Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
75
Countries
1
Sites
4
Metabolic liver disease in HIV-infected people
To evaluate the efficacy of Rilpivirine (RPV) as part of the antiretroviral treatment regimen in HIV-infected people, to slow the progression and/or reduce liver fibrosis of any degree, measured by non-invasive tests
Key facts
- Sponsor
- Fundacion Seimc Gesida, Fundacion Seimc Gesida
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02], Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 5 May 2023 → 7 Jul 2025
- Decision date (initial)
- 2023-03-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To evaluate the efficacy of Rilpivirine (RPV) as part of the antiretroviral treatment regimen in HIV-infected people, to slow the progression and/or reduce liver fibrosis of any degree, measured by non-invasive tests
Conditions and MedDRA coding
Metabolic liver disease in HIV-infected people
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Patients over 18 years of age with HIV infection who have never received antiretroviral treatment with Rilpivirine. 2. Have a stable ART regimen for at least the last 6 months. Simplifications to combination therapies will not be taken into account as long as the patient has a control of the HIV viral load after the change that confirms its undetectability. 3. Not have resistance mutations that compromise the efficacy of Rilpivirine, Dolutegravir, Tenofovir (TDF and/or TAF) or Emtricitabine. 4. Have an HIV viral load < 50 copies/ml for at least the last 6 months, 1 blip less than 500 copies/ml is allowed during this period. 5. Having an EHMG diagnosed by ultrasound or a CAP measurement (Controlled Attenuation Parameter®) > 238 dB/m with an IQR < 30 dB/m. 6. Having an EHMG with some degree of fibrosis diagnosed by ET (Fibroscan®) > 5.2 kPa (the use of a Fibroscan® performed by usual clinical practice in the 3 months prior to the screening visit will be allowed). In patients in whom ET is not possible, have a FIB-4 >1.3. 7. Be able to understand and comply with the requirements and instructions of the protocol 8. Understand the long-term commitment to the study 9. Acceptance of your participation in the study by signing an informed consent
Exclusion criteria 1
- 1. Having a chronic HBV infection (presence of HBsAg+) or HCV (detectable HCV viral load). The inclusion of patients with: • HCV treated and cured before 12/31/2019 whose liver stiffness measured by Fibroscan® was not greater than 9 kPa when they had active HCV infection. • HCV infection resolved spontaneously. 2. Having diabetes mellitus under treatment with SGLT2, GLP1 or plioglitazone for less than 6 months. 3. Have a history of alcohol abuse 4. Having a harmful consumption of alcohol, defined as >30 g of alcohol per day in men and more than >20 g of alcohol per day in women. 5. Having chronic decompensated liver disease, defined as any of the following: presence of encephalopathy, ascites, coagulopathy, esophageal or gastric varices, or persistent jaundice. 6. Any prior physical or mental condition (such as habitual drug use) that the investigator believes may interfere with the patient's ability to comply with the study protocol 7. Pregnant or lactating at the screening visit or at any time during the study or intent to become pregnant during the study period. 8. Previous history of rilpivirine use of any duration
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- no progression and/or regression of liver fibrosis measured by non-invasive tests at month 18, measured as: 1. No change in liver stiffness measured by TE or FIB4 at the 18-month visit from baseline in the intervention group (arms 1 and 2) versus the control group. 2. Reduction in liver stiffness as measured by TE or FIB4 at the 18-month visit from baseline in the intervention group (arms 1 and 2) versus the control group.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 17
Truvada 200 mg/245 mg film-coated tablets
PRD293531 · Product
- Active substance
- Emtricitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 Other
- Max total dose
- 540 Other
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR03 — -
- Marketing authorisation
- EU/1/04/305/002
- MA holder
- GILEAD SCIENCES IRELAND UC
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Truvada 200 mg/245 mg film-coated tablets
PRD8038824 · Product
- Active substance
- Emtricitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 Other
- Max total dose
- 540 Other
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR03 — -
- Marketing authorisation
- EU/1/04/305/003
- MA holder
- GILEAD SCIENCES IRELAND UC
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Descovy 200 mg/25 mg film-coated tablets
PRD4052394 · Product
- Active substance
- Emtricitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 Other
- Max total dose
- 540 Other
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR17 — -
- Marketing authorisation
- EU/1/16/1099/003
- MA holder
- GILEAD SCIENCES IRELAND UC
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Descovy 200 mg/25 mg film-coated tablets
PRD4052395 · Product
- Active substance
- Emtricitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 Other
- Max total dose
- 540 Other
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR17 — -
- Marketing authorisation
- EU/1/16/1099/004
- MA holder
- GILEAD SCIENCES IRELAND UC
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Odefsey 200 mg/25 mg/25 mg film-coated tablets
PRD4191977 · Product
- Active substance
- Emtricitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 Other
- Max total dose
- 540 Other
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR19 — -
- Marketing authorisation
- EU/1/16/1112/002
- MA holder
- GILEAD SCIENCES IRELAND UC
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Descovy 200 mg/25 mg film-coated tablets
PRD8038848 · Product
- Active substance
- Emtricitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 Other
- Max total dose
- 540 Other
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR17 — -
- Marketing authorisation
- EU/1/16/1099/006
- MA holder
- GILEAD SCIENCES IRELAND UC
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Odefsey 200 mg/25 mg/25 mg film-coated tablets
PRD4191976 · Product
- Active substance
- Emtricitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 Other
- Max total dose
- 540 Other
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR19 — -
- Marketing authorisation
- EU/1/16/1112/001
- MA holder
- GILEAD SCIENCES IRELAND UC
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
EDURANT 25 mg film-coated tablets
PRD3349053 · Product
- Active substance
- Rilpivirine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 Other
- Max total dose
- 540 Other
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AG05 — -
- Marketing authorisation
- EU/1/11/736/001
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Truvada 200 mg/245 mg film-coated tablets
PRD293463 · Product
- Active substance
- Emtricitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 Other
- Max total dose
- 540 Other
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR03 — -
- Marketing authorisation
- EU/1/04/305/001
- MA holder
- GILEAD SCIENCES IRELAND UC
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Eviplera 200 mg/25 mg/245 mg film-coated tablets
PRD299085 · Product
- Active substance
- Emtricitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 Other
- Max total dose
- 540 Other
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR08 — -
- Marketing authorisation
- EU/1/11/737/001
- MA holder
- GILEAD SCIENCES IRELAND UC
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Eviplera 200 mg/25 mg/245 mg film-coated tablets
PRD298715 · Product
- Active substance
- Emtricitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 Other
- Max total dose
- 540 Other
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR08 — -
- Marketing authorisation
- EU/1/11/737/002
- MA holder
- GILEAD SCIENCES IRELAND UC
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Emtricitabina/Tenofovir disoproxilo Aurovitas 200 mg/245 mg comprimidos recubiertos con película EFG
PRD8000815 · Product
- Active substance
- Emtricitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 Other
- Max total dose
- 540 Other
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR03 — -
- Marketing authorisation
- 84.875
- MA holder
- AUROVITAS SPAIN,S.A.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Emtricitabine/Tenofovir disoproxil Tillomed 200 mg/245 mg filmdragerade tabletter
PRD10117419 · Product
- Active substance
- Emtricitabine
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 Other
- Max total dose
- 540 Other
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR03 — -
- Marketing authorisation
- 58152
- MA holder
- TILLOMED PHARMA GMBH
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Juluca 50 mg/25 mg film-coated tablets
PRD6191436 · Product
- Active substance
- Dolutegravir Sodium
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 Other
- Max total dose
- 540 Other
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR21 — -
- Marketing authorisation
- EU/1/18/1282/002
- MA holder
- VIIV HEALTHCARE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Tivicay 50 mg film-coated tablets
PRD6421422 · Product
- Active substance
- Dolutegravir Sodium
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 Other
- Max total dose
- 540 Other
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AJ03 — -
- Marketing authorisation
- EU/1/13/892/002
- MA holder
- VIIV HEALTHCARE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Juluca 50 mg/25 mg film-coated tablets
PRD6191432 · Product
- Active substance
- Dolutegravir Sodium
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 Other
- Max total dose
- 540 Other
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR21 — -
- Marketing authorisation
- EU/1/18/1282/001
- MA holder
- VIIV HEALTHCARE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Tivicay 50 mg film-coated tablets
PRD6421418 · Product
- Active substance
- Dolutegravir Sodium
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 Other
- Max total dose
- 540 Other
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AJ03 — -
- Marketing authorisation
- EU/1/13/892/001
- MA holder
- VIIV HEALTHCARE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Seimc Gesida
- Sponsor organisation
- Fundacion Seimc Gesida
- Address
- Calle De Agustin De Betancourt 13 Entreplanta
- City
- Madrid
- Postcode
- 28003
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Seimc Gesida
- Contact name
- Pedro Gil Divasson
Public contact point
- Organisation
- Fundacion Seimc Gesida
- Contact name
- Pedro Gil Divasson
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| Hospital Universitario Dr Peset Aleixandre ORG-100042192
|
Valencia, Spain | Laboratory analysis |
| Hospital Universitario La Paz ORG-100028646
|
Madrid, Spain | Laboratory analysis |
| Fundacion Maria Rafols Para La Investigacion Del Diagnostico Por Imagen ORG-100046408
|
Madrid, Spain | Other |
Fundacion Seimc Gesida
- Sponsor organisation
- Fundacion Seimc Gesida
- Address
- Calle De Agustin De Betancourt 13 Entreplanta
- City
- Madrid
- Postcode
- 28003
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Seimc Gesida
- Contact name
- Pedro Gil Divasson
Public contact point
- Organisation
- Fundacion Seimc Gesida
- Contact name
- Pedro Gil Divasson
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| Hospital Universitario Dr Peset Aleixandre ORG-100042192
|
Valencia, Spain | Laboratory analysis |
| Hospital Universitario La Paz ORG-100028646
|
Madrid, Spain | Laboratory analysis |
| Fundacion Maria Rafols Para La Investigacion Del Diagnostico Por Imagen ORG-100046408
|
Madrid, Spain | Other |
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 75 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitario Infanta Leonor
Internal Medicine, Avenida Gran Via Del Este 80, 28031, Madrid
Hospital Universitario Infanta Sofía
Medicina Interna, Paseo De Europa 34, 28702, San Sebastian De Los Reyes
Hospital Universitario La Paz
Internal Medicine, Paseo Castellana 261, 28046, Madrid
Hospital General Universitario Gregorio Maranon
Infectious Diseases, Calle Del Doctor Esquerdo 46, 28009, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2023-05-05 | 2025-07-07 | 2023-05-25 | 2024-01-08 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-01-23 | Spain | Acceptable 2023-03-02
|
2023-03-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-07-13 | Spain | Acceptable 2023-08-28
|
2023-08-28 |