Rifabutin

Generic Name: Rifabutin

Brand Names: Mycobutin, Talicia

Drug Type: Small Molecule

Chemical Formula: C_₄₆H_₆₂N_₄O_₁₁

CAS Number: 72559-06-9

Unique Ingredient Identifier: 1W306TDA6S

Background: A broad-spectrum antibiotic that is being used as prophylaxis against disseminated Mycobacterium avium complex infection in HIV-positive patients.

Indication: For the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.

Associated Conditions: Helicobacter Pylori Infection, Mycobacterium avium complex infection, Tuberculosis (TB), Late phase Tuberculosis

Associated Therapies: -

Clinical Trials

EARNEST Rifabutin Pharmacokinetics (PK) Substudy

Phase 2

Conditions: HIV
Tuberculosis

Interventions: Drug: Rifabutin

First Posted Date: 2012-08-13

Last Posted Date: 2012-08-13

Lead Sponsor: Justine Boles

Target Recruit Count: 140

Registration Number: NCT01663168

Locations: 🇺🇬
JCRC Fort Portal, Fort Portal, Uganda
🇺🇬
Infectious Diseases Institute (IDI), Kampala, Uganda
🇺🇬
JCRC Mbale, Mbale, Uganda

and more 6 locations

A Study to Explore the Pharmacokinetics of Rilpivirine With Rifabutin in Healthy Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Rilpivirine
Drug: Rifabutin

First Posted Date: 2012-06-08

Last Posted Date: 2014-03-28

Lead Sponsor: Janssen R&D Ireland

Target Recruit Count: 20

Registration Number: NCT01615614

Rifampin-Based Tuberculosis Treatment Versus Rifabutin-Based Tuberculosis Treatment in Persons With HIV

Phase 2

Terminated

Conditions: HIV Infection
Tuberculosis

Interventions: Drug: Standard-dose Lopinavir/Ritonavir
Drug: Double-dose Lopinavir/Ritonavir
Drug: Raltegravir
Drug: Isoniazid
Drug: Pyridoxine
Drug: Pyrazinamide
Drug: Ethambutol
Drug: Rifampin
Drug: Rifabutin

First Posted Date: 2012-05-18

Last Posted Date: 2018-02-13

Lead Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Target Recruit Count: 71

Registration Number: NCT01601626

Locations: 🇵🇪
Asociacion Civil Impacta Salud y Educacion - Miraf CRS (11301), Lima, Peru
🇧🇷
Instituto de Pesquisa Clinica Evandro Chagas (12101), Rio de Janeiro, Brazil
🇭🇹
Les Centres GHESKIO CRS (30022), Port-au-Prince, Haiti

and more 6 locations

TMC207 +/- Rifabutin/Rifampin

Phase 1

Completed

Conditions: Tuberculosis

Interventions: Drug: Rifabutin
Drug: Rifampin
Drug: TMC207

First Posted Date: 2011-04-25

Last Posted Date: 2017-04-21

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 33

Registration Number: NCT01341184

Locations: 🇺🇸
Case Western Reserve University - Case Medical Center - Infectious Disease & HIV Medicine, Cleveland, Ohio, United States

Dosing, Safety and Pharmacokinetic Profile of Rifabutin in Children Receiving Concomitant Treatment With Kaletra

Phase 1

Conditions: Children With Confirmed HIV Infection
Receiving ART Regimen Containing 2 NRTIs + LPV/RTV at Standard Dose
Successfully Completed TB Treatment in the Past 2 to 6 Weeks of Enrollment

Interventions: Drug: Mycobutin

First Posted Date: 2010-12-14

Last Posted Date: 2010-12-14

Lead Sponsor: Harriet Shezi Children's Clinic

Target Recruit Count: 40

Registration Number: NCT01259219

Locations: 🇿🇦
Harriet Shezi Children's Clinic, Johannesburg, Gauteng, South Africa
🇿🇦
Harriet Shezi Children's Clinic, Chris Hani Baragwanath Hospital, WHI, University of the Witwatersrand, Johannesburg, Gauteng, South Africa

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

Phase 1

Completed

Conditions: Infection, Human Immunodeficiency Virus

Interventions: Drug: GSK1349572
Drug: Rifampin
Drug: Rifabutin

First Posted Date: 2010-11-01

Last Posted Date: 2017-06-08

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 27

Registration Number: NCT01231542

Locations: 🇺🇸
GSK Investigational Site, Baltimore, Maryland, United States

Drug Interaction Study Between Rifabutin And Lersivirine (UK-453,061)

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Lersivirine
Drug: Rifabutin

First Posted Date: 2009-06-22

Last Posted Date: 2010-09-21

Lead Sponsor: Pfizer

Target Recruit Count: 18

Registration Number: NCT00925535

Locations: 🇸🇬
Pfizer Investigational Site, Singapore, Singapore

Interaction of Buprenorphine With HIV Medications and Tuberculosis Medications

Phase 1

Completed

Conditions: Opioid Dependency
HIV Infections

Interventions: Drug: Fosamprenavir/Ritonavir
Drug: Darunavir/Ritonavir
Drug: Rifabutin
Drug: Rifampin
Drug: Buprenorphine

First Posted Date: 2009-04-08

Last Posted Date: 2014-05-06

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 63

Registration Number: NCT00877591

Locations: 🇺🇸
San Francisco General Hospital, San Francisco, California, United States

Safety And Efficacy Of Rifabutin In HIV Patients

Completed

Conditions: Non-tuberculous Mycobacterial Diseases
Tuberculosis
Inhibition of Disseminated Mycobacterium Avium Complex Disease Associated With HIV Infections

Interventions: Drug: rifabutin

First Posted Date: 2008-12-18

Last Posted Date: 2019-08-02

Lead Sponsor: Pfizer

Target Recruit Count: 72

Registration Number: NCT00810446

Safety And Efficacy Of Rifabutin In Patients For Non-HIV Patients

Completed

Conditions: Non-tuberculous Mycobacterial Diseases (Including MAC Disease)
Tuberculosis

Interventions: Drug: rifabutin

First Posted Date: 2008-12-18

Last Posted Date: 2019-03-07

Lead Sponsor: Pfizer

Target Recruit Count: 628

Registration Number: NCT00810407

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

© Copyright 2024. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy