Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Patient Compliance, Antiretroviral Therapy Intolerance

Intervention / Treatment
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* Drug: elvitegravir/cobicistat/emtricitabine/tenofovir
* Drug: Darunavir
* Drug: abacavir/lamivudine
* Drug: Ritonavir
* Drug: Lamivudine
* Drug: rilpivirine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: elvitegravir/cobicistat/emtricitabine/tenofovir<br>EVG / COBI / FTC / TDF (Stribild®) 150 elvitegravir, 150 cobicistat, 200 emtricitabine, 245 tenofovir disoproxil. 1 recovered tablet once a day (on a day) | Drug: elvitegravir/cobicistat/emtricitabine/tenofovir<br>* 1 recovered tablet once Per day ● Specify total dose (number and unit): 150 mg de elvitegravir, 150 mg cobicistat, 200 mg emtricitabine , 245 mg tenofovir disoprox milligram(s)<br>* Other names: Stribild;|
| Active Comparator: darunavir+ritonavir+lamivudine<br>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 | Drug: Darunavir<br>* Darunavir 800 mg (Prezista®) 1 recovered tablet 800 mg once a day<br>* Other names: prezista;Drug: Ritonavir<br>* Ritonavir 100 mg recovered tablet once a day<br>* Other names: Norvir;Drug: Lamivudine<br>* lamivudine 300mg (Epivir) 1 recovered tablet<br>* Other names: Epivir;|
| Active Comparator: abacavir/lamivudine+rilpivirine<br>Abacavir 600 mg +lamivudine 300mg (Kivexa®) 1tablet once a day rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day | Drug: abacavir/lamivudine<br>* Abacavir 600 mg /lamivudine 300 mg recovered tablet once a day<br>* Other names: Kivexa;Drug: rilpivirine<br>* rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day<br>* Other names: Edurant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficiency (cost-effectiveness) | 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. | 48 weeks of initiation antiretroviral treatment | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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comparative effectiveness