Safety of Cotrimoxazole in HIV- and HAART-exposed Infants
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.
Acquired Immunodeficiency Syndrome
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Safety of Cotrimoxazole in HIV- and HAART-exposed Infants in Botswana|
- incidence of severe or life-threatening anemia [ Time Frame: between 1 to 6 months of life ] [ Designated as safety issue: Yes ]incidence of severe or life-threatening anemia (as defined by DAIDS toxicity tables, 2004) between 1 and 6 month of life
- incidence of severe or life-threatening neutropenia [ Time Frame: between 1 to 6 months of life ] [ Designated as safety issue: Yes ]incidence of severe or life-threatening neutropenia (as defined by DAIDS toxicity tables, 2004) between 1 and 6 month of life
- composite severe morbidity and mortality [ Time Frame: between 1 and 6 months of life ] [ Designated as safety issue: Yes ]Composite of severe morbidity (grade 3 or 4 illnesses, DAIDS toxicity tables, 2004), hospitalization, and mortality.
|Study Start Date:||February 2009|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Daily oral cotrimoxazole suspension from 1 to 6 months of age at the following weight-based doses:
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01086878
|Scottish Livingstone Hospital|
|Molepolole, Kweneng, Botswana|
|Princess Marina Hospital|
|Principal Investigator:||Shahin Lockman, MD||Harvard School of Public Health|