HIV Infections Clinical Trial
Official title:
Safety of Cotrimoxazole in HIV- and HAART-exposed Infants in Botswana
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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