Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive

Phase 4

• Conditions: Patient Compliance; Antiretroviral Therapy Intolerance
• Interventions: Drug: Darunavir; Drug: abacavir/lamivudine; Drug: elvitegravir/cobicistat/emtricitabine/tenofovir; Drug: Ritonavir; Drug: rilpivirine; Drug: Lamivudine

• Registration Number: NCT02470650
• Lead Sponsor: Juan A. Arnaiz

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

Study Timeline

• Study First Submitted: 2015-05-29
• Study Start: 2015-06
• Study First Submitted QC: 2015-06-09
• Study First Posted: 2015-06-12
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-29
• Last Update Posted: 2016-06-30
• Primary Completion: 2017-07
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
darunavir+ritonavir+lamivudine	Darunavir	Darunavir 800 mg (Prezista®) 1 recovered tablet once a day Ritonavir 100 mg(Norvir® ) 1recovered tablet once a day lamivudine300 mg (Epivir®) 1 recovered tablet once a day
darunavir+ritonavir+lamivudine	Ritonavir	Darunavir 800 mg (Prezista®) 1 recovered tablet once a day Ritonavir 100 mg(Norvir® ) 1recovered tablet once a day lamivudine300 mg (Epivir®) 1 recovered tablet once a day
abacavir/lamivudine+rilpivirine	abacavir/lamivudine	Abacavir 600 mg +lamivudine 300mg (Kivexa®) 1tablet once a day rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day
abacavir/lamivudine+rilpivirine	rilpivirine	Abacavir 600 mg +lamivudine 300mg (Kivexa®) 1tablet once a day rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day
elvitegravir/cobicistat/emtricitabine/tenofovir	elvitegravir/cobicistat/emtricitabine/tenofovir	EVG / COBI / FTC / TDF (Stribild®) 150 elvitegravir, 150 cobicistat, 200 emtricitabine, 245 tenofovir disoproxil. 1 recovered tablet once a day (on a day)
darunavir+ritonavir+lamivudine	Lamivudine	Darunavir 800 mg (Prezista®) 1 recovered tablet once a day Ritonavir 100 mg(Norvir® ) 1recovered tablet once a day lamivudine300 mg (Epivir®) 1 recovered tablet once a day

Primary Outcome Measures

Name	Time	Method
efficiency (cost-effectiveness)	48 weeks of initiation antiretroviral treatment	Antiretroviral treatment effectiveness defined by the number of patients with \<37 copies/ml viral load at the 48 weeks and the treatment cost defined by the sum of cost ogfthe antiretroviral treatment and 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 price of the antiretroviral treatment will be defined by Spanish official price.

Secondary Outcome Measures

Name	Time	Method
Change in the number of CD4 cells	48 weeks	Change in the number of CD4 cells at 48 weeks
Change in body composition and mineral density bone lumbar) measurement with DEXA	48 weeks	Measurement baseline and at 48 weeks. DEXA Scan (Dual X-ray Absorptiometry) to Measure Bone Health
number of patients with virologic response ratio copies mL plasma viral load)	48 weeks	less than 37 copies/mL in plasma viral load
Change in markers of renal function filtration rate - eGFR - estimated rate) and renal tubular function	48 weeks	Defined by creatinine clearance, glomerular filtration rate - eGFR - and renal tubular function at week 48 filtration rate - eGFR - estimated rate) and renal tubular function at 48 weeks

Trial Locations

Locations (1)

Josep Mallolas Masferrer; 🇪🇸 Barcelona, Spain