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

Phase 4

Completed

• Conditions: AIDS

• Registration Number: NCT00207168
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-21
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Disposition First Submitted: 2010-02-03
• Disposition First Submitted QC: 2010-02-03
• Disposition First Posted: 2010-02-05
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-08
• Last Update Posted: 2011-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
To demonstrate that once daily therapy is not-inferioir to continued multiple dosing in terms of proportion of patients with treatment failure.