Effects of Dolutegravir Based Regimen on HIV-1 Reservoir and Immune Activation

September 22, 2015 updated by: University Hospital, Strasbourg, France
We aim at comparing markers of HIV reservoir, monocyte function and immune activation between antiretroviral therapy (ART)-naïve (chronic infection or primary infection), ART-controlled or ART-failing HIV infected adults initiating a dolutegravir (DTG)-based regimen. The investigators' purpose is to measure cell associated HIV-1 DNA, monocyte function [soluble CD14 (sCD14), soluble CD163 (sCD163)], and immune activation [neopterine, interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hsCRP)] biomarkers at different time points between baseline and week 48 post DTG-based regimen initiation in each group.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients visiting an HIV Infection care center at a university hospital will be selected

Description

Inclusion Criteria:

  • Male or female aged from de 18 to 80 years
  • Patient starting a DTG-regimen
  • Patients agreeing to use methods of birthcontrol while on the study and during the 6 weeks after stopping DTG treatment
  • Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • HBV or HCV coinfection
  • Participation in another clinical drug or device trial where the last dose of drug was within the past 30 days or an investigational medical device is currently implanted
  • Documented resistance to DTG
  • Allergy or intolerance to the study drugs or their components or drugs of their class
  • Any acute or verified Grade 4 laboratory abnormality (with the exception of Grade 4 lipids) at Screening.
  • Coadministration with Dofelitide

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ART-naive (primary infection)
ART-naive (primary infection) HIV infected adults
Other: Blood tube bottom analyses
ART-naïve (chronic infection)
ART-naïve (chronic infection) HIV infected adults
Other: Blood tube bottom analyses
ART-controlled
ART-controlled HIV infected adults
Other: Blood tube bottom analyses
ART-failing
ART-failing HIV infected adults
Other: Blood tube bottom analyses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Proviral HIV-1 DNA at Week 48
Time Frame: Baseline and 48 weeks post DTG-based regimen initiation
Baseline and 48 weeks post DTG-based regimen initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of biomarkers of immune activation
Time Frame: Baseline, 24 and 48 weeks post DTG-based regimen initiation
Soluble CD14 (sCD14), soluble CD163 (sCD163), neopterine, interleukin-6 (IL-6), high-sensitivity C-reactive protein (hsCRP)
Baseline, 24 and 48 weeks post DTG-based regimen initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

September 14, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (Estimate)

September 23, 2015

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 6074

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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