Effectiveness of generic split adult tablets and paediatric fixed dose combination (FDC) of d4T/3TC/NVP in the treatment of HIV infected Malawian childre
- Conditions
- Human Immunodeficiency Virus (HIV)Infections and InfestationsAsymptomatic human immunodeficiency virus [HIV] infection status
- Registration Number
- ISRCTN55748789
- Lead Sponsor
- Ministry of Health (Malawi) - HIV department
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 410
1. Confirmed HIV infection (either HIV antibody test or, if <18 months, by HIV DNA test)
2. Caregiver and child, if applicable, counselled about HIV infection
3. Age <15 years
4. Body weight =3kg and <25kg
5. Informed consent given by caregiver and child if applicable
6. Eligible to start Anti-Retroviral Therapy (ART) according to Malawi National ART guidelines (3rd edition 2008)
7. Likely to comply with the study protocol (e.g. a main caregiver, responsible for administrating medication has been identified, caregiver and child have undergone an ART education session using the national paediatric ART education flipchart to understand the implications of ART, patient lives within the Lilongwe district)
1. Previous exposure to ART except Prevention of Mother-To-Child Transmission (PMTCT)
2. Patient requires hospital admission according to assessment of study clinician
3. Obvious liver disease on clinical examination (e.g. jaundice)
4. Obvious renal disease on clinical examination (e.g. lid oedema, hypertension)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of children with viral load of <400 copies/ml at 12 months follow-up
- Secondary Outcome Measures
Name Time Method