HIV Infections
Conditions
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
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
Interventions
None listed
Sponsors
Janssen-Cilag, S.A.
Fundacion SEIMC-GESIDA
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 | — |
| 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 | — |
| 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), |
Countries
Spain
Outcome results
None listed