HIV Infections Clinical Trial
Official title:
Clinical Evaluation of Adjusted Doses of Darunavir/Ritonavir With Rifampicin in HIV-infected Volunteers
The DaRifi study aims:
1. Develop adjusted doses of darunavir/ritonavir for use in HIV-infected patients requiring
co-treatment of TB with a rifampicin-based regimen.
2. Compare the steady state pharmacokinetics of doubled doses of DRV/r with rifampicin (in
once daily and 12-hourly approaches) to standard daily doses without rifampicin.
3. Twenty-eight volunteers will be enrolled for a target of 24 participants completing the
study.
A significant barrier to the use of better tolerated antiretrovirals in many low-to-middle
income countries (LMIC), where tuberculosis (TB) is endemic, is a lack of evidence to support
their use in patients with TB. Access to optimal protease inhibitor (PI)-based regimens for
patients with and without TB is urgent. Switching rifampicin to rifabutin, a weak inducer
that does not significantly reduce PI concentrations, is recommended in high income countries
for patients on boosted PIs who develop TB. However, rifabutin is not available in most LMIC
where TB is typically treated with fixed dose combination tablets.
We will enrol virologically suppressed participants on a second-line DRV/r regimen without
TB. Based on data from a Physiologically-Based PK model, we selected two adjusted doses of
DRV/r (1600/200 mg daily and 800/100 mg 12 hourly) with RIF for comparison to plasma
exposures with DRV/r 800/100 mg daily without RIF, in a cross-over design.
Baseline DRV steady state PK will be determined and RIF added for 7 days, then the dose of
ritonavir will be increased to 200 mg; 7 days later the dose of DRV will be increased; after
another 7 days participants will be crossed over to the alternative adjusted DRV dose.
DRV will be measured in plasma samples after observed doses at baseline and after each dose
adjustment. Non-compartmental analysis will be used to estimate the PK measures. Clinical
adverse events, ALT, and bilirubin will be monitored every 2 to 3 days during treatment with
RIF.
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