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Status
Completed
Phase
IIb
Principal Investigator(s)
Sharon A. Riddler, MD, MPH
Objective
The purpose of this study is to determine if taking daily TDF and FTC/TDF as a part of the study MTN-003 has an effect on bone mineral density (BMD).
Results: TDF-containing oral PrEP resulted in small but significant reversible decreases in hip and spine BMD among young African women.
Prevention Option(s)
Microbicides
Observational
Prospective Cohort
Arms and Assigned Interventions
Description
Daily dosing
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Experimental
Description
Daily dosing
Mode of Delivery
Tablet
ARMs
Placebo Comparator
Official Code
Trial Sponsors
NIAID, MTN
November 2009
May 2013
Enrollment
518
18
Years
45
Years
Population
Women
Sites
Seke South Clinical Research Site
Harare
Zimbabwe
Spilhaus Clinical Research Site
Harare
Zimbabwe
Zengeza 3 Clinic
Harare
Zimbabwe
MUJHU CARE LTD CRS
Kampala
Uganda