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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 160

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

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
Main Objective: To determine whether young people with HIV infection, who do not take their HIV medication at weekends, continue to have low levels of HIV virus in their blood.;Secondary Objective: To look at how the immune system reacts when medication is not taken at weekends compared with participants who take medication every day.<br><br>To evaluate the role of SCT in young people with regard to adherence and acceptability before and after the trial (qualitative substudy).<br>;Primary end point(s): HIV-1 RNA =50 c/ml (confirmed on separate sample within 1 week) at any of week 4, 12, 24, 36 or 48 ;Timepoint(s) of evaluation of this end point: week 4, 12, 24, 36 and 48

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary Outcomes:<br>? HIV-1 RNA <50 copies/ml at 24 and 48 weeks.<br>? Number of HIV mutations present at week 4, 12, 24, 36 or 48 conferring resistance to drugs taken at randomisation or during the trial.<br>? Change in CD4 (absolute and percentage) from randomisation to 24 and 48 weeks.<br>? Change in ART (defined as any change from the ART regimen at randomisation).<br>? Grade 3 or 4 clinical and laboratory adverse events.<br>? ART treatment modifying adverse events (all grades).<br>? New CDC stage B or C diagnosis or death<br>? Changes in fasting glucose, cholesterol, triglycerides, LDL, HDL and VLDL levels through 48 weeks.<br>? Adherence, acceptability, and quality of life over 48 weeks as assessed by patient completed questionnaires.;Timepoint(s) of evaluation of this end point: see above (E.5.2)

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