Clinical trial • Not applicable • Infectious Disease | Immunology
Lamivudine; Doravirine; Tenofovir disoproxil for HIV infection
Not applicable trial of Lamivudine; Doravirine; Tenofovir disoproxil for HIV infection.
Overview
- Trial Therapeutic Area
- Infectious Disease | Immunology
- Trial Disease
- HIV infection
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 15-11-2023
- First CTIS Authorization Date
- 11-03-2024
Trial design
Randomised, open-label, control arm: bictegravir 50 mg / emtricitabine 200 mg / tenofovir alafenamide 25 mg, oral, every day; experimental arm one: doravirine 100 mg oral every day + emtricitabine / tenofovir alafenamide 200/25 mg oral every day; experimental arm two: doravirine 100 mg / lamivudine 300 mg / tenofovir disoproxilo 245 mg oral every day. Not applicable trial across 3 sites in Spain.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Control Arm: Bictegravir 50 mg / Emtricitabine 200 mg / Tenofovir alafenamide 25 mg, oral, every day; Experimental Arm One: Doravirine 100 mg oral every day + Emtricitabine / Tenofovir alafenamide 200/25 mg oral every day; Experimental Arm Two: Doravirine 100 mg / Lamivudine 300 mg / Tenofovir disoproxilo 245 mg oral every day.
- Target Sample Size
- 50
- Trial Duration For Participant
- 336
Eligibility
Recruits 50 Vulnerable population not selected; no specific consent or assent handling described in the record..
- Vulnerable Population
- Vulnerable population not selected; no specific consent or assent handling described in the record.
Inclusion criteria
- {"criterion_text":"- Eligible subjects need to present some degree of liver steatosis (Fibroscan: >=S1-238 a 260 dB/m) or liver fibrosis (>=F2->7Kpa)."}
Exclusion criteria
- {"criterion_text":"- 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 endpoints
- {"endpoint_text":"- Liver steatosis measured and liver fibrosis measured by CAP (Controlled Attenuation-Parameter, expressed in db/m) and transient elastography respectively","definition_or_measurement_approach":"Liver steatosis measured by CAP (Controlled Attenuation Parameter, expressed in dB/m); liver fibrosis measured by transient elastography (expressed in kPa)."}
Secondary endpoints
- {"endpoint_text":"- Fat liver content by MRI","definition_or_measurement_approach":"Fat liver content assessed by MRI (subset of 40 participants)."}
- {"endpoint_text":"- Lipoprotein particles at week 48","definition_or_measurement_approach":"Assessment of lipoprotein particles at week 48 (measurement method not specified)."}
Recruitment
- Planned Sample Size
- 50
- Recruitment Window Months
- 17
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 50
Spain
- Earliest CTIS Part Ii Submission Date
- 08-02-2024
- Latest Decision Or Authorization Date
- 11-03-2024
- Processing Time Days
- 32
- Number Of Sites
- 3
- Number Of Participants
- 50
Sites
- Site Name
- Bellvitge University Hospital
- Department Name
- Infecciosas
- Principal Investigator Name
- Juan Manuel Tiraboschi
- Principal Investigator Email
- jmtiraboschi@bellvitgehospital.cat
- Contact Person Name
- Juan Manuel Tiraboschi
- Contact Person Email
- jmtiraboschi@bellvitgehospital.cat
- Site Name
- Hospital Del Mar
- Department Name
- Infecciosas
- Principal Investigator Name
- Robert Güerrí Fernández
- Principal Investigator Email
- rguerri@psmar.cat
- Contact Person Name
- Robert Güerrí Fernández
- Contact Person Email
- rguerri@psmar.cat
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Infecciosas
- Principal Investigator Name
- Pere Domingo Pedrol
- Principal Investigator Email
- PDomingo@santpau.cat
- Contact Person Name
- Pere Domingo Pedrol
- Contact Person Email
- PDomingo@santpau.cat
Sponsor
Primary sponsor
- Full Name
- Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La Ciencia
- Organisation Type
- Patient organisation/association
- Country Of Registered Address
- Spain
Third parties
- {"country":"","full_name":"Merck & Co. (Merck Sharp and Dohme)","duties_or_roles":"Monetary support","organisation_type":""}
Investigational products
- Investigational Product Name
- Delstrigo 100 mg/300 mg/245 mg film-coated tablets
- Active Substance
- Lamivudine; Doravirine; Tenofovir disoproxil
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (EU marketing authorisation EU/1/18/1333/001)
- Starting Dose
- 100 mg doravirine / 300 mg lamivudine / 245 mg tenofovir disoproxil (as per product name)
- Frequency
- Once daily
- Investigational Product Name
- Pifeltro 100 mg film-coated tablets
- Active Substance
- Doravirine
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (EU marketing authorisation EU/1/18/1332/001)
- Starting Dose
- 100 mg doravirine (as per product name)
- Frequency
- Once daily
- Investigational Product Name
- Descovy 200 mg/25 mg film-coated tablets
- Active Substance
- Emtricitabine; Tenofovir alafenamide
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (EU marketing authorisation EU/1/16/1099/003)
- Starting Dose
- 200 mg emtricitabine / 25 mg tenofovir alafenamide (as per product name)
- Frequency
- Once daily
- Investigational Product Name
- Biktarvy 50 mg/200 mg/25 mg film-coated tablets
- Active Substance
- Bictegravir; Emtricitabine; Tenofovir alafenamide
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (EU marketing authorisation EU/1/18/1289/001)
- Starting Dose
- 50 mg bictegravir / 200 mg emtricitabine / 25 mg tenofovir alafenamide (as per product name)
- Frequency
- Once daily
- Combination Treatment
- Yes
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