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Rifabutin Clinical Trials

A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc
Healthy volunteers are being recruited for this pharmacokinetics study. The objective is to characterize the pharmacokinetic properties of maraviroc alone and when administered with rifabutin and to assess rifabutin and 25-O-desacetyl-rifabutin pharmacokinetics compared to the literature.
Status: Recruiting Start Date: June 2013 Completion Date: October 2014
EARNEST Rifabutin Pharmacokinetics (PK) Substudy
- Background and study aims? Some of the drugs used to treat HIV (anti-retrovirals, or ARVs) can affect the blood levels of other drugs used to treat TB - called a "drug-drug interaction". The main drug used in second-line [more...]  therapy, Aluvia (lopinavir/ritonavir), is one of the drugs that has this effect. This is why people on second-line ARVs usually cannot use one of the main TB drugs, "rifampicin", and instead will be prescribed a slightly different drug called "rifabutin", which is less affected by these drug-drug interactions. Although blood levels of rifabutin are not as badly affected by Aluvia as blood levels of rifampicin, rifabutin levels in the blood are still increased a lot by taking Aluvia at the same time. This could lead to higher levels of side-effects because there is more drug in the body. So in the past doctors have suggested that instead of taking rifabutin every day with Aluvia, it should only be taken three times a week, on Mondays, Wednesdays and Fridays. However, in the last 2 years, new studies have suggested that this three times a week regimen might not be enough and that it may not completely cure TB. So the purpose of this study is to find out whether taking rifabutin every day with Aluvia really does lead to more side-effects, and whether taking rifabutin three times a week with Aluvia really does lead to much lower levels of rifabutin in the blood. - Who can participate? This substudy is specifically for people who are already taking anti-TB drugs in EARNEST, or who need to start anti-TB drugs whilst they are in the EARNEST trial. - What does the study involve? Participants will be selected (by chance, chosen by a computer) to one of the following two rifabutin groups: Group 1: Rifabutin (150 mg) taken three times a week on Monday/Wednesday/Friday Group 2: Rifabutin (150 mg) taken every day On these days, one capsule of rifabutin (150 mg) should be taken in the morning by mouth. Participants will be asked to attend clinic 2 and 12 weeks after entering the sub-study then every 6 weeks until the end of their TB treatment, and then return to their usual EARNEST follow-up schedule. This is roughly the same visit schedule for people with TB who are usually seen more frequently than those without TB, whether or not the patients join this sub-study. The 2 week visit is specifically so the investigators can make sure participants are doing OK on rifabutin and to check carefully that they don't have any side-effects. At all these visits (including the day when participants enroll into the substudy) the investigators will take an extra 10 ml (two teaspoons) of blood to do laboratory tests for side-effects of rifabutin, and to measure the levels of rifabutin and other ARVs in the blood - these are called "pharmacokinetic" or "PK" studies. On the day of these visits, participants should not take their dose of rifabutin until after this blood draw, so the investigators can measure the lowest amount of drug likely in their blood. Instead, participants should bring the rifabutin dose to clinic, so that they can take it straight after the blood draw. At the visit 12 weeks after starting rifabutin, participants will need to stay in clinic for a second blood draw of ~3 ml (half a teaspoon) around 4 hours after they take the rifabutin dose immediately after the first blood draw. We use this second sample to see how quickly rifabutin enters the blood. At this special visit the investigators will make sure participants are first seen as early as possible, so they don't have to stay any longer than necessary for the second blood draw to be taken 4 hours later. After participants have completed their TB treatment they will stay in EARNEST until the end of the trial (144 weeks on second-line therapy). - What are the possible benefits and risks of participating? If participants are allocated to Group 1 (150 mg rifabutin three times a week), there is a risk that they may have lower levels of rifabutin in your blood and this may be less effective at treating the TB. However, participants should have fewer side-effects. In contrast, if participants are allocated to Group 2 (150 mg rifabutin daily), here is a risk that they may get more side-effects, but the levels of rifabutin in the blood should be more than high enough to have a good chance of curing the TB. Having blood taken may cause some discomfort and/or bruising in some people. It is currently impossible to know which rifabutin regimen would be best and participants may find in years to come that they may or may not have received the best treatment. - Where is the study run from? 9 EARNEST sites in Uganda as follows: JCRC Kampala, IDI, San Raphael of St Francis Hospital (Nsambya), JCRC Mbarara, JCRC Mbale, JCRC Kabale, JCRC Kakira, JCRC Gulu - When is study starting and how long is it expected to run? Start 05/03/2012 finish on 31/01/2014 - Who is funding the study? Abbott
Status: Recruiting Start Date: December 2011 Completion Date: January 2014
Rifampin-Based Tuberculosis Treatment Versus Rifabutin-Based Tuberculosis Treatment in HIV
There is a rapidly-growing need to identify evidence-based, safe, and effective co-treatment regimens for HIV-related tuberculosis (TB) among patients who require protease inhibitor-based antiretroviral therapy. This study will compare three alternative co-treatment options among participants in high TB [more...]  endemic resource-constrained settings, in which one co-treatment option explores if an additional anti-HIV drug needs to be used when patients are being treated with a protease inhibitor together with rifabutin-based anti-TB treatment. Accrual will take place in two accrual periods. Accrual period 1 will enroll 60 participants who will undergo an initial dose-finding period before continuing regular study follow-up. Once the review of the dose-finding pharmacokinetic and safety data from accrual period 1 participants is completed, accrual period 2 will begin.
Status: Recruiting Start Date: April 2013 Completion Date: October 2015
Intensive Pharmacokinetics of the Nelfinavir-Rifabutin Interaction in Patients With HIV-Related Tuberculosis Treated With a Rifabutin-Based Regimen
The primary objective of this multi-center sub-study of USPHS Study 23: "Intensive Pharmacokinetic Study of Intermittent Rifabutin and Isoniazid with Daily Efavirenz in Combination with Two Nucleoside Analogs for Treatment of HIV and Tuberculosis Co-infections," is to compare the [more...]  pharmacokinetics of rifabutin at 600 mg twice a week in combination with efavirenz 600 mg daily to the pharmacokinetics of rifabutin 300 mg twice a week without efavirenz. Secondary objectives are: (1) To describe pharmacokinetics of both rifabutin and efavirenz in combination regimen, (2) To evaluate the safety of concomitant efavirenz and rifabutin, (3) To assess the effect on absolute neutrophil count by changing rifabutin dose and adding efavirenz to the regimen, (4) To develop models of optimal sampling times for rifabutin dosed twice a week, (5) To describe the pharmacokinetics of isoniazid in combination with efavirenz daily with two NRTIs, (6) To compare the pharmacokinetics of isoniazid with and without efavirenz.
Status: Recruiting Start Date:  Completion Date: 
Safety And Efficacy Of Rifabutin In HIV Patients
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or [more...]  efficacy of this drug.
Status: Enrolling by invitation Start Date: June 2009 Completion Date: March 2018
Safety And Efficacy Of Rifabutin In Patients For Non-HIV Patients
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or [more...]  efficacy of this drug.
Status: Enrolling by invitation Start Date: November 2008 Completion Date: September 2013
A Study to Explore the Pharmacokinetics of Rilpivirine With Rifabutin in Healthy Participants
The purpose of this study is to explore the pharmacokinetics of different dosing regimens of rilpivirine in combination with rifabutin in healthy participants.
Status: Completed Start Date: April 2012 Completion Date: September 2012
TMC207 +/- Rifabutin/Rifampin
Evaluation of effect of rifampin or rifabutin on single dose PK of TMC207 in healthy volunteers
Status: Completed Start Date: October 2011 Completion Date: May 2012
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
This study will be a phase I, open label, two arm, fixed sequence crossover study to investigate the effect of rifampin and rifabutin on the steady state pharmacokinetics (PK) of GSK1349572 and the safety and tolerability of GSK1349572 and rifamycin co-administration. [more...]  Subjects enrolled in Arm 1 will receive GSK1349572 50 mg once daily for 7 days, GSK1348572 50 mg twice daily for 7 days, and GSK1349572 50 mg twice daily in combination with rifampin 600 mg once daily for 14 days. Subjects in Arm 2 will receive GSK1349572 50 mg once daily for 7 days and GSK1349572 50 mg once daily in combination with rifabutin 300 mg once daily for 14 days. Serial PK sampling will be completed following the last dose of each treatment. Safety and tolerability will be assessed throughout the study through assessment of adverse events (AEs), and clinical laboratory tests. This study will be conducted at one center in the US with healthy adult male and female subjects.
Status: Completed Start Date: May 2011 Completion Date: December 2011
Drug Interaction Study Between Rifabutin And Lersivirine (UK-453,061)
Approximately 1/3 of persons living with HIV infection are co-infected with tuberculosis (TB). Rifabutin, used in the treatment of TB, is an inducer of drug metabolism thus may decrease concentrations of lersivirine if co-administered. Lersivirine is a modest inducer [more...]  of drug metabolism, thus lersivirine may decrease concentrations of rifabutin as well.
Status: Completed Start Date: May 2010 Completion Date: August 2010
Interaction of Buprenorphine With HIV Medications and Tuberculosis Medications
The purpose of this study is to examine the interactions of buprenorphine-naloxone, a medication used to treat opiate (heroin or prescription narcotic) dependence, and medications used in the treatment of HIV disease including atazanavir (Reyataz), fosamprenavir (Lexiva), didanosine (Videx), [more...]  tenofovir (Viread), atazanavir (Reyataz)/ritonavir (Norvir), fosamprenavir (Lexiva)/ritonavir (Norvir), lamivudine (Epivir), or darunavir (please note that we have completed drug interaction studies for buprenorphine with atazanavir, atazanavir/ritonavir, didanosine, tenofovir and lamivudine) at the PI's previous university; for this CHR application only the studies needed to be completed at UCSF/SFGH will be discussed) or tuberculosis(TB) (rifampin or rifabutin) medications (note: supplement application currently pending). Participants are those with opioid dependence who qualify for buprenorphine/naloxone treatment or they are healthy subjects without opioid dependence who participate in pharmacokinetics studies of the antiretroviral medications. A total of 160 such individuals will be enrolled in these studies (please note that the studies have been ongoing at Virginia Commonwealth University for 3 years so that the total number of participants to be recruited at UCSF/SFGH will be about 50 protocol completers). Participants take the HIV or tuberculosis medicine(s) for up to 15 days (depending on the medication(s) administered and ability to schedule blood and urine sampling sessions).
Status: Completed Start Date: April 2008 Completion Date: April 2013
Drug Interaction Study
The purpose of this study is to evaluate the exposure of rifabutin (RIB) when administered with atazanavir and ritonavir (ATV/RTV)
Status: Completed Start Date: April 2008 Completion Date: August 2008
TBTC Study 23C: Pharmacokinetics of Intermittent Rifabutin and Isoniazid With Daily Efavirenz
The aim of this trial is to study the efavirenz-rifabutin interaction. Thus, this trial will enroll patients with HIV and tuberculosis co-infections who are receiving a rifabutin-based regimen and who plan to begin an antiretroviral regimen containing efavirenz [more...]  dosed at 600 mg daily. Enrollment in TB Trials Consortium Study 23 is not a requirement for participation in this study. Primary Objective: To compare the pharmacokinetics of rifabutin at 600 mg twice a week in combination with efavirenz 600 mg daily to the pharmacokinetics of rifabutin 300 mg twice a week without efavirenz.
Status: Completed Start Date: November 1999 Completion Date: February 2004
TBTC Study 23B:Intensive PK of the Nelfinavir Rifabutin Interaction in Patients With HIV-TB
Primary Objective: To define the impact of nelfinavir (given at 1250mg bid as part of a combination antiretroviral regimen) on peak levels and area under the curve for rifabutin and the rifabutin metabolite, 25-O-desacetyl rifabutin when rifabutin is given [more...]  at 300 mg bi-weekly as part of tuberculosis chemotherapy. Secondary Objectives: To compare the pharmacokinetics of nelfinavir given twice daily at 1250 mg bid with twice-weekly isoniazid and rifabutin to the pharmacokinetics of nelfinavir 1250 mg twice-daily in historical HIV-infected patients not receiving isoniazid and rifabutin. To evaluate the correlation between pharmacokinetic parameters of rifabutin and 25-O-desacetyl rifabutin and the occurrence of toxicity attributed to rifabutin in patients with HIV-related tuberculosis. To define detailed pharmacokinetics of isoniazid given at 15mg/kg or 900 mg in patients with HIV-related tuberculosis. To attempt to derive optimal sampling times for nelfinavir and rifabutin pharmacokinetic studies.
Status: Completed Start Date: February 2000 Completion Date: February 2002
TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in HIV-TB
Primary Objectives: 1) To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetic parameters for isoniazid and rifabutin. Secondary Objectives: 1. To determine risk factors for abnormal pharmacokinetic parameters [more...]  for isoniazid and rifabutin. 2. To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the occurrence of toxicity attributed to antituberculous therapy. 3. To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the efficacy of TB therapy. 4. To define and correlate phenotypic INH acetylator status with the results of genotypic acetylator data obtained in the parent trial.
Status: Completed Start Date: July 1999 Completion Date: November 2002
TBTC Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen
Primary objective: To determine the rate of confirmed treatment failure and relapse with an intermittent rifabutin-based regimen for the treatment of isoniazid and rifamycin-susceptible HIV-related tuberculosis (TB).
Status: Completed Start Date: February 1999 Completion Date: February 2003
Effectiveness of Anti-HIV Therapy (HAART) in HIV-Infected Patients With Tuberculosis
The purpose of this study is to see if a type of anti-HIV therapy called HAART is effective in lowering levels of HIV and boosting the immune system in HIV-infected patients with tuberculosis (TB). HIV-infected patients with TB have [more...]  higher levels of HIV and lower CD4 cell counts (cells in the body that fight infection) than HIV-infected patients without TB. HAART has been effective in reducing HIV levels and increasing CD4 cells in patients without TB. However, its effects in HIV-infected patients with TB are unknown.
Status: Completed Start Date:  Completion Date: 
Study of How Indinavir (an Anti-HIV Drug) and Rifabutin (a Drug Used to Treat MAC, an HIV-Associated Disease) Interact in HIV-Positive and HIV-Negative Adults
The purpose of this study is to evaluate the safety of giving indinavir and rifabutin at the same time (simultaneously) vs 4 hours apart (staggered) to HIV-positive and HIV-negative adults. It is important to determine which medications for HIV-associated [more...]  diseases, such as Mycobacterium avium complex (MAC) disease, can be given safely and effectively with anti-HIV drugs. Indinavir and rifabutin have been given simultaneously in the past with good results. This study seeks to examine if staggering the doses will make the 2 drugs more effective. HIV-negative volunteers are used in this study to examine the effect of rifabutin on indinavir and the effect of staggered rifabutin doses. The effect of rifabutin on the drug activity of indinavir is evaluated in HIV-positive patients.
Status: Completed Start Date:  Completion Date: October 2000
Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in HIV Positive Patients With CD4 Counts = or < 200: Treatment IND Study
Primary: To provide rifabutin to HIV positive patients in an attempt to prevent or delay Mycobacterium avium Complex (MAC) infection by a daily dose of rifabutin. Secondary: To further characterize the safety of rifabutin monotherapy in preventing or delaying [more...]  MAC bacteremia in HIV positive patients with CD4 counts = or < 200.
Status: Completed Start Date:  Completion Date: 
A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) and Fungal Infections in HIV-Infected Patients
PRIMARY: To determine the efficacy of azithromycin and rifabutin alone and in combination for the prevention of disseminated Mycobacterium avium Complex (MAC) infection in HIV-infected patients. To determine the efficacy of daily versus weekly fluconazole for the prevention of [more...]  deep fungal infections in this patient population. SECONDARY: To determine the incidence of bacterial (including mycobacterial) infections, cryptosporidiosis, and toxoplasmosis in azithromycin versus non-azithromycin containing regimens. To determine the incidence of oropharyngeal and vaginal candidiasis in patients treated with daily versus weekly fluconazole. To compare survival and outcomes of primary endpoints in the treatment arms.
