Safety of Cotrimoxazole in HIV- and HAART-exposed Infants

NCT ID: NCT01086878

Last Updated: 2011-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2010-10-31

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.

Conditions

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

Keywords

Antiretroviral Therapy, Highly Active; Trimethoprim-Sulfamethoxazole Combination; anemia; neutropenia; safety; hematologic toxicity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Cotrimoxazole

Group Type: EXPERIMENTAL

cotrimoxazole

Intervention Type: DRUG

Daily oral cotrimoxazole suspension from 1 to 6 months of age at the following weight-based doses:

• less than 5kg: 100mg sulfamethoxazole, 20mg trimethoprim
• greater than 5kg: 200mg sulfamethoxazole, 40mg trimethoprim

Interventions

cotrimoxazole

Daily oral cotrimoxazole suspension from 1 to 6 months of age at the following weight-based doses:

• less than 5kg: 100mg sulfamethoxazole, 20mg trimethoprim
• greater than 5kg: 200mg sulfamethoxazole, 40mg trimethoprim

Intervention Type: DRUG

Other Intervention Names

Bactrim; Septrim; Cotrim; Septra; trimethoprim/sulfamethoxazole; trimethoprim-sulfamethoxazole

Eligibility Criteria

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

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

Exclusion Criteria

• involuntary incarceration

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role: collaborator

Harvard Initiative for Global Health

UNKNOWN

Sponsor Role: collaborator

The American Society of Tropical Medicine and Hygiene

OTHER

Sponsor Role: collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role: lead

Responsible Party

Harvard School of Public Health

Principal Investigators

Shahin Lockman, MD

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Locations

Princess Marina Hospital

Gaborone, Gaborone, Botswana

Scottish Livingstone Hospital

Molepolole, Kweneng District, Botswana

Countries

Botswana

References

Dryden-Peterson S, Jayeoba O, Hughes MD, Jibril H, McIntosh K, Modise TA, Asmelash A, Powis KM, Essex M, Shapiro RL, Lockman S. Cotrimoxazole prophylaxis and risk of severe anemia or severe neutropenia in HAART-exposed, HIV-uninfected infants. PLoS One. 2013 Sep 23;8(9):e74171. doi: 10.1371/journal.pone.0074171. eCollection 2013.

Reference Type: DERIVED

PMID: 24086319 (View on PubMed)

Other Identifiers

2P30AI060354-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

3R24TW007988-01S1

Identifier Type: NIH

Identifier Source: secondary_id

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BHP031

Identifier Type: -

Identifier Source: org_study_id