A Randomized, Multi-center, Open Label Study in Well Controlled Treatment-experienced HIV- Infected Patients to Assess Compliance With a Once-daily Regimen

Bristol-Myers Squibb0 sites120 target enrollmentApril 2004

ConditionsAIDS

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: AIDS
Sponsor: Bristol-Myers Squibb
Enrollment: 120
Primary Endpoint: 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.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2004

End Date

December 2006

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Eligibility 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

Outcomes

Primary Outcomes

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.