## Protocol Section
### Identification Module
**NCT ID:** NCT06424964

**Brief Title:** Use of Long-Acting Injectable Cabotegravir/Rilpivirine for the Treatment of HIV in Belgium

**Official Title:** Use of Long-Acting Injectable Cabotegravir/Rilpivirine for the Treatment of HIV in Belgium

#### Organization Study ID Info
**ID:** 2024/1-12
#### Organization
**Class:** OTHER
**Full Name:** Belgian Research on AIDS and HIV Consortium
### Status Module
#### Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-11

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Belgian Research on AIDS and HIV Consortium

#### Responsible Party

**Investigator Affiliation:** Belgian Research on AIDS and HIV Consortium

**Investigator Full Name:** Rakan Nasreddine

**Investigator Title:** Head of Research

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This will be a multi-center, single arm observational cohort study with an assessment of patient-reported outcomes (PROs) and of clinical and virologic outcomes.

Primary outcome • Evaluate patient perception of, and satisfaction with, long-acting injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) for the treatment of HIV

Secondary outcomes

• Description of the demographic, HIV-, and non-HIV-related characteristics of participants included in this analysis

### Conditions Module

**Conditions:**

- Human Immunodeficiency Virus

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 600

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Participants will be asked to complete a 32-item paper questionnaire relating to their HIV treatment of LAI CAB/RPV. Questions will focus on how their daily life and quality of life has been affected by switching to LAI CAB/RPV. The questionnaire that will be used is not a standardized questionnaire but rather a questionnaire that was developped by the study team.

**Measure:** Evaluate participant perception of, and satisfaction with, LAI CAB/RPV for the treatment of HIV

**Time Frame:** Within the first 12 weeks of the study

#### Secondary Outcomes

**Measure:** Proportion of participants with virologic suppression at months 5 and 11 after initiation of LAI CAB/RPV

**Time Frame:** Months 5 and 11

**Measure:** Proportion of participants that experience loss of virologic suppression by month 11

**Time Frame:** Month 11

**Description:** If a participant experiences loss of virologic suppression, then if an HIV resistance test was performed at that time, the resistance-associated mutations observed will be reported.

**Measure:** Description of HIV resistance-associated mutations that are present at the time of loss of virologic suppression

**Time Frame:** Month 11

**Measure:** Proportion of participants with a viral blip at months 5 and 11

**Time Frame:** Months 5 and 11

**Measure:** Change, from baseline, of CD4+ T-cell count and CD4+/CD8+ ratio at months 5 and 11

**Time Frame:** Months 5 and 11

**Description:** LAI CAB/RPV must be taken every two months, which therefore requires that a target date be specified in advance of when the next treatment injection should be. This measure will evaluate the proportion of participants that presented to their clinic to receive their treatment either on the target date or within 7 days after (this will be considered adherent) and the proportion of participants that received their treatment more than 7 days after their target date (this will be considered non adherent)

**Measure:** Proportion of participants that are adherent to treatment at months 5 and 11

**Time Frame:** Months 5 and 11

**Measure:** Proportion of participants that discontinue their treatment over the study period

**Time Frame:** Month 11

**Description:** This measure will be reported in person/years

**Measure:** Incidence of discontinuation of treatment over the study period

**Time Frame:** Month 11

**Description:** This measure will report all the reasons for which participants discontinued their treatment

**Measure:** Reasons for discontinuation of treatment over the study period

**Time Frame:** Month 11

**Description:** This measure will be reported by median time to discontinuation (months) and inter-quartile range

**Measure:** Time to discontinuation of treatment over the study period

**Time Frame:** Month 11

**Measure:** Proportion of participants that experience injection-site reactions (ISRs) and acceptability of ISRs

**Time Frame:** Within the first 12 weeks of the study

**Measure:** Change in weight from baseline and a ≥10% weight gain from baseline at months 5 and 11

**Time Frame:** Months 5 and 11

**Measure:** Proportion of participants that become hepatitis B virus (HBV) seropositive at months 5 and 11

**Time Frame:** Months 5 and 11

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* HIV-1 patients, aged 18 years and above, having received at least 1 dose of LAI CAB/RPV between September 1, 2021, and March 31, 2024.

**Maximum Age:** 99 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Participants will be recruited at one of the participating HIV reference centers (HRCs). These centers are part of the 12 official HIV treatment centers in Belgium and work in concert as members of the Belgian Research on AIDS \& HIV Consortium (BREACH).

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** rakan.nasreddine@stpierre-bru.be

**Name:** Rakan Nasreddine, MD

**Phone:** +32 2 535 4130

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Belgian Research on AIDS & HIV Consortium

**Name:** Stéphane De Wit, MD/PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007153

- Term: Immunologic Deficiency Syndromes

- ID: D000007154

- Term: Immune System Diseases

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000007239

- Term: Infections

- ID: D000015229

- Term: Sexually Transmitted Diseases, Viral

- ID: D000012749

- Term: Sexually Transmitted Diseases

- ID: D000016180

- Term: Lentivirus Infections

- ID: D000012192

- Term: Retroviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000012897

- Term: Slow Virus Diseases

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BXS

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

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M3522

- Name: Acquired Immunodeficiency Syndrome

- Relevance: HIGH

- As Found: Human Immunodeficiency Virus

- ID: M18250

- Name: HIV Infections

- Relevance: HIGH

- As Found: Human Immunodeficiency Virus

- ID: M10199

- Name: Immunologic Deficiency Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15558

- Name: Sexually Transmitted Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17933

- Name: Sexually Transmitted Diseases, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M18640

- Name: Lentivirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15026

- Name: Retroviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15700

- Name: Slow Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000163

- Term: Acquired Immunodeficiency Syndrome

- ID: D000015658

- Term: HIV Infections

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M295

- Name: Rilpivirine

- Relevance: LOW

- As Found: Unknown

- ID: M254021

- Name: Cabotegravir

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
