Safety of Cotrimoxazole in HIV- and HAART-exposed Infants
3 other identifiers
interventional
222
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 12, 2010
CompletedFirst Posted
Study publicly available on registry
March 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedFebruary 25, 2011
February 1, 2011
1.7 years
March 12, 2010
February 24, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incidence of severe or life-threatening anemia
incidence of severe or life-threatening anemia (as defined by DAIDS toxicity tables, 2004) between 1 and 6 month of life
between 1 to 6 months of life
Secondary Outcomes (2)
incidence of severe or life-threatening neutropenia
between 1 to 6 months of life
composite severe morbidity and mortality
between 1 and 6 months of life
Study Arms (1)
Cotrimoxazole
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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)
- years of age or older, and able and willing to sign informed consent
- Proof of Botswana Citizenship
You may not qualify if:
- involuntary incarceration
- younger than 42 days of age
- able to be brought to regular visits at study clinic until at least 6 months postpartum
- known pre-existing birth anomalies resulting in a high probability that the baby will not survive to 6 months
- known hypersensitivity to cotrimoxazole
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Harvard School of Public Health (HSPH)lead
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
- Fogarty International Center of the National Institute of Healthcollaborator
- Harvard Initiative for Global Healthcollaborator
- The American Society of Tropical Medicine and Hygienecollaborator
Study Sites (2)
Princess Marina Hospital
Gaborone, Gaborone, Botswana
Scottish Livingstone Hospital
Molepolole, Kweneng District, Botswana
Related Publications (1)
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.
PMID: 24086319DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shahin Lockman, MD
Harvard School of Public Health (HSPH)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 12, 2010
First Posted
March 15, 2010
Study Start
February 1, 2009
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
February 25, 2011
Record last verified: 2011-02