## Protocol Section
### Identification Module
**NCT ID:** NCT06421259

**Brief Title:** Descriptive Analysis of Changes in Hepatitis B Markers in People Living With HIV on Injectable Therapy.

**Official Title:** To Switch or Not to Switch to CAB/RPV in PLWH With Past HBV Infection? Risk of HBV Reactivation? A Need for New HBV Markers?

#### Organization Study ID Info
**ID:** 24Infectio01
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire de Nice
### Status Module
#### Completion Date
**Date:** 2026-05-20

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-05-20

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Centre Hospitalier Universitaire de Nice

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** In order to assess the risk of hepatitis B reactivation in people living with HIV and undergoing injection therapy, we propose to carry out a descriptive analysis of the evolution of hepatitis B markers in this population.

### Conditions Module

**Conditions:**

- Hiv Infection

- Hepatitis B

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 15

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** HIV infected patients under injectable ART

**Label:** HIV infected patients under injectable ART

### Outcomes Module

#### Primary Outcomes

**Description:** HBV serology, DNA HBV levels

**Measure:** Risk of HBV reactivation under injectable HIV ART

**Time Frame:** From start of injectable HIV treatment to hepatitis B reactivation, assessed up to 24 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

-HIV infected patients under injectable ART

Exclusion Criteria:

-Active HBV infection

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** HIV infected patients attending care in the infectiious disease department of the Universitary Hospital of Nice

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** naqvi.a@chu-nice.fr

**Name:** Alissa NAQVI

**Phone:** 492035468

**Phone Ext:** +33

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Nice

**Contacts:**

***Contact 1:***

- **Email:** naqvi.a@chu-nice.fr

- **Name:** naqvi.a@chu-nice.fr NAQVI

- **Phone:** 0492035468

- **Phone Ext:** +33

- **Role:** CONTACT

***Contact 2:***

- **Email:** naqvi.a@chu-nice.fr

- **Name:** Alissa NAQVI

- **Phone:** 0492035468

- **Phone Ext:** +33

- **Role:** CONTACT

**Country:** France

**Facility:** CHU NiICE

**State:** Alpes Maritimes

**Zip:** 0600

#### Overall Officials

**Official 1:**

**Affiliation:** Centre Hospitalier Universitaire de Nice

**Name:** Alissa NAQVI

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000006525

- Term: Hepatitis, Viral, Human

- ID: D000014777

- Term: Virus Diseases

- ID: D000004769

- Term: Enterovirus Infections

- ID: D000010850

- Term: Picornaviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000018347

- Term: Hepadnaviridae Infections

- ID: D000004266

- Term: DNA Virus Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC06

- Name: Digestive System Diseases

- 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: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9592

- Name: Hepatitis A

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9591

- Name: Hepatitis

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9595

- Name: Hepatitis B

- Relevance: HIGH

- As Found: Hepatitis B

- ID: M3522

- Name: Acquired Immunodeficiency Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M18250

- Name: HIV Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9610

- Name: Hepatitis, Viral, Human

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7930

- Name: Enterovirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M13745

- Name: Picornaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M20487

- Name: Hepadnaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M7442

- Name: DNA Virus Infections

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000006506

- Term: Hepatitis A

- ID: D000006509

- Term: Hepatitis B

- ID: D000006505

- Term: Hepatitis

### Misc Info Module

- Version Holder: 2024-05-31
