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

NO_LONGER_AVAILABLE

Conditions studied: HIV Infection

In brief

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.

Key facts

Study ID

NCT00162227

Run by

Bristol-Myers Squibb

Starts

2000-09-01

Expected to finish

2010-12-01

Last updated by the study team

2014-01-09

Who can join

Age: 3 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Local Institution — Phoenix, Arizona, United States
• Lac & Usc Medical Center — Los Angeles, California, United States
• Local Institution — Washington D.C., District of Columbia, United States
• Children'S Diagnostic Treatment Center — Fort Lauderdale, Florida, United States
• Arnold Palmer Hospital For Children And Woman — Orlando, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• The Children'S Memorial Hospital — Chicago, Illinois, United States
• University Of Chicago — Chicago, Illinois, United States
• Lsu Health Sciences Center — New Orleans, Louisiana, United States
• Children'S Hospital — Boston, Massachusetts, United States
• University Of Massachusetts Medical School — Worcester, Massachusetts, United States
• The Wellness Center — Las Vegas, Nevada, United States
• Umdnj - New Jersey Medical School — Newark, New Jersey, United States
• Schneider'S Childrens Hospital — New Hyde Park, 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
• Harlem Hospital Center — New York, New York, 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
• Bronx Municipal Hospital Center — The Bronx, New York, United States
• Montefiore Medical Center/Aecom — The Bronx, New York, United States
• New York Medical College — Valhalla, New York, United States
• Metro Health Medical Center — Cleveland, Ohio, United States
• Local Institution — Youngstown, Ohio, United States

Full record on ClinicalTrials.gov

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