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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
History of Changes
  Purpose
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.

Condition Intervention Phase
AIDS
 Behavioral: Compliance
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Multi-center, Open Label Study in Well Controlled Treatment-experienced HIV- Infected Patients to Assess Compliance With a Once-daily Regimen

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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:
  • To demonstrate that once daily therapy is not-inferioir to continued multiple dosing in terms of proportion of patients with treatment failure.
Estimated Enrollment: 120
Study Start Date: April 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207168

Sponsors and Collaborators
Bristol-Myers Squibb
Merck Sharp & Dohme Corp.
Dohme Australia
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

ClinicalTrials.gov Identifier: NCT00207168     History of Changes
Other Study ID Numbers: AI454-194  The TEddI Study 
Study First Received: September 12, 2005
Last Updated: April 8, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

ClinicalTrials.gov processed this record on September 28, 2016