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Clinical Trials/NCT00466180
NCT00466180
Completed
Phase 4

Adherence, Efficacy and Tolerance of Once-a-day Nevirapine-based Regimen in HIV-1 Infected Patients

University Hospital, Caen0 sites62 target enrollmentJune 2004
ConditionsHIV Infections

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
HIV Infections
Sponsor
University Hospital, Caen
Enrollment
62
Primary Endpoint
MEMS adherence by electronic devices
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

Taking antiretrovirals once-a-day is considered the simpler way to improve adherence. However, it is not know if this assertion apply to patients taking their medication twice-a-day who change to once-a-day.

We hypothesized that once-daily dosing improves adherence.

Registry
clinicaltrials.gov
Start Date
June 2004
End Date
November 2006
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • HIV-1 infected adults receiving antiretroviral therapy including nevirapine twice-a-day for at least 6 months
  • plasma HIV RNA\<400 cp/ml during the previous 4 months on 2 occasions
  • accept adherence electronic monitoring
  • written informed consent signed

Exclusion Criteria

  • asparate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5N if hepatitis virus B or C were negative
  • AST or ALT\>1.25N if hepatitis virus B or C were positive

Outcomes

Primary Outcomes

MEMS adherence by electronic devices

Time Frame: 28-week period (randomized phase)

Secondary Outcomes

  • Virologic efficacy (RNA HIV<400cp/ml)
  • Immunologic efficacy (CD4 count cells)
  • Tolerance (hepatic, cutaneous, ANRS safety grade scale)
  • Pharmacokinetics (nevirapine dosages)

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