Safety of Cotrimoxazole in HIV- and HAART-exposed Infants

Phase 4

Completed

• Conditions: Acquired Immunodeficiency Syndrome; Infant, Newborn; Anemia; Neutropenia; HIV Infections
• Interventions: Drug: cotrimoxazole

• Registration Number: NCT01086878
• Lead Sponsor: Harvard School of Public Health (HSPH)

Brief 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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2010-03-12
• Study First Submitted QC: 2010-03-12
• Study First Posted: 2010-03-15
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-24
• Last Update Posted: 2011-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

• documented HIV infection
• taking 3-drug highly active antiretroviral therapy at any point during pregnancy (note: can include 2 NRTI+NNRTI, 2NRTI+PI, or 3 NRTI)
• 21 years of age or older, and able and willing to sign informed consent
• Proof of Botswana Citizenship

Maternal

Exclusion Criteria

• involuntary incarceration

Infant Inclusion Criteria:

• younger than 42 days of age
• able to be brought to regular visits at study clinic until at least 6 months postpartum

Infant Exclusion Criteria:

• known pre-existing birth anomalies resulting in a high probability that the baby will not survive to 6 months
• known hypersensitivity to cotrimoxazole

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cotrimoxazole	cotrimoxazole	-

Primary Outcome Measures

Name	Time	Method
incidence of severe or life-threatening anemia	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

Secondary Outcome Measures

Name	Time	Method
incidence of severe or life-threatening neutropenia	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	between 1 and 6 months of life	Composite of severe morbidity (grade 3 or 4 illnesses, DAIDS toxicity tables, 2004), hospitalization, and mortality.

Trial Locations

Locations (2)

Scottish Livingstone Hospital; 🇧🇼 Molepolole, Kweneng, Botswana

Princess Marina Hospital; 🇧🇼 Gaborone, Botswana