An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children With HIV Infection - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00162227

Purpose

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.

Condition	Intervention
HIV Infection	Drug: Efavirenz

MedlinePlus related topics: AIDS

Drug Information available for: Efavirenz

U.S. FDA Resources

Study Type:	Expanded Access
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)

Further study details as provided by Bristol-Myers Squibb:

Study Start Date:	September 2000
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	3 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162227

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations

United States, Arizona
Local Institution
Phoenix, Arizona, United States, 85016
United States, District of Columbia
Local Institution
Washington, District of Columbia, United States, 20010
United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Children'S Diagnostic Treatment Center
Fort Lauderdale, Florida, United States, 33301
United States, Illinois
The Children'S Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Louisiana
Lsu Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
University Of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
United States, Nevada
The Wellness Center
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Umdnj - New Jersey Medical School
Newark, New Jersey, United States, 07103
United States, New York
Montefiore Medical Center/Aecom
Bronx, New York, United States, 10461
Harlem Hospital Center
New York, New York, United States, 10037
Bronx Municipal Hospital Center
Bronx, New York, United States, 10461
New York Medical College
Valhalla, New York, United States, 10595
St Luke'S-Roosevelt Hospital Center
New York, New York, United States, 10025
State University Of New York At Stony Brook
Stony Brook, New York, United States, 11794
Suny Upstate Medical University
Syracuse, New York, United States, 13210
Women And Childrens Care Center
New York, New York, United States, 10032
United States, Ohio
Metro Health Medical Center
Cleveland, Ohio, United States, 44109
Local Institution
Youngstown, Ohio, United States, 44502
United States, Tennessee
St Jude Children'S Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
Local Institution
Houston, Texas, United States, 77030
Puerto Rico
Local Institution
Arecibo, Puerto Rico, 00612

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	AI266-913
Study First Received:	September 9, 2005
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00162227
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Efavirenz
Sexually Transmitted Diseases, Viral
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009