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

HIV-1 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02557997
• Other study ID #: 6074
• Status: Recruiting
• Phase: N/A
• First received: September 14, 2015
• Last updated: September 22, 2015
• Start date: April 2014
• Est. completion date: September 2016

Study information

• Verified date: September 2015
• Source: University Hospital, Strasbourg, France
• Contact: Samira FAFI-KREMER, PhD
• Email: samira.fafi-kremer[@]unistra.fr
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 202
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV-1 Infection

Intervention

Other:
• Blood tube bottom analyses

Locations

Country	Name	City	State
France	Hôpitaux Universitaires de Strasbourg - Trait d'Union	STRASBOURG Cedex

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Proviral HIV-1 DNA at Week 48		Baseline and 48 weeks post DTG-based regimen initiation	No
Secondary	Quantification of biomarkers of immune activation	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	No