Human Immunodeficiency Virus (HIV) Infections and Infestations Asymptomatic human immunodeficiency virus [HIV] infection status
Conditions
Interventions
Two different formulations of generic fixed dose combination of d4T/3TC/NVP tablets are compared in children 10kg and above: split adult tablets and a specific paediatric formulation (Triomune babyTM)
Sponsors
Ministry of Health (Malawi) - HIV department
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of children with viral load of <400 copies/ml at 12 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Monitoring patients' clinical response during routine visits 1.1. Change in body weight and height (z-scores) 1.2. Proportion of patients dying and lost to follow up 1.3. Time from enrolment to death and lost to follow up 1.4. Proportion of patients presenting with new symptoms and signs from enrolment 1.5. Proportion of patients requiring hospital admission 2. Monitoring patients' immunological response (CD4 count adjusted for age at entry, 3, 6, and 12 months) 2.1. Proportion of patients with immunological failure 2.2. Time until immunological failure occurs from enrolment 2.3. Change of Median CD4 percentage 3. Monitoring patients' virological response (HIV RNA at Entry, 3, 6, and 12 months) 3.1. Proportion of children with HIV RNA 0.5 log10) increase in copy number (children = 2 years) 3.4. Time until virological failure occurs from enrolment 4. Monitoring Adverse Reactions 4.1. Signs and symptoms likely to be related to ART according to routine clinic checklist 4.2. Laboratory: 4.2.1. Complete Blood Count (CBC) 4.2.2. Aspartate Aminotransferase (AST) 4.2.3. Alanine Aminotransferase (ALT) 4.2.4. Lipase 4.2.5. Creatinine 4.3. Proportion of patients requiring modification of dosing regimen (e.g. prolonged lead in phase, intermittent stop) 4.4. Proportion of patients permanently stop/withdrawn from initial regimen and/or started on alternative 1st line regimen 5. Proportion of patients with >95% adherence by reported or observed pill count during clinic visits 6. Proportion of patients with >95% adherence with medication intake (ART) according to pill counts during unannounced home visits 7. Proportion of patients presenting in the clinic upon agreed appointment 8. Proportion of patients with detectable and undetectable NVP drug- plasma concentration in samples taken during pharmcokinetics (PK) study 9. Proportion of patients with NVP levels above the threshold at steady state 10. Proportion of patients having HIV drug resistance at bas | — |
Countries
Malawi
Outcome results
None listed