Therapeutic Drug Monitoring in HIV-Infected Children Starting a New Anti-Retroviral Regime.
Suspended
- Registration Number
- NL-OMON20993
- Lead Sponsor
- Paediatric European Network for Treatment of AIDS (PENTA)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 166
Inclusion Criteria
1. Confirmed HIV-infected, i.e. positive plasma HIV-1 RNA or DNA test on two consecutive occasions (for children less than 18 months old), or positive HIV serology (for children aged 18 months and older) aged one month to 17 years inclusive;
2. Parents/guardians, and children where appropriate, are willing and able to give informed consent;
Exclusion Criteria
Grade 3 or 4 creatinine or liver function tests.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The effect of the TDM strategies on the viral load in terms of change from baseline (start or switch of therapy) to 96 weeks.
- Secondary Outcome Measures
Name Time Method 1. The proportion of children who ever achieve plasma HIV-1 RNA <50 copies/ml, and who subsequently maintain plasma HIV-1 RNA <50 copies/ml to 96 weeks;<br /><br>2. Toxicity and tolerability of HAART;<br /><br>3. Adherence to HAART as assessed by caregiver completed questionnaire and CORALs;<br /><br>4. Progression to new AIDS defining event or death;<br /><br>5. Number of switches in antiretroviral therapy;<br /><br>6. The development of new genotypic resistance mutations by 96 weeks;<br /> <br>7. Change in CD4 % and CD4 count from baseline to 96 weeks;<br /><br>8. Number of children in target area for pharmacokinetic parameters after 12 weeks.