Efficacy and Safety Study of Darunavir for the Treatment of HIV/AIDS
Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
Summary
The aim of this pilot study is to assess the feasibility, efficacy and safety of
Darunavir/ritonavir 800/100 mg once daily (DRV/r) monotherapy as a switch-maintenance
strategy for patients receiving second-line ART at Yaoundé Central Hospital in Cameroon.
HIV-infected adults receiving second-line antiretroviral therapy (ART) for ≥3 months with 2
nucleos(t)ide reverse transcriptase inhibitors (NRTIs) plus either lopinavir/ritonavir
(LPV/r) or atazanavir/ritonavir (ATV/r) will undergo plasma HIV-1 RNA ("viral") load testing.
Those with a viral load below 50 copies/ml (<50 cps/ml) will undergo a repeat test ideally
4-6 weeks later (allowed up to 12 weeks); if the viral load is confirmed as <50 cps/ml the
patient will be invited to join the randomised phase of the study. Patients (n=150) will be
randomised 1:2 to either continue the current triple ART regimen (n=50) or switch to DRV/r
monotherapy (n=100). The primary end-point will be viral load suppression <400 cps/ml at week
24; secondary end-points will be viral load suppression <50 cps/ml at week 12 and week 24,
safety, tolerability, and emergence of protease inhibitor (PI) drug-resistance. Patients will
continue observational follow-up depending on the treatment arm they are randomized to. After
week 48, patients will return to local standard of care. Pharmacokinetics (PK) and
pharmacogenomics sub-study to correlate plasma concentrations of DRV to outcomes, HIV-1 drug
resistance testing sub study to detect mutants archived at the time of first-line ART failure
and measuring HIV DNA load will be performed, as well as a cost-effectiveness analysis will
test the hypothesis that savings can be achieved by switching to DRV/r monotherapy without
affecting quality of care. The primary virological objective is to evaluate efficacy in terms
of the percentage of subjects who have plasma HIV-1 RNA levels <400 cps/ml after 24 weeks of
follow-up following a switch to DRV/r monotherapy versus continuing triple therapy containing
2 NRTIs + LPV/r (or ATV/r) (FDA Snapshot method).
Study hypothesis:
we propose that maintenance therapy with DRV/r monotherapy is a feasible, effective and safe
treatment option for patients receiving second-line ART in Yaoundé.
Phase:
Phase 3
Details
Lead Sponsor:
University of Liverpool
Collaborators:
Chantal Biya International Reference Centre for Research on Prevention and Management of HIV/AIDS Janssen Pharmaceutica Yaounde Central Hospital