BREATHER (PENTA 16) Short-Cycle Therapy (SCT) (5 Days on/2 Days Off) in Young People With Chronic HIV-infection
This study is ongoing, but not recruiting participants.
Sponsor:
PENTA Foundation
Collaborators:
Medical Research Council
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Information provided by (Responsible Party):
PENTA Foundation
ClinicalTrials.gov Identifier:
NCT01641016
First received: July 12, 2012
Last updated: February 27, 2015
Last verified: July 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV |
Drug: efavirenz |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | BREATHER (PENTA 16) Short-Cycle Therapy (SCT) (5 Days on/2 Days Off) in Young People With Chronic HIV-infection |
Resource links provided by NLM:
Further study details as provided by PENTA Foundation:
Primary Outcome Measures:
- HIV-1 RNA ≥50 copies/ml (confirmed on a separate sample within 1 week) at any of week 4, 12, 24, 36 or 48. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]This outcome measure only considers HIV-1 RNA measurements at these time points due to the difference in viral load monitoring in the pilot phase and the main trial. However if a young person enrolled in the pilot phase has HIV-1 RNA ≥50 copies/ml at weeks 1, 2 or 3 (reproducible on the same sample) or at week 8 (confirmed on the same sample within 1 week), they will be considered as reaching the primary outcome at week 4 and 12 respectively
Secondary Outcome Measures:
- HIV-1 RNA <50 c/ml at 24 and 48 weeks [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: No ]
- Number of HIV mutations present at week 4, 12, 24, 36 or 48 conferring resistance to drugs taken at randomisation or during the tria [ Time Frame: Weeks 4, 12, 24, 36, 48 ] [ Designated as safety issue: No ]
- Change in CD4 (absolute and percentage) from randomisation to 24 and 48 weeks [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: No ]
- Change in ART (defined as any change from the ART regimen at randomisation) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Grade 3 or 4 clinical and laboratory adverse events [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
- ART treatment modifying adverse events (all grades) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- New CDC stage B or C diagnosis or death [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Changes in fasting glucose, cholesterol, triglycerides, LDL, HDL and VLDL levels through 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Adherence, acceptability, and quality of life over 48 weeks as assessed by patient completed questionnaires [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | June 2016 |
| Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Continuous Therapy
Continue with current antiretroviral therapy regime as per standard care
|
Drug: efavirenz
May be taken as 600mg tablet, 200mg tablet or as part of a combination pill
Other Name: Trade name: Sustiva
|
|
Experimental: Short Cycle Therapy
Take current antiretroviral therapy 5 days a week (2 days off) as instructed by clinician
|
Drug: efavirenz
May be taken as 600mg tablet, 200mg tablet or as part of a combination pill
Other Name: Trade name: Sustiva
|
Eligibility| Ages Eligible for Study: | 8 Years to 24 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- HIV-1 infected young people aged 8 to 24 years inclusive (Young people recruited between the ages of 16-21 must either be in regular physical contact with their clinician or be able to transfer to an adult physician at the same site for follow-up or to an affiliated adult site).
- Parents/carers and/or young people, where applicable, willing to provide informed consent.
- On a stable first-line ART treatment containing at least 2 NRTIs/NtRTIs and EFV for at least 12 months and willing to continue the regimen throughout the study period. Young people on regimens containing nevirapine (NVP) or a boosted protease inhibitor with undetectable viral load for over one year who wish to enrol should switch to EFV. Once they are stable on the EFV containing regimen for more than 12 weeks they may be enrolled (must have 2 subsequent HIV-1 RNA measurements <50 c/ml over a minimum period of 12 weeks). Previous dual therapy and/or substitution of NRTIs is allowed providing any changes were not for disease progression, immunological or virological failure (where virological failure is defined as two successive HIV-1 RNA results>1000 c/ml) subsequent to virological control having been achieved on ART.
- Viral suppression (HIV-1 RNA <50 c/ml) for at least the prior 12 months (at least the last 3 measurements, including screening): young people who have experienced a single viral load >50 but <1000 copies/ml (preceded and followed by VL<50 c/ml) in the last 12 months can be enrolled.
- CD4 cell count ≥350 106/L at screening visit.
- Centre must routinely use an assay which detects HIV RNA-1 viral load ≥50 c/ml.
Exclusion Criteria:
- Pregnancy or risk of pregnancy in females of child bearing potential.
- Acute illness (young people may be enrolled after illness).
- Receiving concomitant therapy for an acute illness (young people may be enrolled after finishing therapy).
- A creatinine, AST or ALT of grade 3 or above at screening.
- On a regimen including nevirapine or a boosted PI (young people may switch to an EFV based regimen).
- Previous ART monotherapy (except for the prevention of mother-to-child transmission)
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01641016
Please refer to this study by its ClinicalTrials.gov identifier: NCT01641016
Locations
| United States, Tennessee | |
| St Jude Children's Research Hospital | |
| Memphis, Tennessee, United States | |
| France | |
| INSERM | |
| Villejuif, France | |
| Germany | |
| Universitätsklinikum Frankfurt | |
| Frankfurt, Frankfurt am Main, Germany, 60596 | |
| Ireland | |
| Our Lady's Children's Hospital | |
| Dublin, Ireland | |
| Thailand | |
| Program for HIV Prevention and Treatment (PHPT)/IRD 174 | |
| Changklan, Muang, Chiang Mai, Thailand, 50100 | |
| HIV-NAT Thai Red Cross AIDS Research Centre | |
| Bangkok, Thailand | |
| Uganda | |
| Joint Clinical Research Centre | |
| Kampala, Uganda | |
| Ukraine | |
| Kiev City AIDS Center | |
| Kiev, Vidpochynku 11, Ukraine, 03115 | |
| United Kingdom | |
| Birmingham Heartlands Hospital | |
| Birmingham, United Kingdom | |
| University Hospital Bristol | |
| Bristol, United Kingdom | |
| Leeds General Infirmary | |
| Leeds, United Kingdom | |
| Leicester Royal Infirmary | |
| Leicester, United Kingdom | |
| Evelina Children's Hospital | |
| London, United Kingdom | |
| Great Ormond Street Hospital | |
| London, United Kingdom | |
| Mortimer Market Centre | |
| London, United Kingdom | |
| St George's Hospital | |
| London, United Kingdom | |
| Nottingham University Hospital | |
| Nottingham, United Kingdom | |
| John Radcliffe Hospital | |
| Oxford, United Kingdom | |
Sponsors and Collaborators
PENTA Foundation
Medical Research Council
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Investigators
| Principal Investigator: | Karina M Butler, MRCPI | Medical Research Council |
More Information
Additional Information:
No publications provided
| Responsible Party: | PENTA Foundation |
| ClinicalTrials.gov Identifier: | NCT01641016 History of Changes |
| Other Study ID Numbers: | BREATHER (PENTA 16), 2009-012947-40 |
| Study First Received: | July 12, 2012 |
| Last Updated: | February 27, 2015 |
| Health Authority: | United Kingdom: Medicines and Healthcare Regulatory Agency (MHRA) |
Keywords provided by PENTA Foundation:
|
short cycle therapy young people HIV |
ClinicalTrials.gov processed this record on March 01, 2015