in patients HIV naive. Randomized clinical, not masked, trial comparing DRVr3TC, ABC3TC (Kivexa) RPV, or EVG COBI FTC TDF (Stribild) for 48 weeks
Conditions
Interventions
Trade Name: Stribild 150 mg/150 mg/200 mg/245 mg comprimidos recubiertos con película
Product Name: Stribild 150 mg/150 mg/200 mg/245 mg comprimidos recubiertos
Pharmaceutical Form: Coated tablet
INN
Sponsors
Fundació Clínic per a la Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 adults (?18 years) 2 negative pregnancy test in women of childbearing age, and commitment to use of acceptable methods of contraception since at least 2 weeks prior to day 1 and even as at least 6 months after the last dose of the drug in the study. 3. stable HIV-1 infection clinically and who have not received prior antiretroviral therapy 4 to submit viral load HIV 100,000 copiasmL 5 have numbers of CD4 100 mm3 6 70mlmin Glomerular filtration 7 have a negative HLA B5701 8. patients should have given their informed written consent 9. in the opinion of the investigator, be able to follow the design of the Protocol visits. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who have had prior virologic failure with any guideline antiretroviral 2 evidence of prior mutations against some of the study drugs 3. use of any other chronic anti-retroviral treatment has been introduced in the 6 months prior to the entry of the patient in the study 4. any contraindication to the drug study 5. any condition that does not allow to ensure the correct adherence to the study at the discretion of the doctor patient 6. uncontrolled pre-existing psychiatric illness 7. any current sign of active addiction or alcoholism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ? patients with virologic response ratio at 48 weeks (less than 50 copiasmL plasma viral load) ? Change in the number of CD4 cells at 48 weeks ? Change in body composition and mineral density bone (body and lumbar) measurement with DEXA at 48 weeks ? Change in markers of renal function (creatinine clearance, glomerular filtration rate - eGFR - estimated rate) and renal tubular function at 48 weeks ? Rate of mortality and clinical progression at 48 weeks ? general tolerability and safety: adverse events (AA) and serious AA description;Primary end point(s): ? Patient with virological failure or clinical progression ? adverse events serious possible or probably related to the study drug. ? Pregnancy during the study. ? express desire of the patient ? medical criteria ? Non-adherence of the patient or failure to comply with testing, assessments or other procedures of the study.;Timepoint(s) of evaluation of this end point: Economic evaluation of costs and efficiency (costeeficacia) is done through construction of decision trees. Efficiency is defined as the likelihood of viral load 37 copiasmL at week 48 analysis by intention to treat. Defined cost of starting treatment with a guideline such as the costs of art with all its consequences (adverse effects, changes of pattern study antiretroviral resistance in case of being necessary, days of sick leave by the patient and hospital admission days) that occur in the 48 weeks. The perspective of the national health system, will be used whereas only differential direct costs: drugs (at official price),;Main Objective: The main objective of this study is to know the efficiency (cost-effectiveness) at 48 weeks of initiation of antiretroviral treatment. three strategies of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? patients with virologic response ratio at 48 weeks (less than 50 copiasmL plasma viral load) ? Change in the number of CD4 cells at 48 weeks ? Change in body composition and mineral density bone (body and lumbar) measurement with DEXA at 48 weeks ? Change in markers of renal function (creatinine clearance, glomerular filtration rate - eGFR - estimated rate) and renal tubular function at 48 weeks ? Rate of mortality and clinical progression at 48 weeks;Timepoint(s) of evaluation of this end point: the completion of the follow-up of the last patient that it entered into the study | — |
Countries
Spain
Contacts
Public ContactAnna Cruceta
CTU -Farmacologia. Hospital clínic
Outcome results
None listed