Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
24
Countries
1
Sites
2
HIV infection
To evaluate the variation in the size of the latent cellular reservoir of HIV-1 after reaching inhibitory tissue concentrations by administration of high doses of antiretroviral drugs.
Key facts
- Sponsor
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 7 Apr 2025 → ongoing
- Decision date (initial)
- 2024-09-09
- 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 variation in the size of the latent cellular reservoir of HIV-1 after reaching inhibitory tissue concentrations by administration of high doses of antiretroviral drugs.
Secondary objectives 1
- - To evaluate the variation of HIV intracellular RNA in total CD4+ T cells and memory phenotypes from baseline to weeks 24 and 48 in both blood and lymphoid tissue. - Compare changes in distribution and activation markers (CD69, PD-1, CD25, HLA-DR, Ki67) in T cell subpopulations (naïve and memory phenotypes). - To evaluate the effects of the intervention on markers of inflammation and bacterial translocation. - Determine antiretroviral drug concentrations in blood and gastrointestinal tract tissue. - Correlate markers of viral persistence (intact HIV DNA and ca-HIV RNA) with drug concentrations, as well as with activation and inflammation parameters of cell subpopulations and plasma. - To evaluate the safety and tolerability of the experimental treatment regimen.
Conditions and MedDRA coding
HIV infection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10020161 | HIV infection | 100000004862 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment period 24 weeks
|
Randomised Controlled | None | control group: Antiretroviral therapy with a triple regimen containing an integrase inhibitor. experimental group: Antiretroviral treatment with high doses of lamivudine 600 mg, dolutegravir 100mg and maraviroc 600 mg |
|
| 2 | Follow-up 24 weeks.
|
Not Applicable | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Undetectable plasma viral load (<50 copies of HIV RNA in blood plasma) for at least 12 months prior to inclusion. ● Antiretroviral treatment with a triple regimen containing an integrase inhibitor. ● R5 viral tropism, determined in proviral DNA.
Exclusion criteria 3
- - Chronic Hepatitis B (HBsAg +) - Untreated chronic hepatitis C - Viral tropism X4
- Impaired renal function (plasma creatinine >1.5 mg/dl, creatinine clearance <60 ml/min/1.73 m2).
- Concomitant treatment with cytochrome CYP3A inducing or inhibiting drugs
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- - Latent cell reservoir size by measuring total and intact proviral DNA (IPDA).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
CELSENTRI 300 mg film-coated tablets
PRD334514 · Product
- Active substance
- Maraviroc
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- J05AX09 — -
- Marketing authorisation
- EU/1/07/418/006
- MA holder
- VIIV HEALTHCARE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lamivudina NORMON 300 mg comprimidos recubiertos con película EFG.
PRD400097 · Product
- Active substance
- Lamivudine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- J05AF05 — LAMIVUDINE
- Marketing authorisation
- 70913
- MA holder
- LABORATORIOS NORMON, S.A.
- MA country
- Spain
- 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
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 24 Week(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 Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal
- Sponsor organisation
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal
- Address
- Carretera Del Colmenar Viejo Km 9100, Por El Pardo Por El Pardo
- City
- Madrid
- Postcode
- 28034
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal
- Contact name
- Itziar de Pablo Lopez de Abechuco
Public contact point
- Organisation
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal
- Contact name
- Itziar de Pablo Lopez de Abechuco
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 24 | 2 |
| 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 | 2025-04-07 | 2025-05-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol V1 20 05 2024 2024-513366-18-00 | 2 |
| Protocol (for publication) | D1_Protocol V3 03 02 2026 2024-513366-18-00 limpia | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF V1 20 05 2024 | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC DOLUTEGRAVIR | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC LAMIVUDINA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC MARAVIROC | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ESP V1 20 05 2024 2024-513366-18-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ESP V3 03 02 2026 2024-513366-18-00 limpia | 3 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-04 | Spain | Acceptable 2024-09-09
|
2024-09-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-04 | Spain | Acceptable 2026-03-26
|
2026-04-10 |