High RIF

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR2009060001493909
• Date of registration: 19/06/2009
• Primary sponsor: African Poverty Related Infection Oriented Research Initiative (APRIORI)
• Public title: High RIF
• Scientific title: Pharmacokinetics and -dynamics of high versus standard dose rifampicin in patients with pulmonary tuberculosis in the Kilimanjaro Region, Tanzania
• Date of first enrolment: 2010-08-13
• Target sample size: 150
• Recruitment status: Open to recruitment: actively recruiting participa
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR2009060001493909
• Study type: interventional
• Study design: Factorial: participants randomly allocated to either no,one,some or all interventions simultaneously,; Randomised,; Blocked randomization (block size: 6), after stratification for gender and HIV-status,; Sealed opaque envelopes,

Countries of recruitment

South Africa

Contacts

• Name: Gibson Kibiki
• Affiliation: Internal medicine physician

• Name: Martin Boeree
• Affiliation: Respiratory medicine physician, medical director University Lung Centre Dekkerswald

Key inclusion & exclusion criteria

Inclusion criteria: 1. Participant has newly diagnosed pulmonary tuberculosis, confirmed by a positive smear of at least two spontaneously produced sputum samples with ZN staining.
2. Participant is willing to be tested for HIV.
3. Participant is at least 18, but no more than 65 years of age at the day of the first dosing of study medication.
4. Participant is admitted to Kibong'oto National Tuberculosis Hospital (KNTH) or Kilimanjaro Christian Medical Centre (KCMC) during the intensive phase of TB treatment.
5. Participant is able and willing to attend to KNTH or KCMC regularly during the continuation phase of TB treatment.
6. Participant is able to understand and willing to sign the Informed Consent Form prior to screening evaluations.
Exclusion criteria: 1. Participant has been treated with anti-tuberculosis drugs during the past three years.
2. Participant's body weight is less than 50 kg.
3. Participant has abnormal liver function test or creatinine (defined as levels higher than the upper limit of normal).
4. Participant has a relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion (i.e. chronic gastro-intestinal disease, Diabetes Mellitus, renal or hepatic disease, use of concomitant drugs that interfere with the pharmacokinetics of anti-TB drugs).
5. Participant is on anti-retroviral treatment at inclusion.
6. Participant has a CD4 count less than 350 cells/mm3
7. Participant has a Karnovsky score of less than 40.
8. Participant is pregnant or breastfeeding.
9. Participant is using immunosuppressive drugs, such as steroids or cyclofosfamides.
10. Participant has a rifampin resistant or Multi Drug Resistant (MDR-) TB for which another than the standard regimen is needed.

Age minimum: 18 Year
Age maximum: 65 Year
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberculosis
null

Primary Outcome(s)

Occurrence of adverse events

Pharmacokinetics of rifampicin

Short-term bacteriological response (sputum culture conversion and Serial Sputum Colony Forming Units Count, SSCC)

Secondary Outcome(s)

Accuracy of surrogate markers (SSCC, mRNA, cytokines)

Occurrence of mixed Mycobacterium tuberculosis strain infections

Secondary ID(s)

NCT00760149

Source(s) of Monetary Support

European & Developing Countries Clinical Trials Partnership (EDCTP)

Secondary Sponsor(s)

Dr. M.J. Boeree

Dr. R.E. Aarnoutse