DRIVESHAFT: Darunavir/Ritonavir In HIV-infected Virologically-suppressed Experienced Subjects
Status:
Completed
Trial end date:
2015-04-01
Target enrollment:
Participant gender:
Summary
Darunavir is a nonpeptidic protease inhibitor with a high genetic barrier to resistance that
evolved from a prototype compound synthesized using structure-based design strategies.
Once-daily darunavir at 800mg boosted with 100mg of ritonavir is an effective antiretroviral
agent indicated for HIV-infected treatment-naïve patients. In treatment-experienced patients,
darunavir was initially approved for twice-daily administration boosted with twice-daily
ritonavir at 600mg and 100mg, respectively. Recently, once-daily darunavir/ritonavir was
approved for use in treatment-experienced adult patients with viremia with no darunavir
resistance mutations. In treatment-experienced patients with viral suppression, switching
from an antiretroviral taken twice-daily to a once-daily dose is an attractive option to
promote greater patient acceptability and adherence, and potentially minimize side effects
and toxicities. Because of darunavir/ritonavir's high genetic barrier to resistance and
well-established safety profile at a once-daily dose, switching patients with virologic
suppression from twice-daily darunavir/ritonavir to once-daily darunavir/ritonavir will
likely confer attributes more favorable to patients through a simplified dosing schedule and
lower potential for lipid elevation without the loss of virologic control. DRIVESHAFT is a
48-week Phase 4, randomized, open label, comparative study. The study will be conducted in 60
HIV-1 infected, antiretroviral experienced, virologically-suppressed patients on regimens
containing darunavir 600mg/ ritonavir 100mg twice-daily and a minimum of two other
antiretrovirals, with a history of 0-1 darunavir-associated resistance mutations. Subjects
will be randomized 1:1 to switch to darunavir 800mg/ ritonavir 100mg once-daily or continue
on their current regimen. Rates of virologic suppression of once-daily darunavir/ritonavir
regimens relative to darunavir/ritonavir twice-daily regimens will be compared, and safety,
change from baseline fasting lipid parameters, and adherence will be evaluated.
Phase:
Phase 4
Details
Lead Sponsor:
Ruth M. Rothstein CORE Center
Collaborator:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA