RCT of effect of cotrimoxazole on the health of HIV-exposed unifected infants

Not Applicable

• Conditions: HIV/AIDS

• Registration Number: PACTR201311000621110
• Lead Sponsor: niversity of KwaZulu Natal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-21
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 1298

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

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;

Study & Design

• Study Type: Interventional
• Study Design: Not specified