Estudio primario

No clasificado

Randomized multicenter study on security and efficacy of therapeutic switch to maraviroc + darunavir/ritonavir once daily in patients who are in triple antiretroviral regimen with three drugs belonging at least to one of the three historical classes and have an optimal virological control

Año 2010
Registro de estudios EU Clinical Trials Register
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INTERVENTION:

Trade Name: CELSENTRI Pharmaceutical Form: Coated tablet Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ Trade Name: PREZISTA Pharmaceutical Form: Coated tablet Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 800‐ Trade Name: NORVIR Pharmaceutical Form: Capsule, soft INN or Proposed

INN:

Ritonavir Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐

CONDITION:

Infection of HIV ; MedDRA version: 9.1 Level: PT Classification code 10020161

PRIMARY OUTCOME:

Main Objective: To demonstrate the non virological inferiority at 48 weeks of therapeutic simplification to maraviroc (MVC) QD + darunavir/ritonavir (DRV/r) QD compared to the prosecution of the previous treatment in patients with tropic R5‐virus, who are treated with at least 3 ARV, who have a toxicity of any grade and type with the current therapy or wish a therapeutic simplification or a proactive NRTI interruption and have a persistent virological suppression in the last 24 weeks. Primary end point(s): percentage of patients with virological failure (defined as 2 HIV‐RNA consecutive values above 50 copies/mL or a single value above 1000 copies/mL) (TLOVR) at 48 weeks according to the analysis for protocol switch=failure. Switch=suspension or addition of any drug in the MVC+DRV/r arm; idem in the control arm. Secondary Objective: Verify and compare the trend of immunological and toxicity parameters between the two randomized arms and the impact in pharmaco‐economic terms of the proposed simplification

INCLUSION CRITERIA:

Patients receiving at least three antiretroviral drugs (ritonavir is not considered in the 3) unchanged for at least 12 weeks Aged greater or equal to18 years old who will sign the informed consent. With viremia <50 copies/mL in at least two consecutives determinations since at least 6 months (tolerance of two weeks) With CD4 >200 cells/mm3 for at least 3 months and absence of major active opportunistic infections or other AIDS‐defined diseases for at least one year prior to the screening. With R5 viral tropism predicted on the basis of the interpretation of the sequence of the V3 region of viral DNA and other clinical parameters according to geno2pheno ``clonal`` Who provided informed consent to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for t

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Estudio primario

No clasificado

A prospective, randomized, open-label trial of two abacavir/lamivudine based regimen (ABC/3TC + darunavir/ritonavir or ABC/3TC + raltegravir) in late presenter naïve patients (with CD4 count <200 cells/µL - advanced HIV disease)

Año 2012
Autores [No se listan los autores]
Registro de estudios EU Clinical Trials Register
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INTERVENTION:

Trade Name: KIVEXA*FL 30CPR RIV 600MG+300M Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

ABACAVIR SULFATE CAS Number: 188062‐50‐2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600‐ INN or Proposed

INN:

LAMIVUDINE CAS Number: 134678‐17‐4 Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 300‐ Trade Name: ISENTRESS*FL 60CPR RIV 400MG Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

RALTEGRAVIR POTASSIUM CAS Number: 871038‐72‐1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400‐ Trade Name: PREZISTA*60CPR RIV 400MG Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

DARUNAVIR ETHANOLATE CAS Number: 635728‐49‐3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400‐ Trade Name: NORVIR*FL 30CPR RIV 100MG 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‐

CONDITION:

Advanced HIV disease, defined as a CD4 cell count <200 cells/µL or the presence of an AIDS‐defining event. ; MedDRA version: 14.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 ‐ Infections and infestations Therapeutic area: Diseases [C] ‐ Virus Diseases [C02]

PRIMARY OUTCOME:

Main Objective: Proportion of patients with undetectable viremia (HIV‐1 RNA<50 copies/mL) after 48 weeks Primary end point(s): Proportion of patients with undetectable viremia (HIV‐1 RNA<50 copies/mL) after 48 weeks Secondary Objective: Change in CD4+ cell count from baseline through week 48; Time to virological rebound, defined as plasma HIV RNA >50 copies/mL measured on two consecutive occasions at least one month apart. Timepoint(s) of evaluation of this end point: 48 weeks

SECONDARY OUTCOME:

Secondary end point(s): Time to virological rebound, defined as plasma HIV RNA >50 copies/mL measured on two consecutive occasions at least one month apart. Timepoint(s) of evaluation of this end point: 48 weeks

