NCT00466180

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for phase_4 hiv-infections

Timeline
Completed

Started Jun 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
Last Updated

October 28, 2010

Status Verified

October 1, 2010

First QC Date

April 25, 2007

Last Update Submit

October 27, 2010

Conditions

HIV Infections

Keywords

Once-a-dayAdherenceNevirapinePatient noncomplianceAdministration and dosageTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • MEMS adherence by electronic devices

    28-week period (randomized phase)

Secondary Outcomes (4)

  • Virologic efficacy (RNA HIV<400cp/ml)

  • Immunologic efficacy (CD4 count cells)

  • Tolerance (hepatic, cutaneous, ANRS safety grade scale)

  • Pharmacokinetics (nevirapine dosages)

Interventions

Nevirapine from twice-a-day to once-a-dayBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Parienti JJ, Das-Douglas M, Massari V, Guzman D, Deeks SG, Verdon R, Bangsberg DR. Not all missed doses are the same: sustained NNRTI treatment interruptions predict HIV rebound at low-to-moderate adherence levels. PLoS One. 2008 Jul 30;3(7):e2783. doi: 10.1371/journal.pone.0002783.

    PMID: 18665246BACKGROUND

  • Parienti JJ, Massari V, Reliquet V, Chaillot F, Le Moal G, Arvieux C, Vabret A, Verdon R; POSOVIR Study Group. Effect of twice-daily nevirapine on adherence in HIV-1-infected patients: a randomized controlled study. AIDS. 2007 Oct 18;21(16):2217-22. doi: 10.1097/QAD.0b013e3282eff388.

    PMID: 18090049RESULT

MeSH Terms

Conditions

HIV InfectionsPatient Compliance

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Jean-Jacques Parienti, MD

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 25, 2007

First Posted

April 27, 2007

Study Start

June 1, 2004

Study Completion

November 1, 2006

Last Updated

October 28, 2010

Record last verified: 2010-10