Impact of Starting a Dolutegravir-based Regimen on HIV-1 Proviral DNA Reservoir Of Treatment Naïve and Experienced Patients

HIV-1 Infection Clinical Trial

— DRONE  

Official title:

Impact of Starting a Dolutegravir-based Regimen on HIV-1 Proviral DNA Reservoir Of Treatment Naïve and Experienced Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02370979
• Other study ID #: 5973
• Status: Recruiting
• Phase: Phase 4
• First received: January 26, 2015
• Last updated: August 6, 2015
• Start date: February 2015
• Est. completion date: July 2017

Study information

• Verified date: August 2015
• Source: University Hospital, Strasbourg, France
• Contact: Samira FAFI-KREMER, PhD
• Phone: +33369551438
• Email: samira.fafi-kremer[@]unistra.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

This is a multi-center prospective study. The primary objective of DRONE study is to investigate the change of the size of HIV-1 DNA reservoir in blood from baseline to week 48 (W48) in participants treated by DTG-based regimen. Secondary objectives include: DTG pharmacokinetic and analysis of biomarkers of immune activation from baseline to W48.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 202
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• 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

• An active AIDS-defining condition at Screening

• 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV-1 Infection

Intervention

Biological:
• Blood samples

Locations

Country	Name	City	State
France	Centre hospitalier de Belfort-Montbéliard	Belfort
France	Centre hospitalier de Colmar	Colmar
France	Centre hospitalier de Mulhouse	Mulhouse Cedex
France	Hôpitaux Universitaire de Strasbourg	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 (Day 0) and Week 48	No
Secondary	Dolutegravir pharmacokinetic (dolutegravir pharmacological blood levels)		Week 4, Week 24 and Week 48	No
Secondary	Quantification of biomarkers of immune activation	CRPus, IL-6, neopterin, D-dimer, CD14s	baseline (Day 0), Week 24 and Week 48	No