CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Dolutegravir 50 MGdrug
Likely dose
Dolutegravir 50 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05351684
NCT05351684Phase 2Completed

Effect of Dolutegravir Intensification on Blood and Tissue Latent HIV-1 Reservoirs and on Residual Viremia Despite ART

University of Liege·interventional·Posted Apr 28, 2022·Updated Dec 15, 2022

In Brief

A Phase 2 clinical trial evaluating Dolutegravir 50 MG for HIV-1-infection. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Persistent HIV viremia occurs in most ART-treated patients and could arise from reactivation of viral expression from latently-infected cells that constitute the viral latent reservoir (LR) and/or residual ongoing viral replication during cART, for instance in anatomical compartment where drug penetration is sub-optimal. The question of the sources of persistent viremia is of the utmost importance. If ongoing viral replication occurs, it could induce deleterious consequences on reservoirs size and immune activation.We propose to better characterize the role ongoing viral replication to HIV persistence under ART by undertaking a treatment intensification trial with high-dose dolutegravir. Tissue/blood samples and replication-competent reservoir measurements will be included as outcomes as well as immune activation markers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1-infection
CountriesBelgium
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedApr 28, 2022
Enrollment StartJan 1, 2019
Primary CompletionAug 28, 2022
Study CompletionDec 13, 2022
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 4.2 years ago

Interventions

Dolutegravir 50 MGdrug

already included in arm/group descriptions.