NCT02470650

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Juan A. Arnaiz · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Patient Compliance
• Antiretroviral Therapy Intolerance

Interventions

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

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-07-01
• Completion: 2017-10-01
• First posted: 2015-06-12
• Last updated: 2025-07-30