Study of Protease Inhibitor Regimen Switch in HIV-1 Infected Patients With Undetectable Viral Load to Prove the Non-inferiority of Once Daily Dose Regimen Versus the Current Twice Daily Regimen to Maintain the Viral Load Under the Limit of Detection.

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-09-30

Brief Summary

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Darunavir boosted with ritonavir (darunavir/r) is a powerful protease inhibitor, able to reduce the viral load in patients infected with multi-resistant HIV strains; In vitro and in vivo studies have shown that the induction of resistance mutations in the protease gene is much more difficult with the association darunavir/r compared to the other ritonavir-boosted protease inhibitors (PI/r), testifying of a significantly higher genetic barrier to resistance. Moreover, the tolerance to darunavir is good, and the pharmacologic profile of this molecule allows a once daily administration with a 800/100 mg dose in patients infected with a wild HIV strain or with a slightly resistant to darunavir/r strain.

Thus, we propose to evaluate the efficacy of the darunavir/r association once daily as a substitute to a protease inhibitor regimen administered twice daily in patients with undetectable viral load receiving a tritherapy including a protease inhibitor administered twice daily.

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Detailed Description

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Conditions

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HIV-1 Infection HIV Infections

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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Darunavir/r

Group Type EXPERIMENTAL

darunavir

Intervention Type DRUG

darunavir/r 800/100 mg once daily by oral route, 48 weeks of treatment

Interventions

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darunavir

darunavir/r 800/100 mg once daily by oral route, 48 weeks of treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HIV-1 infected patients
* Treatment with an association of 3 molecules including two Nucleotidic Reverse Trasncriptase Inhibitors and a ritonavir-boosted protease inhibitor BID, unchanged for at least one month
* At least two documented undetectable viral loads (under 50 copies/ml) within the last 3 months
* Naiive from darunavir
* Free from any opportunistic infection
* Creatinin \< 3N
* ASAT \& ALAT \< 5N
* Haemoglobin \> 7 g/dl
* Platelets \> 50 000/mm3
* Negative pregnancy test for women of childbearing potential and use of a mechanic contraceptive during sexual relationships
* Signed informed consent

* Patients with a documented problem of treatment compliance within the last 12 months
* Ongoing active treatment against any opportunistic infection or tuberculosis
* Any critic concomitant condition (alcohol consumption, fatigue) that may jeopardize treatment compliance and/olr tolerance, and interfere with the protocol compliance
* Any concomitant treatment that may potentialize or inhibit hepatic cyotchrome-based enzymes
* Patient already treated with darunavir
* Patient treated with tipranavir, enfuvirtide, raltegravir, etravirine, and/or maraviroc