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

NCT01345630

Last updated date
Study Location
University of Alabama at Birmingham - 1917 Research Clinic
Birmingham, Alabama, 35294, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV-1
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Comparative Trial Of Maraviroc + Darunavir/Ritonavir Versus Emtricitabine/Tenofovir + Darunavir/Ritonavir For The Treatment Of Antiretroviral-Naive Hiv-Infected Patients With Ccr5-Tropic Hiv-1
Brief Summary 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.
Detailed 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE HIV-1
Intervention  ICMJE
  • 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
  • Drug: darunavir/ritonavir 800/100 mg
    darunavir/ritonavir 800/100 mg
  • Drug: placebo for emtricitabine/tenofovir
    placebo for emtricitabine/tenofovir
    Other Name: Truvada
  • Drug: placebo for maraviroc
    placebo for maraviroc
    Other Name: Selzentry, Celsentri
Study Arms  ICMJE
  • Experimental: Maraviroc
    Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
    Interventions:
    • Drug: Maraviroc
    • Drug: darunavir/ritonavir 800/100 mg
    • Drug: placebo for 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.
    Interventions:
    • Drug: Emtricitabine/tenofovir
    • Drug: placebo for emtricitabine/tenofovir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 11, 2015)
813
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2011)
804
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   Denmark,   Finland,   France,   Germany,   Hungary,   Italy,   Netherlands,   Poland,   Portugal,   Puerto Rico,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries Mexico
 
Administrative Information
NCT Number  ICMJE NCT01345630
Other Study ID Numbers  ICMJE A4001095
2010-021785-30 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ViiV Healthcare
Study Sponsor  ICMJE ViiV Healthcare
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account ViiV Healthcare
Verification Date December 2015

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