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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02557997
First Posted: September 23, 2015
Last Update Posted: September 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
  Purpose
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.

Condition Intervention
HIV-1 Infection Other: Blood tube bottom analyses

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Dolutegravir Based Regimen on HIV-1 Reservoir and Immune Activation

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

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

Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 202
Study Start Date: April 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients visiting an HIV Infection care center at a university hospital will be selected
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557997


Contacts
Contact: Samira FAFI-KREMER, PhD samira.fafi-kremer@unistra.fr
Contact: Pierre GANTNER, PhD pierre.gantner@chru-strasbourg.fr

Locations
France
Hôpitaux Universitaires de Strasbourg - Trait d'Union Recruiting
STRASBOURG Cedex, France, 67091
Contact: David REY, MD       david.rey@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
  More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02557997     History of Changes
Other Study ID Numbers: 6074
First Submitted: September 14, 2015
First Posted: September 23, 2015
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by University Hospital, Strasbourg, France:
HIV reservoir
HIV-1 DNA
Immune activation
Monocyte function
Activation biomarkers

Additional relevant MeSH terms:
Dolutegravir
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents