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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

Tracking Information
First Submitted Date  ICMJE May 29, 2015
First Posted Date  ICMJE June 12, 2015
Last Update Posted Date June 30, 2016
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2015)
  • Change in the number of CD4 cells [ Time Frame: 48 weeks ]
    Change in the number of CD4 cells at 48 weeks
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 9, 2015)
Rate of mortality and clinical progression [ Time Frame: 48 weeks ]
Defined by diagnostic AIDS diseases or death
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Patient Compliance
  • Antiretroviral Therapy Intolerance
Intervention  ICMJE
  • 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
  • Drug: Darunavir
    Darunavir 800 mg (Prezista®) 1 recovered tablet 800 mg once a day
    Other Name: prezista
  • Drug: abacavir/lamivudine
    Abacavir 600 mg /lamivudine 300 mg recovered tablet once a day
    Other Name: Kivexa
  • Drug: Ritonavir
    Ritonavir 100 mg recovered tablet once a day
    Other Name: Norvir
  • Drug: Lamivudine
    lamivudine 300mg (Epivir) 1 recovered tablet
    Other Name: Epivir
  • Drug: rilpivirine
    rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day
    Other Name: Edurant
Study Arms  ICMJE
  • 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)
    Intervention: Drug: elvitegravir/cobicistat/emtricitabine/tenofovir
  • 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
    Interventions:
    • Drug: Darunavir
    • Drug: Ritonavir
    • Drug: Lamivudine
  • 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
    Interventions:
    • Drug: abacavir/lamivudine
    • Drug: rilpivirine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 9, 2015)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02470650
Other Study ID Numbers  ICMJE Cost-Effect-Clinic
2014-004820-24 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Juan A. Arnaiz, Hospital Clinic of Barcelona
Study Sponsor  ICMJE Juan A. Arnaiz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mallolas Hospital Clinic
PRS Account Hospital Clinic of Barcelona
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP