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Dolutegravir Impact on Residual Replication

NCT02500446 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-11-20

No results posted yet for this study

Summary

Several studies have suggested that despite suppressive combination antiretroviral therapy (ART) in people who are HIV-positive, in some individuals there may be on-going viral replication. Clarifying the extent of on-going viral replication on ART is important for the development of HIV-1 curative strategies and for reducing HIV-1 associated immune activation. The investigators hypothesize that treatment intensification with dolutegravir will inhibit residual virus replication in HIV-1 infected patients on ART. The primary objective of this study is to determine the effects of dolutegravir intensification on residual virus replication in circulating cluster of differentiation 4 (CD4+) T cells.

Conditions

Interventions

DRUG

dolutegravir

Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir.

OTHER

Placebo

A film-coated tablet identical in appearance to the active drug tablet but not containing any dolutegravir or any other active ingredient

Sponsors & Collaborators

Principal Investigators

  • Sharon Lewin · Doherty Institute for Immunity and Infection

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-28
Primary Completion
2016-09-16
Completion
2017-09-30

Countries

  • Australia

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02500446 on ClinicalTrials.gov