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

HIV Infection Clinical Trial

Official title:

Canadian Sustiva Oral Liquid Expanded Access Program: An Open-Label, Multicenter Expanded Access Study of the Liquid Formulation of Sustiva (Efavirenz, DMP266)

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT00162188
• Other study ID #: AI266-914
• Status: No longer available
• Phase: N/A
• First received: September 9, 2005
• Last updated: January 8, 2014
• Start date: May 2001
• Est. completion date: December 2010

Study information

• Verified date: January 2014
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Expanded Access

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 16 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infection
• HIV Infections

Intervention

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

Locations

Country	Name	City	State
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Canada, 

External Links

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