Patient Compliance, Antiretroviral Therapy Intolerance
Conditions
Keywords
comparative effectiveness
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.
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
Interventions
DRUGelvitegravir/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)
DRUGDarunavir
Darunavir 800 mg (Prezista®) 1 recovered tablet 800 mg once a day
Abacavir 600 mg /lamivudine 300 mg recovered tablet once a day
DRUGRitonavir
Ritonavir 100 mg recovered tablet once a day
DRUGLamivudine
lamivudine 300mg (Epivir) 1 recovered tablet
DRUGrilpivirine
rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day
Sponsors
Juan A. Arnaiz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficiency (cost-effectiveness) | 48 weeks of initiation antiretroviral treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the number of CD4 cells | 48 weeks | Change in the number of CD4 cells at 48 weeks |
| number of patients with virologic response ratio copies mL plasma viral load) | 48 weeks | less than 37 copies/mL in plasma viral load |
| Change in body composition and mineral density bone lumbar) measurement with DEXA | 48 weeks | Measurement baseline and at 48 weeks. DEXA Scan (Dual X-ray Absorptiometry) to Measure Bone Health |
| Change in markers of renal function filtration rate - eGFR - estimated rate) and renal tubular function | 48 weeks | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of mortality and clinical progression | 48 weeks | Defined by diagnostic AIDS diseases or death |
Outcome results
None listed