Study of Daily Rifapentine for Pulmonary Tuberculosis
NCT00814671 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 153
Last updated 2018-02-06
Summary
The goal of this Phase 2 study is to determine the microbiological activity and safety of rifapentine when given as a component of multidrug intensive phase treatment of smear-positive pulmonary tuberculosis (TB).
Funding Source- FDA Office of Orphan Products Development (OOPD)
Conditions
Interventions
- DRUG
-
Rifapentine 450
rifapentine 450 mg
- DRUG
-
Rifapentine 600
rifapentine 600 mg
- DRUG
-
rifampin 600 mg
Sponsors & Collaborators
-
University of Cape Town Lung Institute
collaborator OTHER -
University of Cape Town
collaborator OTHER - lead OTHER
Principal Investigators
-
Susan Dorman, MD · Johns Hopkins University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-04-30
- Primary Completion
- 2013-06-30
- Completion
- 2014-09-30
Countries
- South Africa
Study Locations
More Related Trials
-
Rifapentine Plus Moxifloxacin for Treatment of Pulmonary Tuberculosis
NCT00728507 ·Status: TERMINATED ·Phase: PHASE2
-
Optimizing(O) RIfapentine-based(RI) Regimen and shortENing(EN) the Treatment of Drug-sensitive Tuberculosis(T)
NCT05401071 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Pharmacokinetics, Safety and Tolerability of Escalating Rifapentine Doses in Healthy Volunteers
NCT01162486 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (CL-010)
NCT00944021 ·Status: COMPLETED ·Phase: PHASE2
-
A Randomised Trial to Evaluate Toxicity and Efficacy of 1200mg and 1800mg Rifampicin for Pulmonary Tuberculosis
NCT02581527 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Tolerability, Extended Early Bactericidal Activity and PK of Higher Doses Rifampicin in Adults With Pulmonary TB
NCT01392911 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluating a Shorter, Rifampicin-Based Treatment for People With Less Severe Tuberculosis Disease
NCT07118696 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Pragmatic Optimized Rifampicin Trial
NCT06057519 ·Status: RECRUITING ·Phase: PHASE3
-
Phase 1, Open Label, Two Arm, Fixed Sequence Study to Evaluate the Effect of Rifampin and Rifabutin on GSK1349572 Pharmacokinetics in Healthy Male and Female Volunteers
NCT01231542 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Efficacy and Pharmacokinetics of OPC-67683 in Patients With Pulmonary Tuberculosis
NCT00401271 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (TMC207-CL001)
NCT01215110 ·Status: COMPLETED ·Phase: PHASE2
-
TMC207 +/- Rifabutin/Rifampin
NCT01341184 ·Status: COMPLETED ·Phase: PHASE1
-
Tuberculosis Clinical Trials Consortium Study 35
NCT03730181 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Rifampin-Based Tuberculosis Treatment Versus Rifabutin-Based Tuberculosis Treatment in Persons With HIV
NCT01601626 ·Status: TERMINATED ·Phase: PHASE2
-
TBTC Study 25PK: Intensive Pharmacokinetic Study of Three Doses of Rifapentine and 25-Desacetyl Rifapentine
NCT00023387 ·Status: COMPLETED ·Phase: NA
-
Rifampicin vs Rifabutin in HIV/AIDS Patients Combined With Tuberculosis
NCT03478033 ·Status: UNKNOWN ·Phase: NA
-
Comparing Treatment Completion Of Daily Rifapentine & Isoniazid For One Month (1HP) To Weekly High Dose Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in Household Contacts of Recently Diagnosed Tuberculosis Patients
NCT05118490 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
Ultra Curto (Ultra Short) TB Prevention Therapy
NCT04703075 ·Status: COMPLETED ·Phase: PHASE4
-
Trial of High-Dose Rifampin in Patients With TB
NCT01408914 ·Status: COMPLETED ·Phase: PHASE2
-
PK Interaction Between Rifapentine or Rifampicin and a Single Dose of TMC207 in Healthy Subjects (TMC207-CL002)
NCT02216331 ·Status: COMPLETED ·Phase: PHASE1
-
TBTC Study 25: Study of the Tolerability of Higher Doses of Rifapentine in the Treatment of Tuberculosis
NCT00023426 ·Status: COMPLETED ·Phase: PHASE2
-
The Utility of Intensified Case Finding Combined With a Package of Novel TB Diagnostics Using a Mobile Clinic in Africa
NCT01990274 ·Status: COMPLETED ·Phase: NA
-
Test to Treat TB: Impact of Sputum Sequencing-guided Individualised Therapy on Outcomes in Drug-resistant Tuberculosis
NCT05007795 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
TBTC Study 26 PK: Rifapentine Pharmacokinetics in Children During Treatment of Latent TB Infection
NCT00164450 ·Status: COMPLETED ·Phase: NA
-
Rifapentine and Isoniazid TB Preventive Therapy (3HP) for Children Taking Dolutegravir-based Antiretroviral Treatment (DOLPHIN KIDS)
NCT05122767 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2