Safety of Cotrimoxazole in HIV- and HAART-exposed Infants

President and Fellows of Harvard College

Status and phase: Completed; Phase 4

Conditions: Anemia; Neutropenia; Infant, Newborn; HIV Infections; Acquired Immunodeficiency Syndrome

Treatments: Drug: cotrimoxazole

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01086878

2P30AI060354-06 (U.S. NIH Grant/Contract)

3R24TW007988-01S1 (U.S. NIH Grant/Contract)

BHP031

Details and patient eligibility

About

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.

Full 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.

Enrollment: 222 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Both maternal and infant criteria need to be met:

Maternal 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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222 participants in 1 patient group

Cotrimoxazole

Experimental group

Treatment:

Drug: cotrimoxazole