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| Name | Class |
|---|---|
| Janssen-Cilag, S.A. | INDUSTRY |
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This is a retrospective observational study of patients who have taken a regimen containing DRV / c at least 24 weeks prior to study initiation
The study will include 750 patients and will record data at 24 weeks. The study will also record data at 48 weeks for those patients whom these data are available
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DArunavir/cobicistat | Patients starting treatment with a regimen containing Darunavir / cobicistat for at least 24 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Virological effectiveness data: Percentage of patients with undetectable viral load | Virological effectiveness data at 24 weeks: Percentage of patients with undetectable viral load, defined as HIV RNA <50 copies / m. | 24 weeks |
| Virological effectiveness data: change in the number of CD4 + T cells at 24 weeks | Change in the number of CD4 + T cells at 24 weeks | 24 weeks |
| Virological effectiveness data: time to loss of virological efficacy. | Defined virological failure as two consecutive levels of HIV RNA > 50 copies / mL or single HIV RNA ≥ 500 copies / mL | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Virological effectiveness data: Percentage of patients with undetectable viral load, defined as HIV RNA levels ≤ 50 copies / mL or limit of detection of the center, at 48 weeks | Virological effectiveness data at 48 weeks | 48 weeks |
| Virological effectiveness data: change in the number of CD4 + T cells, at 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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HIV patients that initiated treatment with a régimen containing DRV/c at least 24 weeks prior initiation of study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Costa del Sol | Málaga | Marbella | Spain | |||
| Hospital Clinic i Provincial |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33501995 | Derived | Perez Elias MJ, Alejos B, Gutierrez MM, Crespo M, De Los Santos Gil I, Ribera E, Galindo MJ, Lozano F, Payeras Cifre A, Boix V, Montero-Alonso M, Sanz J, De La Torre Lima J, Palacios R, De La Fuente Moral S, Martinez E; Codar Study Group. Dynamics of creatinine estimated glomerular filtration rate using one or more antiretrovirals that inhibit creatinine tubular secretion. J Antimicrob Chemother. 2021 Mar 12;76(4):1046-1050. doi: 10.1093/jac/dkaa547. | |
| 31236601 |
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Virological effectiveness data at 48 weeks: change in the number of CD4 + T cells |
| 48 weeks |
| Changes in the renal profile: Comparison of mean values of Creatinine and eFG (CKD-EPI). | Creatinine (mg/dl), eFG (CKD-EPI) (ml/min/1,73 m2), | Basal and 24 weeks/48 weeks |
| Changes in the lipid profile: Comparison of mean values of total cholesterol values, Col LDL, Col HDL and TG. | Units: mg/dl or mmol/l | basal and 24 weeks/48 weeks |
| Changes in the hepatic profile: comparison of mean values of GOT, GPT, FA, GGT and BrT | GOT, GPT, FA, GGT in units: UI/l or μKat/l or mU/ml. BrT in units: mg/dl or micromol/l | basal and 24 weeks/48 weeks |
| Tolerability data:Rate of patients discontinuing treatment for toxicity. | Toxicity to the treatment or virological failure | 24 weeks/48 weeks |
| Tolerability data: Rate of patients discontinuing treatment for virological failure at 24 weeks / 48 weeks | Virological failure defined as two consecutive levels of HIV RNA > 50 copies / mL or single HIV RNA ≥ 500 copies / mL | 24 weeks/48 weeks |
| Rate of patients who develop any adverse effects:frequency of adverse events,frequency of serious adverse events, frequency of adverse events leading to discontinuation of treatment, number of deaths and frequency of laboratory abnormalities. | 24 weeks/48 weeks |
| Representative subgroups of patients according to the treatment that patient is taking: Percentage of patients with different Darunavir/cobicistat based regimens (Monotherapy, Bitherapy, triple Therapy, others) | 24 weeks / 48 weeks |
| Provenance treatments: Percentage of patients with different prior therapies (Darunavir Therapy, Other PI therapies, NNRTI based regimen, INI bases regimen | 24 weeks / 48 weeks |
| Reason for the change prior the initiation:Percentage of patients with each main reason to change to a DRV/c based regimen (first regimen, simplification, intolerance or toxicity, prior adherence problems, prior interactions, prior failure, others) | 24 weeks / 48 weeks |
| Barcelona |
| Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain |
| Hospital del Mar | Barcelona | Spain |
| Hospital del Vall d'Hebron | Barcelona | Spain |
| Hospital Germans Trias i Pujol | Barcelona | Spain |
| Hospital de Guadalajara | Guadalajara | Spain |
| Hospital Infanta Leonor | Madrid | Spain |
| Hospital La Paz | Madrid | Spain |
| Hospital La Princesa | Madrid | Spain |
| Hospital Príncipe de Asturias | Madrid | Spain |
| Hospital Puerta de Hierro | Madrid | Spain |
| Hospital Ramón y Cajal | Madrid | Spain |
| Hospital Virgen de la Victoria | Málaga | Spain |
| Hospital de Son Llatzer | Palma de Mallorca | Spain |
| Hospital de Valme | Seville | Spain |
| Complejo Hospitalario de Toledo | Toledo | Spain |
| Hospital Clínico de Valencia | Valencia | Spain |
| Hospital La Fe | Valencia | Spain |
| Complejo Hospitalaria Alvaron Cunqueiro | Vigo | Spain |
| Derived |
| Perez Elias MJ, Alejos B, Vivancos MJ, Ribera E, Galindo MJ, Vilanova-Trillo L, Garcia-Fraile Fraile LJ, de La Fuente Moral S, Garcia De Lomas J, Lozano F, Mateo Garcia MG, Tasias Pitarch M, Diez Martinez M, Rojas J, Raya-Cruz M, Sepulveda MA, Troya J, Del Campo S, Martinez E; CODAR study group. Outcomes by sex following treatment initiation with darunavir/cobicistat in a large Spanish cohort of the CODAR study (GeSIDA 9316). J Antimicrob Chemother. 2019 Oct 1;74(10):3044-3048. doi: 10.1093/jac/dkz254. |
| 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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