At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-blind, Placebo-controlled 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
In Brief
A Phase 3 clinical trial evaluating Raltegravir, Placebo, and 1 other intervention for HIV. Completed, enrolled 61 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Raltegravir 1200 mg (2 tablets x 600mg) once daily plus current ART during 48 weeks from randomization
Placebo (2 tablets of placebo) once daily plus current ART during 48 weeks from randomization.
3-drug antiretroviral treatment including PI/r/c or NNRTI