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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Phase IV, open, multicentre and single-arm study. 50 HIV infection naive patients with severe immunosuppression will be recruited to evaluate the efficacy and safety of elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide as a first-line treatment.
The patients included in the study will be treated during 48 weeks and will have to perform the selection/basal visit, week 4 visit, week 8 visit, week 12 visit, week 24 visit, week 48 visit and follow up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Naive HIV patients with severe immunosuppression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genvoya® | Drug | Patents treated with elvitegravir (EVG) 150mg / cobicistat (COBI) 150mg / emtricitabine (FTC) 200mg / tenofovir (TAF) 10mg once a day as the first line treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with undetectable plasma viral load | study the effectiveness of the combination of TAF/FTC/EVG-cb | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with virological failure | Proportion of patients with Plasma viral load of HIV-1 RNA ≥50 copies / mL in the last measurement while the patient receives the treatment in the window period, patients who interrupt the treatment prematurely due to lack / loss of efficacy in which the last viral load was ≥50 copies / mL or in which the antiretroviral treatment was modified before 48 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Costa del Sol | Marbella | Malaga | Spain | |||
| H. Ramón y Cajal |
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Single arm, phase 4 study. The naive patients will be treated with elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide as a first-line treatment
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|
| From basal until week 48 |
| Proportion of patients with virological failure | Proportion of patients who interrupt the treatment prematurely due to absence or loss of efficacy | From basal visit until week 48 |
| Proportion of patients with virological failure | Proportion of patients who interrupt the treatment prematurely by others reasons (other than an adverse event, death or loss of effectiveness) and whose last viral load at the time of abandonment was ≥50 copies / mL. | From basal visit until week 48 |
| Time to virological suppression | viral load <50 copies / mL | From basal until week 48 |
| Proportion of patients with virological failure while receiving antiretroviral treatment (ART), having previously been suppressed . | virological failure defined by protocol as viral load> 1000 copies / mL at week 24 or 2 consecutive viral loads> 50 copies / mL (at least 2 weeks apart) | From basal until week 48 |
| Time to virological failure | Viral load ≥50 copias/mL | From basal until week 48 |
| Incidence of genotypic resistance in patients with virological failure | From basal until week 48 |
| Changes in viral load | plasma concentration of HIV RNA | Weeks 4, 8, 12, 24, 36 and 48 |
| Change in the CD4+ lymphocyte count | Week 48 |
| Proportion of patients who have a CD4+ lymphocyte count > 200 cells / μL | Week 48 |
| Mean time to reach a CD4 + lymphocyte count> 200 cells / μL | From basal until week 48 |
| Madrid |
| 28034 |
| Spain |
| H. Clínico San Carlos | Madrid | 28040 | Spain |
| H. Doce de Octubre | Madrid | 28041 | Spain |
| Hospital Infanta Leonor | Madrid | Spain |
| Hospital virgen del Rocío | Seville | 41013 | Spain |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069545 | Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000069547 | Cobicistat |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| 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 |
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