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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jean-Jacques Parienti, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

References

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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.

Reference Type BACKGROUND

PMID: 18665246 (View on PubMed)

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.

Reference Type RESULT

PMID: 18090049 (View on PubMed)

Other Identifiers

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POSOVIR

Identifier Type: -

Identifier Source: org_study_id