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Tipranavir

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121. Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-1)

after consultation with the GlaxoSmithKline study team prior to randomization. Considerations include participant's ability to attend all visits on schedule, and possible drug and study procedure compatibility). A history of use of any regimen consisting of only single NNRTI therapy (even if only for peri-partum treatment), or only single or dual NRTI therapy prior to starting cART. Current or prior history of etravirine (ETR) use. Current use of tipranavir/ritonavir or fosamprenavir/ritonavir

2015 Clinical Trials

122. Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-2)

single NNRTI therapy (even if only for peri-partum treatment), or only single or dual NRTI therapy prior to starting cART. Current or prior history of etravirine (ETR) use. Current use of tipranavir/ritonavir or fosamprenavir/ritonavir. Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication. Note: Any prohibited medications that decrease DTG or RPV concentrations should be discontinued for a minimum of four weeks or a minimum of three

2015 Clinical Trials

123. Effect of Cytoreductive Chemotherapy and a CCR5 Coreceptor Antagonist on HIV-1 Eradication

(Treatment) Patients receiving intensive chemotherapy with/without stable antiretroviral therapy and Maraviroc. Patients not receiving antiretroviral therapy will start this theraphy together with Maraviroc. Drug: Maraviroc Patients randomized to experimental control will start Maraviroc treatment before, during and after chemotherapy until lymphocytes level recovery. Maraviroc Dose: 300 mg/12 hours For patients receiving an HIV-protease inhibitor (except tipranavir or Fosamprenavir), the dose

2015 Clinical Trials

124. High prevalence of PI resistance in patients failing second-line ART in Vietnam. (Full text)

. 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 PubMed

125. Inhibition Profiling of Retroviral Protease Inhibitors Using an HIV-2 Modular System (Full text)

, 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 PubMed

126. Third-line antiretroviral therapy in Africa: effectiveness in a Southern African retrospective cohort study (Full text)

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 PubMed

127. Clinical and virological follow-up in perinatally HIV-1-infected children and adolescents in Madrid with triple-class antiretroviral drug resistant viruses. (Full text)

% among those 197 with resistance data. Among them, 95.8% were diagnosed before 2003, 91.7% were Spaniards, 89.6% carried HIV-1-subtype B and 75% received mono/dual therapy as first regimen. The most common TC-DRM present in ≥50% of them were D67NME, T215FVY, M41L and K103N (retrotranscriptase) and L90M (protease). The susceptibility to darunavir, tipranavir, etravirine and rilpivirine was 67.7%, 43.7%, 33.3% and 33.3%, respectively, and all reported high resistance to didanosine, abacavir (...) and nelfinavir. Despite the presence of HIV-1 resistance mutations to the three main antiretroviral families in our paediatric cohort, some drugs maintained their susceptibility, mainly the new protease inhibitors (tipranavir and darunavir) and nonnucleoside reverse transcriptase inhibitors (etravirine and rilpivirine). These data will help to improve the clinical management of HIV-infected children with triple resistance in Spain. Copyright © 2015 European Society of Clinical Microbiology and Infectious

2015 Clinical Microbiology and Infection PubMed

128. Immunologic Effects of HCV Therapy With HARVONI in HCV Genotype 1 Chronically Mono-infected Active and Former IDUs

Inhibitors: tipranavir-ritonavir Antiarrhythmic Drugs : amiodarone (Cordarone®, Nexterone®, Pacerone®) Participants will be provided with a 12-week course of FDC LDV-SOF which will provide a near 99% likelihood of a SVR in participants who are adherent to therapy with low likelihood of significant adverse events and drug-drug interactions. In treating HCV effectively the investigators will measure changes in immune activation and gene expression that accompany HCV treatment. Study Design Go to Layout (...) drug use for at least 2 years (excluding marijuana) HIV, HCV and HBV uninfected Exclusion Criteria: HIV infection Chronic infection with Hepatitis B Uncompensated cirrhosis Required use of: Anticonvulsants: carbamazepine, oxycarbazepine, phenobarbital, and phenytoin Antimycobacterials: rifabutin, rifampin, rifapentine Herbal Supplements: St. John's wort HIV Protease Inhibitors: tipranavir-ritonavir Antiarrhythmic Drugs: amiodarone (Cordarone, Nexterone, Pacerone) Any medical condition

2015 Clinical Trials

129. Conserved hydrogen-bonding network of P2 bis-tetrahydrofuran containing HIV-1 protease inhibitors (PI) with protease active site amino acid-backbone aid in their activity against PI-resistant HIV. (Full text)

], 0.029 and 0.002 μM, respectively) against a multidrug-resistant clinical isolate of HIV-1 (HIVA02) compared to ritonavir (RTV; EC50, >1.0 μM) and tipranavir (TPV; EC50, 0.364 μM). Additionally, GRL008 showed potent antiviral activity against an HIV-1 variant selected in the presence of DRV over 20 passages (HIVDRV(R)P20), with a 2.6-fold increase in its EC50 (0.097 μM) compared to its corresponding EC50 (0.038 μM) against wild-type HIV-1NL4-3 (HIVWT). Based on X-ray crystallographic analysis, both

