Clinical trial • Phase II|Phase IV • Infectious Disease
Lamivudine for HIV infection
Phase II|Phase IV trial of Lamivudine for HIV infection.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- HIV infection
- Trial Stage
- Phase II|Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 04-06-2024
- First CTIS Authorization Date
- 09-09-2024
Trial design
Randomised, open-label, control group: continue usual antiretroviral therapy (triple regimen containing an integrase inhibitor). experimental group: antiretroviral treatment with high doses of lamivudine 600 mg, dolutegravir 100 mg and maraviroc 600 mg for 24 weeks (treatment phase), followed by resumption of standard antiretroviral treatment; both arms include a 24-week follow-up phase. Phase II|Phase IV trial across 2 sites in Spain.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Control group: continue usual antiretroviral therapy (triple regimen containing an integrase inhibitor). Experimental group: antiretroviral treatment with high doses of lamivudine 600 mg, dolutegravir 100 mg and maraviroc 600 mg for 24 weeks (treatment phase), followed by resumption of standard antiretroviral treatment; both arms include a 24-week follow-up phase.
- Target Sample Size
- 24
- Trial Duration For Participant
- 336
Eligibility
Recruits 24 No vulnerable population selected; isVulnerablePopulationSelected = false. Consent/assent handling not specified in the available extracted documents..
- Vulnerable Population
- No vulnerable population selected; isVulnerablePopulationSelected = false. Consent/assent handling not specified in the available extracted documents.
Inclusion criteria
- {"criterion_text":"- Undetectable plasma viral load (<50 copies of HIV RNA in blood plasma) for at least 12 months prior to inclusion.\n- Antiretroviral treatment with a triple regimen containing an integrase inhibitor.\n- R5 viral tropism, determined in proviral DNA."}
Exclusion criteria
- {"criterion_text":"- Chronic Hepatitis B (HBsAg +)\n- Untreated chronic hepatitis C\n- Viral tropism X4\n- Impaired renal function (plasma creatinine >1.5 mg/dl, creatinine clearance <60 ml/min/1.73 m2).\n- Concomitant treatment with cytochrome CYP3A inducing or inhibiting drugs"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Latent cell reservoir size by measuring total and intact proviral DNA (IPDA).","definition_or_measurement_approach":"Measure total and intact proviral DNA using the IPDA (intact proviral DNA assay) to assess latent cellular reservoir size."}
Recruitment
- Planned Sample Size
- 24
- Recruitment Window Months
- 36
- Consent Approach
- Informed consent required; Subject information and informed consent form available (document: 'L1_SIS and ICF V1 20 05 2024'). Specifics on assent, age-specific documents or languages available are not specified in the extracted data.
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 24
Spain
- Earliest CTIS Part Ii Submission Date
- 23-08-2024
- Latest Decision Or Authorization Date
- 10-04-2026
- Processing Time Days
- 595
- Number Of Sites
- 2
- Number Of Participants
- 24
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- HIV Infection Unit
- Principal Investigator Name
- Maria de Lagarde Sebastian
- Principal Investigator Email
- estudioshiv12@gmail.com
- Contact Person Name
- Maria de Lagarde Sebastian
- Contact Person Email
- estudioshiv12@gmail.com
- Site Name
- Ramon y Cajal University Hospital
- Department Name
- infectious diseases service
- Principal Investigator Name
- Santiago Moreno Guillen
- Principal Investigator Email
- smguillen@salud.madrid.org
- Contact Person Name
- Santiago Moreno Guillen
- Contact Person Email
- smguillen@salud.madrid.org
Sponsor
Primary sponsor
- Full Name
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Lamivudina NORMON 300 mg comprimidos recubiertos con película EFG.
- Active Substance
- Lamivudine
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketing authorisation present: 70913)
- Starting Dose
- 600 mg (as used in experimental regimen)
- Dose Levels
- 600 mg
- Maximum Dose
- 600 mg
- Investigational Product Name
- Tivicay 50 mg film-coated tablets
- Active Substance
- Dolutegravir sodium
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketing authorisation present: EU/1/13/892/001)
- Starting Dose
- 100 mg (as used in experimental regimen)
- Dose Levels
- 100 mg
- Maximum Dose
- 100 mg
- Investigational Product Name
- CELSENTRI 300 mg film-coated tablets
- Active Substance
- Maraviroc
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketing authorisation present: EU/1/07/418/006)
- Starting Dose
- 600 mg (as used in experimental regimen)
- Dose Levels
- 600 mg
- Maximum Dose
- 600 mg
- Combination Treatment
- Yes
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