Trial intelligence / Profile preview

Safety of Cotrimoxazole in HIV- and HAART-exposed Infants

NCT01086878Phase 4

Key facts

Status: Completed
Start: Feb 2009
Primary completion: Oct 2010
Countries: 1
Sponsor: Harvard T.H. Chan School of Public Health
Modality: Small Molecules

Drugs: trimethoprim + sulfamethoxazole
Conditions: human immunodeficiency virus infection (HIV)

Overview

Phase 4, open-label trial of trimethoprim + sulfamethoxazole in human immunodeficiency virus infection (HIV) (2 arms), sponsored by Harvard T.H. Chan School of Public Health. Primary endpoint: Incidence of severe or life-threatening anemia. Started Feb 2009; status: completed.

Design

2 arms

Study design: Non-randomizedOpen-label

Cotrimoxazole
Infants receiving daily oral cotrimoxazole prophylaxis
Historical Control
Historical cohort of infants who did not receive cotrimoxazole

Who it enrols

Infants younger than 42 days born to HIV-infected women who took 3-drug HAART during pregnancy. Must be Botswana citizens. Excludes infants with life-threatening birth anomalies or hypersensitivity to cotrimoxazole.

Endpoints

Primary

Incidence of severe or life-threatening anemia1 to 6 months of life

Secondary

Incidence of severe or life-threatening neutropenia1 to 6 months of life
Composite severe morbidity and mortality1 to 6 months of life

Beyond the preview

Go deeper on NCT01086878.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT01086878.