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NCT00162227 Clinical Trial

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

HIV Infection Clinical Trial

Official title:
US Sustiva Oral Liquid Expanded Access Program: an Open-label, Multicenter Expanded Access Study of the Liquid Formulation of Sustiva (Efavirenz, DMP 266)

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT00162227
Other study ID # AI266-913
Secondary ID
Status No longer available
Phase N/A
First received September 9, 2005
Last updated January 8, 2014
Start date September 2000
Est. completion date December 2010

Study information
Verified date January 2014
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
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 3-16 who are failing or intolerant of 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 regimen

- Limited available viable therapeutic options

- Inability to take capsules/tablets

Exclusion Criteria:

- Less than 10kg

- Failure on or concomitant use of other 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

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
Puerto Rico Local Institution Arecibo
Puerto Rico Local Institution San Juan
United States Children'S Hospital Boston Massachusetts
United States Bronx Municipal Hospital Center Bronx New York
United States Montefiore Medical Center/Aecom Bronx New York
United States The Children'S Memorial Hospital Chicago Illinois
United States University Of Chicago Chicago Illinois
United States Metro Health Medical Center Cleveland Ohio
United States Children'S Diagnostic Treatment Center Fort Lauderdale Florida
United States Local Institution Houston Texas
United States The Wellness Center Las Vegas Nevada
United States Lac & Usc Medical Center Los Angeles California
United States St Jude Children'S Research Hospital Memphis Tennessee
United States Schneider'S Childrens Hospital New Hyde Park New York
United States Lsu Health Sciences Center New Orleans Louisiana
United States Harlem Hospital Center New York New York
United States Office Of John Montana New York New York
United States St Luke'S-Roosevelt Hospital Center New York New York
United States Women And Childrens Care Center New York New York
United States Umdnj - New Jersey Medical School Newark New Jersey
United States Arnold Palmer Hospital For Children And Woman Orlando Florida
United States Local Institution Phoenix Arizona
United States State University Of New York At Stony Brook Stony Brook New York
United States Suny Upstate Medical University Syracuse New York
United States New York Medical College Valhalla New York
United States Local Institution Washington District of Columbia
United States Cleveland Clinic Florida Weston Florida
United States University Of Massachusetts Medical School Worcester Massachusetts
United States Local Institution Youngstown Ohio

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Puerto Rico, 

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