NCT01641016

BREATHER (PENTA 16) Short-Cycle Therapy (SCT) (5 Days on/2 Days Off) in Young People With Chronic HIV-infection

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: PENTA Foundation · Network
• Sex: All
• Age: 8 Years – 24 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	efavirenz	May be taken as 600mg tablet, 200mg tablet or as part of a combination pill

Timeline

• Start date: 2011-04-01
• Primary completion: 2014-06-01
• Completion: 2016-06-01
• First posted: 2012-07-16
• Last updated: 2015-03-02

Locations

18 sites across 8 countries: United States, France, Germany, Ireland, Thailand, Uganda, Ukraine, United Kingdom