drugset / Trial / NCT03178084
Effects of Maraviroc vs. Efavirenz on CD4/CD8 Ratio
Phase 3
Completed
721 enrolled
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2014-10-15
- Primary completion
- 2016-11-05
- Completion
- 2017-03-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Efavirenz | Other / unclassified | 600 mg | — |
| Subject | Maraviroc | Other / unclassified | 300 mg | — |
| Background | Lamivudine | Other / unclassified | 150 mg | — |
| Background | Zidovudine | Small molecule | 300 mg | — |