Study of Darunavir/r + Tenofovir/Emtricitabine vs. Darunavir/r + Raltegravir in HIV-infected Antiretroviral naïve Subjects

Phase 3

Completed

• Conditions: HIV Infections
• Interventions: Drug: darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination); Drug: darunavir/ritonavir QD + raltegravir BID

• Registration Number: NCT01066962
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief Summary

The triple therapy darunavir/r + tenofovir/emtricitabine is likely to become a relevant first-line treatment option in the years to come. The dual combination of boosted darunavir + raltegravir is an innovative treatment option that combines two potent new antiretroviral drugs, one of which belongs to a new drug class (integrase inhibitor). The expected efficacy profile of this combination is promising. Moreover, this combination might have a better tolerance profile and has the advantage of sparing the NRTI class.

In the context of tenofovir/emtricitabine currently being a reference backbone in first-line antiretroviral regimens, we hypothesise that, in combination with darunavir/r, raltegravir may be an alternative option if its efficacy is non-inferior to tenofovir/emtricitabine.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-09
• Study First Submitted QC: 2010-02-09
• Study First Posted: 2010-02-10
• Study Start: 2010-08
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-05
• Last Update Posted: 2013-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• Patient with confirmed HIV infection
• Age ≥ 18 years
• Written informed consent
• Male patient or non-pregnant, non-lactating female
• No previous treatment with any antiretroviral drugs
• HIV-1 RNA > 1000 copies/ml
• Indication to start an antiretroviral treatment as long as subject has also a CD4 cell count ≤ 500/mm3 either at screening or on a sample taken within 3 months before screening
• No major IAS-USA mutations on genotypic testing at the screening visit or on any historical genotype, if available

Non-inclusion Criteria:

• Woman without effective contraception method (recommended contraception during the trial is mechanical + a second method other than an oral contraceptive)
• Pregnant or breastfeeding woman
• Woman expecting to conceive during the study
• HIV-2 co-infection
• Creatinine clearance < 60 ml/mn (Cockcroft & Gault equation), alkaline phosphatase, ASAT, or ALAT ≥ 5 ULN
• Patient with significant impairment of hepatic function, defined as serum albumin < 2.8 g/dl or INR > 1.7 or presence of ascites, in the absence of another explanation for the abnormal finding
• CD4 > 500/mm3 at screening, except in case of symptomatic HIV disease (defined by conditions qualifying for CDC category B or C) or CD4 ≤ 500/mm3 on a sample taken within 3 months before screening.
• Any major IAS-USA mutation conferring resistance to one or more of reverse transcriptase or protease inhibitors on genotypic testing at screening
• Mycobacteriosis under treatment
• Malignancy requiring chemotherapy or radiotherapy
• Positive HBs Ag
• HCV infection for which specific treatment is ongoing or planned during the first year on trial treatment
• Known hypersensitivity to one of the trial drugs or its excipients
• Contraindicated concomitant treatment
• Anticipated non-compliance with the protocol
• Participation in another clinical trial with an on-going exclusion period at screening
• Subject under legal guardianship or incapacitation
• Subject, who in the opinion of the investigator, is unable to complete the study period

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
darunavir/r + tenofovir/emtricitabine	darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination)	-
darunavir/r + raltegravir	darunavir/ritonavir QD + raltegravir BID	-

Primary Outcome Measures

Name	Time	Method
Time to virologic or clinical failure, as the first occurrence of one of six protocol-defined components	minimum 2 years

Trial Locations

Locations (77)

Allgemeines Krankenhaus der Stadt Wien; 🇦🇹 Wien, Austria

Otto Wagner Spital mit Pflegezentrum; 🇦🇹 Wien, Austria

ITZ Antwerpen; 🇧🇪 Antwerpen, Belgium

CHU Saint Pierre; 🇧🇪 Brussels, Belgium

UZ Gent; 🇧🇪 Gent, Belgium

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark

Hôpital Pellegrin; 🇫🇷 Bordeaux, France

Hôpital Saint André; 🇫🇷 Bordeaux, France

Hôpital Henri Mondor; 🇫🇷 Créteil, France

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