To Assess Compliance With a Once-daily Regimen of Lamivudine, Efavirenz and Didanosine

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Dohme Australia
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00207168
First received: September 12, 2005
Last updated: April 8, 2011
Last verified: April 2011

September 12, 2005
April 8, 2011
April 2004
December 2006   (final data collection date for primary outcome measure)
To determine over 24 weeks the levels of adherence in two groups of HIV-infected subjects randomized to receive either a once daily 3-drug regimen or to continue a minimum 3-drug regimen requiring more frequent dosing.
Same as current
Complete list of historical versions of study NCT00207168 on ClinicalTrials.gov Archive Site
To demonstrate that once daily therapy is not-inferioir to continued multiple dosing in terms of proportion of patients with treatment failure.
Same as current
Not Provided
Not Provided
 
To Assess Compliance With a Once-daily Regimen of Lamivudine, Efavirenz and Didanosine
A Randomized, Multi-center, Open Label Study in Well Controlled Treatment-experienced HIV- Infected Patients to Assess Compliance With a Once-daily Regimen

To assess compliance of once daily dosing to assess their benefits in terms of potency and safety as well as their impact on adherence and quality of life.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
AIDS
Behavioral: Compliance
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
December 2006
December 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 or older, required lab results, currently taking no more than two of the proposed once daily arm medications with medications administered twice daily and women of child bearing potential.

Exclusion Criteria:

  • virological failure, serious medical condition, known toxicities to any of the once daily arm medications, lab abnormalities, women who are pregnant/breastfeeding
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00207168
AI454-194, The TEddI Study
Not Provided
Not Provided
Bristol-Myers Squibb
  • Merck Sharp & Dohme Corp.
  • Dohme Australia
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
April 2011

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