Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1 (MODERN)

ViiV Healthcare

Status and phase: Terminated; Phase 3

Conditions: HIV-1

Treatments: Drug: placebo for emtricitabine/tenofovir; Drug: Emtricitabine/tenofovir; Drug: Maraviroc; Drug: placebo for maraviroc; Drug: darunavir/ritonavir 800/100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01345630

A4001095

2010-021785-30 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to assess whether maraviroc administered once daily is non-inferior to emtricitabine/tenofovir also administered once daily each in combination with darunavir/ritonavir in the treatment of antiretroviral-naive patients as evaluated at Week 48 of treatment.

Full description

The study was terminated on October 8, 2013 following a preliminary review of the Week 48 primary efficacy data by the study's external independent Data Monitoring Committee (DMC). The DMC assessed the data as demonstrating significant differences between the treatment arms in virologic responses and failures. The DMC recommended and the Sponsor concurred that the study be terminated because of the inferior efficacy of the Maraviroc arm as compared to the comparator arm (Emtricitabine/Tenofovir).

Enrollment: 813 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Plasma HIV-1 RNA equal to or greater than 1,000 copies/mL measured at the Screening Visit.
• CD4 count equal to or greater than 100 cells/mm3 at Screening.
• Have only R5 HIV 1 at Screening as verified by a randomized tropism assay.

Exclusion criteria

• Prior treatment with any other HIV antiretroviral therapy for more than 14 days at any time.
• Any evidence of genotypic/phenotypic resistance to darunavir, tenofovir, and emtricitabine.
• CXCR4 using virus detected using randomized tropism determination or repeated failure to obtain an interpretable tropism result.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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813 participants in 2 patient groups

Maraviroc

Experimental group

Description:

Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.

Treatment:

Drug: placebo for maraviroc

Drug: darunavir/ritonavir 800/100 mg

Drug: Maraviroc

Emtricitabine/tenofovir

Active Comparator group

Description:

Emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.

Treatment:

Drug: placebo for emtricitabine/tenofovir

Drug: Emtricitabine/tenofovir