Clinical trial

The Effects of Maraviroc Versus Efavirenz in Combination With Zidovudine/Abacavir on the CD4/CD8 Ratio in Treatment-naïve HIV-infected Individuals

Name
MeritRate
Description
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 arms
Trial start
2014-10-15
Estimated PCD
2016-11-05
Trial end
2017-03-07
Status
Completed
Phase
Early phase I
Treatment
Maraviroc (UK-427,857) QD + Zidovudine/Lamivudine BID
maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily
Arms:
Maraviroc (UK-427,857) QD + Zidovudine/Lamivudine BID
Efavirenz QD + Zidovudine/Lamivudine BID
efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily)
Arms:
Efavirenz QD + Zidovudine/Lamivudine BID
Maraviroc (UK-427,857) BID + Zidovudine/Lamivudine QD
maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily
Arms:
Maraviroc (UK-427,857) BID + Zidovudine/Lamivudine BID
Size
721
Primary endpoint
Change From Baseline in CD4/CD8 ratio
From baseline to week 120
Eligibility criteria
All patients analysed in the Merit trial (Cooper, JAIDS 2010)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 721, 'type': 'ACTUAL'}}
Updated at
2023-09-13

1 organization

3 products

1 indication

Indication
HIV/AIDS
Product
Maraviroc