Estudio primario

No clasificado

Año 2011
Autores Janssen Cilag
Registro de estudios EU Clinical Trials Register

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INTERVENTION:

Trade Name: Prezista Product Name: TMC114 Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

Darunavir CAS Number: 635728‐49‐3 Other descriptive name: DARUNAVIR ETHANOLATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400‐ Trade Name: Norvir Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

RITONAVIR CAS Number: 155213‐67‐5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Trade Name: Kaletra Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

LOPINAVIR CAS Number: 192725‐17‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ INN or Proposed

INN:

RITONAVIR CAS Number: 155213‐67‐5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Trade Name: Retrovir Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

ZIDOVUDINE CAS Number: 30516‐87‐1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ Trade Name: Viread Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

TENOFOVIR DISOPROXIL FUMARATE CAS Number: 202138‐50‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ Trade Name: Sustiva Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

EFAVIRENZ CAS Number: 154598‐52‐4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600‐ Trade Name: Retrovir Pharmaceutical Form: Capsule, hard INN or Proposed

INN:

ZIDOVUDINE CAS Number: 30516‐87‐1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250‐ Trade Name: Truvada Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

EMTRICITABINE CAS Number: 143491‐57‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ INN or Proposed

INN:

TENOFOVIR DISOPROXIL FUMARATE CAS Number: 202138‐50‐9 Concentration unit: mg milligram(s) Concentration type:

CONDITION:

HIV postexposure prophylaxis ; MedDRA version: 14.1 Level: PT Classification code 10054925 Term: Prophylaxis against HIV infection System Organ Class: 10042613 ‐ Surgical and medical procedures Therapeutic area: Body processes [G] ‐ Immune system processes [G12]

SECONDARY OUTCOME:

Secondary end point(s): ‐ to evaluate: ; • Tolerability and safety of HIV PEP. ; • Patient reported outcome (PRO) assessment of subject wellbeing and HIV PEP tolerability, as calculated from subject responses to SDS (Sheehan Disability Scale) questionnaire. ; Timepoint(s) of evaluation of this end point: 21 month

INCLUSION CRITERIA:

Potential subjects must satisfy all of the following criteria to be enrolled in the study: • Man or woman greater than 18 years of age. • Occupational injury or non ocupational injury with documented HIV exposure, or potential for HIV exposure. • Indication for HIV PEP, as determined by the treating physician and/or the investigator. • If standard of care HIV PEP was initiated prior to screening, this should have occurred no more than 72 hours after injury and no more than 36 hours before screening. • If standard of care HIV PEP is to be initiated after screening, this should occur no more than 72 hours after injury. • Women must be: • postmenopausal (for at least 2 years), • surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), • abstinent (at the discretion of the investigator/per local regulations), or • if sexually active, be practicing a highly

PRIMARY OUTCOME:

Main Objective: To assess the rate of early discontinuation from randomized HIV PEP for any reason other than confirmation of the negative HIV infection status of the index person in subjects receiving HIV PEP for at least 28 days and maximum 30 days. Primary end point(s): ‐ to assess the rate of early discontinuation from randomized HIV PEP for any reason other than confirmation of the negative HIV infection status of the index person in subjects receiving HIV PEP for at least 28 days and maximum 30 days; Secondary Objective: To evaluate:; • Tolerability and safety of HIV PEP.; • Patient reported outcome (PRO) assessment of functional impairment in conjunction with HIV PEP in 3 inter‐related domains (work, social life, and family life), as calculated from subject responses to the Sheehan Disability Scale (SDS) questionnaire.; Timepoint(s) of evaluation of this end point: 21 month

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Estudio primario

No clasificado

Año 2017
Autores Kirby Institute
Registro de estudios clinicaltrials.gov

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D²EFT is a randomised, open-label study in HIV-1 infected patients failing first-line antiretroviral therapy (ART). The study compares 2 regimens of second-line ART (dolutegravir and darunavir pharmaco-enhanced with ritonavir and dolutegravir and 2 prespecified NRTIs) with the WHO recommended regimen of 2NRTIs plus a ritonavir-boosted PI (Standard of Care (SOC)). 1,010 participants from 14 predominantly low-middle income countries will be followed for 96 weeks with the primary endpoint at week 48. The design is based on the hypothesis that one or both of the new regimens will be non-inferior to SOC in terms of virologic control while being easier to take, economically viable and affording simplification of treatment programs.

