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Tipranavir

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101. Incidence and risk factors for liver enzymes elevations in highly treatment-experienced patients switching from enfuvirtide to raltegravir: a sub-study of the ANRS-138 EASIER trial. Full Text available with Trip Pro

), and 5 and 1 % (p = 0.14) of patients in the RAL and ENF arms, respectively. The 48-week incidence of grade 2 or more LEE was 11.6 per 100-pts-years for ALT, 24.5 per 100-pts-years for γ-GT and 4.5 per 100-pts-years for ALP, respectively. In the multivariate analysis, tipranavir/ritonavir use (OR 3.66; 95 % CI [1.20-11.1], p = 0.022) and elevated ALT at baseline (OR 10.3; 95 % CI [2.67-39.6], p < 10(-3)) were significantly associated with a grade 2 or more ALT elevation during follow-up.The incidence (...) of LEE was relatively high in these highly treatment-experienced patients switching to a RAL-based regimen. Both tipranavir/ritonavir use and high baseline ALT levels were associated with an increased risk of ALT.ClinicalTrials.gov identifier: NCT00454337.

2016 AIDS research and therapy Controlled trial quality: uncertain

102. Effect of Methamphetamine on Spectral Binding, Ligand Docking and Metabolism of Anti-HIV Drugs with CYP3A4 Full Text available with Trip Pro

of 0.016±0.001 and 204±18 μM, respectively. Methamphetamine-CYP3A4 docking showed that methamphetamine binds to the heme of CYP3A4 in two modes, both leading to N-demethylation. We then studied the effect of methamphetamine binding on PIs with CYP3A4. Our results showed that methamphetamine alters spectral binding of nelfinavir but not the other type I PIs (lopinavir, atazanavir, tipranavir). The change in spectral binding for nelfinavir was observed at both δAmax (0.004±0.0003 vs. 0.0068±0.0001

2016 PloS one

103. Development of an HPLC–UV assay method for the simultaneous quantification of nine antiretroviral agents in the plasma of HIV-infected patients Full Text available with Trip Pro

Development of an HPLC–UV assay method for the simultaneous quantification of nine antiretroviral agents in the plasma of HIV-infected patients A new method using high-performance liquid chromatography coupled with ultra violet detection (HPLC-UV) was developed and validated for the simultaneous quantification of atazanavir, dolutegravir, darunavir, efavirenz, etravirine lopinavir, raltegravir, rilpivirine and tipranavir in human plasma. For the first time we reported here the development

2016 Journal of Pharmaceutical Analysis

104. Structural analyses of 2015-updated drug-resistant mutations in HIV-1 protease: an implication of protease inhibitor cross-resistance Full Text available with Trip Pro

(Atazanavir-ATV, Darunavir-DRV, Indinavir-IDV, Lopinavir-LPV, Nelfinavir-NFV, Saquinavir-SQV, and Tipranavir-TPV) showed that cross-resistance can develop easily across NFV, SQV, LPV, IDV, and DRV, but not for ATV or TPV. Through estimation of the changes in vibrational entropies caused by each reported mutation, some secondary mutations were found to destabilize protease structure. Our findings provide an insight into the mechanism of PI cross-resistance and may also be useful in guiding the selection

2016 BMC bioinformatics

105. Statin Neuroprotection and Carotid Endarterectomy: Safety, Feasibility and Outcomes

/Antivirals (e.g. rotanavir or plus rotanavir, tipranavir, lopinavir, boceprevir, saquinovir, darunavir, fosamprenavir, nelfinavir, efavirenz/tenofobir, atazanavir, simeprevir); Hep C Protease Inhibitor/Antivirals (e.g. telapravir); Antibiotics (i.e. cobicistat-containing products like Tybost, rifampin/rifampicin, clarithromycin, telithromycin, erythromycin); Anti-fungals (i.e. itraconazole, ketoconazole, posaconazole, voriconazole, fluconazole); *Gemfibrozil; Other Fenofibrates (e.g. Tricor, fibric acid

2016 Clinical Trials

106. Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults

of tipranavir/ritonavir or fosamprenavir/ritonavir Subjects receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951052 Sponsors and Collaborators ViiV

2016 Clinical Trials

107. Clinical Study Evaluating the Effects of First-line Oral cOmbination theraPy of maciTentan and tadalafIl in Patients With Newly Diagnosed pulMonary Arterial Hypertension (OPTIMA)

stable for at least 1 week prior to RHC. Treatment with other PDE-5i for erectile dysfunction. Treatment with strong inducers of CYP3A4 (e.g., carbamazepine, rifampin, rifampicin, rifabutin, rifapentin, phenobarbital, phenytoin, and St. John's wort) ≤ 28 days prior to Day 1. Treatment with strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, boceprevir, telaprevir, saquinavir, lopinavir, fosamprenavir, darunavir, tipranavir

2016 Clinical Trials

108. Trial of Venetoclax (ABT-199) and Dexamethasone for Relapsed or Refractory Systemic AL Amyloidosis

days before the first dose of study drug. Patients who are taking and are required to take any of the following agents that are CYP3A inhibitors: Amiodarone, Erythromycin, Fluconazole, Itraconazole, Ketoconazole, Miconazole, Diltiazem, Verapamil, Amprenavir, Fosamprenavir, Clarithromycin, Telithromycin, Nefazodone, Atazanavir, Darunavir, Indinavir, Lopinavir, Nelfinavir, Ritonavir, Saquinavir, Tipranavir. Contacts and Locations Go to Information from the National Library of Medicine To learn more

2016 Clinical Trials

109. Apalutamide in Treating Patients With Prostate Cancer Who Are in Active Surveillance

, voriconazole, grapefruit juice (or grapefruits) Note: If a patient is on a strong CYP3A4 inhibitor, they can be reconsidered for enrollment if they can safely stop said medication; a two week or 5 half-lives, whichever is longer, washout will be required prior to enrolling on study; subject may not resume medication while receiving apalutamide Strong CYP3A4 inducers, including: phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, efavirenz, tipranavir, St. John's wort **Note

2016 Clinical Trials

110. Efficacy Study of Fluconazole to Treat Coccidioidomycosis Pneumonia (Valley Fever)

of immunosuppressive agents*. *including anti-neoplastic chemotherapy or cytotoxic radiation therapy for cancer, anti-TNF medications, or other immunomodulating agents. History of a solid organ or bone marrow transplant. Have poorly controlled HIV-infection or HIV-infection treated with Lopinavir, Tipranavir, Etravirine or Didanosine. Poorly controlled HIV is defined as HIV RNA > 50 copies/mm^3 (or greater than the lower limit of quantification [LLOQ] of the local HIV RNA assay if the LLOQ is > 50) in the 6 months

2016 Clinical Trials

111. Hepatitis C Virus(HCV) Heart and Lung Study

with chronic hypercapnia (baseline partial pressure of arterial carbon dioxide [PaCO2] > 45) Exclusion Criteria: Chronic HCV Infection with Genotype 2 or 3 Treatment with any of the following agents Amiodarone. Subjects previously treated with amiodarone must have stopped the amiodarone at least 60 days prior to day 1 of SOF/LDV FDC Carbamazepine, phenytoin, phenobarbital, oxcarbazepine Rifabutin, rifampin or rifapentine HIV regimens containing tenofovir or tipranavir/ritonavir St. John's wort Rosuvastatin

2016 Clinical Trials

112. Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery

or planned treatment with strong inhibitors (e.g. ketoconazole, clarithromycin, etcetera [etc]) or strong inducers (e.g. carbamazepine, phenytoin, rifampin, phenobarbital, efavirenz, tipranavir, St. John's wort) of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) Human immunodeficiency virus (HIV) positive with cluster of differentiation 4 (CD4) count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided

2016 Clinical Trials

113. Clinical Trial of Patidegib Gel 2%, 4%, and Vehicle Applied Once or Twice Daily to Decrease the GLI1 Biomarker in Sporadic Nodular Basal Cell Carcinomas

) or plans to participate in an experimental drug study while enrolled in this study. The participant is on a concomitant medication that is a strong CYP3A4 inhibitor. These include, but are not limited to: larithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, and tipranavir. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may

2016 Clinical Trials

114. Cost effectiveness of darunavir/ritonavir 600/100mg bid in treatment-experienced, lopinavir-naive, protease inhibitor-resistant, HIV-infected adults in Belgium, Italy, Sweden and the UK

resistance. Interventions The two treatments were HAART containing darunavir and HAART containing lopinavir. HAART included an optimised background regimen of two or more nucleoside reverse transcriptase inhibitors, with or without a non-nucleoside reverse transcriptase inhibitor. If either treatment failed, patients were given tipranavir plus ritonavir. Location/setting UK, Belgium, Italy, and Sweden/primary and secondary care. Methods Analytical approach: A published Markov model of HIV management (...) , with a lifetime horizon, was used to simulate the treatment options. The authors stated that the analysis was carried out from the perspective of the public payer. Effectiveness data: The clinical inputs were from a selection of relevant studies. The treatment effect and patients’ characteristics were from a subgroup of patients in a phase III clinical trial (TMC114/r In Treatment-Experienced Patients Naive to Lopinavir; TITAN). The data for tipranavir were from two trials (Randomized Evaluation of Strategic

2010 NHS Economic Evaluation Database.

115. Cost effectiveness of darunavir/ritonavir 600/100mg bid in protease inhibitor-experienced, HIV-1-infected adults in Belgium, Italy, Sweden and the UK

treatment failed, it was assumed that patients were switched to tipranavir plus ritonavir. Location/setting UK, Belgium, Italy, and Sweden/primary and secondary care. Methods Analytical approach: The analysis used a published US Markov model, in which the health states were defined by ranges of the patients' cluster of differentiation (CD) 4 cell counts. This was adapted for each country. A lifetime horizon was considered. The authors stated that the analysis was carried out from the perspective (...) sources. The efficacy of tipranavir plus ritonavir was from two clinical trials, with similar patients to those of POWER 1 and 2. HIV-related mortality was from the EuroSIDA cohort study database. Country-specific life tables were used. Monetary benefit and utility valuations: The utility values were from a study that transformed European Quality of life (EQ-5D) questionnaire scores, from 21,000 HIV trial participants, into utility weights using a published preference weight method. Measure of benefit

2010 NHS Economic Evaluation Database.

116. US cost effectiveness of darunavir/ritonavir 600/100mg bid in treatment-experienced, HIV-infected adults with evidence of protease inhibitor resistance included in the TITAN trial

reverse transcriptase inhibitors (NRTIs), with or without a non-nucleoside reverse transcriptase inhibitor (NNRTI). These were chosen on the basis of each patient’s treatment history and resistance profile. Darunavir 600mg plus ritonavir 100mg, given twice daily, was compared with lopinavir 400mg plus ritonavir 100mg, given twice daily. In both cases, it was assumed that tipranavir plus ritonavir was given if treatment failed. Location/setting USA/primary and secondary care. Methods Analytical (...) In Treatment-Experienced Patients Naive to Lopinavir; TITAN). The data for tipranavir were from the Randomized Evaluation of Strategic Intervention in Multi-drug Resistant Patients with Tipranavir (RESIST) 1 and 2 trials. The long-term transition probabilities were calculated from cohort study data, using assumed regressions. HIV mortality was from international cohort studies and general mortality was from US life tables. The rate of virologic response and the duration of phases of CD4 count response were

2010 NHS Economic Evaluation Database.

117. Cost effectiveness of darunavir/ritonavir in highly treatment-experienced, HIV-1-infected adults in the USA

ritonavir and an optimised background regimen versus control protease inhibitors plus the optimised background regimen. The protease inhibitors included lopinavir boosted with ritonavir, amprenavir, atazanavir, saquinavir, indinavir, nelfinavir, and boosting dosages of ritonavir. Darunavir 600mg plus ritonavir 100mg was given twice daily. If any treatment failed, it was assumed that tipranavir plus ritonavir was given. Location/setting USA/primary and secondary care. Methods Analytical approach (...) in the short-term. The virologic response at 24 weeks from the beginning of each treatment regimen was a key input for the model. Long-term disease progression was from observational studies and other published sources. The efficacy of tipranavir plus ritonavir was from two clinical trials, with a similar patients to those in POWER 1 and 2. Mortality data were from official databases and US life tables. Some assumptions were needed. Monetary benefit and utility valuations: The utility weights were from

2010 NHS Economic Evaluation Database.

118. High prevalence of PI resistance in patients failing second-line ART in Vietnam. Full Text available with Trip Pro

. Of the patients with VF, 14 (64%) carried at least one major protease mutation [median: 2 (IQR: 1-3)]; 13 (59%) had multiple protease mutations conferring intermediate- to high-level resistance to lopinavir/ritonavir. Mutations conferring cross-resistance to etravirine, rilpivirine, tipranavir and darunavir were identified in 55%, 55%, 45% and 27% of patients, respectively. Higher viral load, adherence <95% and previous indinavir use were independent predictors of VF. The 2 year outcomes of the patients

2015 Journal of Antimicrobial Chemotherapy

119. Inhibition Profiling of Retroviral Protease Inhibitors Using an HIV-2 Modular System Full Text available with Trip Pro

, the treatment-associated resistance mutations (I54M, L90M) were introduced into the modular system, and comparative inhibition assays were performed to determine their effect on the susceptibility of the protease. Our results indicate that darunavir, saquinavir, indinavir and lopinavir were very effective HIV-2 protease inhibitors, while tipranavir, nelfinavir and amprenavir showed a decreased efficacy. I54M, L90M double mutation resulted in a significant reduction in the susceptibility to most (...) of the inhibitors with the exception of tipranavir. To our knowledge, this modular system constitutes a novel approach in the field of HIV-2 protease characterization and susceptibility testing.

2015 Viruses

120. Third-line antiretroviral therapy in Africa: effectiveness in a Southern African retrospective cohort study Full Text available with Trip Pro

private sector disease management programme.Retrospective observational cohort study with linkage to the national death register. Adults (≥18 years) who started salvage ART between July 2007 and December 2011 were included. Salvage ART was defined by inclusion of darunavir or tipranavir in an ART regimen after having failed another PI. For Kaplan-Meier (KM) analysis, patients were followed up until event, or censored at death (only for virologic outcomes), leaving the programme, or April 2014.152 (...) patients were included. Subtype was known for 113 patients: 111 (98 %) were infected with subtype C. All 152 had a genotype resistance test demonstrating major PI resistance mutations. Salvage drugs included were: darunavir/ritonavir (n = 149), tipranavir/ritonavir (n = 3), raltegravir (n = 58), and etravirine (n = 8). Median follow-up was 2.5 years (IQR = 1.5-3.3). 82.9 % achieved a viral load ≤400 copies/ml and 71.1 % ≤50 copies/ml. By the end of the study 17 (11.2 %) of the patients had died. The KM

2015 AIDS research and therapy

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