B24
Conditions
Interventions
Group 1: Treatment arm - ART will be continued as usual
Group 2: Treatment interruption arm - usual ART will be interrupted for a maximum of 24 weeks or until there is an indication to restart ART.
Sponsors
J.W. Goethe Universität
Zentrum für Kinder- und Jugendmedizin
Eligibility
Sex/Gender
All
Age
3 Years to 11 Years
Inclusion criteria
Inclusion criteria: Informed consent Girls and Boys between 3 and 11 years HIV infection under stable antiretroviral therapy based on a protease inhibitor viral load 30% CDC classification N1 or A1 start of ART in first year of live, only because of age <12 months participating in the ped. cohort of the competence network HIV/AIDS
Exclusion criteria
Exclusion criteria: co-infection NNRTI-based antiretroviral therapy non-adherence condition that interferes with study participation according to the study physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of children without indication for ART after 24 weeks of ART-interruption. | — |
Secondary
| Measure | Time frame |
|---|---|
| Dynamics of CD4 cell count and increase of viral load, development of resistance mutations, occurence of CDC class B- and C symptoms/diseases, occurence of AIDS-defining illnesses, grade 3 or 4 lab-abnormalties according to DAIDS, changes of ART in control arm. All criteria will be checked at each visit (Screening, week 0, 2, 4, 6, 8, 12, 16, 20, 24, Follow-up) by clinical assessment and laboratory parameters. | — |
Countries
Germany
Contacts
Public ContactStephan Schultze-Strasser
J.W. Goethe Universität, Zentrum für Kinder- und Jugendmedizin
Outcome results
None listed