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QoL and Adherence to One-pill Once-a-day HAART

NCT ID: NCT00990600

Last Updated: 2009-10-29

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

PHASE3

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infection HIV Infections

Keywords

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adherence Qol virologic efficacy immunologic efficacy patients' preference once-daily HAART treatment experienced

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Simplified one pill regimen

Fixed dose combination of tenofovir + emtricitabine + efavirenz

Group Type EXPERIMENTAL

reduced number of pills

Intervention Type OTHER

Switch to a fixed dose combination one pill/daily HAART

Interventions

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reduced number of pills

Switch to a fixed dose combination one pill/daily HAART

Intervention Type OTHER

Other Intervention Names

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efavirenz EFV emtricitabine FTC tenofovir TDF

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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A.O. Ospedale Papa Giovanni XXIII

OTHER

Sponsor Role lead

Responsible Party

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Divisione di Malattie Infettive, Ospedali Riuniti, Bergamo

Principal Investigators

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Franco Maggiolo, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedali Riuniti, Bergamo

Other Identifiers

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EUDRACT NUMBER: 2007-007839-33

Identifier Type: -

Identifier Source: secondary_id

ADONE

Identifier Type: -

Identifier Source: org_study_id