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

Expanded access is currently available for this treatment.
Verified May 2013 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00162227
First received: September 9, 2005
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  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

Study Type: Expanded Access     What is 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)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Efavirenz
U.S. FDA Resources

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:
    Drug: Efavirenz
    Oral Solution, Oral 200 - 600 mg (weight based), once daily. Until further treatment with Sustiva Oral Solution is not warranted.
    Other Names:
    • Sustiva
    • BMS-561525
  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.

  Show 29 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  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

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00162227     History of Changes
Other Study ID Numbers: AI266-913
Study First Received: September 9, 2005
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
 Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 21, 2013