Infectious disease - Paediatric HIV Infections and Infestations Human immunodeficiency virus
Conditions
Interventions
1. Short cycle therapy - 5 days on ART, 2 days off
2. Routine care - continuous ART
Once randomised participants will be followed for 48 weeks. However all participant
Sponsors
PENTA Foundation (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 16/01/2013 1. 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). 2. Parents/carers and/or young people, where applicable, willing to provide informed consent. 3. 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 1000 c/ml) subsequent to virological control having been achieved on ART. 4. Viral suppression (HIV-1 RNA 50 but <1000 copies/ml (preceded and followed by VL<50 c/ml) in the last 12 months can be enrolled. 5. CD4 cell count =350 106/L at screening visit. 6. Centre must routinely use an assay which detects HIV RNA-1 viral load =50 c/ml. Previous inclusion criteria until 16/01/2013: 1. HIV-1 infected young people aged 8 to 21 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). Previous inclusion criteria until 08/05/2012: 1. HIV-1 infected young people (either sex) aged 8 to 21 years inclusive (young people recruited between the ages of 16 - 21 years must either be in regular physical contact with their paediatrician or be able to transfer to an adult physician at the same site for follow-up or to an affiliated adult site) 2. Parents/carers and young people, where applicable, willing to provide informed consent 3. On a stable first-line anti-retroviral therapy (ART) regimen containing at least two nucleoside reverse transcriptase inhibitors (NRTIs) and efavirenz (EFV) for at least 12 months and willing to continue the regimen throughout the study period. Children on regimens containing nevirapine (NVP) or a boosted protease inhibitor with undetectable viral load wishing to enrol should switch to EFV, and may be enrolled if they have three subsequent HIV-1 ribonucleic acid (RNA) measurements less than 50 copies/ml over a minimum period of 12 weeks. 4. Viral suppression (HIV-1 RNA less than 50 copies/ml) for at least the prior 12 months (at least the last three measurements). Young people who have experienced a single viral load blip in the last 12 months can be enrolled; where the blip is defined as 'one or more detectable v
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 08/05/2012: 1. Pregnancy or risk of pregnancy in females of child-bearing potential. 2. Acute illness (young people may be enrolled after illness). 3. Receiving concomitant therapy for an acute illness (young people may be enrolled after finishing therapy). 4. A creatinine, AST or ALT of grade 3 or above at screening. 5. On a regimen including nevirapine or a boosted PI (young people may switch to an EFV based regimen). 6. Previous ART monotherapy (except for the prevention of mother-to-child transmission) Previous exclusion criteria: 1. Pregnancy or risk of pregnancy in females of child bearing potential 2. Acute illness 3. Receiving concomitant therapy for an acute illness except antibiotic prophylaxis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HIV-1 RNA greater than or equal to 50 c/ml (confirmed) at any of week 4, 8, 12, 24, 36 or 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. HIV-1 RNA less than 50 c/ml at 24 and 48 weeks 2. Number of HIV mutations present at week 4, 8, 12, 24, 36 or 48 conferring resistance to drugs taken at randomisation or during the trial 3. Change in CD4 (absolute and percentage) from randomisation to 24 and 48 weeks 4. Change in ART (defined as any change from the ART regimen at randomisation) 5. ART-related grade 3 or 4 clinical and laboratory adverse events 6. New CDC stage C diagnosis or death 7. Changes in fasting cholesterol, triglycerides, low density lipoprotein (LDL), high density lipoprotein (HDL) and very low density lipoprotein (VLDL) levels through 48 weeks 8. Adherence, acceptability, and well-being over 48 weeks as assessed by patient completed questionnaires | — |
Countries
Argentina, Belgium, Denmark, Germany, Ireland, Spain, Thailand, Uganda, Ukraine, United Kingdom, United States of America
Outcome results
None listed