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Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02470650
Recruitment Status : Unknown
Verified June 2016 by Juan A. Arnaiz, Hospital Clinic of Barcelona.
Recruitment status was:  Recruiting
First Posted : June 12, 2015
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona

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.

Condition or disease Intervention/treatment Phase
Patient Compliance Antiretroviral Therapy Intolerance Drug: elvitegravir/cobicistat/emtricitabine/tenofovir Drug: Darunavir Drug: abacavir/lamivudine Drug: Ritonavir Drug: Lamivudine Drug: rilpivirine Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Lamivudine

Arm Intervention/treatment
Experimental: 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)
Drug: elvitegravir/cobicistat/emtricitabine/tenofovir
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)
Other Name: Stribild

Active Comparator: darunavir+ritonavir+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
Drug: Darunavir
Darunavir 800 mg (Prezista®) 1 recovered tablet 800 mg once a day
Other Name: prezista

Drug: Ritonavir
Ritonavir 100 mg recovered tablet once a day
Other Name: Norvir

Drug: Lamivudine
lamivudine 300mg (Epivir) 1 recovered tablet
Other Name: Epivir

Active Comparator: abacavir/lamivudine+rilpivirine
Abacavir 600 mg +lamivudine 300mg (Kivexa®) 1tablet once a day rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day
Drug: abacavir/lamivudine
Abacavir 600 mg /lamivudine 300 mg recovered tablet once a day
Other Name: Kivexa

Drug: rilpivirine
rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day
Other Name: Edurant




Primary Outcome Measures :
  1. efficiency (cost-effectiveness) [ Time Frame: 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 :
  1. Change in the number of CD4 cells [ Time Frame: 48 weeks ]
    Change in the number of CD4 cells at 48 weeks

  2. number of patients with virologic response ratio copies mL plasma viral load) [ Time Frame: 48 weeks ]
    less than 37 copies/mL in plasma viral load

  3. Change in body composition and mineral density bone lumbar) measurement with DEXA [ Time Frame: 48 weeks ]
    Measurement baseline and at 48 weeks. DEXA Scan (Dual X-ray Absorptiometry) to Measure Bone Health

  4. Change in markers of renal function filtration rate - eGFR - estimated rate) and renal tubular function [ Time Frame: 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


Other Outcome Measures:
  1. Rate of mortality and clinical progression [ Time Frame: 48 weeks ]
    Defined by diagnostic AIDS diseases or death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470650


Contacts
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Contact: Pep Mallolas, MD jmallolas@clinic.ub.es

Locations
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Spain
Josep Mallolas Masferrer Recruiting
Barcelona, Spain, 08025
Contact: Joan Albert Arnaiz, MD    932275400 ext 3898    jaarnaiz@clinic.ub.es   
Contact: ana Cruceta, MD       acruceta@clinic.ub.es   
Sponsors and Collaborators
Juan A. Arnaiz
Investigators
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Principal Investigator: Mallolas Hospital Clinic
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Responsible Party: Juan A. Arnaiz, Josep Mallolas, Principal Investigator, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT02470650    
Other Study ID Numbers: Cost-Effect-Clinic
2014-004820-24 ( EudraCT Number )
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: June 2016
Keywords provided by Juan A. Arnaiz, Hospital Clinic of Barcelona:
comparative effectiveness
Additional relevant MeSH terms:
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Ritonavir
Darunavir
Tenofovir
Lamivudine
Emtricitabine
Abacavir
Cobicistat
Rilpivirine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors