Antiretroviral research for Watoto

Medical Research Council (UK)0 个研究点目标入组 1,200 人开始时间: 2006年6月9日最近更新: 2021年8月2日

试验速览

•1. Children should have an adult carer in the household who is either:
•1.1. Participating in the DART trial (ISRCTN13968779) or
•1.2. Being treated with ART or
•1.3. HIV positive but not yet needing treatment but with access to a treatment program when ART is required or
•1.4. HIV negative
•2. Parents or guardians, and children where appropriate according to age and knowledge of HIV status, must be willing and able to give informed consent for randomisation to clinically driven monitoring (CDM) or laboratory and clinical monitoring (LCM) and to first-line ART strategy
•3. Participants must have a confirmed and documented diagnosis of HIV-1 infection
•4. At entry participants should be aged:
•4.1. 6 Months to 17 years among children and adolescents from DART households
•4.2. 6 Months to 12 years among children in non-DART households
•5. Participants must be ART naive (except for exposure to perinatal ART for the prevention of mother-to-child HIV transmission)
•6. Participants must meet the criteria for requiring ART according to World Health Organization (WHO) stage and CD4 count or CD4 cell percent

•1. Cannot, or unlikely to attend regularly
•2. Likelihood of poor adherence
•3. Presence of acute infection
•4. In receipt of medication contraindicated by ART or on chemotherapy for malignancy
•5. Laboratory abnormalities, which are a contraindication for the patient to start ART
•6. Pregnant or breastfeeding

发起方

Medical Research Council (UK)