Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive

NCT02470650 | Withdrawn Phase 4

• 2 other identifiers: Cost-Effect-Clinic2014-004820-24
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Patient Compliance; Antiretroviral Therapy Intolerance

Keywords

comparative effectiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in the number of CD4 cells

  48 weeks

• number of patients with virologic response ratio copies mL plasma viral load)

  48 weeks

• Change in body composition and mineral density bone lumbar) measurement with DEXA

  48 weeks

• Change in markers of renal function filtration rate - eGFR - estimated rate) and renal tubular function

  48 weeks

Other Outcomes (1)

• Rate of mortality and clinical progression

  48 weeks

Study Arms (3)

elvitegravir/cobicistat/emtricitabine/tenofovir

EXPERIMENTAL

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

darunavir+ritonavir+lamivudine

ACTIVE COMPARATOR

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; Drug: Ritonavir; Drug: Lamivudine

abacavir/lamivudine+rilpivirine

ACTIVE COMPARATOR

Abacavir 600 mg +lamivudine 300mg (Kivexa®) 1tablet once a day rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day

Drug: abacavir/lamivudine; Drug: rilpivirine

Interventions

elvitegravir/cobicistat/emtricitabine/tenofovir DRUG

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)

Also known as: Stribild

elvitegravir/cobicistat/emtricitabine/tenofovir

Darunavir DRUG

Darunavir 800 mg (Prezista®) 1 recovered tablet 800 mg once a day

Also known as: prezista

darunavir+ritonavir+lamivudine

abacavir/lamivudine DRUG

Abacavir 600 mg /lamivudine 300 mg recovered tablet once a day

Also known as: Kivexa

abacavir/lamivudine+rilpivirine

Ritonavir DRUG

Ritonavir 100 mg recovered tablet once a day

Also known as: Norvir

darunavir+ritonavir+lamivudine

Lamivudine DRUG

lamivudine 300mg (Epivir) 1 recovered tablet

Also known as: Epivir

darunavir+ritonavir+lamivudine

rilpivirine DRUG

rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day

Also known as: Edurant

abacavir/lamivudine+rilpivirine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• negative pregnancy test in women of childbearing age
• stable HIV-1 infection clinically and not take antiretroviral therapy
• viral load HIV \<100,000 copies
• CD4 cells \>100 cels/mm3
• Glomerular filtration \>70mlmin
• have a negative HLA B5701
• patients should have given informed written consent
• in the opinion of the investigator, be able to follow the design of the Protocol visits

You may not qualify if:

• Patients who had virologic failure with any antiretroviral therapy
• evidence of prior mutations of the study drugs
• use of any anti-retroviral treatment in the 6 months prior to the entry of the study
• contraindication to the drugs study
• any condition that does not allow to ensure the correct compliance to the study
• uncontrolled previous psychiatric illness
• Current or active addiction or alcoholism

Sponsors & Collaborators

• Juan A. Arnaiz: lead

MeSH Terms

Conditions

Patient Compliance

Interventions

elvitegravir; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Darunavir; abacavir, lamivudine drug combination; Ritonavir; Lamivudine; Rilpivirine

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cobicistat; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Tenofovir; Organophosphonates; Organophosphorus Compounds; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations; Sulfonamides; Amides; Sulfones; Furans; Zalcitabine; Dideoxynucleosides; Nitriles

Study Officials

• Mallolas

  Hospital Clínic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Josep Mallolas, Principal Investigator

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 12, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: October 1, 2017
• Last Updated: July 30, 2025

Record last verified: 2025-07