Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00990600
NCT00990600
Completed
Phase 3

Adherence to a One Pill, Once-a-day Antiretroviral Regimen

A.O. Ospedale Papa Giovanni XXIII0 sites212 target enrollmentApril 2008
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsHIV InfectionHIV Infections

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
HIV Infection
Sponsor
A.O. Ospedale Papa Giovanni XXIII
Enrollment
212
Primary Endpoint
Proportion of adherence to HAART
Status
Completed
Last Updated
16 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

Primary objective of the study is:

To verify if simplification of the antiretroviral regimen, measured as the reduction of pill burden alone, may affect adherence rate of patients.

Registry
clinicaltrials.gov
Start Date
April 2008
End Date
May 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
A.O. Ospedale Papa Giovanni XXIII

Eligibility Criteria

Inclusion Criteria

  • •Age \> 18 years
  • •Informed consent signed
  • •Effective ongoing treatment (HIV-RNA \< 50 copies/ml) for at least three months
  • •Being on a stable HAART regimen based either on two possible drug associations:
  • •3TC/FTC + TDF + EFV
  • •FTC/TDF (fixed dose combination) + EFV
  • •No previous documented virologic failure

Exclusion Criteria

  • •Childbearing or breastfeeding. Women of childbearing potential will be asked to adopt effective contraceptive methods or behaviours
  • •Any ongoing grade 4 laboratory abnormality

Outcomes

Primary Outcomes

Proportion of adherence to HAART

Time Frame: 6 months

Secondary Outcomes

  • QoL (VAS scale) preferences of patients virologic and immunologic outcomes(6 months)

Similar Trials

Completed
Not Applicable
Managing MedicationsHIV Infections
NCT00222716University of Pittsburgh349
Completed
Not Applicable
Adherence Support Intervention for Persons Living With HIV/AIDS (PLWHA) on Antiretroviral Therapy (ART) in EstoniaHIVAIDSMedication Adherence
NCT01789138University of Tartu519
Completed
Phase 2
Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV InfectionHIV Infections
NCT00959894University of North Carolina, Chapel Hill80
Completed
Phase 4
Adherence, Efficacy and Tolerance of Once-a-day Nevirapine-based Regimen in HIV-1 Infected PatientsHIV Infections
NCT00466180University Hospital, Caen62
Unknown
Phase 4
Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France: Trial IMEA 055 - FASTHIV Seropositivity
NCT03858478Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba110