University of Cape Town

The lack of evidence to support the use of optimized antiretrovirals in patients with tuberculosis(TB) remains a significant barrier especially in resource limited settings where TB co-infection rates are still incessantly high.

The World Health Organisation TB County Profile tool: http://www.who.int/tb/country/data/profiles/en/ effectively illustrates TB infection rates as reported per country.

The University of Cape Town (UCT) in affiliation with primary health care facilities like the Hannan Crusaid Treatment Centre (HCTC) and other stakeholders are conducting a series of clinical studies to explore the impact of Rifampacin in both first-line and second-line regimens, through pharmacokinetic (PK) evaluations.

These PK clinical studies include the following :-

Trial Name / Protocol Number Trial Aim Trial Summary and Updates
1. Clinical evaluation of adjusted doses of Darunavir/Ritonavir with Rifampicin in HIV infected volunteers (DaRifi) To compare the steady state pharmacokinetics of Darunavir/r when given in standard doses of 800mg/100 mg without Rifampicin to various other timed doses of Darunavir with Rifampicin Clinical evaluation of adjusted doses of darunavir/ritonavir with rifampicin in HIV infected volunteers

(DaRifi)

Investigators – McIlleron, Maartens, Orrell, Wiesner, Court, Moorhouse

Sponsor – University of Cape Town

The aims of the study is to compare the steady state PK of DRV when given in standard DRV/r doses of 800/100 mg without rifampicin to 1) DRV/r 1600/200 mg once daily with rifampicin, and 2) DRV/r 800/100 mg 12 hourly with rifampicin. To describe the safety of the adjusted doses of DRV/r with rifampicin in HIV infected patients established on PI-based ART.

To read the study paper, click on the link

2. Associations between Darunavir plasma concentrations and virological suppression, lipids and glucose, in participants on a low-dose Darunavir second-line antiretroviral regimen: a pharmacokinetic sub-study of WRHI 052 To explore associations between plasma Darunavir levels and HIV-1 RNA levels in second-line antiretroviral treatment in patients receiving a low dose Darunavir regimen. Pharmacokinetic Sub-study of WRHI052 Project Plan