Status: Completed Start Date:  Completion Date: 
The Safety and Effectiveness of Rifabutin, Combined With Clarithromycin or Azithromycin, in HIV-Infected Patients
PER 03/10/94 AMENDMENT: PART B. To determine whether there is an effect on plasma drug levels of azithromycin and rifabutin as measured by changes in the plasma concentration-time curve (AUC) when these drugs are taken concomitantly. ORIGINAL PRIMARY: To [more...]  gain preliminary information about the safety and tolerance of clarithromycin and azithromycin in combination with rifabutin (three potential agents against Mycobacterium avium-intracellulare) in HIV-infected patients with CD4 counts < 200 cells/mm3. ORIGINAL SECONDARY: To determine whether there is an effect on the pharmacokinetics of the macrolide antibiotics or rifabutin when these drugs are taken concomitantly. To monitor the effect of rifabutin therapy on dapsone serum levels in patients taking dapsone for PCP prophylaxis. To monitor the effect of macrolide/rifabutin combination therapies on AZT or ddI serum levels. Two new macrolide antibiotics, clarithromycin and azithromycin, and rifabutin (a rifamycin derivative) have all demonstrated in vitro and in vivo activity against Mycobacterium avium-intracellulare, a common systemic bacterial infection complicating AIDS. Further information is needed, however, regarding the clinical and pharmacokinetic interaction of these drugs used in combination.
Status: Completed Start Date:  Completion Date: July 1998
Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites
To determine the effects of fluconazole and either rifabutin or clarithromycin, alone and in combination, on the pharmacokinetics of first sulfamethoxazole-trimethoprim and then dapsone in HIV-infected patients. Although prophylaxis for more than one opportunistic infection is emerging as a [more...]  common clinical practice in patients with advanced HIV disease, little is known about possible adverse drug interactions. The need exists to define pharmacokinetics and pharmacodynamic adverse interactions of the many combination prophylactic regimens that may be prescribed.
Status: Completed Start Date:  Completion Date: May 1999
The Safety and Effectiveness of Clarithromycin and Rifabutin Used Alone or in Combination to Prevent Mycobacterium Avium Complex (MAC) or Disseminated MAC Disease in HIV-Infected Patients
To compare the efficacy and safety of clarithromycin alone versus rifabutin alone versus the two drugs in combination for the prevention or delay of Mycobacterium avium Complex (MAC) bacteremia or disseminated MAC disease. To compare other parameters such as survival, [more...]  toxicity, and quality of life among the three treatment arms. To obtain information on the incidence and clinical grade of targeted gynecologic conditions. Persons with advanced stages of HIV are considered to be at particular risk for developing disseminated MAC disease. The development of an effective regimen for the prevention of disseminated MAC disease may be of substantial benefit in altering the morbidity and possibly the mortality associated with this disease and its treatment.
Status: Completed Start Date:  Completion Date: June 1996
Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial
The primary objectives of this trial are: To compare the safety of oral rifabutin versus placebo in the treatment of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200 cells/mm3. To investigate the incidence of MAC [more...]  in these patients. A secondary objective is to compare clinical response, quality of life (Karnofsky), and survival between these two groups.
Status: Completed Start Date:  Completion Date: 
A Study of Rifabutin, Used Alone or With Ethambutol in the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in Patients With AIDS
To optimize Mycobacterium avium Complex (MAC) prophylaxis in AIDS patients by measuring serum rifabutin levels and adjusting the dose accordingly. To combine rifabutin with ethambutol to examine the effect of combination therapy in preventing or delaying the incidence of [more...]  MAC bacteremia in this patient population.
Status: Completed Start Date:  Completion Date: 
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Clinical trials allow volunteers access to medical treatment options before they are available to the general public. Participants often receive the best healthcare available for their condition.

Risks are a reality, however, and may include more frequent doctor visits, health risks (possibly life-threatening), and/or the treatment being ineffective. Trials are federally regulated with strict guidelines to protect participants.

Rifabutin Clinical Trials Information presented on ClinicalTrialsSearch.org is not intended to be a substitute for qualified medical advice visit or treatment with a real physician. We are not physicians. Always consult with a medical doctor (MD). ClinicalTrialsSearch.org is a website dedicated to listing clinical research studies in human subjects, including those specifically related to Rifabutin. Clinical research trials and medical trials take place in hundreds of cities across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectiveness of new treatments and drugs. The purpose of the studies is to answer specific human health questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions. Clinical trials allow volunteers access to medical treatment options before they are available to the general public. Many times the participants receive treatment for free, and sometimes they are paid for their time. Participants often receive the best healthcare available possible for their condition. Risks are a reality, however, and may include more frequent doctor visits, health risks (possibly life-threatening), and/or the treatment being ineffective. U.S. - based Rifabutin studies are federally regulated with strict guidelines to protect patients.

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