NCT02356302

Brief Summary

Research is currently underway to develop new HIV prevention strategies. Intravaginal rings (IVRs) are one drug delivery method that is currently being studied. This study will evaluate the safety and pharmacokinetics of IVRs containing vicriviroc, MK-2048, and a combination of vicriviroc/MK-2048, in healthy, HIV-uninfected women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Timeline
Completed

Started May 2015

Shorter than P25 for phase_1 hiv-infections

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

October 25, 2021

Status Verified

March 1, 2016

Enrollment Period

10 months

First QC Date

February 2, 2015

Last Update Submit

October 15, 2021

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (4)

  • Proportion of women in each of the four IVR regimens with genitourinary events Grade 1 or higher judged to be related to study product

    As defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, Dec 2004 (Clarification dated August 2009), Addendum 1, (Female Genital Grading Table for Use in Microbicide Studies)

    Measured through Day 35

  • Proportion of women in each of the four IVR regimens with adverse events Grade 2 or higher

    As defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, Dec 2004 (Clarification dated August 2009)

    Measured through Day 35

  • Measurement of local and systemic concentrations of vicriviroc (MK-4176)

    In plasma, vaginal fluids, and cervical tissue during and after 28 days of continuous use of an IVR containing 182 mg vicriviroc (MK-4176), or 30 mg MK-2048, or 182 mg vicriviroc (MK-4176) + 30 mg MK-2048 (MK-2048A)

    Measured through Day 35

  • Measurement of local and systemic concentrations of MK-2048

    In plasma, vaginal fluids, and cervical tissue during and after 28 days of continuous use of an IVR containing 182 mg vicriviroc (MK-4176), or 30 mg MK-2048, or 182 mg vicriviroc (MK-4176) + 30 mg MK-2048 (MK-2048A)

    Measured through Day 35

Secondary Outcomes (2)

  • Participant report of acceptability

    Measured through Day 35

  • Participant report of frequency of study IVR removal/expulsion and duration without IVR inserted in vagina

    Measured through Day 35

Study Arms (4)

Vicriviroc (MK-4176) Intravaginal Ring (IVR)

EXPERIMENTAL

The vicriviroc (MK-4176) IVR will be inserted during the enrollment visit (Day 0), and it will be removed on Day 28.

Device: Vicriviroc (MK-4176) Intravaginal Ring (IVR)

MK-2048 IVR

EXPERIMENTAL

The MK-2048 IVR will be inserted during the enrollment visit (Day 0), and it will be removed on Day 28.

Device: MK-2048 IVR

MK-2048A IVR

EXPERIMENTAL

The MK-2048A IVR will be inserted during the enrollment visit (Day 0), and it will be removed on Day 28.

Device: MK-2048A IVR

Placebo IVR

PLACEBO COMPARATOR

The placebo IVR will be inserted during the enrollment visit (Day 0), and it will be removed on Day 28.

Device: Placebo IVR

Interventions

Vicriviroc (MK-4176) Intravaginal Ring (IVR)DEVICE

Contains 182 mg vicriviroc (MK-4176).

Vicriviroc (MK-4176) Intravaginal Ring (IVR)
MK-2048 IVRDEVICE

Contains 30 mg MK-2048.

MK-2048 IVR
MK-2048A IVRDEVICE

Contains 182 mg vicriviroc (MK-4176) and 30 mg MK-2048.

