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The main objective of this study is to compare the tolerability and adherence to a new drug regimen of post-exposure prophylaxis (PEP) for HIV,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenofovir+emtricitabine | Active Comparator |
| |
| Elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir + emtricitabine (Truvada),+lopinavir/ritonavir (Kaletra) | Drug | (TRUVADA) film-coated 200/245 mg tablet / day tablets (Kaletra) film-coated 200/50 mg tablets twice / day tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who leave the initial treatment of post-exposure prophylaxis (PEP) for HIV for any reason | A subject is considered to abandon treatment if within 28 days
| Twenty Eigth days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of clinical adverse events and / or laboratory alterations. | twenty-four weeks | |
| Proportion of patients who discontinued treatment due to toxicity or intolerance in each of the treatment arms at 24 weeks follow-up | twenty four weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felipe GarcÃa, MD | Hospital clÃnic y provincial de Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital clÃnico y provincial de Barcelona | Barcelona | Barcelona | 08036 | Spain |
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| elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil | Drug | Film-coated tablets of 150 mg of elvitegravir, cobicistat 150 mg, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil. One tablet once / day. |
|
|
| degree of adhesion during the treatment period | Measured by pill count and patient adherence questionnaire | twenty eight days |
| time to loss of adherence to TARV | twenty eight days |
| Proportion of patients with seroconversion in both treatment arms at 24 weeks follow-up. | twenty four weeks |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| D019438 | Ritonavir |
| C558899 | lopinavir-ritonavir drug combination |
| C509700 | elvitegravir |
| D000069545 | Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D000069547 | Cobicistat |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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