Botswana-Baylor ANtiretroviral Assessment: A study comparing the management of human immunodeficiency virus (HIV) in children using continuous or structured interrupted antiretroviral treatment

Completed

• Conditions: HIV in children; Infections and Infestations; Unspecified human immunodeficiency virus [HIV] disease

• Registration Number: ISRCTN14354426
• Lead Sponsor: Botswana-Baylor Children's Clinical Centre of Excellence (Botswana)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-18
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 600

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 <6 weeks of antiretroviral therapy and are Center for Disease Control and Prevention (CDC) immunologic category 2 or 3.
2. Children aged <18 months of age are considered infected if they have two positive PCR tests - qualitative DNA or quantitative RNA, or combination of both. For those aged >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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Drug associated toxicity or intolerance<br>2. Disease progression [growth failure, neuropsychological / neurological deterioration, opportunistic infections or conditions) or death]<br>3. Development of major genotypic resistance mutations<br><br>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 Outcome Measures

Name	Time	Method
Cost of treatment