Paediatric Human Immunodeficiency Virus (HIV) Infections and Infestations Paediatric Human Immunodeficiency Virus (HIV)
Conditions
Interventions
Status of trial as of 24/09/2007: Closed to recruitment. In follow-up.
Randomised controlled trial of planned treatment interruptions in children who are taking antiretoviral therapy
Sponsors
The Paediatric European Network for the Treatment of AIDS (PENTA) Foundation (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria amended as of 24/09/2007: 1. Aged 2 to 15 years inclusive 2. Parents/guardians, and children where appropriate, willing and able to give informed consent 3. Children currently on the same regimen of three or more antiretroviral (ART) drugs for at least 24 weeks 4. Children and parents prepared to restart the same ART regimen after treatment interruption if CD4% falls to 7 years) (confirmed on a second sample) or after 48 weeks on a PTI 5. Most recent two plasma HIV-1 Ribonucleic Acid (RNA) viral load less than 50 copies/ml (at least one month apart) 6. Most recent two CD4% >30% (children aged 2-6 years) or most recent two CD4% >25% and CD4 count >500 cells/mm3 (children aged >7 years); most recent two CD4% should be stable (different by no more than 4%) 7. Most recent two Total Lymphocyte Count (TLC) more than 1000 (at least one month apart) 8. Willing to attend 4 weekly monitoring visits if CD4 declines to <400 cells/mm3 or CD4% <22% Inclusion criteria provided at time of registration: 1. Aged 2 to 15 years inclusive 2. Parents/guardians, and children where appropriate, willing and able to give informed consent 3. Children currently on the same regimen of three or more antiretroviral (ART) drugs for at least 24 weeks 4. Children and parents prepared to restart the same ART regimen after treatment interruption if CD4% falls below 20% (aged two to six years) or CD4% falls to less than 20% and CD4 count falls to less than 350 cells/mm^3 (confirmed on a second sample). Children and parents prepared to continue on current therapy until clinical or virological failure if randomised to the continuous therapy arm 5. Most recent two plasma HIV-1 Ribonucleic Acid (RNA) viral load less than 50 copies/ml (at least one month apart) 6. Most recent two CD4% equal 30% (children aged two to six years) or most recent two CD4% equals 25% and CD4 count is more than 350 cells/mm^3. Most recent two CD4% should be stable (different by no more than 4%) 7. Most recent two Total Lymphocyte Count (TLC) more than 1000 (at least one month apart)
Exclusion criteria
Exclusion criteria: Exclusion criteria amended as of 24/09/2007: 1. Cannot or unwilling to attend regularly 2. Unwilling to restart ART if CD4 percent or count indicates this is necessary 3. Intercurrent illness (randomisation can take place after the illness) 4. Pregnancy or risk of pregnancy in girls of child-bearing potential 5. Previous symptomatic thrombocytopaenia with platelets <50 x 10 (to the power of 9)/l 6. Positive for hepatitis B surface antigen and receiving either lamivudine or tenofavir Exclusion criteria provided at time of registration: 1. Cannot or unwilling to attend regularly 2. Unwilling to restart ART if CD4 percent or count indicates this is necessary 3. Intercurrent illness (randomisation can take place after the illness) 4. Pregnancy or risk of pregnancy in girls of child-bearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures amended as of 24/09/2007: CD4% less than 15% and/or new Centers for Disease Control and Prevention (CDC) stage C diagnosis: 1. CD4% less than 15% (age 2-6 years) 2. CD4% less than 15% and CD4 7 years) 3. New CDC stage C diagnosis 4. Death Primary outcome measures provided at time of registration: CD4% less than 15% and/or new CDC (Centers for Disease Control and Prevention) stage C diagnosis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in ART (defined as any change from the ART regimen at randomisation) 2. Acute retroviral syndrome 3. ART-related grade three and four clinical and laboratory adverse events 4. HIV-1 RNA equals 400 copies/ml at week 72 having received ART continuously for the preceding 12 weeks 5. HIV-1 RNA equals 50 copies/ml at week 72 having received ART continuously for the preceding 12 weeks 6. Number of HIV mutations present at 72 weeks conferring resistance to drugs taken at entry or during the trial 7. Adherence to ART as assessed by caregiver completed questionnaire 8. Acceptability of the two strategies of ART administration to paediatricians and families | — |
Countries
France, Germany, Ireland, Italy, Spain, Switzerland, Thailand, United Kingdom, United States of America
Outcome results
None listed