Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004820-24 | EudraCT Number |
Not provided
Not provided
Not provided
No participants enrolled
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main objective of this study is to know the efficiency (costeffectiveness) at 48 weeks of initiation of antiretroviral treatment. three strategies of treatment.
Secondary objectives:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of CD4 cells | Change in the number of CD4 cells at 48 weeks | 48 weeks |
| number of patients with virologic response ratio copies mL plasma viral load) | less than 37 copies/mL in plasma viral load |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of mortality and clinical progression | Defined by diagnostic AIDS diseases or death | 48 weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mallolas | Hospital Clínic | Principal Investigator |
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 4, 2014 | Jul 25, 2025 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| C509700 | elvitegravir |
| D000069545 | Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D000069454 | Darunavir |
| C492871 | abacavir, lamivudine drug combination |
| D019438 | Ritonavir |
| D019259 | Lamivudine |
| D000068696 | Rilpivirine |
| ID | Term |
|---|---|
| D000069547 | Cobicistat |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Darunavir | Drug | Darunavir 800 mg (Prezista®) 1 recovered tablet 800 mg once a day |
|
|
| abacavir/lamivudine | Drug | Abacavir 600 mg /lamivudine 300 mg recovered tablet once a day |
|
|
| Ritonavir | Drug | Ritonavir 100 mg recovered tablet once a day |
|
|
| Lamivudine | Drug | lamivudine 300mg (Epivir) 1 recovered tablet |
|
|
| rilpivirine | Drug | rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day |
|
|
| 48 weeks |
| 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 |
| 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 |
| D009930 |
| Organic Chemicals |
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013450 | Sulfones |
| D005663 | Furans |
| D016047 | Zalcitabine |
| D015224 | Dideoxynucleosides |
| D009570 | Nitriles |