EUCTR2009-012947-40-DEActive, not recruitingPhase 1
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)
PENTA Foundation0 sites160 target enrollmentStarted: March 1, 2013Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 160
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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)
Investigators
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