Rifabutin 150mg tablet three times a week (Mon-Wed-Fri) in combination with daily lopinavir/ritonavir taken as part of second-line ART for duration of TB treatment (24 weeks)

Rifabutin 150mg tablet daily in combination with daily lopinavir/ritonavir taken as part of second-line ART for duration of TB treatment (24 weeks)

Tuberculosis

Rifabutin

Click here for more information about this study: EARNEST Rifabutin PK substudy

JCRC Fort Portal

JCRC Gulu

JCRC Kabale

JCRC Kakira

Infectious Diseases Institute (IDI)

JCRC Kampala

San Raphael of St Francis Hospital, Nsambya

JCRC Mbale

JCRC Mbarara

EARNEST Rifabutin Pharmacokinetics (PK) Substudy

Toxicity and Pharmacokinetics of Different Rifabutin Doses in HIV-infected Adults and Adolescents Taking Lopinavir / Ritonavir as Second-line Anti-retroviral Therapy (ART) (EARNEST Rifabutin PK Substudy)

The primary analysis will be the difference in proportions ever experiencing one or more grade 3 or 4 adverse events (AEs) after substudy randomisation, with non-inferiority demonstrated if the upper limit of the 90% confidence interval around the risk difference(Group 2 - Group 1) lies below +20%.

Population PK models being developed at the University of Capetown for daily and thrice weekly rifabutin dosing will be used to estimate rifabutin PK parameters (time-concentration curve (AUC), trough (Cmin), and apparent oral clearance (CL/F)), which will be compared between groups using geometric means (ttest for the log-transformed values).

Population PK models being developed at the University of Capetown for daily and thrice weekly rifabutin dosing will be used to estimate lopinavir and ritonavir PK parameters (time-concentration curve (AUC), trough (Cmin), and apparent oral clearance (CL/F)), which will be compared between groups using geometric means (ttest for the log-transformed values).

Population PK models as above. Parameters include time-concentration curve (AUC), trough (Cmin), and apparent oral clearance (CL/F)

Culture positive at 24 weeks or subsequent relapse/recurrence

Justine Boles

Dr Cissy Kityo Mutuluuza, JCRC Deputy Director

Abbott

Rifabutin is a red-violet powder souble in chloroform and methanol, sparingly souluble in ethanol, and very slightly soluble in water. Mycobutin capsules contain the antimycobacterial agent rifabutin, which is a semisynthetic ansamycin antibiotic derived from rifamycin S. Mycobutin capsules for oral administered contain 150mg of rifabutin, USP, per capsule, along with the inactive ingredients microcrystalline cellulose magenesium stearate, red iron oxide3, silica gel, sodium lauryl sulfate, titanium dioxide, and edible white ink.

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

Indication and Usage:
Mycobutin capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV Infection.
Dosage and Directions for use:
Mycobutin cab be administred as a single daily dose, independent of meals. In all cases Mycobutin is to be administred in combination regimens.
Identification:
Red-brown, self locking, hard gelatin capsule, size 0, containing a violet powder.

uveitis/protease

EARNEST Rifabutin Pharmacokinetics (PK) Substudy

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

Най-пълната база данни за лечебни билки, подкрепена от науката