CoDAR: Study of the Effectiveness and Safety of Darunavir/Cobicistat (DRV/c) Containing Regimens in Routine Clinical Practice
Study Details
Study Description
Brief Summary
This is a retrospective observational study of patients who have taken a regimen containing DRV / c at least 24 weeks prior to study initiation
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Detailed Description
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| DArunavir/cobicistat Patients starting treatment with a regimen containing Darunavir / cobicistat for at least 24 weeks |
Outcome Measures
Primary Outcome Measures
- Virological effectiveness data: Percentage of patients with undetectable viral load [24 weeks]
Virological effectiveness data at 24 weeks: Percentage of patients with undetectable viral load, defined as HIV RNA <50 copies / m.
- Virological effectiveness data: change in the number of CD4 + T cells at 24 weeks [24 weeks]
Change in the number of CD4 + T cells at 24 weeks
- Virological effectiveness data: time to loss of virological efficacy. [24 weeks]
Defined virological failure as two consecutive levels of HIV RNA > 50 copies / mL or single HIV RNA ≥ 500 copies / mL
Secondary Outcome Measures
- 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 [48 weeks]
Virological effectiveness data at 48 weeks
- Virological effectiveness data: change in the number of CD4 + T cells, at 48 weeks [48 weeks]
Virological effectiveness data at 48 weeks: change in the number of CD4 + T cells
- Changes in the renal profile: Comparison of mean values of Creatinine and eFG (CKD-EPI). [Basal and 24 weeks/48 weeks]
Creatinine (mg/dl), eFG (CKD-EPI) (ml/min/1,73 m2),
- Changes in the lipid profile: Comparison of mean values of total cholesterol values, Col LDL, Col HDL and TG. [basal and 24 weeks/48 weeks]
Units: mg/dl or mmol/l
- Changes in the hepatic profile: comparison of mean values of GOT, GPT, FA, GGT and BrT [basal and 24 weeks/48 weeks]
GOT, GPT, FA, GGT in units: UI/l or μKat/l or mU/ml. BrT in units: mg/dl or micromol/l
- Tolerability data:Rate of patients discontinuing treatment for toxicity. [24 weeks/48 weeks]
Toxicity to the treatment or virological failure
- Tolerability data: Rate of patients discontinuing treatment for virological failure at 24 weeks / 48 weeks [24 weeks/48 weeks]
Virological failure defined as two consecutive levels of HIV RNA > 50 copies / mL or single HIV RNA ≥ 500 copies / mL
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with HIV infection
-
Inform consent document.
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To have initiated therapy containing DRV / c and have a follow-up of at least 24 Weeks.
Exclusion Criteria:
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Not having evaluable clinical data of the patient
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Patients not routinely followed in the center
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Patient less than 18 years of age.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Costa del Sol | Malaga | Marbella | Spain | |
| 2 | Hospital Clinic i Provincial | Barcelona | Spain | ||
| 3 | Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | ||
| 4 | Hospital del Mar | Barcelona | Spain | ||
| 5 | Hospital del Vall d'Hebron | Barcelona | Spain | ||
| 6 | Hospital Germans Trias i Pujol | Barcelona | Spain | ||
| 7 | Hospital de Guadalajara | Guadalajara | Spain | ||
| 8 | Hospital Infanta Leonor | Madrid | Spain | ||
| 9 | Hospital La Paz | Madrid | Spain | ||
| 10 | Hospital La Princesa | Madrid | Spain | ||
| 11 | Hospital Príncipe de Asturias | Madrid | Spain | ||
| 12 | Hospital Puerta de Hierro | Madrid | Spain | ||
| 13 | Hospital Ramón y Cajal | Madrid | Spain | ||
| 14 | Hospital Virgen de la Victoria | Malaga | Spain | ||
| 15 | Hospital de Son Llatzer | Palma de Mallorca | Spain | ||
| 16 | Hospital de Valme | Sevilla | Spain | ||
| 17 | Complejo Hospitalario de Toledo | Toledo | Spain | ||
| 18 | Hospital Clínico de Valencia | Valencia | Spain | ||
| 19 | Hospital La Fe | Valencia | Spain | ||
| 20 | Complejo Hospitalaria Alvaron Cunqueiro | Vigo | Spain |
Sponsors and Collaborators
- Fundacion SEIMC-GESIDA
- Janssen-Cilag, S.A.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GESIDA 9316