An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children With HIV Infection
US Sustiva Oral Liquid Expanded Access Program: an Open-label, Multicenter Expanded Access Study of the Liquid Formulation of Sustiva (Efavirenz, DMP 266)
1 other identifier
expanded_access
N/A
2 countries
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2000
Longer than P75 for all trials
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJanuary 9, 2014
January 1, 2014
10.3 years
September 9, 2005
January 8, 2014
Conditions
Interventions
Oral Solution, Oral 200 - 600 mg (weight based), once daily. Until further treatment with Sustiva Oral Solution is not warranted.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Local Institution
Phoenix, Arizona, 85016, United States
Lac & Usc Medical Center
Los Angeles, California, 90033, United States
Local Institution
Washington D.C., District of Columbia, 20010, United States
Children'S Diagnostic Treatment Center
Fort Lauderdale, Florida, 33301, United States
Arnold Palmer Hospital For Children And Woman
Orlando, Florida, 32806, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
The Children'S Memorial Hospital
Chicago, Illinois, 60614, United States
University Of Chicago
Chicago, Illinois, 60637, United States
Lsu Health Sciences Center
New Orleans, Louisiana, 70112, United States
Children'S Hospital
Boston, Massachusetts, 02115, United States
University Of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
The Wellness Center
Las Vegas, Nevada, 89102, United States
Umdnj - New Jersey Medical School
Newark, New Jersey, 07103, United States
Schneider'S Childrens Hospital
New Hyde Park, New York, 11042, United States
Office Of John Montana
New York, New York, 10011, United States
St Luke'S-Roosevelt Hospital Center
New York, New York, 10025, United States
Women And Childrens Care Center
New York, New York, 10032, United States
Harlem Hospital Center
New York, New York, 10037, United States
State University Of New York At Stony Brook
Stony Brook, New York, 11794, United States
Suny Upstate Medical University
Syracuse, New York, 13210, United States
Bronx Municipal Hospital Center
The Bronx, New York, 10461, United States
Montefiore Medical Center/Aecom
The Bronx, New York, 10461, United States
New York Medical College
Valhalla, New York, 10595, United States
Metro Health Medical Center
Cleveland, Ohio, 44109, United States
Local Institution
Youngstown, Ohio, 44502, United States
St Jude Children'S Research Hospital
Memphis, Tennessee, 38105, United States
Local Institution
Houston, Texas, 77030, United States
Local Institution
Arecibo, 00612, Puerto Rico
Local Institution
San Juan, 00936, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 13, 2005
Study Start
September 1, 2000
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
January 9, 2014
Record last verified: 2014-01