Pharmacokinetic Study of the Dapivirine Vaginal Ring in Lactating Women

NCT02808949 | Completed Phase 1 DMC

• 1 other identifier: MTN-029/IPM 039
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1 PK Study of the Dapivirine Vaginal Ring in Lactating Women.

Conditions

Human Immunodeficiency Virus

Keywords

Prevention; Lactating Women; Healthy

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics

  To assess the pharmacokinetics of dapivirine vaginal ring used for 14 consecutive days in lactating women

  14 Days

Secondary Outcomes (2)

• Safety and Tolerability of dapivirine ring in lactating women

  14 days

• Adherence to dapivirine vaginal ring use in lactating women

  14 days

Study Arms (1)

Age Groups

EXPERIMENTAL

Dapivirine levels in breast milk will be measured in 16 participants. All participants will wear the Dapivirine Vaginal Ring for 14 consecutive days.

Drug: Dapivirine

Interventions

Dapivirine DRUG

Participants will receive a silicone elastomer vaginal matrix ring containing 25 mg of dapivirine to wear for approximately 14 continuous days. Participants age 18 and over, at least 6 weeks postpartum, able to produce and express breast milk for 14 consecutive days.

Also known as: Dapivirine vaginal ring

Age Groups

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 or older at screening as verified per site SOP
• Per participant report, at least 6 weeks postpartum at Enrollment
• Willing and able to provide written informed consent to be screened for and take part in the study
• Willing and able to provide adequate locator information, as defined in site SOP
• Willing and able to communicate in spoken and written English
• HIV-1/2 uninfected at Screening and Enrollment, per applicable algorithm in Appendix II and willing to receive HIV test results Note: HIV-1/2 screening may be omitted at Enrollment if the time between Screening and Enrollment is \< 30 days
• Prior to Enrollment, breastfeeding of child has stopped
• Willing and able to express breast milk at least twice daily for the duration of study drug exposure
• 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-029/IPM 039 include: hormonal methods (except contraceptive VRs), intrauterine device (IUD) inserted at least 28 days prior to enrollment, engages in sex exclusively with women, sterilized (self or partner), 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 the Severity of Adult and Pediatric Adverse Events, Version 1.0, November 2007), or satisfactory evaluation with no treatment required of Grade 1 or higher Pap result
• At Screening, participant states a willingness to refrain from receptive sexual activity (including penile-vaginal intercourse, anal intercourse, receptive oral intercourse, finger stimulation) and from inserting any non-study objects into the vagina (including tampons, sex toys, female condoms, diaphragms, menstrual cups, cervical caps or any other vaginal barrier method, etc.), for 24 hours prior to each clinic visit.
• At Screening, participant states a willingness to refrain from the use of vaginal products, including, spermicides, lubricants, contraceptive VRs, douches, vaginal medications, etc., for the duration of study participation

You may not qualify if:

• Women who meet any of the following criteria (by self-report, unless otherwise indicated) will be excluded from the study:
• Participant report of any of the following:
• History of adverse reaction to any component of dapivirine VR
• Participation in investigational drug or device trial within 30 days prior to the Enrollment Visit (Day 0)
• Use of vaginal medication(s) 5 days prior to Enrollment (Day 0)
• Complication of lactation requiring treatment, e.g., mastitis
• At the time of Screening and Enrollment, clinical evidence of milk supply less than 1 ounce per expression
• As determined by the IoR/designee, any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease
• Grade 2 or higher AST/ALT at Screening Visit:
• Positive urine pregnancy test at screening or enrollment
• Diagnosed with urinary tract infection (UTI) at Screening or Enrollment Note: Otherwise eligible participants diagnosed with UTI during screening are offered treatment and may be enrolled after completing treatment and all symptoms have resolved.
• Diagnosed with an STI or a reproductive tract infection (RTI) requiring treatment per current Centers for Disease Control and Prevention (CDC) guidelines at Screening or Enrollment
• On pelvic exam, any of the following findings:
• Incomplete postpartum involution of the uterus
• Clinically apparent Grade 2 or higher pelvic exam finding (observed by study staff)

Sponsors & Collaborators

• International Partnership for Microbicides, Inc.: lead

Study Sites (1)

Alabama CRS

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Noguchi LM, Hoesley C, Kelly C, Scheckter R, Bunge K, Nel A, Marzinke MA, Hendrix CW, Dezzutti CS, Hillier SL, Bogen DL, Piper JM, Beigi RH. Pharmacokinetics of Dapivirine Transfer into Blood Plasma, Breast Milk, and Cervicovaginal Fluid of Lactating Women Using the Dapivirine Vaginal Ring. Antimicrob Agents Chemother. 2019 Feb 26;63(3):e01930-18. doi: 10.1128/AAC.01930-18. Print 2019 Mar.

  PMID: 30602513 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Dapivirine

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Craig Hoesley, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: June 22, 2016
• Study Start: February 1, 2015
• Primary Completion: March 3, 2018
• Study Completion: March 3, 2018
• Last Updated: March 13, 2018

Record last verified: 2018-03

Locations

US (1)