HIV-1 Infection MedDRA version: 14.1 Level: LLT Classification code 10008922 Term: Chronic infection with HIV System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: ATRIPLA*30CPR RIV600+200+245MG
Pharmaceutical Form: Tablet
INN or Proposed INN: TENOFOVIR DISOPROXIL FUMARATE
CAS Number: 202138-50-9
Concentration unit: mg milligram(s)
Concentration type
Sponsors
ISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age> 18 years; - Treatment with a stable regimen containing efavirenz and tenofovir / emtricitabine for at least 24 weeks before screening; - Nadir CD4 +> 200 cells / mmc and CD4 +> 300 cells / mmc at screening; - Viral load =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients aged 65 years; - HIV RNA> 40 copies / mL in the 6 months prior to screening; - Previous virological failure or evidence of intermediate / high-level resistance to efavirenz, tenofovir or cytidine analogs; - Co-infection with HBV; - Creatinine clearance <50 mL / min at screening or evidence of renal involute years; - Pregnancy or desire for parenthood; - Opportunistic infections or AIDS defining illnesses in place; - History of any solid or haematological malignancy; - Use of psychoactive substances that may in any way interfere with the patient's adherence to the prescribed treatment regimen; - Persons who, in the opinion of the investigator, does not ensure adequate adherence to the study; - Patients who are receiving or have received antineoplastic or immunomodulatory (IL-2, GMCSF ...) in the last 12 months; - Patients with liver cirrhosis; - Participation in other clinical trials or pharmacological treatment with experimental drugs in the 30 days prior to entry in the protocol; - Allergy to any drugs in the regimen; - Inability to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessing non-inferiority of the regimen with Atripla at alternate days (arm A) versus the standard of care (arm B) at week 48 in terms of proportion of patients with HIV RNA below 40 copies/mL.;Secondary Objective: # Evaluate the changes in CD4 + T lymphocyte counts in the two arms. # Evaluate the changes in safety parameters in the two arms. # Assess the proportion of new mutations EFV-associated in case of virological failure in the two arms. # Evaluate the plasma concentrations (C trough) of efavirenz in the two arms. # Evaluate the impact of both regimens on quality of life. # Evaluate the impact of both dosing regimens on adherence to ARV therapy. # To assess the prevalence of SNPs in the CYP2B6 and the correlation between SNPs and plasma concentrations of efavirenz in both arms. # Evaluate the change in lipid parameters in both arms. # Perform a cost-effective in both arms.;Primary end point(s): Assessing the proportion of patients with virological failure in the Atripla at alternate days arm (A) versus the standard of care (arm B) at week 48;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): # Evaluate the changes in CD4 + T lymphocyte counts in the two arms. # Assess the proportion of new mutations EFV-associated in case of virological failure in the two arms.;Timepoint(s) of evaluation of this end point: 48 weeks. | — |
Countries
Italy
Contacts
Public ContactUOC Malattie Infettive e Tropicali
Istituto Nazionale per le Malattie Infettive ''Lazzaro Spallanzani''
Outcome results
None listed