TMC278-MWRI-01
Status:Completed
Phase:I
Principal Investigator(s):
Objective:The purpose of this study is to evaluate the safety, acceptability, pharmacokinetics, and ex vivo pharmacodynamics of TMC278 long acting when administered as an intramuscular injection in adult participants who are HIV negative.
Prevention Option(s):PrEP
Study Design:Open label, Randomized
Arms and Assigned Interventions
DescriptionArm 1A:
Female participants will receive a single dose of long acting TMC278 (1200 mg) at baseline.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionArm 1B: Male participants will receive a single dose of long acting TMC278 (1200 mg) at baseline.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionArm 2A: Female participants will receive a single dose of long acting TMC278 (600 mg) at baseline.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionArm 2B: Male participants will receive a single dose of long acting TMC278 (600 mg) at baseline.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionArm 3A:
Female participants will receive 3 bi-monthly injections of long acting TMC278 (1200 mg) at baseline, Months 2 and 4.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionArm 3B:
Male participants will receive 3 bi-monthly injections of long acting TMC278 (1200 mg) at baseline, Months 2 and 4.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionArm 4A:
Female participants will receive a single dose of long acting TMC278 (1200 mg) at baseline followed by TMC278 (900 mg) at Months 2 and 4.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionArm 4B:
Male participants will receive a single dose of long acting TMC278 (1200 mg) at baseline followed by TMC278 (900 mg) at Months 2 and 4.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionArm 5A:
Female participants will receive a single dose of long acting TMC278 (1200 mg) at baseline followed by TMC278 (600 mg) at Months 2 and 4.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionArm 5B:
Male participants will receive a single dose of long acting TMC278 (1200 mg) at baseline followed by TMC278 (600 mg) at Months 2 and 4
Mode of DeliveryIntradermal
ARMsExperimental
Official Code:
NCT01656018
Trial Sponsors:
Janssen Research & Development
Start Date
End Date
November 2, 2012
January 1, 2016
Enrollment:90
Age range:
18 Years ↔
45 Years
Population:Cisgender Men, Cisgender Women