INCLUSION CRITERIA:

1. Males or females aged 18‐64 years who are HIV‐1 antibody seropositive, with a CD4 count <200 cells/uL. 2. All patients should be antiretroviral‐naive 3. All patients should be HLA B57 or HLA B5701 negative 4. Patients must have an HIV RNA level <500,000 copies/mL 5. Patients with an active opportunistic infection could be enrolled as long as this was diagnosed more than 2 weeks prior to screening. 6. Patients must meet the following laboratory criteria. Neutrophil count ? 1,000 cells/mm3 Haemoglobin > 9.0 grams/dl (men and women) Platelet count = 75,000 cells/mm3 Alkaline phosphatase < 3.0 the upper limit of normal ALT and AST < 3.9 times the upper limit of normal Total bilirubin < 1.5 times the upper limit of normal. 7. Female patients of childbearing potential must be willing to use a reliable form of contraception, which will include a medically approved form of barrier contraception. 8. Patients must be able to provide written consent to c

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Estudio primario

No clasificado

Efficacy and safety of darunavir (Prezista®) with low-dose ritonavir and other antiretroviral medications in subtype F HIV-1 infected, treatment-experienced subjects in Romania: A post-authorization, open-label, one-cohort, non-interventional, prospective study

Año 2014
Revista Germs
Enlaces Pubmed , PMC , DOI

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Introduction The aim of the study was to assess the safety and efficacy of darunavir (Prezista®) used in subtype F human immunodeficiency virus – type 1 (HIV-1) infected, antiretroviral therapy (ART)-experienced patients in Romania in routine clinical practice.
Results Treatment with DRV/r administered with other ARV medications resulted in the expected, statistically relevant improvement of CD4 cell count and viral load in subjects eligible for such treatment. In addition, adherence to treatment was high and the treatment-emergent safety profile observed during this study was consistent with the established safety profile of darunavir.
Conclusion DRV/r administered in combination with other ARV medications in subtype F HIV-1 infected subjects in naturalistic settings proved to be an effective and safe treatment in Romania.
Methods This was a post-authorization, open-label, one-cohort, non-interventional, prospective study conducted at multiple sites in Romania to assess efficacy (CD4 cell count, viral load, and treatment compliance) and safety ([serious] adverse events, clinical laboratory evaluation, and vital signs) of darunavir in combination with low-dose ritonavir (DRV/r) and other antiretroviral (ARV) medications in subtype F HIV-1 infected subjects in naturalistic settings. Seventy-eight subjects were recruited by 9 investigational sites and received 600/100 mg DRV/r twice daily.
Trial registration NCT01253967.

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Estudio primario

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TMC114-TiDP3-C176 - A Study in Healthy Volunteers Investigating the Bioequivalence Between Two Commercially Available 400-mg Tablets to One New 800-mg Tablet of Darunavir (DRV) in the Presence of Low-dose Ritonavir Under Fed and Fasted Conditions

Año 2011
Registro de estudios ClinicalTrials.gov
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In this study participants will be given 800 mg darunavir, either as one 800-mg tablet formulation (G002), or as two commercially available 400-mg tablets formulation (F030), to evaluate the effect between both, in the presence of low-dose ritonavir under fasted and fed conditions.

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Estudio primario

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A Phase 2B Multicenter, Randomized, Comparative Trial Of UK-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleos(t)Ide Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced HIV-1 Infected Subjects With Evidence Of NNRTI Resistant HIV-1

Año 2009
Autores Pfizer
Registro de estudios ClinicalTrials.gov
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This is a 96 week study to determine if UK- 453,061 in combination with Darunavir /ritonavir and a Nucleos(t)ide Reverse Transcriptase inhibitor is as efficacious, safe and tolerable as etravirine in combination with Darunavir /ritonavir and a Nucleos(t)ide Reverse Transcriptase inhibitor in HIV-1 infected patients who have been previously treated with antiretroviral drugs and have NNRTI resistance mutations.

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Estudio primario

No clasificado

The MONET trial: week 144 analysis of the efficacy of darunavir/ritonavir (DRV/r) monotherapy versus DRV/r plus two nucleoside reverse transcriptase inhibitors, for patients with viral load < 50 HIV-1 RNA copies/mL at baseline

Año 2012
Revista HIV medicine
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BACKGROUND:

In the MONotherapy in Europe with Tmc114 (MONET) trial, darunavir/ritonavir (DRV/r) monotherapy showed noninferior efficacy vs. two nucleoside reverse transcriptase inhibitors (NRTIs) plus DRV/r at the primary 48-week analysis. The trial was continued to week 144 to assess the durability of the results.

