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TMC278-MWRI-01

Status
Completed
Phase
I
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
Randomized
Open label
Arms and Assigned Interventions
Description
Arm 1A: Female participants will receive a single dose of long acting TMC278 (1200 mg) at baseline.
Mode of Delivery
Intramuscular
Products
TMC 278
ARMs
Experimental
Description
Arm 1B: Male participants will receive a single dose of long acting TMC278 (1200 mg) at baseline.
Mode of Delivery
Intramuscular
Products
TMC 278
ARMs
Experimental
Description
Arm 2A: Female participants will receive a single dose of long acting TMC278 (600 mg) at baseline.
Mode of Delivery
Intramuscular
Products
TMC 278
ARMs
Experimental
Description
Arm 2B: Male participants will receive a single dose of long acting TMC278 (600 mg) at baseline.
Mode of Delivery
Intramuscular
Products
TMC 278
ARMs
Experimental
Description
Arm 3A: Female participants will receive 3 bi-monthly injections of long acting TMC278 (1200 mg) at baseline, Months 2 and 4.
Mode of Delivery
Intramuscular
Products
TMC 278
ARMs
Experimental
Description
Arm 3B: Male participants will receive 3 bi-monthly injections of long acting TMC278 (1200 mg) at baseline, Months 2 and 4.
Mode of Delivery
Intramuscular
Products
TMC 278
ARMs
Experimental
Description
Arm 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 Delivery
Intramuscular
Products
TMC 278
ARMs
Experimental
Description
Arm 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 Delivery
Intramuscular
Products
TMC 278
ARMs
Experimental
Description
Arm 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 Delivery
Intramuscular
Products
TMC 278
ARMs
Experimental
Description
Arm 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 Delivery
Intradermal
Products
TMC 278
ARMs
Experimental
Official Code
NCT01656018
Trial Sponsors
Janssen Research & Development, LLC
November 2012
January 2016
Enrollment
90
18
Years
45
Years
Population
Women
Men
Sites

Pittsburg Clinical Research Site

Pittsburg, Pennsylvania
United States of America