Clinical trial NCT02470650: Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive
Official title: Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive. Randomized Clinical, Not Masked, Trial Comparing DRVr3TC, ABC3TC (Kivexa) RPV, or EVG COBI FTC TDF (Stribild) for 48 Weeks
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Patient Compliance
Antiretroviral Therapy Intolerance
Keywords: comparative effectiveness
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2015-06-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to know the efficiency (costeffectiveness) at 48 weeks of initiation of antiretroviral treatment. three strategies of treatment.

Detailed description: Secondary objectives:

* patients with virologic response ratio at 48 weeks (less than 50 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 (bone mineral density scan) 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

Eligibility criteria: Inclusion Criteria:

* 1-negative pregnancy test in women of childbearing age
* 2- stable HIV-1 infection clinically and not take antiretroviral therapy
* 3- viral load HIV \<100,000 copies
* 4- CD4 cells \>100 cels/mm3
* 5- Glomerular filtration \>70mlmin
* 6- have a negative HLA B5701
* 7-.patients should have given informed written consent
* 8- in the opinion of the investigator, be able to follow the design of the Protocol visits

Exclusion Criteria:

* 1-. Patients who had virologic failure with any antiretroviral therapy
* 2- evidence of prior mutations of the study drugs
* 3- use of any anti-retroviral treatment in the 6 months prior to the entry of the study
* 4- contraindication to the drugs study
* 5- any condition that does not allow to ensure the correct compliance to the study
* 6- uncontrolled previous psychiatric illness
* 7- Current or active addiction or alcoholism

Primary outcomes:
measure: efficiency (cost-effectiveness)
timeFrame: 48 weeks of initiation antiretroviral treatment
Secondary outcomes:
measure: Change in the number of CD4 cells
timeFrame: 48 weeks
measure: number of patients with virologic response ratio copies mL plasma viral load)
timeFrame: 48 weeks
measure: Change in body composition and mineral density bone lumbar) measurement with DEXA
timeFrame: 48 weeks
measure: Change in markers of renal function filtration rate - eGFR - estimated rate) and renal tubular function
timeFrame: 48 weeks
Other outcomes:
measure: Rate of mortality and clinical progression
timeFrame: 48 weeks
Locations:
city: Barcelona
country: Spain
facility: Josep Mallolas Masferrer
Study officials:
affiliation: Hospital Clinic
name: Mallolas
role: PRINCIPAL_INVESTIGATOR
References: