## Protocol Section
### Identification Module
**NCT ID:** NCT02370979

**Acronym:** DRONE

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

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

#### Organization Study ID Info
**ID:** 5973
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Strasbourg, France
### Status Module
#### Completion Date
**Date:** 2017-07

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2015-08-07

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-08-06

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2017-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2015-02

**Status Verified Date:** 2015-08

#### Study First Post Date
**Date:** 2015-02-25
**Type:** ESTIMATED
**Study First Submit Date:** 2015-01-26
**Study First Submit QC Date:** 2015-02-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Strasbourg, France

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- HIV-1 Infection

**Keywords:**

- Dolutegravir

- Proviral HIV-1 DNA

- Reservoir

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 202

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Biological: Blood samples

**Label:** Dolutegravir

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dolutegravir

**Name:** Blood samples

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Change from baseline in Proviral HIV-1 DNA at Week 48

**Time Frame:** baseline (Day 0) and Week 48

#### Secondary Outcomes

**Measure:** Dolutegravir pharmacokinetic (dolutegravir pharmacological blood levels)

**Time Frame:** Week 4, Week 24 and Week 48

**Description:** CRPus, IL-6, neopterin, D-dimer, CD14s

**Measure:** Quantification of biomarkers of immune activation

**Time Frame:** baseline (Day 0), Week 24 and Week 48

### Eligibility Module

**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
* 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

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** samira.fafi-kremer@unistra.fr

**Name:** Samira FAFI-KREMER, PhD

**Phone:** +33369551438

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Belfort

**Country:** France

**Facility:** Centre hospitalier de Belfort-Montbéliard

**Status:** ACTIVE_NOT_RECRUITING

**Zip:** 90000

**Location 2:**

**City:** Colmar

**Contacts:**

***Contact 1:***

- **Email:** martin.martinot@ch-colmar.fr

- **Name:** Martin MARTINOT, MD

- **Role:** CONTACT

**Country:** France

**Facility:** Centre hospitalier de Colmar

**Status:** RECRUITING

**Zip:** 68024

**Location 3:**

**City:** Mulhouse Cedex

**Contacts:**

***Contact 1:***

- **Email:** beck-wirthg@ch-mulhouse.fr

- **Name:** Geneviève BECK WIRTH, MD

- **Role:** CONTACT

**Country:** France

**Facility:** Centre hospitalier de Mulhouse

**Status:** RECRUITING

**Zip:** 68070

**Location 4:**

**City:** Strasbourg Cedex

**Contacts:**

***Contact 1:***

- **Email:** david.rey@chru-strasbourg.fr

- **Name:** David REY, PhD

- **Role:** CONTACT

**Country:** France

**Facility:** Hôpitaux Universitaire de Strasbourg

**Status:** RECRUITING

**Zip:** 67091

#### Overall Officials

**Official 1:**

**Affiliation:** Hôpitaux Universitaires de Strasbourg

**Name:** David REY, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3522

- Name: Acquired Immunodeficiency Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M18250

- Name: HIV Infections

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M347662

- Name: Dolutegravir

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
