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Measure of Pharmacokinetic Parameters and Adherence With MEMS in Naive HIV Infected Patients Treated With Reyataz Once Daily Combined With Norvir and Truvada

NCT ID: NCT00528060

Last Updated: 2011-12-22

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

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-11-30

Brief Summary

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the trial assessed the pharmacokinetics and long term plasma exposure of the following antiretrovirals: atazanavir when combined to ritonavir and the tenofovir/emtricitabine fixed-dose combination. All drugs will be delivered in MEMS electronic device to monitor dosing history.

Detailed Description

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The trial is a phase II, open label, non-randomized, prospective multicenter trial to assess the pharmacokinetics and long term plasma exposure of the following antiretrovirals: atazanavir when combined to ritonavir and the tenofovir/emtricitabine fixed-dose combination. All drugs will be delivered in MEMS electronic device to monitor dosing history.

Conditions

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HIV Infections

Keywords

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HIV infections atazanavir Pharmacokinetics Treatment Naive

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Atazanavir

2pills/day

Intervention Type DRUG

Ritonavir

1 pill/day

Intervention Type DRUG

Tenofovir/emtricitabine

1 pill/day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Naïve of treatment HIV -1 infected patients
* CD4 above 100/mm3

Exclusion Criteria

* pregnancy
* renal failure
* hepatitic disease
* ongoing opportunistic disease
* Hb under 8g/dl; platelets under 50 000/mm3; neutrophils under 750/mm3; Prothrombin index under 80%, Ca or Ph \> 2.5 N
* drugs interacting with investigational drugs
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Gilead Sciences

INDUSTRY

Sponsor Role collaborator

French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cécile Goujard, MD

Role: PRINCIPAL_INVESTIGATOR

AP-HP Kremlin-Bicetre

France Mentre, PHD

Role: STUDY_DIRECTOR

AP-HP Bichat, Inserm U738

Locations

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Hopital du Kremlin Bicêtre Service de médecine interne

Kremlin Bicëtre, , France

Site Status

Hopital Bichat CIC

Paris, , France

Site Status

Countries

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France

References

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Parienti JJ, Barrail-Tran A, Duval X, Nembot G, Descamps D, Vigan M, Vrijens B, Panhard X, Taburet AM, Mentre F, Goujard C. Adherence profiles and therapeutic responses of treatment-naive HIV-infected patients starting boosted atazanavir-based therapy in the ANRS 134-COPHAR 3 trial. Antimicrob Agents Chemother. 2013 May;57(5):2265-71. doi: 10.1128/AAC.02605-12. Epub 2013 Mar 4.

Reference Type DERIVED
PMID: 23459496 (View on PubMed)

Other Identifiers

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2007-003203-12

Identifier Type: -

Identifier Source: org_study_id