All  
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

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
Local Institution
Edmonton, Alberta, Canada, T6G 2J3
Local Institution
Vancouver, British Columbia, Canada, V6H 3N1
Local Institution
Toronto, Ontario, Canada, M5G 1X8
Local Institution
Montreal, Quebec, Canada, H3T 1C5

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol Myers Squibb Bristol-Myers Squibb
More Information

More Information

Additional Information:

BMS Clinical Trials Disclosure

Additional Information:

Investigator Inquiry form

Additional Information:

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

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  

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Efavirenz

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.