2014 Antimicrobial Agents and Chemotherapy PubMed

130. Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy

or nevirapine or etravirine or rilpivirine Tenofovir+Emtricitabine+Third agent (Including a ritonavir-boosted protease inhibitor : saquinavir or indinavir or fosamprenavir or tipranavir or darunavir or atazanavir or lopinavir Tenofovir+Emtricitabine+Third agent (Including an unboosted protease inhibitor: atazanavir or indinavir Tenofovir+Emtricitabine+Third agent (Including an integrase inhibitor raltegravir or dolutegravir or cobicistat-boosted elvitegravir Tenofovir+Emtricitabine+Third agent (Including

2014 Clinical Trials

131. A Phase IIIb Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen

regimen will switch to ABC/DTG/3TC FDC and be followed for an additional 24 weeks. Individuals initially randomly assigned to ABC/DTG/3TC FDC will continue on that treatment arm for an additional 24 weeks. A pharmacokinetic (PK) substudy will be conducted at a small number of sites (approximately 10) to evaluate predose DTG concentrations as well as residual drug concentrations of efavirenz (EFV), nevaripine (NVP), amprenavir (APV) and tipranavir (TPV) in a subgroup of subjects who switch from EFV (...) , NVP, fosamprenavir/ritonavir (FPV/r) or tipranavir/ritonavir (TPV/r). Condition or disease Intervention/treatment Phase Infection, Human Immunodeficiency Virus Drug: ABC/DTG/3TC FDC Drug: Ongoing cART regimen Phase 3 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 555 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: 201147: a Phase

2014 Clinical Trials

132. Effect of Steady State TPV/r on Intracellular Concentrations of Zidovudine and Carbovir for Patients With HIV

Update Posted : September 1, 2014 Sponsor: Boehringer Ingelheim Information provided by (Responsible Party): Boehringer Ingelheim Study Details Study Description Go to Brief Summary: To determine the effect of steady-state tipranavir 500 mg/ritonavir 200 mg (TPV/r) on intracellular concentrations of zidovudine triphosphate (ZDV-TP) and carbovir triphosphate (CBV-TP) and plasma viral load Condition or disease Intervention/treatment Phase HIV Infections Drug: Tipranavir capsules Drug: Ritonavir (...) Resource links provided by the National Library of Medicine related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: TPV/r (Tipranavir co-administered with low dose ritonavir) Drug: Tipranavir capsules Drug: Ritonavir capsules Outcome Measures Go to Primary Outcome Measures : AUC0-12h (Area under curve) of intracellular ZDV-TP [ Time Frame: Up to 12 hours after drug administration ] AUC0-12h (Area under curve) of carbovir-TP [ Time Frame: Up to 12 hours after

2014 Clinical Trials

133. Effects of Steady-state TPV/RTV on the Single-dose Pharmacokinetics of Rifabutin and the Effects of Single-dose Rifabutin on the Steady-state Pharmacokinetics of TPV in Healthy Adult Volunteers

sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT02251171 Recruitment Status : Completed First Posted : September 29, 2014 Last Update Posted : September 29, 2014 Sponsor: Boehringer Ingelheim Information provided by (Responsible Party): Boehringer Ingelheim Study Details Study Description Go to Brief Summary: Study to determine the effects of steady-state Tipranavir (TPV) / Ritonavir (...) (RTV) (500mg/200mg bid) on the single-dose pharmacokinetics of Rifabutin (RFB) and to determine the effects of single-dose RFB on the steady-state pharmacokinetics of TPV 500mg (co-administered with RTV 200mg) Condition or disease Intervention/treatment Phase Healthy Drug: Tipranavir Drug: Ritonavir Drug: Rifabutin Phase 1 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 24 participants Intervention Model: Single Group Assignment

2014 Clinical Trials

134. Study to Determine the Pharmacokinetics on TPV/r in Subjects With Mild and Moderate Hepatic Insufficiency

: September 26, 2014 Sponsor: Boehringer Ingelheim Information provided by (Responsible Party): Boehringer Ingelheim Study Details Study Description Go to Brief Summary: To determine the pharmacokinetics of single-dose and steady-state Tipranavir/Ritonavir (TPV/r) 500/200 mg in subjects with mild to moderate hepatic insufficiency Condition or disease Intervention/treatment Phase Hepatic Insufficiency Drug: Tipranavir (TPV) Drug: Ritonavir (r) Phase 1 Study Design Go to Layout table for study information (...) Library of Medicine available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: Scheme A, mild hepatic subjects multi-dose Drug: Tipranavir (TPV) Drug: Ritonavir (r) Experimental: Scheme B, moderate hepatic subjects single dose Drug: Tipranavir (TPV) Drug: Ritonavir (r) Outcome Measures Go to Primary Outcome Measures : AUC0-∞ (area under the concentration time curve of drug in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Up to day 12 after first

2014 Clinical Trials

135. COPANLISIB (BAY80-6946) Drug-drug Interaction Study in Advanced Solid Tumor Patients

by CYP3A4, such as dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine), atazanavir, darunavir, fosamprenavir, ritonavir-boosted saquinavir, saquinavir, or tipranavir 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

2014 Clinical Trials

136. Effects of TPV/r on the Pharmacokinetics of Carbamazepine in Healthy Adult Volunteers

provided by (Responsible Party): Boehringer Ingelheim Study Details Study Description Go to Brief Summary: Study to assess the steady-state pharmacokinetics of carbamazepine (CBZ) at 200 mg or 100 mg twice daily, depending on tolerability, and administered alone and in combination with tipranavir/ritonavir (TPV/r) after a single dose (500/200 mg) and at steady-state (500/200 mg twice-daily) Condition or disease Intervention/treatment Phase Healthy Drug: Carbamazepine Drug: Tipranavir Drug: Ritonavir (...) Actual Primary Completion Date : June 2006 Resource links provided by the National Library of Medicine available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: CBZ - TPB/r+CBZ Days 1-14: carbamazepine (CBZ) twice daily Days 15-22: CBZ twice daily plus TPV/r twice daily Drug: Carbamazepine Drug: Tipranavir Drug: Ritonavir Outcome Measures Go to Primary Outcome Measures : Area under the concentration-time curve of Carbamazepine in plasma over the time interval t0h to t12h

2014 Clinical Trials

137. A Novel Compound for Alcoholism Treatment

, azithromycin, captopril, carvedilol, clarithromycin, conivaptan, cyclosporine, diltiazem, dronedarone, erythromycin, felodipine, itraconazole, ketoconazole, lopinavir and ritonavir, quercetin, quinidine, ranolazine, verapamil Inducers: Avasimibe, carbamazepine, phenytoin, rifampin, St John s wort, tipranavir/ritonavir [From Drug Development and Drug Interactions: Table of Substrates, Inhibitors and Inducers, table 12, from http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources

2014 Clinical Trials

138. Study of Orally Administered AG-120 in Subjects With Advanced Solid Tumors, Including Glioma, With an IDH1 Mutation

the following sensitive cytochrome P450 (CYP) 3A4 substrate medications are excluded from the study unless they can be transferred to other medications prior to enrolling: alfentanil, aprepitant, budesonide, buspirone, conivaptan, darifenacin, darunavir, dronedarone, eletriptan, eplerenone, felodipine, indinavir, fluticasone, lopinavir, lovastatin, lurasidone, maraviroc, midazolam, nisoldipine, quetiapine, saquinavir, sildenafil, simvastatin, tolvaptan, tipranavir, triazolam, ticagrelor, vardenafil

2014 Clinical Trials

139. Surveillance and Treatment of Prisoners With Hepatitis C

inhibitors: Tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), emtricitabine (FTC)Non-nucleoside reverse transcriptase inhibitors: Rilpivirine Protease inhibitors: Atazanavir, darunavir, lopinavir, ritonavir Integrase inhibitors: Dolutegravir, raltegravir, elvitegravir/cobicistat Contraindicated ARV include: Efavirenz (50% reduction in velpatasvir exposure) Didanosine Zidovudine Tipranavir Other ARV agents may be permissible at the time of study commencement pending further drug-drug

2014 Clinical Trials

140. Effects of Single-dose and Steady-state TPV/RTV on the Steady-state Pharmacokinetics of Fluconazole in Healthy Adult Volunteers

: Completed First Posted : July 21, 2014 Last Update Posted : July 21, 2014 Sponsor: Boehringer Ingelheim Information provided by (Responsible Party): Boehringer Ingelheim Study Details Study Description Go to Brief Summary: Study to determine the effects of single-dose and steady-state TPV/RTV 500/200 mg on the steady-state pharmacokinetics of fluconazole Condition or disease Intervention/treatment Phase Healthy Drug: Tipranavir (TPV) Drug: Ritonavir (RTV) Drug: Fluconazole (FCZ) Phase 1 Study Design Go (...) Completion Date : July 2003 Resource links provided by the National Library of Medicine available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: TPV + RTV + FCZ Drug: Tipranavir (TPV) 500 mg bid on days 7-14 Drug: Ritonavir (RTV) 200 mg bid on days 7-14 Drug: Fluconazole (FCZ) 200 mg loading dose on day 1, followed by 100 mg qd until day 13 Outcome Measures Go to Primary Outcome Measures : Area under plasma concentration time curve from 0-24 hours (AUC0-24h) for FCZ [ Time

2014 Clinical Trials

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