Relative Bioavailability Trial of Dapivirine Ring-004 and Ring-008

Last updated: July 2, 2024
Sponsor: International Partnership for Microbicides, Inc.
Overall Status: Completed

Phase

1

Condition

Hiv Infections

Treatment

dapivirine

Clinical Study ID

NCT05416021
IPM 054
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study Summary

A Phase I, Open-Label, Randomized, Crossover Trial to Investigate the Relative Bioavailability of the 25 mg Dapivirine Vaginal Ring-004 inserted every 30 days and 100 mg Dapivirine Vaginal Ring-008 inserted for 90 days in Healthy Female Participants

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Assigned female sex at birth per participant report*

  2. Age 18 through 45 years (inclusive) at Screening, verified by nationalidentification book/card

  3. Able and willing to provide written informed consent to be screened for and enrolledin IPM 054

  4. Able and willing to provide adequate locator information for trial retentionpurposes and be reachable per local standard procedures, eg, by home visit ortelephone, or via family or close neighbour contacts (confidentiality to bemaintained)

  5. Able to complete a diary card

  6. Available for all visits and able and willing to comply with all trial proceduralrequirements

  7. Willing to comply with abstinence and other protocol requirements

  8. Willing to use male condoms for penile-vaginal intercourse and penile-rectalintercourse for the duration of trial participation

  9. Per participant report; using an effective method of contraception for at least 30days (inclusive) prior to Enrolment, and intending to continue use of an effectivemethod for the duration of trial participation; effective methods include:

  10. hormonal methods (except a contraceptive ring)

  11. intrauterine device (IUD); with no vaginal or gynaecological complaintsassociated with its use prior to enrolment

  12. sterilisation of participant at least 3 months prior to enrolment Note: Womennot at risk of becoming pregnant by virtue of having had a partial hysterectomyor having sex exclusively with cisgender women may be enrolled.

  13. In general good health as determined by the Investigator/designee at Screening andEnrolment

  14. Human Immunodeficiency Virus (HIV)-negative as determined by an HIV test at the timeof screening and enrolment

  15. Per participant report at Screening, regular menstrual cycles with at least 21 daysbetween menses

  16. Per participant report at Screening and Enrolment, states a willingness to refrainfrom inserting any non-trial vaginal products or objects into the vagina including,but not limited to tampons, spermicides, female condoms, diaphragms, intravaginalrings, vaginal medications, menstrual cups, cervical caps, douches, lubricants, andsex toys (vibrators, dildos, etc.) for the duration of trial participation

  17. Upon pelvic examination (using a speculum) at the time of Enrolment, the cervix andvagina appear normal as determined by the Investigator/Physician

  18. Willing to refrain from participation in any other research trial for the durationof this trial

Exclusion

Exclusion Criteria:

  1. Pregnant at Screening or Enrolment or plans to become pregnant during the trialperiod* 2) Diagnosed with a urinary tract infection (UTI) or reproductive tractinfection (RTI) at Screening or Enrolment based on clinical assessment* 3)Diagnosed with an acute sexually transmitted infection (STI) requiringtreatment per current local guidelines at Screening such as gonorrhoea (GC),chlamydia trachomatis (CT), trichomonas, and/or syphilis* 4) Has an abnormalcytology finding at screening or clinically apparent Grade 1 or higher pelvicexamination finding (observed by trial staff) at Screening or Enrolment, as perthe DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events,Version 2.1, March 2017, and/or Addendum (Female Genital Grading Table for Usein Microbicide Studies [Dated November 2007])* 5) Participant report and/orclinical evidence of any of the following:*
  1. Known adverse reaction to any of the trial products (ever)

  2. Chronic and/or recurrent vaginal candidiasis

  3. Misuse of legal and illegal medication or substances in the 12 months prior toEnrolment

  4. Last pregnancy outcome less than 90 days prior to Enrolment

  5. Gynaecologic or genital procedure (eg, tubal ligation, dilation and curettage,piercing) 45 days or less prior to Enrolment Note: Colposcopy and cervicalbiopsies for evaluation of an abnormal Pap test as well as IUDinsertion/removal are not exclusionary.

  6. Currently breastfeeding or planning to breastfeed during the trial period

  7. Participation in any other research trial involving drugs, medical devices,vaginal products or vaccines, in the 60 days prior to Enrolment 6) Completeduse of oral pre-exposure prophylaxis (PrEP) for HIV prevention and/orpost-exposure prophylaxis (PEP) for potential HIV exposure within one monthprior to screening, and/or anticipated use and/or unwillingness to abstain fromPrEP during trial participation 7) Has any Grade 1 or higher laboratoryabnormalities at the Screening Visit 8) Participant has a positive test forHepatitis B surface antigen (HBsAg) or is Hepatitis C virus antibody (HCV-Ab)positive 9) Participant has a positive urine drug test or a positive alcoholbreath test.

  1. Has any other condition that, in the opinion of the Investigator, wouldpreclude informed consent, make trial participation unsafe, complicate theinterpretation of trial outcome data, or otherwise interfere withachieving the trial objectives including any significant uncontrolledactive or chronic medical condition 11) Has plans to relocate away fromthe trial site area after starting the trial and unable to return fortrial visits

Study Design

Total Participants: 124
Treatment Group(s): 1
Primary Treatment: dapivirine
Phase: 1
Study Start date:
August 01, 2022
Estimated Completion Date:
July 02, 2024

Study Description

IPM 054 is a Phase I, open-label, randomized, crossover trial to determine the relative bioavailability in plasma and vaginal fluid of two formulations of the dapivirine vaginal ring in HIV-negative women. The trial will compare the dapivirine concentrations achieved in plasma and vaginal fluid over all timepoints for each 90-day use period in a two-period, two-sequence, crossover design.

Participants will be randomized to one of two treatment sequences (AB or BA). During two consecutive 90-day treatment periods, the participants will receive each of the following treatments according to their assigned treatment sequence. The treatment periods will be separated by a 28-day washout period.

Treatment Sequence 1:

• 25 mg dapivirine ring (Ring-004) for 90 days (replaced every 30 days) (Treatment A), followed by the 100 mg dapivirine ring (Ring-008) used continuously for 90 days (Treatment B)

Treatment Sequence 2:

• 100 mg dapivirine ring (Ring-008) used continuously for 90 days (Treatment B), followed by the 25 mg dapivirine ring (Ring-004) for 90 days (replaced every 30 days) (Treatment A)

Connect with a study center

  • FARMOVS

    Bloemfontein,
    South Africa

    Site Not Available

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