An open label, randomized pilot study to evaluate diagnostic treatment interruption in HIV-positive children under a stable antiretroviral therapy in order to save medication and reduce possible side effects.
Not Applicable
- Conditions
- B24Unspecified human immunodeficiency virus [HIV] disease
- Registration Number
- DRKS00000473
- Lead Sponsor
- J.W. Goethe UniversitätZentrum für Kinder- und Jugendmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 1
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 <40cps
CD4 cells >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
co-infection
NNRTI-based antiretroviral therapy
non-adherence
condition that interferes with study participation according to the study physician
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of children without indication for ART after 24 weeks of ART-interruption.
- Secondary Outcome Measures
Name Time Method 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.<br><br>