Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive

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

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

Study Overview

• Status: Withdrawn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

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: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Recruiting
    • Josep Mallolas Masferrer
    • Contact: Joan Albert Arnaiz, MD; Phone Number: 3898 932275400; Email: jaarnaiz@clinic.ub.es
    • Contact: ana Cruceta, MD; Email: acruceta@clinic.ub.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: prezista; Drug: Ritonavir; Ritonavir 100 mg recovered tablet once a day; Other Names: Norvir; Drug: Lamivudine; lamivudine 300mg (Epivir) 1 recovered tablet; Other Names: 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 Names: Kivexa; Drug: rilpivirine; rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day; Other Names: Edurant

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of mortality and clinical progression	Defined by diagnostic AIDS diseases or death	48 weeks

Collaborators and Investigators

• Sponsor: Juan A. Arnaiz
• Investigators: Principal Investigator: Mallolas, Hospital Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2015
• Primary Completion (Estimated): July 1, 2017
• Study Completion (Estimated): October 1, 2017

Study Registration Dates

• First Submitted: May 29, 2015
• First Submitted That Met QC Criteria: June 9, 2015
• First Posted (Estimated): June 12, 2015

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 25, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: comparative effectiveness
• Additional Relevant MeSH Terms: Viral Protease Inhibitors; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Nucleic Acid Synthesis Inhibitors; Antiviral Agents; Cytochrome P-450 Enzyme Inhibitors; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Integrase Inhibitors; HIV Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Tenofovir; Emtricitabine; Cobicistat; Darunavir; Rilpivirine; Ritonavir; Lamivudine; Abacavir; Elvitegravir
• Other Study ID Numbers: Cost-Effect-Clinic; 2014-004820-24 (EudraCT Number)