ECLAIR
Status:Completed
Phase:II
Principal Investigator(s):
Objective:To evaluate the safety and tolerability of the injectable agent in HIV uninfected men. *Results presented at the 2016 Conference on Retroviruses and Opportunisitic Infections (CROI) 2016 suggest injections every 8 weeks rather than every 12, as in this trial, may be optimal. Study participants preferred injections to once-daily tablets.*
Prevention Option(s):PrEP
Study Design:Blind, Controlled, Placebo, Randomized
Arms and Assigned Interventions
DescriptionInjections (800 mg) 3 times over 12 weeks
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionOral phase: 30mg tablet daily for 4 weeks followed by a 1 week washout.
Participants will then be transferred to injection phase.
Mode of DeliveryTablet
ARMsExperimental
Official Code:
NCT02076178
Trial Sponsors:
ViiV
Start Date
End Date
March 31, 2014
March 31, 2016
Enrollment:127
Age range:
18 Years ↔
65 Years
Population:Cisgender Men