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Estudio primario

No clasificado

Año 2014
Autores Fundacion SEIMC-GESIDA
Registro de estudios clinicaltrials.gov

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This is an open label randomized clinial trial to evaluate the treatment with darunavir/ritonavir (800mg/100mg) plus lamivudine (300 mg) once daily versus continuing with darunavir/ritonavir (800mg/100mg) once daily plus tenofovir/emtricitabine (300mg/200mg) or abacavir/lamivudine (600mg/300mg) in HIV infected subject with suppressed plasma viremia.

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Estudio primario

No clasificado

Año 2010
Revista Antiviral therapy

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Background: We explored a treatment simplification strategy to darunavir/ritonavir 900/100 mg once dally guided by the darunavir virtual Inhibitory quotient (vlQ) in patients receiving salvage therapy with darunavir/ritonavir 600/100 mg twice daily. Methods: Open-label, randomized pilot study in HIV-infected patients on darunavir/ritonavir 600/100 mg twice dally (viral load <50 copies/ml; darunavir vlQ >2). Thirty patients were randomized to darunavir/ritonavir 900/100 mg once daily (once-daily group, n=15) or 600/100 mg twice dally (twice-daily group, n=15). Viral load, blood chemistry, and darunavir and ritonavir trough plasma concentrations (C trough) were determined up to 48 weeks. If the darunavir vlQ fell to <1.5, the dosage was switched to 600/100 mg twice daily. The primary end point was the percentage of 48-week treatment failure. Results: Patients had taken a mean 11.6 (SD ±3.9) antiretroviral regimens before darunavir/ritonavir administration. The proportion of patients without 48-week treatment failure was 86.7% In both groups. The median (interquartile range [IQR]) darunavir Ctrough decreased from 3.09 mg/l (IQR 2.43-3.93) at baseline to 1.60 mg/l (IQR 1.25-2.04) at week 48 (P=0.001) in the once-daily group. Three once-daily group patients switched to darunavir/ritonavir 600/100 mg twice dally. Fewer patients had triglyceride levels >200 mg/dl at week 48 in the once-daily group (20.0%) than in the twice-daily group (20.0% versus 57.1%; P=0.046). Conclusions: Treatment simplification to darunavir/ritonavir 900/100 mg once dally guided by the darunavir vlQ in treatment-experienced HIV-infected patients receiving darunavir/ritonavir 600/100 mg twice-daily seems to be safe enough to be tested in adequately powered clinical trials.

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Estudio primario

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Año 2019
Revista AIDS research and human retroviruses

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Our aim was to evaluate the effectiveness and safety of darunavir/cobicistat (DRV/c) monotherapy as an antiretroviral treatment simplification strategy in HIV-infected patients already on suppressive darunavir/ritonavir (DRV/r) monotherapy in routine clinical practice. We conducted a retrospective multicenter study including all adult patients switched from DRV/r monotherapy to DRV/c monotherapy while HIV-1 RNA was <50 copies/mL and who had at least one follow-up visit. The primary endpoint was the percentage of patients remaining free of treatment failure (TF), defined as discontinuation of monotherapy for any reason, including loss of follow-up. Virological failure (VF) was defined as a confirmed HIV-1 RNA ≥50 copies/mL or any change in the regimen after a single determination with HIV-1 RNA ≥50 copies/mL. Changes in renal function parameters and lipid profile were also evaluated. Factors associated with VF were analyzed using Cox regression. In this study, 173 subjects were included. The median (interquartile range) time of follow-up was 58 (50-67) weeks. Overall, 90% of patients remained free of TF during follow-up. Ten (6%) patients discontinued DRV/c monotherapy for nonvirological reasons and eight (5%) developed VF. No DRV-related mutations were identified in patients with VF. A decrease in triglyceride levels (p = .006) and estimated glomerular filtration rate (p = .005) were observed during follow-up. The presence of blips and CD4+ nadir <100 cells/mm3 were predictors of VF. In conclusion, switching to DRV/c monotherapy seems to be safe and effective in routine clinical practice in HIV-infected patients undergoing suppressive DRV/r monotherapy.

