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

An Open-label Randomised Two-year Trial Comparing Two First-line Regimens in HIV-infected Antiretroviral naïve Subjects: Darunavir/r + Tenofovir/Emtricitabine vs. Darunavir/r + Raltegravir (ANRS 143/NEAT 001)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01066962
Acronym
ANRS 143
Enrollment
800
Registered
2010-02-10
Start date
2010-08-31
Completion date
2013-10-31
Last updated
2013-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV-infected antiretroviral naïve subjects

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.

Interventions

DRUGdarunavir/ritonavir QD + raltegravir BID

darunavir 800 mg, i.e. 2 tablets of 400 mg once daily (QD) ritonavir 100 mg, 1 tablet once daily (QD) raltegravir 400 mg, 1 tablet twice daily (BID)

DRUGdarunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination)

darunavir 800 mg, i.e. 2 tablets of 400 mg once daily (QD) ritonavir 100 mg, 1 tablet once daily (QD) tenofovir/emtricitabine 245/200 mg, fixed dose combination, 1 tablet once daily (QD)

Sponsors

NEAT - European AIDS Treatment Network
CollaboratorOTHER
ANRS, Emerging Infectious Diseases
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Time to virologic or clinical failure, as the first occurrence of one of six protocol-defined componentsminimum 2 years

Countries

Austria, Belgium, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Spain, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026