HPTN 076
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, Double-blind, Placebo, Randomized
Arms and Assigned Interventions
DescriptionRilpivirine 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 DeliveryIntramuscular
ARMsExperimental
Official Code:
NCT02165202
Trial Sponsors:
Bill & Melinda Gates Foundation, NIAID, NIH, PATH
Start Date
End Date
October 31, 2014
October 31, 2017
Enrollment:132
Age range:
18 Years ↔
45 Years
Population:Cisgender Women