NCT02557997

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
202

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

2.4 years

First QC Date

September 14, 2015

Last Update Submit

September 22, 2015

Conditions

HIV-1 Infection

Keywords

HIV reservoirHIV-1 DNAImmune activationMonocyte functionActivation biomarkers

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Proviral HIV-1 DNA at Week 48

    Baseline and 48 weeks post DTG-based regimen initiation

Secondary Outcomes (1)

  • Quantification of biomarkers of immune activation

    Baseline, 24 and 48 weeks post DTG-based regimen initiation

Study Arms (4)

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

Interventions

Blood tube bottom analysesOTHER
ART-controlledART-failingART-naive (primary infection)ART-naïve (chronic infection)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Strasbourg - Trait d'Union

Strasbourg, 67091, France

RECRUITING

Related Publications (2)

  • Gantner P, Barnig C, Partisani M, Lee GQ, Beck-Wirth G, Faller JP, Martinot M, Mosheni-Zadeh M, Cheneau C, Batard ML, Fischer P, Fuchs A, Uring-Lambert B, Bahram S, Rey D, Fafi-Kremer S. Distribution and reduction magnitude of HIV-DNA burden in CD4+ T cell subsets depend on art initiation timing. AIDS. 2018 Apr 24;32(7):921-926. doi: 10.1097/QAD.0000000000001770.

    PMID: 29424775DERIVED

  • Gantner P, Lee GQ, Rey D, Mesplede T, Partisani M, Cheneau C, Beck-Wirth G, Faller JP, Mohseni-Zadeh M, Martinot M, Wainberg MA, Fafi-Kremer S. Dolutegravir reshapes the genetic diversity of HIV-1 reservoirs. J Antimicrob Chemother. 2018 Apr 1;73(4):1045-1053. doi: 10.1093/jac/dkx475.

    PMID: 29244129DERIVED

Central Study Contacts

Samira FAFI-KREMER, PhD

CONTACT

samira.fafi-kremer@unistra.fr

Pierre GANTNER, PhD

CONTACT

pierre.gantner@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2015

First Posted

September 23, 2015

Study Start

April 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

FR(1)