HIV/AIDS
Conditions
Interventions
CTX prophylaxis
No CTX prophylaxis
Sponsors
University of KwaZulu Natal
eThekwini Municipality Health Unit
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Infant born to a woman with confirmed HIV infection; Written informed consent to enroll infant into study obtained from mother; Infant age 6 weeks (between day 35-49) at study entry; Infant should be breastfeeding at time of screening and should be planning to breastfeed for at least 6 months; HIV-negative from a screening test performed prior to study entry; Mother (or infant) should be receiving PMTCT regimen or mother should be receiving lifelong ART; Singleton birth; Birth weight >2000g; Infant has not had any illness and has not received prior antibiotics or traditional medications;
Exclusion criteria
Exclusion criteria: Indeterminate HIV test result at screening; Receipt of antibiotics or traditional medications prior to study entry; A known requirement for CTX prophylaxis prior to study entry; A known contra-indication for CTX prophylaxis prior to study entry; Infants with any major serious illness (eg., heart, liver, kidney disease) or congenital malformation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare incidence of grade 3 and 4 common childhood illnesses or all-cause mortality through 54 weeks of age in HEUs receiving CTX or no CTX. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare incidence of grade 3 and 4 diarrheal events through 54 weeks of age in group receiving CTX vs no CTX;To compare incidence of grade 3 and 4 pneumonia events through 54 weeks of age in group receiving CTX vs no CTX;To compare the incidence of growth faltering events through 54 weeks of age in the group recieving CTX vs no CTX;To compare concentrations of LPS and 16s ribosomal RNA in infant plasma in a subsample of infants receiving CTX vs no CTX;To compare characteristics of gut microbiota in a subsample of infants receiving CTX vs no CTX | — |
Countries
South Africa
Contacts
Public ContactEshia Moodley-Govender
Postdoctoral Fellow
Outcome results
None listed