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Status
Completed
Phase
II
Principal Investigator(s)
Jessica Justman & Sally Hodder
Objective
To test the safety and acceptability of TMC278 LA, which is the long-acting form of rilpivirine, a non-nucleoside reverse transcriptase inhibitor in HIV uninfected women.
Results: PV LA, 1200 mg IM every eight weeks was well tolerated and safe through 76 weeks in African and US women. RPV plasma concentration at Week 76 was above the PA-IC90 in 92% and detectable in 99% of participants.
Prevention Option(s)
PrEP
Study Design
Controlled
Placebo
Randomized
Double-blind
Arms and Assigned Interventions
Description
Rilpivirine 25 mg capsules once daily for four weeks. Followed by injections of TMC278 LA, 1200mg dose at 8 week intervals (week 4 - 44).
Mode of Delivery
Intramuscular
Products
TMC 278
ARMs
Experimental
Description
Placebo comparator. Placebo capsules and IM injections of saline following same schedule as Rilpivirine arm.
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
Official Code
Trial Sponsors
PATH, Bill and Melinda Gates Foundation, NIAID, NIH
October 2014
October 2017
Enrollment
132
18
Years
45
Years
Population
Women
Sites
New Jersey Medical School Clinical Research Center CRS
Newark, New Jersey
United States of America
Bronx- Lebanon Hospital Center Clinical Research Site
Bronx, New York
United States of America
Emavundleni (EMA) CRS
Cape Town
South Africa
Spilhaus Clinical Research Site
Harare
Zimbabwe