Towards infant AIDS cures through early combination antiretroviral therapy (cART): investigating novel diagnostics.

Organization: 
Stellenbosch University
Organization Location: 
Cape Town, South Africa

The first well-documented case of a probable HIV-1 cure by early infant combination antiretroviral therapy (cART), initiated within hours after birth, has recently been publicized. Recent evidence also suggests that very early cART would improve prognosis, even when cure is not achieved. Diagnosis of HIV-1 within 48h of birth indicates intra-uterine infection, which most often occurs in the days preceding delivery, thus offering a unique opportunity to treat HIV-1 at a very early stage. A highly sensitive point-of-care assay would facilitate diagnosis in a busy labor ward setting. The lateral flow p24 antigen assay (LYNX) has comparable diagnostic sensitivity to the reference TaqMan HIV-1 qualitative total nucleic acid PCR(TNA) in older infants, but it is not known how LYNX will perform at early stages of infection with low viraemia. This key knowledge gap will be addressed in the current proposal. We will compare the sensitivity and specificity LYNX with a highly-sensitive, quantitative TaqMan HIV-1 RNA, version-2, PCR assay, and the current reference TNA assay. We will target a specimen-to-result turnaround-time within 48h. Early diagnosis of intra-uterine HIV-1 infection feasible would facilitate initiation of cART within 48h of birth, which would improve health outcomes and enable us to study a potential cure of HIV-1 infection.

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