HIV in children Infections and Infestations Unspecified human immunodeficiency virus [HIV] disease
Conditions
Interventions
Those randomized to the continuous arm are treated continuously while those randomized to the treatment interruption arm (STI) are treated initially for a minimum of six months and until the CDC immun
3TC at 4 mg/kg bid (up to a maximum of 300 mg per day)
ZDV at 180 mg/m2 bid (up to a maximum of 600 mg per day)
and Kaletra in accordance with the package insert dosing table up to a maximum of 800 mg lopinavir daily. Interim analyses of study data are conducted at such intervals as was determined by the Data S
Sponsors
Botswana-Baylor Children's Clinical Centre of Excellence (Botswana)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children between 6 months up to the 13th birthday who weigh >7kg at the time of enrolment are invited to participate if they have documented laboratory evidence of HIV-1 infection, have received 18 months, a positive HIV antibody test [(enzyme-linked immunosorbent assay (ELISA) or enzyme immunoassay (EIA)] can substitute for one of the PCR-based tests. Children who were enrolled in the BANA1 study are eligible after a one-week washout period. BANA1 was the first trial that started in 2001 to show that antiretrovirals (ARVs) would work in African as well as in western children, as the prevailing view at that time was not so. The study was stopped after one year when the standard of care in Botswana changed. BANA2, this study, is the sequential successor of BANA1. 3. Written informed consent is obtained from all participant's legal guardians. Assent is obtained from children aged 6 years or more.
Exclusion criteria
Exclusion criteria: 1. Liver function test values >5x above the upper limit of normal and documented or suspected acute hepatitis within 30 days prior to study entry, irrespective of [aspartate transaminase (serum glutamic oxaloacetic transaminase) (AST(SGOT)] and alanine transaminase (serum glutamic pyruvate transaminase) ALT(SGPT) values 2. Any grade 3 or greater toxicity 3. Known intolerance to study drug and current use of medications likely to interact with study drug (including rifampicin)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Drug associated toxicity or intolerance 2. Disease progression [growth failure, neuropsychological / neurological deterioration, opportunistic infections or conditions) or death] 3. Development of major genotypic resistance mutations The study was not designed to have a fixed end point in time. Rather it was designed to generate a working database with oversight by a Data and Safety Monitoring Board. The primary outcomes (death, growth failure; change in neurodevelopment status and major reverse transcriptase or protease resistance mutations) are measured by events (rates/1000 person yrs). Patients have been followed up for >2000 person years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cost of treatment | — |
Countries
Botswana
Outcome results
None listed