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Study of the Effectiveness and Safety of Darunavir/Cobicistat (DRV/c) Containing Regimens in Routine Clinical Practice (CoDAR)
This study has been completed.
Sponsor:
Fundacion SEIMC-GESIDA
Collaborator:
Janssen-Cilag, S.A.
Information provided by (Responsible Party):
Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier:
NCT03042390
First received: December 19, 2016
Last updated: July 7, 2017
Last verified: December 2016
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Purpose
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 |
|---|
| HIV Infections |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Control Time Perspective: Retrospective |
| Official Title: | Multicenter Retrospective Study of the Effectiveness and Safety of Darunavir/Cobicistat (DRV/c) Containing Regimens in Routine Clinical Practice |
Resource links provided by NLM:
Further study details as provided by Fundacion SEIMC-GESIDA:
Primary Outcome Measures:
- Virological effectiveness data: Percentage of patients with undetectable viral load [ Time Frame: 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 [ Time Frame: 24 weeks ]Change in the number of CD4 + T cells at 24 weeks
- Virological effectiveness data: time to loss of virological efficacy. [ Time Frame: 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 [ Time Frame: 48 weeks ]Virological effectiveness data at 48 weeks
- Virological effectiveness data: change in the number of CD4 + T cells, at 48 weeks [ Time Frame: 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). [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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) [ Time Frame: 24 weeks / 48 weeks ]
- Provenance treatments: Percentage of patients with different prior therapies (Darunavir Therapy, Other PI therapies, NNRTI based regimen, INI bases regimen [ Time Frame: 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) [ Time Frame: 24 weeks / 48 weeks ]
| Enrollment: | 762 |
| Actual Study Start Date: | December 23, 2016 |
| Study Completion Date: | May 9, 2017 |
| Primary Completion Date: | May 9, 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
DArunavir/cobicistat
Patients starting treatment with a regimen containing Darunavir / cobicistat for at least 24 weeks
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
HIV patients that initiated treatment with a régimen containing DRV/c at least 24 weeks prior initiation of study.
Criteria
Inclusion Criteria:
- Patients with HIV infection
- Inform consent document.
- To have initiated therapy containing DRV / c and have a follow-up of at least 24 Weeks.
Exclusion Criteria:
- Not having evaluable clinical data of the patient
- Patients not routinely followed in the center
- Patient less than 18 years of age.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03042390
Please refer to this study by its ClinicalTrials.gov identifier: NCT03042390
Locations
| Spain | |
| Hospital Costa del Sol | |
| Malaga, Marbella, Spain | |
| Hospital Clinic i Provincial | |
| 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 | |
| Malaga, Spain | |
| Hospital de Son Llatzer | |
| Palma de Mallorca, Spain | |
| Hospital de Valme | |
| Sevilla, Spain | |
| Complejo Hospitalario de Toledo | |
| Toledo, Spain | |
| Hospital Clínico de Valencia | |
| Valencia, Spain | |
| Hospital La Fe | |
| Valencia, Spain | |
| Complejo Hospitalaria Alvaron Cunqueiro | |
| Vigo, Spain | |
Sponsors and Collaborators
Fundacion SEIMC-GESIDA
Janssen-Cilag, S.A.
More Information
| Responsible Party: | Fundacion SEIMC-GESIDA |
| ClinicalTrials.gov Identifier: | NCT03042390 History of Changes |
| Other Study ID Numbers: |
GESIDA 9316 |
| Study First Received: | December 19, 2016 |
| Last Updated: | July 7, 2017 |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Darunavir Cobicistat |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |
ClinicalTrials.gov processed this record on July 17, 2017