METHODS:

A total of 256 patients with viral load < 50 HIV-1 RNA copies/mL on current highly active antiretroviral therapy (HAART) for at least 6 months switched to DRV/r 800/100 mg once daily, either as monotherapy (n=127) or with two NRTIs (n=129). Treatment failure was defined as two consecutive HIV RNA levels above 50 copies/mL [time to loss of virological response (TLOVR)] by week 144, or discontinuation of study drugs.

RESULTS:

Eighty-one per cent of patients were male and 91% were Caucasian, and they had a median baseline CD4 count of 575 cells/uL. More patients in the DRV/r monotherapy arm had hepatitis C virus coinfection at baseline than in the control arm (18% vs. 12%, respectively). By week 144, the percentage of patients with HIV RNA < 50 copies/mL [intent to treat (ITT), TLOVR, switch=failure method] was 69% vs. 75% in the DRV/r monotherapy and triple therapy arms [difference= -5.9%; 95% confidence interval (CI) -16.9%, +5.1%]; by a strict ITT analysis (switches not considered failures), the percentage of patients with HIV RNA < 50 copies/mL was 84% vs. 83.5%, respectively (difference= +0.5%; 95% CI -8.7%, +9.7%). Twenty-one and 13 patients had two consecutive HIV RNA results above 50 copies/mL in the DRV/r monotherapy arm and triple therapy arm, respectively, of whom 18 of 21 (86%) and 10 of 13 (77%) had HIV RNA < 50 copies/mL at week 144.

CONCLUSIONS:

In this study, for patients with HIV RNA < 50 copies/mL at baseline, switching to DRV/r monotherapy showed noninferior efficacy to DRV/r plus two NRTIs in a strict ITT (switches not considered failures) analysis, but not in a TLOVR switch equals failure analysis.

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Estudio primario

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A PHASE 2B MULTICENTER, RANDOMIZED, COMPARATIVE TRIAL OF UK-453,061 VERSUS ETRAVIRINE IN COMBINATION WITH DARUNAVIR/RITONAVIR AND A NUCLEOTIDE/NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR FOR THE TREATMENT OF ANTIRETROVIRAL EXPERIENCED HIV-1 INFECTED SUBJECTS WITH EVIDENCE OF NNRTI RESISTANT HIV-1 - ND

Año 2009
Autores [No se listan los autores]
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INTERVENTION:

Product Code: UK‐453,061 Pharmaceutical Form: Tablet CAS Number: 473921‐12‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Intelence Pharmaceutical Form: Tablet INN or Proposed

INN:

ETRAVIRINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐

CONDITION:

HIV Infection ; MedDRA version: 9.1 Level: LLT Classification code 10020178 Term: HIV infection with specific secondary infections

PRIMARY OUTCOME:

Main Objective: The primary objective is to assess the efficacy of UK‐453,061 when used in combination; with darunavir/ritonavir and an optimized NRTI for the treatment of subjects with prior; NNRTI use and documented evidence of NNRTI resistance associated mutations. Efficacy; will be measured by the percentage of subjects with HIV‐1 RNA <48 copies/mL at 24 weeks. Primary end point(s): The percentage of subjects with HIV‐1 RNA <48 copies/mL at 24 weeks Secondary Objective: To assess efficacy as measured by percentage of subjects with HIV‐1 RNA; <48 copies/mL at 48 and 96 weeks.; To assess efficacy as measured by percentage of subjects with HIV‐1 RNA; <400 copies/mL.; To assess efficacy as measured by change from baseline in log10 transformed; HIV‐1 RNA levels.; To assess the pharmacokinetics (PK) and pharmacokinetic/pharmacodynamic; (PK/PD)‐relationship of UK‐453,061.; To assess pharmacokinetic parameters of UK‐453,061 AUC24, Cmax and C24h; (PK sub‐study).; To assess safety and tolerability of UK‐453,061.

INCLUSION CRITERIA:

1. Evidence of a signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. 2. Male or female at least 18 years of age available for a follow‐up period of at least 96 weeks. 3. HIV‐1 RNA viral load of ≥1,000 copies/mL measured by the Roche COBAS AmpliPrep/COBAS TaqMan HIV‐1 test at the screening visit.4. Virologically failed a single NNRTI‐based regimen with documented evidence of NNRTI resistance mutations at screening or on historical genotype. Subjects may have PI experience/resistance. 5. Negative urine pregnancy test at the Day 1 visit, prior to receiving the first dose of study medication, for Women of Child Bearing Potential (WOCBP).

