NCT02028338

Brief Summary

To assess the safety of dapivirine (25 mg) administered via a silicone vaginal ring in HIV-uninfected adolescent females, when inserted once every 4 weeks during 24-week of study product use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2014

Typical duration for phase_2

Geographic Reach
1 country

11 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

January 2, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

June 27, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2016

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2018

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

October 24, 2022

Completed
Last Updated

October 24, 2022

Status Verified

June 1, 2022

Enrollment Period

2 years

First QC Date

January 2, 2014

Results QC Date

June 30, 2022

Last Update Submit

September 26, 2022

Conditions

Human Immunodeficiency Virus

Keywords

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

  • The Safety of Dapivirine (25 mg) Administered Via a Silicone Vaginal Ring in HIV-uninfected Adolescent Females, When Inserted Once Every 4 Weeks During 24 Weeks of Study Product Use

    Grade 2 AEs as defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December 2004 (Clarification dated August 2009), Addendum 1 (Female Genital Grading Table for Use in Microbicide Studies) judged to be related to IP. Grade 3 or higher AEs as defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December 2004 (Clarification dated August 2009).

    6 months

Secondary Outcomes (4)

  • The Acceptability of the Study VR (Dapivirine or Placebo) in HIV Uninfected Adolescent Females, When Inserted Once Every 4 Weeks for a 24 Week Period

    6 months

  • Adherence to the Study VR (Dapivirine or Placebo) in HIV Uninfected Adolescent Females, When Inserted Once Every 4 Weeks for a 24 Week Period

    6 months

  • The Systemic Dapivirine Exposure

    6 months

  • Local Dapivirine Exposure

    6 months

Study Arms (2)

Dapivirine ring

EXPERIMENTAL

dapivirine vaginal ring (25 mg)

Combination Product: dapivirine ring

Placebo ring

PLACEBO COMPARATOR

silicone vaginal ring

Combination Product: placebo ring

Interventions

placebo ringCOMBINATION_PRODUCT

intravaginal ring silicone elastomer intravaginal ring containing no drug product

Placebo ring
dapivirine ringCOMBINATION_PRODUCT

intravaginal ring silicone elastomer intravaginal ring containing 25 mg dapivirine

Dapivirine ring

Eligibility Criteria

Age15 Years - 17 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age 15 through 17 years (inclusive) at Enrollment, verified per site SOPs
  • Able and willing to provide written informed assent/consent and able to obtain written parental or guardian permission (as specified in site SOP) to be screened for and to enroll in MTN-023/IPM 030
  • Able and willing to provide adequate locator information, as defined in site SOPs
  • Able to communicate in spoken and written English
  • Able and willing to comply with all study procedural requirements
  • Per participant report at Screening and Enrollment, willing to abstain from inserting anything into the vagina for 72 hours prior to each follow-up visit, including abstaining from penile-vaginal intercourse. Note: In the event the vaginal ring has been expelled and requires reinsertion, repositioning the vaginal ring is permitted
  • In general good health as determined by the Investigator of Record (IoR)/designee at Screening and Enrollment
  • Assessment of onset and progression of puberty, as measured by Tanner stage 4 or 5 at Screening, per participant report and/or clinician assessment
  • HIV-uninfected based on testing performed at Screening and Enrollment (per protocol algorithm in Appendix II)
  • Per participant report at Screening, history of sexual intercourse (at least one episode in participant's lifetime)
  • Per participant report at Screening and Enrollment, agrees to use condoms for sexual intercourse
  • Negative pregnancy test at Screening and Enrollment
  • Per participant report, using an effective method of contraception for at least 30 days (inclusive) prior to Enrollment, and intending to continue use of an effective method for the duration of study participation; effective methods include:
  • hormonal methods (except contraceptive ring)
  • intrauterine device (IUD)
  • +3 more criteria

You may not qualify if:

  • Per participant report at Screening, intends to do any of the following during the study participation period:
  • become pregnant
  • relocate away from the study site
  • travel away from the study site for more than 4 consecutive weeks
  • Diagnosed with a urinary tract infection (UTI) and/or reproductive tract infection (RTI) at Screening and/or Enrollment. Note: Otherwise eligible participants diagnosed with UTI during Screening will be offered treatment and may be enrolled after completing treatment and all symptoms have resolved. If treatment is completed and symptoms have resolved within 56 days of obtaining informed consent for Screening, the participant may be enrolled.
  • Diagnosed with pelvic inflammatory disease and/or an sexually transmitted infection (STI) requiring treatment per current Centers for Disease Control and Prevention (CDC) guidelines within 60 days of Enrollment (inclusive)
  • Participant report and/or clinical evidence of any of the following:
  • Known adverse reaction to any of the study products (ever)
  • Known HIV-infected partner
  • Non-therapeutic injection drug use in the 12 months prior to Screening
  • The use of HIV Post-exposure prophylaxis (PEP) and/or Pre-exposure prophylaxis (PrEP) within the 6 months prior to Enrollment
  • Currently breastfeeding
  • Last pregnancy outcome within 90 days or less of Screening
  • Participation in any other research study involving drugs, medical devices, vaginal products, or vaccines, within 60 days of Screening
  • Participant report of 3 or more penile-vaginal sexual partners in the month prior to Screening
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Alabama CRS 84519th street south, BBRB 203A

Birmingham, Alabama, 35294-2170, United States

Location

The university of Colorado, 13123 E. 16th Ave., Box 025

Aurora, Colorado, 80045, United States

Location

The University of Colorado; 13123 E. 16th Ave., Box 025

Aurora, Colorado, 80045, United States

Location

The Fenway Institute, 1340 Boylston Street

Boston, Massachusetts, 02215, United States

Location

The Fenway Institute; 1340 Boylston Street

Boston, Massachusetts, 02215, United States

Location

Montefiore Medical Center, 3514 Wayne Ave

The Bronx, New York, 104467, United States

Location

Montefiore Medical Center; 3514 Wayne Ave

The Bronx, New York, 10467, United States

Location

University of Pittsburgh CRS, 3601 fifth Ave, Room 737

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh CRS, 3601 Fifth Avenue, Room 737; Falk Medical Building,

Pittsburgh, Pennsylvania, 15213, United States

Location

St. Jude Children's Research Hospital 262 Danny Thomas PL.

Memphis, Tennessee, 38105, United States

Location

St. Jude Children's Research Hospital; 262 Danny Thomas Pl.

Memphis, Tennessee, 38105, United States

Location

Related Publications (1)

  • Bunge KE, Levy L, Szydlo DW, Zhang J, Gaur AH, Reirden D, Mayer KH, Futterman D, Hoesley C, Hillier SL, Marzinke MA, Hendrix CW, Gorbach PM, Wilson CM, Soto-Torres L, Kapogiannis B, Nel A, Squires KE; MTN-023/IPM 030 Study Team. Brief Report: Phase IIa Safety Study of a Vaginal Ring Containing Dapivirine in Adolescent Young Women. J Acquir Immune Defic Syndr. 2020 Feb 1;83(2):135-139. doi: 10.1097/QAI.0000000000002244.

    PMID: 31929401DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr John Steytler
Organization
International Partnership for Microbicides
jsteytler@ipmglobal.org

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2014

First Posted

January 7, 2014

Study Start

June 27, 2014

Primary Completion

July 5, 2016

Study Completion

June 8, 2018

Last Updated

October 24, 2022

Results First Posted

October 24, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(11)