• This phase 2b randomized, open label clinical trial compares the antimicrobial activity and safety of a standard daily intensive phase TB treatment regimen comprised of rifampin (10 mg/kg/dose) + isoniazid + pyrazinamide + ethambutol (RHZE) to that of an experimental regimen comprised of rifapentine (10 mg/kg/dose) + isoniazid + pyrazinamide + ethambutol (PHZE). (case.edu)
  • This phase 2b trial will evaluate the safety, tolerability, and antimicrobial activity of a regimen in which rifampin is replaced by rifapentine during intensive phase (first 8 weeks) of pulmonary TB treatment. (case.edu)
  • This is a one-period, non-blinded, multi-center pharmacokinetic substudy of rifapentine and rifampin in patients with tuberculosis enrolled in TBTC Study 29. (case.edu)
  • Rifamycin nitrosamine impurities - In August 2020, the US Food and Drug Administration (FDA) announced detection of nitrosamine impurities in samples of rifampin and rifapentine [ 9 ]. (medilib.ir)
  • To preserve availability of rifampin and rifapentine for TB treatment, the FDA temporarily increased the maximum daily limits of these contaminants. (medilib.ir)
  • With a goal of shortening treatment for latent tuberculosis infection (LTBI), I also serve as protocol pharmacologist on IMPAACT 2024, a high-impact dose-finding and safety study which evaluates the BRIEF-TB 1HP regimen, a novel one-month regimen of daily rifapentine and isoniazid (1HP), in children with and without HIV. (jhu.edu)
  • I am principal investigator of the UNITAID-funded DOLPHIN-TOO study, which assesses the safety and PK of a three-month weekly regimen of isoniazid and rifapentine (3HP) in antiretroviral naïve people with HIV. (jhu.edu)
  • A Cochrane review found no difference in efficacy between a 3- to 4-month regimen of rifampicin and a 6-month regimen of isoniazid for preventing active tuberculosis in patients not infected with HIV, and patients who received rifampicin had a lower rate of hepatotoxicity. (wikipedia.org)
  • Our approach - For treatment of drug-susceptible pulmonary TB, options include the traditional regimen (≥6 months) or a shortened rifapentine-moxifloxacin (four-month) regimen. (medilib.ir)
  • See 'Rifapentine-moxifloxacin-based four-month regimen' below. (medilib.ir)
  • Not just antiretroviral therapy (ART), not just ART plus IPT [isoniazid preventive therapy], but other things as well, and if we do all of these things - and all of these things are achievable now - we could really start to make a big difference in terms of TB prevention. (aidsmap.com)
  • The primary objective of this study is to characterize rifapentine pharmacokinetic parameters (AUC 0-24 and peak concentration) in patients with TB during combination chemotherapy. (case.edu)
  • Animal studies indicate that rifapentine-based regimens are highly potent and can reduce overall TB treatment duration to approximately 3 months. (case.edu)
  • An extension phase (Study 29X) was subsequently activated to increase enrollment and site participation to further evaluate Rifapentine in this study. (case.edu)
  • The goals of this study were to evaluate safety and tolerability of window prophylaxis in young children and determine the proportion and predictors of developing TB infection or disease in these exposed children. (cdc.gov)
  • Studies have shown that 12 weekly doses of isoniazid and rifapentine (INH-RPT) to treat LTBI resulted in high completion rates with good tolerability. (cdc.gov)
  • In addition, I have served as protocol team member and pharmacology advisor for a separate UNITAID-funded trial of the safety, tolerability, and PK of 1HP vs. 3HP to treat LTBI in HIV-infected and HIV-uninfected pregnant and postpartum women (DOLPHIN Moms) and a similar study in children (DOLPHIN-Kids). (jhu.edu)
  • In total, 752 children (41% cohabitating with the index patient) received prophylaxis during the window period, usually directly observed therapy with isoniazid. (cdc.gov)
  • As previously reported by aidsmap , the Thibela TB study showed that giving a nine-month course of isoniazid preventive therapy (IPT) to everyone working at randomly selected South African gold mines had no effect on TB incidence, TB prevalence or all-cause mortality in the population, when compared to a cluster of gold mines randomised to standard TB programme management. (aidsmap.com)
  • The World Health Organization (WHO) now endorses several short-course combination TPT regimens for household contacts, including 3HP (12 weekly doses of rifapentine and isoniazid) and 3RH (3 months of daily rifampicin and isoniazid) [ 7 ]. (biomedcentral.com)
