A Study to Evaluate Safety, Acceptability, Pharmacokinetics, and ex Vivo Pharmacodynamics of TMC278 Long Acting Formulation in HIV-1 Seronegative Participants

Completed · Phase 1

Conditions studied: Healthy

In brief

The purpose of this study is to evaluate the safety, acceptability, pharmacokinetics (what the body does to the medication), and ex vivo (tested outside the body) pharmacodynamics (what the medication does to the body) of TMC278 long acting (slowly effective after initial dosage and maintaining its effects over a long period of time) when administered as an intramuscular (ie, in to the muscle) injection in adult participants who are seronegative for human immunodeficiency virus type 1 (HIV-1).

Key facts

Study ID

NCT01656018

Run by

Janssen Research & Development, LLC

People needed

4

Starts

2012-11-01

Expected to finish

2016-01-01

Last updated by the study team

2016-04-07

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Human immunodeficiency virus type 1 (HIV-1) seronegative at screening and enrollment
• Not pregnant or breastfeeding females
• Agrees to protocol-defined method of contraception
• Abstinence from insertion of anything in rectum (eg, medication, enema, penis, or sex toy) for 72 hours before and 72 hours after each rectal biopsy visit
• Abstinence from insertion of anything in vagina (eg, tampon, medication, douche, penis, or sex toy) for 72 hours before and 72 hours after each cervical and vaginal biopsy visit

You may not qualify if…

• Post-exposure prophylaxis for HIV exposure within 6 months prior to screening and known HIV-infected partners
• Use of systemic immunomodulatory medications within the 4 weeks prior to the enrollment
• Use of vaginally or rectally administered medications or products (including condoms) containing Nonoxynol-9 (N-9) within the 4 weeks prior to the enrollment
• Abnormalities of the cervical, vaginal, or colorectal mucosa, or significant symptom(s), which in the opinion of the clinician represents a contraindication to protocol-required biopsies
• History of recurrent urticaria
• History of or electrocardiogram demonstrating prolonged QT interval
• History of significant gastrointestinal bleeding

Where it is running

• Study site — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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