Phase 2a Study of Dapivirine Ring in Adolescent Females

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Microbicide Trials Network
National Institutes of Health (NIH)
Information provided by (Responsible Party):
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT02028338
First received: January 2, 2014
Last updated: August 24, 2016
Last verified: September 2015
  Purpose
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 12 weeks of study product use

Condition Intervention Phase
Human Immunodeficiency Virus
Device: placebo ring
Drug: dapivirine ring
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Phae 2A Study of a Vaginal Ring Containing Dapivirine in Adolescent Females

Resource links provided by NLM:


Further study details as provided by International Partnership for Microbicides, Inc.:

Primary Outcome Measures:
  • Grade 2 AEs judged to be related to study product, Grade 3 or higher AEs [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 96
Study Start Date: March 2014
Estimated Study Completion Date: August 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dapivirine ring
dapivirine vaginal ring (25 mg)
Drug: dapivirine ring
intravaginal ring silicone elastomer intravaginal ring containing no drug product
Placebo Comparator: Placebo ring
silicone vaginal ring
Device: placebo ring
intravaginal ring silicone elastomer intravaginal ring containing no drug product

Detailed Description:

MTN-023/IPM 030 is a Phase 2a, two-arm, placebo-controlled, double-blinded, multi-site, randomized trial of dapivirine vaginal ring (VR) versus placebo VR. The clinical trial is designed to assess the safety of dapivirine (25 mg) administered via a silicone vaginal ring (primary objective) and evaluate the acceptability of the dapivirine or placebo VR in sexually experienced, HIV-uninfected adolescent females, when inserted once every 4 weeks during 12 weeks of study product use.

Approximately 96 participants will be randomized in a 3:1 ratio to receive either a silicone elastomer vaginal ring containing 25 mg of dapivirine or a placebo VR. The ring will be replaced every 4 weeks during the 12 week study product use period.

Use of a VR to provide sustained delivery of microbicides is a novel investigational method for prevention of heterosexual transmission of HIV in women. This drug delivery method may circumvent potential difficulties related to adherence to daily or coitally-dependent uses of microbicide regimens.

  Eligibility

Ages Eligible for Study:   15 Years to 17 Years   (Child)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 15 through 17 years (inclusive) at Enrollment, verified per site SOPs
  2. 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
  3. Able and willing to provide adequate locator information, as defined in site SOPs
  4. Able to communicate in spoken and written English
  5. Able and willing to comply with all study procedural requirements
  6. 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
  7. In general good health as determined by the Investigator of Record (IoR)/designee at Screening and Enrollment
  8. Assessment of onset and progression of puberty, as measured by Tanner stage 4 or 5 at Screening, per participant report and/or clinician assessment
  9. HIV-uninfected based on testing performed at Screening and Enrollment (per protocol algorithm in Appendix II)
  10. Per participant report at Screening, history of sexual intercourse (at least one episode in participant's lifetime)
  11. Per participant report at Screening and Enrollment, agrees to use condoms for sexual intercourse
  12. Negative pregnancy test at Screening and Enrollment
  13. 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)
    • sterilization (of participant, as defined in site SOPs)
  14. At Screening and Enrollment, participant states a willingness to refrain from inserting the following vaginal products and/or objects into the vagina; spermicides, diaphragms, contraceptive vaginal rings, menstrual cups, cervical caps (or any other vaginal barrier method), douches, lubricants, for the 5 days prior to Enrollment throughout the duration of study participation. Note: Neither the use of tampons or sex toys, nor participant engagement in coitus is restricted.
  15. At Screening and Enrollment, agrees not to participate in other research studies involving drugs, medical devices, vaginal products, or vaccines for the duration of study participation, unless approved by the PSRT

Exclusion Criteria:

  1. Per participant report at Screening, intends to do any of the following during the study participation period:

    1. become pregnant
    2. relocate away from the study site
    3. travel away from the study site for more than 4 consecutive weeks
  2. 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.
  3. 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)
  4. At Enrollment, has a clinically apparent Grade 2 or higher pelvic exam finding (observed by study staff)** Note: Cervical bleeding associated with speculum insertion and/or specimen collection judged to be within the range of normal according to the clinical judgment of the IoR/designee is considered expected non-menstrual bleeding and is not exclusionary. Note: Otherwise eligible participants with exclusionary pelvic exam findings may be enrolled/randomized after the findings have improved to a non-exclusionary severity grading or resolved. If improvement to a non-exclusionary grade or resolution is documented within 56 days of providing informed consent for screening, the participant may be enrolled.
  5. Participant report and/or clinical evidence of any of the following:

    1. Known adverse reaction to any of the study products (ever)
    2. Known HIV-infected partner
    3. Non-therapeutic injection drug use in the 12 months prior to Screening
    4. The use of HIV Post-exposure prophylaxis (PEP) and/or Pre-exposure prophylaxis (PrEP) within the 6 months prior to Enrollment
    5. Currently breastfeeding
    6. Last pregnancy outcome within 90 days or less of Screening
    7. Participation in any other research study involving drugs, medical devices, vaginal products, or vaccines, within 60 days of Screening
    8. Participant report of 3 or more penile-vaginal sexual partners in the month prior to Screening
    9. At Enrollment, as determined by the IoR/designee, has any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease
  6. Has any of the following Grade 1 or higher* laboratory abnormalities at Screening Visit:

    1. Aspartate aminotransferase (AST) or alanine transaminase (ALT)
    2. Creatinine
    3. Hemoglobin
    4. Platelet count Note: Otherwise eligible participants with an exclusionary test may be re-tested during the screening process. Please see the MTN-023/IPM 030 SSP for additional details.
  7. Has any other condition that, in the opinion of the IoR/designee, would preclude informed assent/consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

    • Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009) **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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02028338

Locations
United States, Alabama
Alabama CRS 84519th street south, BBRB 203A
Birmingham, Alabama, United States, 35294-2170
United States, Colorado
The university of Colorado, 13123 E. 16th Ave., Box 025
Aurora, Colorado, United States, 80045
The University of Colorado; 13123 E. 16th Ave., Box 025
Aurora, Colorado, United States, 80045
United States, Massachusetts
The Fenway Institute, 1340 Boylston Street
Boston, Massachusetts, United States, 02215
The Fenway Institute; 1340 Boylston Street
Boston, Massachusetts, United States, 02215
United States, New York
Montefiore Medical Center, 3514 Wayne Ave
Bronx, New York, United States, 104467
Montefiore Medical Center; 3514 Wayne Ave
Bronx, New York, United States, 10467
United States, Pennsylvania
University of Pittsburgh CRS, 3601 fifth Ave, Room 737
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsburgh CRS, 3601 Fifth Avenue, Room 737; Falk Medical Building,
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
St. Jude Children's Research Hospital 262 Danny Thomas PL.
Memphis, Tennessee, United States, 38105
St. Jude Children's Research Hospital; 262 Danny Thomas Pl.
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Microbicide Trials Network
National Institutes of Health (NIH)
  More Information

Responsible Party: International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier: NCT02028338     History of Changes
Other Study ID Numbers: MTN-023/IPM 030  11927 
Study First Received: January 2, 2014
Last Updated: August 24, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 24, 2016