  • Rifampicin is used for the treatment of tuberculosis in combination with other antibiotics, such as pyrazinamide, isoniazid, and ethambutol. (wikipedia.org)
  • A Cochrane review found no difference in efficacy between a 3- to 4-month regimen of rifampicin and a 6-month regimen of isoniazid for preventing active tuberculosis in patients not infected with HIV, and patients who received rifampicin had a lower rate of hepatotoxicity. (wikipedia.org)
  • TB caused by Mycobacterium tuberculosis isolates resistant to at least isoniazid and rifampicin) and decrease further with resistance patterns beyond XDR-TB [ 3 ]. (ersjournals.com)
  • Isoniazid daily for 9 months is the recommended regimen for latent tuberculosis infection (LTBI) in solid organ transplant (SOT) candidates, but its use is controversial, due to reports of hepatotoxicity and low treatment completion rates. (nih.gov)
  • The 10-year trial, one of the largest US government clinical trials ever conducted on latent TB preventive therapy, consisted of 8053 participants who were randomized to receive either 3 months of once-weekly rifapentine 900 mg plus isoniazid 900 mg (administered with directly observed supervision), or the current standard treatment regimen for latent TB infection (9 months of self-administered daily isoniazid 300 mg). (medscape.com)
  • Ongoing data are being collected on the tolerability of the regimen among children 2 to 11 years of age and among people who are infected with HIV, who are at a greater risk of developing overt TB from a latent infection. (medscape.com)
  • The rifapentine regimen reduces the required treatment from 270 doses to just 12 doses, he emphasized. (medscape.com)
  • Studies have shown that 12 weekly doses of isoniazid and rifapentine (INH-RPT) to treat LTBI resulted in high completion rates with good tolerability. (cdc.gov)
  • A 9-month course of isoniazid is highly efficacious, but its effectiveness is diminished by low completion rates - generally less than 50%," said principal investigator Timothy Sterling, MD, from Vanderbilt University in Nashville, Tennessee. (medscape.com)
  • A shorter regiment is needed - one with high completion rates, effectiveness, and tolerability," Dr. Sterling observed. (medscape.com)
  • Phase III clinical trial to compare the effectiveness of a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) and a nine-month (270-dose) regimen of daily isoniazid (9INH). (nih.gov)
  • A 12-week course of once weekly directly observed therapy (DOT) with isoniazid plus rifapentine (3HP) is a new LTBI treatment regimen. (nih.gov)
  • The WHO task force on pharmacokinetics and pharmacodynamics analysed available evidence from clinical trials of rifapentine and suggested a simplified dose for various weight bands for 3HP and 1HP as summarized in Table 5.2 (2020 guideline update). (tbksp.org)
  • The time to onset and clinical features of hepatic injury due to ethionamide resemble those of isoniazid, the latency ranging from 2 weeks to more than 6 months after starting (most arise within 1 to 3 months), and the pattern of enzyme elevations typically being hepatocellular and resembling acute viral hepatitis. (nih.gov)
  • Individuals at risk for peripheral neuropathy, such as those with malnutrition, chronic alcohol dependence, HIV infection, renal failure or diabetes, or who are pregnant or breastfeeding, should receive vitamin B6 supplements when taking isoniazid-containing regimen. (tbksp.org)
  • Some attendees at the presentation emphasized the importance of the fact that administration of the rifapentine regimen was directly observed. (medscape.com)
  • In total, 752 children (41% cohabitating with the index patient) received prophylaxis during the window period, usually directly observed therapy with isoniazid. (cdc.gov)
  • Further research to define the appropriate dose of rifapentine and identify drug-drug interactions (such as dolutegravir) among children under two years of age for both 3HP and 1HP will facilitate the use of 3HP/1HP in this age group. (tbksp.org)
  • Like isoniazid, ethionamide therapy may be associated with development of autoantibodies (typically ANA), but titers are generally low and rarely accompanied by autoimmune conditions. (nih.gov)
  • Ethionamide (eth" eye on' a mide) is a thio-isonicotinamide somewhat similar in structure to isoniazid. (nih.gov)