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Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With Ccr5 Tropic HIV 1 (MODERN)

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01345630
First received: April 27, 2011
Last updated: February 20, 2014
Last verified: February 2014

April 27, 2011
February 20, 2014
September 2011
August 2013   (final data collection date for primary outcome measure)
The proportion of subjects with plasma HIV 1 RNA <50 copies/mL at Week 48. [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
Number of subjects who meet the primary endpoint.
The proportion of patients with plasma HIV 1 RNA <50 copies/mL at Week 48. [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01345630 on ClinicalTrials.gov Archive Site
  • Safety: Frequency, severity and relationship of adverse events to test drug; serious adverse events; discontinuations due to adverse events; and frequency and severity of abnormal laboratory values. [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]
    Number of subjects who meet the specified endpoint
  • The relationship between the proportion of patients with plasma HIV 1 RNA <50 copies/mL at the Week 48 and Week 96 visits and the screening tropism test (Genotype test or Enhanced Sensitivity Trofile Assay [ESTA]). [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Virologic Response: Proportion of patients with plasma HIV RNA <50 copies/mL at Week 96. [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Immunological Response at Week 48 and Week 96: a.Changes in CD4+ T lymphocyte (CD4) cell counts and percent change from Baseline; b.Changes in CD8+ T lymphocyte (CD8) cell counts and percent change from Baseline; c.Changes in CD4+/CD8+ ratio and [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • changes from Baseline. [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Evolution of viral resistance and tropism change between Screening or Baseline and the time of confirmation of virologic failure or the last on treatment time point: a.HIV 1 tropism (Genotype test) b.For virologic failure with R5 virus, viral [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • resistance to maraviroc (maraviroc treated patients only). c.Viral resistance (Genotype and Phenotype) to nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) and non nucleoside reverse transcriptase inhibitors (NNRTI) [reverse transcriptase [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • inhibitors, RTI] and protease inhibitors (PI). [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Changes in peripheral fat distribution and trunk to limb fat ratio (using Dual Energy X-ray Absorptiometry [DEXA] scan) from Baseline and at Weeks 48 and 96 (107 patients per treatment arm). [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]
  • Changes in bone mineral density (using DEXA scan and serum markers) from Baseline and at Weeks 48 and 96 (107 patients per treatment arm). [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]
  • Safety: Frequency, severity and relationship of adverse events to test drug; serious adverse events; discontinuations due to adverse events; and frequency and severity of abnormal laboratory values. [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]
  • The relationship between the proportion of patients with plasma HIV 1 RNA <50 copies/mL at the Week 48 and Week 96 visits and the screening tropism test (Genotype test or Enhanced Sensitivity Trofile Assay [ESTA]). [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Virologic Response: Proportion of patients with plasma HIV RNA <50 copies/mL at Week 96. [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Immunological Response [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    1. Changes in CD4+ T lymphocyte (CD4) cell counts and percent change from Baseline;
    2. Changes in CD8+ T lymphocyte (CD8) cell counts and percent change from Baseline;
    3. Changes in CD4+/CD8+ ratio and changes from Baseline.
  • Evolution of viral resistance and tropism change between Screening or Baseline and the time of confirmation of virologic failure or the last on treatment time point: [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    1. HIV 1 tropism (Genotype test)
    2. For virologic failure with R5 virus, viral resistance to maraviroc (maraviroc treated patients only).
    3. Viral resistance (Genotype and Phenotype) to nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) and non nucleoside reverse transcriptase inhibitors (NNRTI) [reverse transcriptase inhibitors, RTI] and protease inhibitors (PI).
  • Changes in peripheral fat distribution and trunk to limb fat ratio (using Dual Energy X-ray Absorptiometry [DEXA] scan) from Baseline and at Weeks 48 and 96 (107 patients per treatment arm). [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]
  • Changes in bone mineral density (using DEXA scan and serum markers) from Baseline and at Weeks 48 and 96 (107 patients per treatment arm). [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With Ccr5 Tropic HIV 1
A Multicenter, Randomized, Double Blind, Comparative Trial Of Maraviroc + Darunavir/Ritonavir Versus Emtricitabine/Tenofovir +Darunavir/Ritonavir For The Treatment Of Antiretroviral-Naïve HIV Infected Patients With Ccr5 Tropic HIV 1

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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV-1
  • Drug: Maraviroc
    Maraviroc tablet 150 mg once daily for 96 weeks.
    Other Name: Selzentry, Celsentri
  • Drug: Emtricitabine/tenofovir
    Emtricitabine/tenofovir tablet 200/300 mg once daily for 96 weeks.
    Other Name: Truvada
  • Experimental: Maraviroc
    Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
    Intervention: Drug: Maraviroc
  • Active Comparator: Emtricitabine/tenofovir
    Emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
    Intervention: Drug: Emtricitabine/tenofovir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
804
January 2014
August 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   Denmark,   Finland,   France,   Germany,   Hungary,   Italy,   Netherlands,   Poland,   Portugal,   Puerto Rico,   Spain,   Sweden,   Switzerland,   United Kingdom
 
NCT01345630
A4001095
Yes
ViiV Healthcare
ViiV Healthcare
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
ViiV Healthcare
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP