BREATHER (PENTA 16) Short-Cycle Therapy (SCT) (5 Days on/2 Days Off) in Young People With Chronic HIV-infection (BREATHER)
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ClinicalTrials.gov Identifier: NCT01641016 |
Recruitment Status
: Unknown
Verified July 2013 by PENTA Foundation.
Recruitment status was: Active, not recruiting
First Posted
: July 16, 2012
Last Update Posted
: March 2, 2015
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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 or disease | Intervention/treatment | Phase |
---|---|---|
HIV | Drug: efavirenz | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 160 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | April 2011 |
Actual Primary Completion Date : | June 2014 |
Estimated Study Completion Date : | June 2016 |

Arm | Intervention/treatment |
---|---|
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
|
- 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 ]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
- HIV-1 RNA <50 c/ml at 24 and 48 weeks [ Time Frame: 24 and 48 weeks ]
- 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 ]
- Change in CD4 (absolute and percentage) from randomisation to 24 and 48 weeks [ Time Frame: 24 and 48 weeks ]
- Change in ART (defined as any change from the ART regimen at randomisation) [ Time Frame: 48 weeks ]
- Grade 3 or 4 clinical and laboratory adverse events [ Time Frame: 48 weeks ]
- ART treatment modifying adverse events (all grades) [ Time Frame: 48 weeks ]
- New CDC stage B or C diagnosis or death [ Time Frame: 48 weeks ]
- Changes in fasting glucose, cholesterol, triglycerides, LDL, HDL and VLDL levels through 48 weeks [ Time Frame: 48 weeks ]
- Adherence, acceptability, and quality of life over 48 weeks as assessed by patient completed questionnaires [ Time Frame: 48 weeks ]

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Ages Eligible for Study: | 8 Years to 24 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01641016
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 |
Principal Investigator: | Karina M Butler, MRCPI | Medical Research Council |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | PENTA Foundation |
ClinicalTrials.gov Identifier: | NCT01641016 History of Changes |
Other Study ID Numbers: |
BREATHER (PENTA 16) 2009-012947-40 ( EudraCT Number ) |
First Posted: | July 16, 2012 Key Record Dates |
Last Update Posted: | March 2, 2015 |
Last Verified: | July 2013 |
Keywords provided by PENTA Foundation:
short cycle therapy young people HIV |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Efavirenz Reverse Transcriptase Inhibitors |
Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers |