The Children with HIV Early Antiretroviral Therapy (CHER) trial is a phase 3, randomized, open-label trial conducted by the Comprehensive International Program for Research in AIDS — South Africa in collaboration with the Medical Research Council Clinical Trials Unit, United Kingdom, and the Division of AIDS (DAIDS) of the National Institutes of Health (NIH). The study is being conducted in two centers in South Africa: the Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, in Soweto, and the Children's Infectious Diseases Clinical Research Unit, Tygerberg Children's Hospital, in Cape Town.
We enrolled infants 6 to 12 weeks of age who had HIV infection (defined by a positive polymerase-chain-reaction [PCR] test for HIV-1 DNA and a plasma HIV-1 RNA level on PCR of >1000 copies per milliliter) and a CD4 percentage of 25% or more. Exclusion criteria are listed in theSupplementary Appendix , available with the full text of this article at www.nejm.org . Infants were randomly assigned to receive one of three treatments: early limited antiretroviral therapy for 96 weeks, early limited antiretroviral therapy for 40 weeks, or deferred therapy. Immunologic criteria for initiating antiretroviral therapy in the deferred-therapy group or reinitiating antiretroviral therapy in the early-therapy groups were a CD4 percentage of less than 20%5 or, in the case of children younger than 12 months, a CD4 percentage of less than 25% or a CD4 count of less than 1000 cells per cubic millimeter, according to World Health Organization (WHO) guidelines updated in 2006.6 Clinical criteria for initiating or reinitiating antiretroviral therapy7 were Centers for Disease Control and Prevention (CDC) stage C or investigator-selected (severe) stage B events (see the Supplementary Appendix ), including symptomatic lymphoid interstitial pneumonitis, bronchiectasis, nephropathy, cardiomyopathy, and failure to thrive. GlaxoSmithKline provided lamivudine and zidovudine, and the South African Department of Health provided lopinavir–ritonavir. Written informed consent was obtained from the parents or legal guardians of all the infants. The authors vouch for the completeness and accuracy of the data.
We enrolled infants 6 to 12 weeks of age who had HIV infection (defined by a positive polymerase-chain-reaction [PCR] test for HIV-1 DNA and a plasma HIV-1 RNA level on PCR of >1000 copies per milliliter) and a CD4 percentage of 25% or more. Exclusion criteria are listed in the