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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Janssen Research & Development, LLC
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01656018
First received: July 31, 2012
Last updated: October 8, 2014
Last verified: October 2014

July 31, 2012
October 8, 2014
November 2012
July 2015   (final data collection date for primary outcome measure)
  • Number of participants with adverse events [ Time Frame: Up to 280 days ] [ Designated as safety issue: Yes ]
  • Number of participants who would consider using long acting TMC278 for Human immunodeficiency virus (HIV) prevention in the future [ Time Frame: Up to 280 days ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: up to 280 Days ] [ Designated as safety issue: Yes ]
    Grade 2 or higher clinical and laboratory adverse events (as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events) will be evaluated.
  • The number of participants who would consider using long acting TMC278 for Human immunodeficiency virus (HIV) prevention in the future [ Time Frame: up to 252 Days ] [ Designated as safety issue: No ]
    The number of participants who would consider using long acting TMC278 for HIV prevention in the future will be evaluated.
Complete list of historical versions of study NCT01656018 on ClinicalTrials.gov Archive Site
  • TMC278 concentration in plasma [ Time Frame: Up to 280 days ] [ Designated as safety issue: No ]
  • TMC278 concentration in endocervical fluid [ Time Frame: Up to 280 days ] [ Designated as safety issue: No ]
  • TMC278 concentration in vaginal fluid [ Time Frame: Up to 280 days ] [ Designated as safety issue: No ]
  • TMC278 concentration in rectal fluid [ Time Frame: Up to 280 days ] [ Designated as safety issue: No ]
  • TMC278 concentration in cervical tissue [ Time Frame: Up to 280 days ] [ Designated as safety issue: No ]
  • TMC278 concentration in vaginal tissue [ Time Frame: Up to 280 days ] [ Designated as safety issue: No ]
  • TMC278 concentration in rectal tissue [ Time Frame: Up to 280 days ] [ Designated as safety issue: No ]
Determination of the TMC278 concentration in plasma, endocervical fluid, vaginal fluid, rectal fluid, cervical tissue, vaginal tissue, and rectal tissue [ Time Frame: up to 252 Days ] [ Designated as safety issue: No ]
TMC278 concentration in plasma, endocervical fluid, vaginal fluid, rectal fluid, cervical tissue, vaginal tissue, and rectal tissue will be evaluated.
Not Provided
Not Provided
 
A Study to Evaluate Safety, Acceptability, Pharmacokinetics, and ex Vivo Pharmacodynamics of TMC278 Long Acting Formulation in HIV-1 Seronegative Participants
Phase 1 Open Label Safety, Acceptability, Pharmacokinetic and ex Vivo Pharmacodynamic Study of TMC278 Long Acting (LA) Administered Intramuscularly to HIV-1 Seronegative Individuals

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).

This is an open-label (all people know the identity of the intervention), multi-arm (more than one treatment group), dose-ranging study (clinical study where different doses of study medication are tested against each other) to evaluate the safety, acceptability, pharmacokinetics, and ex vivo pharmacodynamics of a single and multiple intramuscular injections of long acting TMC278 to human immunodeficiency virus type 1 (HIV-1) seronegative (having a negative serum reaction) male and female participants. The study consists of 3 phases including screening phase, treatment phase, and the follow up phase (approximately 4 to 6 months after the first dose of study medication). In treatment phase, enrolled participants will be divided in to 2 arms, ie, Arm A (female participants) which will be further divided in to Arm 1A, Arm 2A, Arm 3A, Arm 4A, and Arm 5A with 12 female participants per arm; and Arm B (male participants) which will be further divided in to Arm 1B, Arm 2B, Arm 3B, Arm 4B, and Arm 5B with 6 male participants per arm. Safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, physical examination, and vital signs which will be monitored throughout the study. The total duration of study for each participant will be approximately 5 to 7 months.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Drug: TMC278, Long acting (LA)
TMC278 long acting will be administered IM to the participants as follows: a single dose of TMC278 600 mg will be administered at baseline in Arm 2A and Arm 2B; at Months 2 and 4 in Arm 5A and Arm 5B. A single dose of TMC278 900 mg will be administered at Months 2 and 4 in Arm 4A and Arm 4B. A single dose of TMC278 1200 mg will be administered at baseline in Arm 1A, Arm 1B; Arm 3A, Arm 3B, Arm 4A, Arm 4B, Arm 5A and Arm 5B; at Months 2 and 4 in Arm 3A and Arm 3B.
Other Name: TMC278
  • Experimental: Arm 1A
    Female participants will receive a single dose of long acting TMC278 1200 mg intramuscularly (IM) at baseline (Day 0) in Arm 1A.
    Intervention: Drug: TMC278, Long acting (LA)
  • Experimental: Arm 1B
    Male participants will receive a single dose of long acting TMC278 1200 mg IM at baseline in Arm 1B.
    Intervention: Drug: TMC278, Long acting (LA)
  • Experimental: Arm 2A
    Female participants will receive a single dose of long acting TMC278 600 mg IM at baseline in Arm 2A.
    Intervention: Drug: TMC278, Long acting (LA)
  • Experimental: Arm 2B
    Male participants will receive a single dose of long acting TMC278 600 mg IM at baseline in Arm 2B.
    Intervention: Drug: TMC278, Long acting (LA)
  • Experimental: Arm 3A
    Female participants will receive 3 bi-monthly injections of long acting TMC278 1200 mg IM at baseline, Months 2 and 4 in Arm 3A.
    Intervention: Drug: TMC278, Long acting (LA)
  • Experimental: Arm 3B
    Male participants will receive 3 bi-monthly injections of long acting TMC278 1200 mg IM at baseline, Months 2 and 4 in Arm 3B.
    Intervention: Drug: TMC278, Long acting (LA)
  • Experimental: Arm 4A
    Female participants will receive a single dose of long acting TMC278 1200 mg IM at baseline followed by TMC278 900 mg at Months 2 and 4 in Arm 4A.
    Intervention: Drug: TMC278, Long acting (LA)
  • Experimental: Arm 4B
    Male participants will receive a single dose of long acting TMC278 1200 mg IM at baseline followed by TMC278 900 mg at Months 2 and 4 in Arm 4B.
    Intervention: Drug: TMC278, Long acting (LA)
  • Experimental: Arm 5A
    Female participants will receive a single dose of long acting TMC278 1200 mg IM at baseline followed by TMC278 600 mg at Months 2 and 4 in Arm 5A.
    Intervention: Drug: TMC278, Long acting (LA)
  • Experimental: Arm 5B
    Male participants will receive a single dose of long acting TMC278 1200 mg IM at baseline followed by TMC278 600 mg at Months 2 and 4 in Arm 5B.
    Intervention: Drug: TMC278, Long acting (LA)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
December 2015
July 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years to 45 Years
Yes
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com
United States
 
NCT01656018
CR100803, TMC278-MWRI-01
No
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Not Provided
Study Director: Janssen Research and Development, LLC Clinical Trial Janssen Research and Development LLC
Janssen Research & Development, LLC
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP