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

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00162227
First received: September 9, 2005
Last updated: January 8, 2014
Last verified: January 2014

September 9, 2005
January 8, 2014
September 2000
December 2010   (final data collection date for primary outcome measure)
Not Provided
Obtain information on the safety profile of the oral liquid solution
Complete list of historical versions of study NCT00162227 on ClinicalTrials.gov Archive Site
Not Provided
Assess effect of treatment on HIV-1RNA levels and CD4 cell counts in children
Not Provided
Not Provided
 
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)

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.

Not Provided
Expanded Access
Not Provided
Not Provided
HIV Infection
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
No longer available
Not Provided
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
3 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00162227
AI266-913
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP