Safety of Cotrimoxazole in HIV- and HAART-exposed Infants
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|ClinicalTrials.gov Identifier: NCT01086878|
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : February 25, 2011
|Condition or disease||Intervention/treatment||Phase|
|Acquired Immunodeficiency Syndrome Infant, Newborn Anemia Neutropenia HIV Infections||Drug: cotrimoxazole||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||222 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety of Cotrimoxazole in HIV- and HAART-exposed Infants in Botswana|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
Daily oral cotrimoxazole suspension from 1 to 6 months of age at the following weight-based doses:
- incidence of severe or life-threatening anemia [ Time Frame: between 1 to 6 months of life ]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 ]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 ]Composite of severe morbidity (grade 3 or 4 illnesses, DAIDS toxicity tables, 2004), hospitalization, and mortality.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086878
|Scottish Livingstone Hospital|
|Molepolole, Kweneng, Botswana|
|Princess Marina Hospital|
|Principal Investigator:||Shahin Lockman, MD||Harvard School of Public Health|