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 by Bristol-Myers Squibb, July 2009

First Received: September 9, 2005 Last Updated: September 2, 2009 History of Changes

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00162188

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
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: 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:

Oral Solution, Oral 200 - 600 mg (weight based), once daily. Until further treatment with Sustiva Oral Solution is not warranted.

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
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:

BMS Clinical Trials Disclosure 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 ( Study Director )
Study ID Numbers:	AI266-914
Study First Received:	September 9, 2005
Last Updated:	September 2, 2009
ClinicalTrials.gov Identifier:	NCT00162188 History of Changes
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Efavirenz
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Antiviral Agents
Immunologic Deficiency Syndromes

Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
Efavirenz
Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection

Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 11, 2009