BREATHER (PENTA 16) Short-Cycle Therapy (SCT) (5 Days on/2 Days Off) in Young People With Chronic HIV-infection
Status:
Unknown status
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
The overall aim of the BREATHER trial is to evaluate the role of Short-Cycle Therapy (SCT) in
the management of HIV-infected young people who have responded well to antiretroviral therapy
(ART) and to determine whether young people with chronic HIV infection undergoing Short-Cycle
Therapy of five days on ART and two days off maintain the same level of viral load
suppression as those on continuous therapy, over 48 weeks.
To assess the advantages and disadvantages of the strategy, the incidence of toxicities,
immunological control, resistance mutations, acceptability, quality of life and adherence to
the randomised strategy will also be compared.
Importantly, because of insufficient data on short-term viral load rebound after stopping ART
in this population, the trial will incorporate an initial pilot phase in selected centres, to
assess the safety of the SCT strategy by evaluating detailed HIV-1 RNA profiles of
participants on the SCT strategy.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
PENTA Foundation
Collaborators:
ANRS, Emerging Infectious Diseases French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) Medical Research Council