Effects of Maraviroc vs. Efavirenz on CD4/CD8 Ratio
MeritRate
The Effects of Maraviroc Versus Efavirenz in Combination With Zidovudine/Abacavir on the CD4/CD8 Ratio in Treatment-naïve HIV-infected Individuals
1 other identifier
interventional
721
0 countries
N/A
Brief Summary
A low CD4/CD8 ratio is considered a surrogate marker of immunosenescence and is an independent predictor of non-AIDS-related morbidity and mortality. Given the strong clinical implications the impact of different regimens on the CD4/CD8 ratio recovery needs to be analyzed. The MERIT study is a completed a randomized, double-blind, multicenter phase IIb/III study with an open-label extension phase (240-week follow-up) to assess the efficacy of zidovudine/lamivudine in combination with maraviroc (MVC) or efavirenz (EFV) in treatment-naïve patients. Anonymised patient level data of the MERIT trial to compare the trajectories of the CD4/CD8 ratio of participants treated with maraviroc vs. efavirenz will be used.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2017
CompletedFirst Submitted
Initial submission to the registry
April 7, 2017
CompletedFirst Posted
Study publicly available on registry
June 6, 2017
CompletedSeptember 13, 2023
June 1, 2017
2.1 years
April 7, 2017
September 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in CD4/CD8 ratio
From baseline to week 120
Secondary Outcomes (2)
Change From Baseline in CD8+ T cells
From baseline to week 120
Change From Baseline in CD4/CD8 ratio
From baseline to week 120
Study Arms (3)
Maraviroc (UK-427,857) QD + Zidovudine/Lamivudine BID
EXPERIMENTALMaraviroc (UK-427,857) 300 mg once daily added to Zidovudine/Lamivudine (300 mg/150 mg twice daily). Following a review of the interim analysis data, the DSMB recommended to terminate the UK-427,857 300 mg QD arm based on pre-specified protocol non-inferiority criteria not being met for the QD arm versus efavirenz
Efavirenz QD + Zidovudine/Lamivudine BID
ACTIVE COMPARATOREfavirenz (600 mg once daily) added to Zidovudine/Lamivudine (300 mg/150 mg twice daily
Maraviroc (UK-427,857) BID + Zidovudine/Lamivudine BID
EXPERIMENTALMaraviroc (UK-427,857) 300 mg twice daily added to Zidovudine/Lamivudine (300 mg/150 mg twice daily)
Interventions
maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily
efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily)
maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily
Eligibility Criteria
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Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2017
First Posted
June 6, 2017
Study Start
October 15, 2014
Primary Completion
November 5, 2016
Study Completion
March 7, 2017
Last Updated
September 13, 2023
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share