A randomized, CD4+ cell guided, Kaletra-based, structured interrupted antiretroviral treatment in HIV infected infants and children in Botswana

Botswana-Baylor Children's Clinical Centre of Excellence (Botswana)0 个研究点目标入组 600 人开始时间: 2013年9月18日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•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.

•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)

发起方

Botswana-Baylor Children's Clinical Centre of Excellence (Botswana)