Safety of Cotrimoxazole in HIV- and HAART-exposed Infants
Information source: Harvard School of Public Health
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acquired Immunodeficiency Syndrome; Infant, Newborn; Anemia; Neutropenia; HIV Infections
Intervention: cotrimoxazole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Harvard School of Public Health Official(s) and/or principal investigator(s): Shahin Lockman, MD, Principal Investigator, Affiliation: Harvard School of Public Health
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.
Clinical Details
Official title: Safety of Cotrimoxazole in HIV- and HAART-exposed Infants in Botswana
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: incidence of severe or life-threatening anemia
Secondary outcome: incidence of severe or life-threatening neutropeniacomposite severe morbidity and mortality
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Princess Marina Hospital, Gaborone, Botswana
Scottish Livingstone Hospital, Molepolole, Kweneng, Botswana
Additional Information
Starting date: February 2009
Last updated: February 24, 2011
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