NOTE:

WOCBP includes any female who has experienced menarche and who has not undergone successful surgical sterilization or is not post‐menopausal (ie, no menstrual per

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Estudio primario

No clasificado

Study to Assess the Acceptability of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Pediatric Participants, Using Matching Placebo Tablets

Año 2019
Registro de estudios clinicaltrials.gov
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This study will be performed in 24 human immunodeficiency virus type 1 (HIV‐1) infected pediatric participants. This study is being conducted to obtain data needed to assist in further pediatric development of D/C/F/TAF by assessing the acceptability of the scored film‐coated D/C/F/TAF FDC tablet administered as a matching placebo tablet in a pediatric population. At Day 1, each participant will sequentially take 2 placebo tablets and the sequence of placebo tablet, swallowed whole or as split tablet, is assigned by computer generated randomization. After each intake period (within 15 minutes and before the next intake period, as applicable), participants will be asked to fill out an acceptability questionnaires. Every attempt should be made for the participant to complete the questionnaire (marking the correct box to correspond with their impact of taking the placebo tablet). Caregivers may explain the wording/text in the questionnaire to aid in completion. If a participant and his or her caregiver have difficulties in completing the questionnaire, then the study‐site personnel may assist. Primarily ability to swallow the scored film‐coated D/C/F/TAF FDC tablet, irrespective of the mode of intake will be assessed. Participants safety will be evaluated throughout the study from signing of the Informed Consent Form (ICF)/Assent Form onwards until the last study‐related visit.

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Estudio primario

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Assessment of swallowability and acceptability of scored darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablets in HIV-1-infected children aged ≥6 to <12 years, using matching placebo tablets: A randomized study.

Año 2024
Revista Antiviral therapy
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BACKGROUND:

Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) was developed as a once-daily, complete antiretroviral (ARV) regimen therapy to address the need for simplified protease inhibitor-based ARV regimens. This study assessed the swallowability and acceptability for long-term use of scored placebo tablets matching the D/C/F/TAF FDC tablets in children living with HIV-1.

METHODS:

This study (NCT04006704) was a Phase 1, open-label, randomized, single-dose, 2-period, 2-sequence crossover study in children living with HIV-1, aged ≥6 to <12 years and weighing ≥25 to <40 kg, on a stable ARV regimen for ≥3 months. Participants were asked to swallow whole (size, 21 × 11 × 7 mm) and split matching placebo D/C/F/TAF tablets. Swallowability of the matching placebo D/C/F/TAF tablets (primary endpoint) was assessed by observers. Acceptability of taking matching placebo D/C/F/TAF tablets and current ARVs was evaluated by participants using a 3-point questionnaire. Participants rated the acceptability for long-term daily use of the placebo D/C/F/TAF tablets, and observers assessed how easily caregivers could split a scored tablet by hand, using 3-point questionnaires.

RESULTS:

Among the 24 participants who enrolled and completed the study, 95.8% (23/24) were able to swallow the whole and split matching placebo D/C/F/TAF tablets after 1 or 2 attempts. Most participants (>70%) rated the acceptability of tablets for long-term daily use as acceptable or good to take. Breaking the tablets was considered easy or OK by 79.2% (19/24) of caregivers.

CONCLUSION:

Scored D/C/F/TAF FDC tablets are swallowable - with whole favoured over split - and considered at least acceptable for long-term daily intake in children living with HIV-1 aged ≥6 to <12 years.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT04006704.

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Estudio primario

No clasificado

Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants

Año 2015
Autores Janssen R&D Ireland
Registro de estudios clinicaltrials.gov
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The purpose of this study is to demonstrate non-inferiority in efficacy while switching to a once-daily single-tablet regimen containing darunavir (DRV)/ cobicistat (COBI)/ emtricitabine (FTC)/ tenofovir alafenamide (TAF) (D/C/F/TAF tablet) relative to continuing the current regimen consisting of a boosted protease inhibitor (bPI) combined with tenofovir disoproxil fumarate (FTC/TDF) in virologically-suppressed (human immunodeficiency virus type 1 ribonucleic acid \[HIV-1 RNA\] concentrations less than \[\<\] 50 copies per milliliter \[copies/mL\]) HIV-1 infected participants.

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