Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1
NCT01345630
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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.
- 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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Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | 813 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |