drugset

drugset / Trial / NCT01086878

Safety of Cotrimoxazole in HIV- and HAART-exposed Infants

NCT01086878 ↗

Phase 4 Completed 222 enrolled Harvard School of Public Health (HSPH) Fogarty International Center of the National Institute of Health · collab Harvard Initiative for Global Health · collab National Institute of Allergy and Infectious Diseases (NIAID) · collab The American Society of Tropical Medicine and Hygiene · collab

Non-randomizedSingle-groupOpen-labelPrevention

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.

Timeline

Start: 2009-02
Primary completion: 2010-10
Completion: 2010-10

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sulfamethoxazole	Small molecule	100 mg	Oral
Subject	Sulfamethoxazole	Small molecule	200 mg	Oral
Subject	Trimethoprim	Small molecule	20 mg	Oral
Subject	Trimethoprim	Small molecule	40 mg	Oral

Indications