Clinical trial NCT00162227: An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children With HIV Infection
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)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: HIV Infection
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-09-13
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no

Brief 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.


Eligibility criteria: 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

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