Safety of Cotrimoxazole in HIV- and HAART-exposed Infants

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01086878
• Date of registration: 12/03/2010
• Prospective Registration: No
• Primary sponsor: Harvard School of Public Health
• Public title: Safety of Cotrimoxazole in HIV- and HAART-exposed Infants
• Scientific title: Safety of Cotrimoxazole in HIV- and HAART-exposed Infants in Botswana
• Date of first enrolment: February 2009
• Target sample size: 222
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01086878
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 4

Countries of recruitment

Botswana

Contacts

• Name: Shahin Lockman, MD
• Affiliation: Harvard School of Public Health

Key inclusion & 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



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Anemia

Acquired Immunodeficiency Syndrome

Infant, Newborn

HIV Infections

Neutropenia

Intervention(s)

Drug: cotrimoxazole

Primary Outcome(s)

incidence of severe or life-threatening anemia [Time Frame: between 1 to 6 months of life]

Secondary Outcome(s)

composite severe morbidity and mortality [Time Frame: between 1 and 6 months of life]

incidence of severe or life-threatening neutropenia [Time Frame: between 1 to 6 months of life]

Secondary ID(s)

3R24TW007988-01S1

2P30AI060354-06

BHP031

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Allergy and Infectious Diseases (NIAID)

John E. Fogarty International Center (FIC)

The American Society of Tropical Medicine and Hygiene

Harvard Initiative for Global Health