drugset / Trial / NCT03029689
Clinical Trial to Evaluate the Effect of Raltegravir Intensification (1.200 mg QD) on the Gut Microbiota of Chronically HIV-1 Infected Subject Over Time: THE RAGTIME STUDY
Phase 3
Completed
61 enrolled
Fight AIDS and Infectious Diseases Foundation
Merck Sharp & Dohme LLC · collab
RandomizedParallel-groupDouble-blindBasic science
Summary
The project presented here will be the first prospective, randomized evaluation of the effect of ART on the structure and function of the gut microbiome. This study provides a unique opportunity to understand the benefits of ART with high intestinal penetration on the gut microbiome. It is thus a key study to understand the bidirectional interactions between the microbiome and the host in people living with HIV/AIDS.
Timeline
- Start
- 2017-07-28
- Primary completion
- 2020-04-30
- Completion
- 2020-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Raltegravir | Other / unclassified | 1200 mg | — |