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

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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.

Background information
Trial ID: 
NCT00162227
Other unique IDs: 
AI266-913
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)

Detailed description: 

 

Number to be enrolled: 
0 patients
Clinical information
Age groups: 
Child
Gender: 
Both
Eligibility 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

Interventions: 
Efavirenz
Conditions treated: 
HIV Infection
Funding
Funding types: 
INDUSTRY
Sponsor: 
Bristol-Myers Squibb
Dates
Date the data was first received: 
Fri, 2005-09-09
Trial start date: 
Fri, 2000-09-01
Trial completion date: 
Wed, 2010-12-01
Trial last updated: 
Wed, 2009-05-20