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

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.
 
ClinicalTrials.gov Identifier: NCT02557997
Recruitment Status : Unknown
Verified September 2015 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : September 23, 2015
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Tracking Information
First Submitted Date September 14, 2015
First Posted Date September 23, 2015
Last Update Posted Date September 23, 2015
Study Start Date April 2014
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 22, 2015)
Change from baseline in Proviral HIV-1 DNA at Week 48 [ Time Frame: Baseline and 48 weeks post DTG-based regimen initiation ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 22, 2015)
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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Dolutegravir Based Regimen on HIV-1 Reservoir and Immune Activation
Official Title Effects of Dolutegravir Based Regimen on HIV-1 Reservoir and Immune Activation
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients visiting an HIV Infection care center at a university hospital will be selected
Condition HIV-1 Infection
Intervention Other: Blood tube bottom analyses
Study Groups/Cohorts
  • ART-naive (primary infection)
    ART-naive (primary infection) HIV infected adults
    Intervention: Other: Blood tube bottom analyses
  • ART-naïve (chronic infection)
    ART-naïve (chronic infection) HIV infected adults
    Intervention: Other: Blood tube bottom analyses
  • ART-controlled
    ART-controlled HIV infected adults
    Intervention: Other: Blood tube bottom analyses
  • ART-failing
    ART-failing HIV infected adults
    Intervention: Other: Blood tube bottom analyses
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 22, 2015)
202
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2016
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02557997
Other Study ID Numbers 6074
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Strasbourg, France
Study Sponsor University Hospital, Strasbourg, France
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Strasbourg, France
Verification Date September 2015