BREATHER (PENTA 16): Short-cycle therapy (SCT) (5 days on/ 2 days off) in young people with chronic HIV-infection - BREATHER(PENTA 16) Trial: Short-Cycle Therapy(SCT)

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 199

Inclusion Criteria

•HIV-1 infected young people aged 8 to 24 years inclusive (Young people recruited between the ages of 16-24 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 and EFV for at least 12 months and willing to continue the regimen throughout the study period. Young people on regimens containing NVP or a boosted protease inhibitor with undetectable viral load wishing to enrol should switch to EFV, and may be enrolled if they 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): young people who have experienced a single viral load >50 but <1000 copies/ml in the last 12 months can be enrolled.
•Started HAART naïve (i.e. no previous mono or dual therapy unless for prevention of mother-to-child transmission).
•May have experienced more than 2 classes of ARVs as long as any changes were due to toxicity or simplification rather than due to virological failure (where virological failure is defined as two successive HIV-1 RNA results>1000 c/ml (confirmed) more than 6 months after starting HAART).
•CD4 cell count =350 10x6/L at screening visit.
•Centre must routinely use an assay which detects HIV RNA-1 viral load =50 c/ml

Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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