Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive

Juan A. Arnaiz

Status and phase: Withdrawn; Phase 4

Conditions: Patient Compliance; Antiretroviral Therapy Intolerance

Treatments: Drug: Ritonavir; Drug: Lamivudine; Drug: Darunavir; Drug: elvitegravir/cobicistat/emtricitabine/tenofovir; Drug: rilpivirine; Drug: abacavir/lamivudine

Study type: Interventional

Funder types: Other

Identifiers

NCT02470650

Cost-Effect-Clinic

2014-004820-24 (EudraCT Number)

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

elvitegravir/cobicistat/emtricitabine/tenofovir

Experimental group

Description:

EVG / COBI / FTC / TDF (Stribild®) 150 elvitegravir, 150 cobicistat, 200 emtricitabine, 245 tenofovir disoproxil. 1 recovered tablet once a day (on a day)

Treatment:

Drug: elvitegravir/cobicistat/emtricitabine/tenofovir

darunavir+ritonavir+lamivudine

Active Comparator group

Description:

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

Treatment:

Drug: Lamivudine

Drug: Darunavir

Drug: Ritonavir

abacavir/lamivudine+rilpivirine

Active Comparator group

Description:

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

Treatment:

Drug: abacavir/lamivudine

Drug: rilpivirine