An observational study in HIV Infections, sponsored by Fundacion SEIMC-GESIDA. Completed at 20 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-05.
Sponsored by Fundacion SEIMC-GESIDA · Observational
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
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 762 is above the median of 200 across 713 observational studies indexed under HIV Infections.
Browse HIV Infections studies →Fundacion SEIMC-GESIDA is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
HIV patients that initiated treatment with a régimen containing DRV/c at least 24 weeks prior initiation of study.
Exclusion Criteria:
Patients starting treatment with a regimen containing Darunavir / cobicistat for at least 24 weeks
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.
Time frame: 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
Time frame: 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
Time frame: 24 weeks
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
Time frame: 48 weeks
Virological effectiveness data: change in the number of CD4 + T cells, at 48 weeks
Virological effectiveness data at 48 weeks: change in the number of CD4 + T cells
Time frame: 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),
Time frame: 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
Time frame: 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
Time frame: basal and 24 weeks/48 weeks
Tolerability data:Rate of patients discontinuing treatment for toxicity.
Toxicity to the treatment or virological failure
Time frame: 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
Time frame: 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.
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
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Fundacion SEIMC-GESIDA