Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive

Patient Compliance Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02470650
• Other study ID #: Cost-Effect-Clinic
• Secondary ID: 2014-004820-24
• Status: Recruiting
• Phase: Phase 4
• First received: May 29, 2015
• Last updated: June 29, 2016
• Start date: June 2015
• Est. completion date: October 2017

Study information

• Verified date: June 2016
• Source: Hospital Clinic of Barcelona
• Contact: Pep Mallolas, MD
• Email: jmallolas[@]clinic.ub.es
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Antiretroviral Therapy Intolerance
• Patient Compliance

Intervention

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)
• Darunavir
Darunavir 800 mg (Prezista®) 1 recovered tablet 800 mg once a day
• abacavir/lamivudine
Abacavir 600 mg /lamivudine 300 mg recovered tablet once a day
• Ritonavir
Ritonavir 100 mg recovered tablet once a day
• Lamivudine
lamivudine 300mg (Epivir) 1 recovered tablet
• rilpivirine
rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day

Locations

Country	Name	City	State
Spain	Josep Mallolas Masferrer	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Juan A. Arnaiz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of mortality and clinical progression	Defined by diagnostic AIDS diseases or death	48 weeks	Yes
Primary	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	No
Secondary	Change in the number of CD4 cells	Change in the number of CD4 cells at 48 weeks	48 weeks	No
Secondary	number of patients with virologic response ratio copies mL plasma viral load)	less than 37 copies/mL in plasma viral load	48 weeks	Yes
Secondary	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	No
Secondary	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	No