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Estudio primario

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Año 2020
Revista Journal of acquired immune deficiency syndromes (1999)
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BACKGROUND:

This study aims to evaluate the pharmacokinetics of an increased dose of darunavir (800 mg twice daily) with 100 mg ritonavir during pregnancy and postpartum.

METHODS:

Darunavir (DRV) and ritonavir (RTV; r) intensive pharmacokinetic evaluations were performed at steady state during the second and third trimesters of pregnancy (DRV/r 800/100 mg bid) and 2-3 weeks postpartum (DRV/r 600/100 mg twice daily). Plasma concentrations of darunavir and ritonavir were measured using high-performance liquid chromatography. Target darunavir area under the concentration time curve (AUC) was >70% (43.6 μg × h/mL) of median AUC (62.3 μg × h/mL) in nonpregnant adults on twice daily darunavir-ritonavir 600/100 mg.

RESULTS:

Twenty-four women were included in the analysis. Darunavir AUC0-12 was lower with the increased dose during the second {[geometric mean ratio (GMR) of 0.62 (IQR 0.44-0.88); P = 0.055]} and third trimesters [GMR 0.64 (IQR 0.55-0.73); P = <0.001] compared with postpartum. Darunavir apparent clearance was higher during the second [GMR 1.77 (IQR 1.24-2.51); P = 0.039] and third trimesters [GMR 2.01 (IQR 1.17-2.35); P = <0.001] compared with postpartum. Similarly, ritonavir AUC0-12 was lower during the third trimester [GMR 0.65 (IQR 0.52-0.82); P = 0.007] compared with postpartum, whereas its apparent clearance was higher during the third trimester [GMR 1.53 (IQR 1.22-1.92); P = 0.008] compared with postpartum. No major drug-related safety concerns were noted.

CONCLUSIONS:

Increasing darunavir dose to 800 mg BID failed to significantly increase darunavir exposure compared with 600 mg BID. Other strategies, such as increasing the ritonavir dose should be investigated.

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Estudio primario

No clasificado

Año 2008
Autores Estrada, V , Fuster, M
Revista Enfermedades infecciosas y microbiologia clinica

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The ARTEMIS study compared the efficacy of darunavir/ritonavir at once‐daily doses of 800/100 mg versus once‐ or twice‐daily doses of lopinavir/ritonavir, together with 300 mg of tenofovir and 200 mg of emtricitabine, both in once‐daily doses, in treatment‐naive patients. The results at 48 weeks show that darunavir/ritonavir is not inferior to lopinavir/ritonavir; the increase in CD4 count observed with both regimens was similar. Darunavir/ritonavir was superior to lopinavir/ritonavir in patients with high viral loads (>100,000 copies/mL). The use of darunavir/ritonavir was associated with a lower proportion of grades 2‐4 adverse effects, especially gastrointestinal effects such as diarrhea and with a lower frequency of lipidic adverse effects, such as increased triglyceride and total cholesterol levels. Once‐daily darunavir/ritonavir may be an option in first‐line antiretroviral therapy, with the added advantage of a reduced dose of ritonavir and high efficacy in patients with elevated viral loads.

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Estudio primario

No clasificado

Año 2018
Autores Makerere University
Registro de estudios clinicaltrials.gov

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This study will evaluate the pharmacokinetic properties of rilpivirine and darunavir when used in combination with etonogestrel

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Estudio primario

No clasificado

Año 2011
Registro de estudios clinicaltrials.gov
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This is a clinical trial to characterize drug interactions between silimarine and the protease inhibitor darunavir/ritonavir.

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Estudio primario

No clasificado

Año 2008
Registro de estudios ClinicalTrials.gov

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The purpose of this study is to determine whether a combination of raltegravir and darunavir is as effective as standard regimens in the treatment of HIV-infected patients who have not previously used antiretroviral drug (treatment naive)

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