Primary HIV-1 infection among infants in sub-Saharan Africa: HPTN 024.
OBJECTIVE
Our objectives were to assess clinical signs and diagnoses associated with primary HIV-1 infection among infants.


METHODS
We analyzed data from a clinical trial (HIV Prevention Trials Network Protocol 024) in sub-Saharan Africa. Study visits were conducted at birth, at 4-6 weeks, and at 3, 6, 9, and 12 months. The study population comprised live born, singleton, first-born infants of HIV-1-infected women with negative HIV-1 RNA assays who were still breastfeeding at 4-6 weeks.


RESULTS
Of 1317 HIV-1-exposed infants, 84 became HIV-1 infected after 4-6 weeks and 1233 remained uninfected. There were 102 primary and 5650 nonprimary infection visits. The most common signs were cough and diarrhea, and the most common diagnoses were malaria and pneumonia. Primary infection was associated with significantly increased odds of diarrhea [odds ratio (OR) = 2.4], pneumonia (OR = 3.5), otitis media (OR = 3.1), and oral thrush (OR = 2.9). For the clinical signs and diagnoses evaluated, sensitivity was low (1%-16.7%) and specificity was high (88.2%-99%). Positive predictive values ranged from 0.1%-1.4%. Negative predictive values ranged from 28.0%-51.1%.


CONCLUSIONS
Certain clinical signs and diagnoses, although more common during primary HIV-1 infection, had low sensitivity and high specificity. Efforts to expand access to laboratory assays for the diagnosis of primary HIV-1 infection among infants of HIV-1-infected women should be emphasized.
Pediatric, Adolescent, and Maternal AIDS Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Department of Health and Human Services, Bethesda, MD 20892-7510, USA. jennifer_read@nih.gov
Jennifer S
JS
Read
Anthony
A
Mwatha
Barbra
B
Richardson
Megan
M
Valentine
Lynda
L
Emel
Karim
K
Manji
Irving
I
Hoffman
Usha
U
Sharma
Robert L
RL
Goldenberg
Taha E
TE
Taha
D017954:Africa South of the Sahara / Q000453:epidemiology; D018791:CD4 Lymphocyte Count; D015897:Comorbidity; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000175:diagnosis* / Q000453:epidemiology* / Q000635:transmission; D015497:HIV-1; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000706:statistics & numerical data*; D008297:Male; D015995:Prevalence; D012680:Sensitivity and Specificity; D019562:Viral Load