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Observational, ambispective single-center cohort study, including 150 patients who received or are receiving a doravirine-based regimen plus two NRTI or a dual therapy of doravirine plus dolutegravir (DTG) or bDRV in routinely clinical practice.
Observational, ambispective single-center cohort study, including 150 patients who received or are receiving a doravirine-based regimen plus two NRTI or a dual therapy of doravirine plus dolutegravir (DTG) or bDRV in routinely clinical practice.
All patients who were switched to a doravirine-based regimen from date of its availability in the center (September 2020) due to clinical considerations and have available records will be retrospectively included until date of study approval (expected on July 2021).
Minor resistances in a basal genotype to NNRTI or previous failure to NNRTI as nevirapine or efavirenz will be accepted if doravirine it is combined with a high genetic barrier drug with complete activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | Patients who received a doravirine-based regimen. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with an HIV-1 viral load ≤ 50 and ≤ 200* copies/ml using snapshot algorithm. | FDA snapshot algorithm (ITT-exposed). | Up to 96 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of changes in renal biomarkers. | Changes in renal biomarkers from baseline (mean absolute changes in glomerular filtrate estimation (eGFR and CKD-epi equation)/24 (interim analysis) and 48 weeks. | Up to 48 weeks. |
| Rate of changes in hepatic parameters. |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who were switched to a doravirine-based regimen from the date of its availability in our center (September 2020) due to clinical considerations and have records available will be retrospectively included until the study approval date (expected July 2021).
Minor resistances in a baseline genotype to NNRTI or prior failure to NNRTI such as nevirapine or efavirenz will be accepted if doravirine is combined with a fully active high genetic barrier drug.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nuria Espinosa Aguilera | Contact | 955 01 30 98 | nuriai.espinosa.sspa@juntadeandalucia.es | |
| Carlos García Pérez | Contact | 955 04 31 27 | administracion.eecc.hvm.sspa@juntadeandalucia.es |
| Name | Affiliation | Role |
|---|---|---|
| Nuria Espinosa Aguilera | Virgen del Rocío University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen del Rocío | Seville | 41009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38916326 | Derived | Mejias-Trueba M, Gutierrez-Valencia A, Llaves-Flores S, Roca-Oporto C, Herrero M, Sotomayor de la Piedra C, Lopez-Cortes LF, Espinosa N. Long-term effectiveness, safety, and tolerability of doravirine in antiretroviral-experienced people with HIV in real life. Microbiol Spectr. 2024 Aug 6;12(8):e0065424. doi: 10.1128/spectrum.00654-24. Epub 2024 Jun 25. |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Changes in hepatic parameters from baseline (median percentage of change in ASL, AST, GGT, AF and bilirubin). |
| Up to 48 weeks. |
| Rate of changes in lipid parameters. | Changes in lipid parameters from baseline (median percentage of change in total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, CT-HDL ratio. | Up to 48 weeks |
| Tolerability rate of study patients. | Number of interactions, adverse events and toxicities. | Up to 48 weeks. |
| Death rates among trial patients. | Number of patients who died during or after the trial. | Up to 48 weeks. |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |