Overview
Sponsor-declared trial summary
Human Immunodeficiency Virus
Determine changes in liver steatosis measured by CAP (Controlled Attenuation Parameter, expressed in db/m) and liver fibrosis measured by transient elastography (expressed in Kpa) in HIV asymptomatic individuals who present with some degree of confirmed liver steatosis (>=S1-238 a 260 dB/m) or liver fibrosis (>=F2->7Kp…
Key facts
- Sponsor
- Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La Ciencia
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02], Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 13 Jan 2025 → ongoing
- Decision date (initial)
- 2024-03-11
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Merck & Co. (Merck Sharp and Dohme)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
Determine changes in liver steatosis measured by CAP (Controlled Attenuation Parameter, expressed in db/m) and liver fibrosis measured by transient elastography (expressed in Kpa) in HIV asymptomatic individuals who present with some degree of confirmed liver steatosis (>=S1-238 a 260 dB/m) or liver fibrosis (>=F2->7Kpa) who switch to a regimen based in Doravirine. Changes in HIV general outcomes as well as metabolic results will be evaluated at baseline and week 48.
Secondary objectives 2
- Determine changes in fat liver content by MRI in a subset of 40 PLWH included in the study who change to a regimen based in Doravirine.
- Determine changes in lipoprotein particles at week 48.
Conditions and MedDRA coding
Human Immunodeficiency Virus
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Switch Or Continue The participate in this study where they will be randomly assigned to one of the three groups.
|
Randomised Controlled | None | Control Arm: Bictegravir 50mg / Emtricitabine 200mg / Tenenofovir alafanamide 25 mg Oral Every Day Experimental Arm One: Doravirine 100 mg Oral Every Day + Emtricitabine / Tenofovir Alafanamide 200/25 mg Oral Every Day Experimental Arm Two: Doravirine 100 mg / Lamivudine 300 mg / Tenofovir disoproxilo 245 mg Oral Every Day |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Eligible subjects need to present some degree of liver steatosis (Fibroscan: >=S1-238 a 260 dB/m) or liver fibrosis (>=F2->7Kpa).
Exclusion criteria 1
- Any evidence of current or previous Hepatitis B or C [Active Surface Hepatitis B Ag (HBAgS) OR negative HBAgS and negative hepatitis B surface antibody (anti-HBs) with positive anti-core antibody (anti-HBc) and positive HBV DNA. Hepatitis C IgG positive]
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Liver steatosis measured and liver fibrosis measured by CAP (Controlled Attenuation-Parameter, expressed in db/m) and transient elastography respectively
Secondary endpoints 2
- Fat liver content by MRI
- Lipoprotein particles at week 48
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
Delstrigo 100 mg/300 mg/245 mg film-coated tablets
PRD6778264 · Product
- Active substance
- Lamivudine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 U unit(s)
- Max total dose
- 1 U unit(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- J05AR24 — -
- Marketing authorisation
- EU/1/18/1333/001
- MA holder
- MERCK SHARP & DOHME BV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pifeltro 100 mg film-coated tablets
PRD6790340 · Product
- Active substance
- Doravirine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 U unit(s)
- Max total dose
- 1 U unit(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- J05AG06 — -
- Marketing authorisation
- EU/1/18/1332/001
- MA holder
- MERCK SHARP & DOHME BV
- 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 U unit(s)
- Max total dose
- 1 U unit(s)
- Max treatment duration
- 48 Week(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
Comparator 1
Biktarvy 50 mg/200 mg/25 mg film-coated tablets
PRD6357588 · Product
- Active substance
- Emtricitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 U unit(s)
- Max total dose
- 1 U unit(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- J05AR20 — -
- Marketing authorisation
- EU/1/18/1289/001
- MA holder
- GILEAD SCIENCES IRELAND UC
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La Ciencia
- Sponsor organisation
- Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La Ciencia
- Address
- Carretera Canyet S/n
- City
- Badalona
- Postcode
- 08916
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La Ciencia
- Contact name
- Juan Manuel Tiraboschi, PhD
Public contact point
- Organisation
- Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La Ciencia
- Contact name
- Silvia Gel
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruitment ended | 50 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
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 | 2025-01-13 | 2025-03-03 | 2026-04-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol DORALI_v1_7_16-02-2024 | 1.7 |
| Summary of Product Characteristics (SmPC) (for publication) | Biktarvy_SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Descovy_SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Delstrigo_for pub | 01MAY2023 |
| Summary of Product Characteristics (SmPC) (for publication) | Pifeltro_SmPC | 1 |
| Synopsis of the protocol (for publication) | Resumen Protocolo DORALI_v1_4_08_11_2023 | 1.4 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-15 | Spain | Acceptable with conditions 2024-02-29
|
2024-03-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-02 | Spain | Acceptable 2024-09-18
|
2024-09-18 |