MK-2048A IVR
Placebo IVRDEVICE
Placebo IVR

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Born female. Note: Participants who were female at birth, who now identify as male, will not be excluded so long as they are not on female-to-male transition therapy.
  • Age 18 through 45 years (inclusive) at Screening, verified per site SOPs
  • Able and willing to provide written informed consent to be screened for and take part in this study (MTN-027)
  • Able and willing to provide adequate locator information, as defined by the site SOPs
  • HIV-uninfected, based on testing performed by study staff at Screening and Enrollment (per applicable algorithm in Appendix II of the protocol) and willing to receive results
  • In general good health at Screening and Enrollment, as determined by the site Investigator of Record (IoR) or designee
  • At Screening, participant states willingness to abstain from receptive sexual activity (including penile-vaginal intercourse, anal intercourse, receptive oral intercourse, finger stimulation, and the use of sex toys) for the 5 days prior to the Enrollment Visit and for the duration of study participation
  • Per participant report, using an effective method of contraception at Enrollment, and intending to continue the use of an effective method for the duration of study participation. Effective methods for MTN-027 include: hormonal methods (except contraceptive IVRs), intrauterine device (IUD) inserted at least 28 days prior to enrollment, engages in sex exclusively with women, sterilized (self or partner), and/or sexually abstinent for the past 90 days.
  • Women over the age of 21 (inclusive) must have documentation of a satisfactory Pap within the past 3 years prior to Enrollment consistent with Grade 0 according to the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 1.0, December 2004 (Clarification dated August 2009), or satisfactory evaluation with no treatment required of Grade 1 or higher Pap result
  • Per participant report at Screening and Enrollment, agrees not to participate in other research studies involving drugs, medical devices, or vaginal products for the duration of study participation
  • Per participant report at Screening, regular menstrual cycles with at least 21 days between menses. Note: This criterion is not applicable to participants who report using a progestin-only method of contraception at Screening, e.g., Depo-Provera or levonorgestrel-releasing IUD nor to participants using continuous combination oral contraceptive pills, as the absence of regular menstrual cycles is an expected, normal consequence in this context.
  • At Screening, participant states a willingness to refrain from inserting any non-study vaginal products or objects into the vagina, including, but not limited to, spermicides, female condoms, diaphragms, contraceptive IVRs, vaginal medications, menstrual cups, cervical caps (or any other vaginal barrier method), douches, lubricants, sex toys (vibrators, dildos, etc.) for the 5 days prior to Enrollment and for the duration of their study participation

You may not qualify if:

  • Participant report of any of the following at Screening and/or Enrollment:
  • History of adverse reactions to any of the components of the study products
  • Non-therapeutic injection drug use in the 12 months prior to Screening and Enrollment
  • Post-exposure prophylaxis (PEP) for HIV exposure within 6 months prior to Enrollment
  • Pre-exposure prophylaxis (PrEP) for HIV prevention within the 6 months prior to Enrollment
  • Regular use and/or anticipated regular use during the period of study participation of CYP3A inducer(s) and/or inhibitor(s)
  • Use and/or anticipated use during the period of study participation of female-to-male transition therapy
  • Chronic and/or recurrent candidiasis
  • Gonorrhea, chlamydia, and/or syphilis diagnosis in the 6 months prior to Enrollment
  • Last pregnancy outcome 90 days or less prior to Screening
  • Currently breastfeeding
  • Has had a hysterectomy
  • Intends to become pregnant within the next 3 months
  • Has plans to relocate away from the study site area in the next 3 months
  • Current sexual partner is known to be HIV-positive
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alabama CRS

Birmingham, Alabama, 35294, United States

Location

University of Pittsburgh CRS

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Hoesley CJ, Chen BA, Anderson PL, Dezzutti CS, Strizki J, Sprinkle C, Heard F, Bauermeister J, Hall W, Jacobson C, Berthiaume J, Mayo A, Gundacker H, Richardson-Harman N, Piper J; Microbicide Trials Network 027 Study Team. Phase 1 Safety and Pharmacokinetics Study of MK-2048/Vicriviroc (MK-4176)/MK-2048A Intravaginal Rings. Clin Infect Dis. 2019 Mar 19;68(7):1136-1143. doi: 10.1093/cid/ciy653.

    PMID: 30289435DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Craig Hoesley, MD

    University of Alabama at Birmingham

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2015

First Posted

February 5, 2015

Study Start

May 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

October 25, 2021

Record last verified: 2016-03

Locations

US(2)