Clinical trials: Multiple-drug Resistance
Pharmacokinetics of MDV3100, Castration Resistant Prostate Cancer (CRPC)
Drug-drug Interaction Study With MDV3100 and a Cocktail of Substrates
A drug-drug interaction study to investigate the potential pharmacokinetic interaction between MDV3100 and a cocktail of substrates for pioglitazone (CYP2C8 substrate), S-warfarin (CYP2C9 substrate), omeprazole (CYP2C19…
- Trial name
- NCT01911728
- Testing
- MDV3100, Pioglitazone, Warfarin
- Where
- 2 sites in South Africa
- Volunteers
- 14 people
- Sponsor
- Astellas Pharma Europe B.V.
HIV Infections, Multi-Antiviral Resistance
A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab
The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical trials. This study will expand ibalizumab's clinical data set and allow a better understanding of the virologic response durability on ARV…
- Trial name
- PROMISE-US (NCT05388474)
- Testing
- No ibalizumab or Pre-ibalizumab treatment, On ibalizumab treatment
- Where
- 36 sites in United States
- Volunteers
- 168 people
- Sponsor
- Theratechnologies
Pulmonary Tuberculosis
Evaluation of Early Bactericidal Activity and Safety in Pulmonary Tuberculosis With WX-081
This is a multi-center, randomized, parallel, open-label, positive-controlled Phase 2 clinical trial, which aims to evaluate the early bactericidal activity, safety and tolerability of WX-081 in patients with…
- Trial name
- WX-081 (NCT04608955)
- Testing
- WX-081, Bedaquiline, Standard treatment
- Where
- China
- Volunteers
- 99 people
- Sponsor
- Shanghai Jiatan Pharmatech Co., Ltd
HIV-1 Infection
UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection
The purpose of this phase III study is to evaluate the efficacy between treatments (UB-421 Arm vs. Placebo Arm) by measuring the proportion of subjects with reduction in HIV-1 RNA viral load.
- Trial name
- NCT04406727
- Testing
- UB-421, Antiretroviral (ARV)
- Volunteers
- 50 people
- Sponsor
- United BioPharma
Non-Small Cell Lung Cancer
A Study of CBT-1 and Paclitaxel With Carboplatin in Patients With Advanced Inoperable Non-small Cell Lung Cancer
Multiple Drug Resistance is the phenomena whereby cells become resistant to a variety of drugs with different mechanisms of action.
- Trial name
- NCT00437749
- Testing
- CBT-1
- Where
- United States
- Volunteers
- 214 people
- Sponsor
- CBA Research
Multi-drug Resistant Tuberculosis
A Study to Evaluate the Efficacy and Safety of TMC207 in Patients With Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis
The purpose of this study is to provide safety and efficacy data for TMC207 and to demonstrate that TMC207 added to a background regimen (BR) is superior to treatment with the BR plus placebo.
- Trial name
- NCT01600963
- Testing
- Arm A Double-blind Phase: TMC207, Treatment Failure During Double-blind Phase: TMC207, Treatment Failure During Follow-up Phase: TMC207
- Where
- 44 sites in Brazil, Cambodia and 15 more
- Sponsor
- Janssen Infectious Diseases BVBA
Tuberculosis, Multidrug-Resistant
A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683
A phase 2, multicenter, uncontrolled, open-label trial in participants with Multi-drug Resistant Tuberculosis (MDR-TB). Only participants who completed Trial 242-07-204 (NCT00685360) were eligible.
- Trial name
- NCT02573350
- Testing
- Delamanid, OBR
- Where
- 8 sites in China, Estonia and 4 more
- Volunteers
- 213 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis, Multidrug-Resistant
Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen in Korean Patients with FQ-sensitive MDR-TB (MDR-END Registry)
This study is to evaluate the effectiveness and safety of a 9-month MDR-END regimen as a treatment for fluoroquinolone-sensitive multidrug resistant pulmonary tuberculosis in the real-world clinical setting.
- Trial name
- NCT06674291
- Testing
- No intervention (observational study)
- Volunteers
- 222 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
HIV Infections
Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients
The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068) is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug resistance.
- Trial name
- NCT02362503
- Testing
- BMS-663068
- Where
- 139 sites in United States, Argentina and 23 more
- Volunteers
- 371 people
- Sponsor
- ViiV Healthcare
Ovarian Cancer
Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected
The objective of this study was to evaluate the efficacy and safety of alpelisib in combination with olaparib compared with single-agent cytotoxic chemotherapy in participants with platinum-resistant or platinum-refractory…
- Trial name
- NCT04729387
- Testing
- Alpelisib, Olaparib, Paclitaxel
- Where
- 93 sites in United States, Argentina and 24 more
- Volunteers
- 358 people
- Sponsor
- Novartis Pharmaceuticals
Multidrug Resistant Tuberculosis
A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)
The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen (OBR) of other anti-tuberculosis drugs in…
- Trial name
- NCT01859923
- Testing
- Delamanid, Delamanid Pediatric Formulation (DPF), Optimized Background Regimen (OBR)
- Where
- 3 sites in Philippines, South Africa
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Pulmonary Multi-drug Resistant Tuberculosis
A Prospective Patient Registry of Patients Exposed to Bedaquiline
The purpose of this study is to describe the medical indication and utilization of expert medical consultation among participants treated with bedaquiline (BDQ), BDQ susceptibility based on minimum inhibitory concentrations…
- Trial name
- NCT02274389
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Janssen Research & Development, LLC
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer
The purpose of this study is to evaluate the efficacy of [177Lu]Lu-PSMA-617 over a change of androgen receptor-directed therapy (ARDT) treatment in prolonging radiographic progression free survival (rPFS) in Chinese metastatic…
- Trial name
- NCT05658003
- Testing
- [177Lu]Lu-PSMA-617, ARDT, [68Ga]Ga-PSMA-11
- Where
- 15 sites in China
- Volunteers
- 63 people
- Sponsor
- Novartis Pharmaceuticals
Tuberculosis
Early Access of TMC207 in Patients With Extensively Drug Resistant or Pre-XDR Pulmonary Tuberculosis
The purpose of this is a study to provide early access of TMC207 to patients with pulmonary infection due to strains of Mycobacterium tuberculosis (M.
- Trial name
- NCT01464762
- Testing
- TMC207
- Where
- 5 sites in Lithuania, Russia
- Sponsor
- Janssen Infectious Diseases BVBA
Tuberculosis, MDR
FS-1 Drug for Treatment of Multiple Drug-resistant Tuberculosis
Drug-resistant tuberculosis is becoming a major problem for the whole humanity, and development of new Anti-TB drugs is of great importance.
- Trial name
- FS-1 (NCT02607449)
- Testing
- FS-1
- Where
- 6 sites in Kazakhstan, Kyrgyzstan
- Volunteers
- 344 people
- Sponsor
- Scientific Center for Anti-infectious Drugs, Kazakhstan
Plasma Cell Myeloma Refractory
Isatuximab in Combination With Novel Agents in RRMM - Master Protocol
The purpose of this umbrella study is to evaluate isatuximab when combined with novel agents with or without dexamethasone in participants with relapsed or refractory myeloma. Substudy 01 is the control Substudy.
- Trial name
- NCT04643002
- Testing
- Isatuximab, Dexamethasone, Pomalidomide
- Where
- 25 sites in United States, Australia and 7 more
- Volunteers
- 258 people
- Sponsor
- Sanofi
HIV Infections
Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST)
Demonstrate the safety and efficacy of Tipranavir/Ritonavir versus an active treatment regimen in highly treatment experienced Human Immunodeficiency virus 1(HIV-1) infected patients.
- Trial name
- NCT00054717
- Testing
- Tipranavir, Ritonavir(r), Comparator Protease Inhibitor (CPI)
- Where
- 117 sites in United States, Australia and 2 more
- Volunteers
- 630 people
- Sponsor
- Boehringer Ingelheim
Multiple Myeloma, Myeloma
Vincristine, DOXIL (Doxorubicin HCl Liposome Injection) and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
The purpose of this study is to determine how well newly diagnosed multiple myeloma patients respond to an experimental regimen of Vincristine, DOXIL (doxorubicin HCl liposome injection) and Dexamethasone (VDD) versus the…
- Conditions
- Multiple Myeloma, Myeloma, M-Protein, Myeloma Proteins
- Trial name
- NCT00344422
- Testing
- Vincristine, DOXIL (doxorubicin HCl liposomal injection), and Dexamethasone (VDD) vs. Vincristine, Doxorubicin and Dexamethasone (VAD)
- Volunteers
- 198 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
HIV Infections
Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)
The objective of this study is to demonstrate the safety and efficacy of tipranavir/ritonavir versus an active control arm in highly treatment experienced Human immunodeficiency virus-1 infected patients.
- Trial name
- NCT00144170
- Testing
- Tipranavir (with low dose ritonavir), Comparator protease inhibitor(CPI)/low dose ritonavir(r)
- Where
- 174 sites in Argentina, Austria and 15 more
- Volunteers
- 882 people
- Sponsor
- Boehringer Ingelheim
Seizures
Cannabidiol Oral Solution in Pediatric Participants With Treatment-resistant Seizure Disorders
This is a Phase 1/2, open-label trial designed to assess the pharmacokinetics, safety, tolerability, and preliminary efficacy of 3 multiple ascending doses of Cannabidiol Oral Solution in a sequential fashion.
- Trial name
- NCT02324673
- Testing
- Cannabidiol Oral Solution
- Where
- 10 sites in United States
- Volunteers
- 61 people
- Sponsor
- INSYS Therapeutics Inc