NCT01086878

Safety of Cotrimoxazole in HIV- and HAART-exposed Infants

Safety of Cotrimoxazole in HIV- and HAART-exposed Infants in Botswana

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 222 (estimated)
• Sponsor: Harvard School of Public Health (HSPH) · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if prophylactic cotrimoxazole makes severe anemia or neutropenia more common in infants exposed to maternal HIV and combination antiretroviral therapy.

Detailed description

Each year, more than 2 million children are born to HIV-infected women. The World Health Organization (WHO) recommends that these infants receive cotrimoxazole (CTX) prophylaxis starting at 4-6 weeks of age until the period of infant HIV transmission risk is over, and the infant is known to be HIV-uninfected. There is also increasing interest in studying CTX prophylaxis given to all infants of HIV-infected women at the time of initiation of replacement feeding, regardless of infant HIV infection status, to mitigate the high risk of infant morbidity and mortality associated with formula feeding in the developing world. However, infant in utero exposure to maternal antiretroviral drugs can lead to hematologic toxicities in infants. It is critical to know whether infant CTX prophylaxis exacerbates the hematologic toxicity associated with perinatal ARV exposure. This question, with broad public health implications, has never been studied. We will study the hematologic toxicity associated with CTX prophylaxis given to infants exposed to maternal HAART in Botswana. We will use existing data from a large cohort that did not receive CTX, and enroll a smaller cohort that does receive CTX according to Botswana national guidelines.

Conditions

• Acquired Immunodeficiency Syndrome
• Infant, Newborn
• Anemia
• Neutropenia
• HIV Infections

Interventions

Type	Name	Description
DRUG	cotrimoxazole	Daily oral cotrimoxazole suspension from 1 to 6 months of age at the following weight-based doses: * less than 5kg: 100mg sulfamethoxazole, 20mg trimethoprim * greater than 5kg: 200mg sulfamethoxazole, 40mg trimethoprim

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2010-03-15
• Last updated: 2011-02-25

Locations

2 sites across 1 country: Botswana