Phase 2
N=96
Study of Dapivirine Vaginal Ring (VR) in Adolescents
Human Immunodeficiency Virus
Bottom Line
View on ClinicalTrials.gov: NCT02028338 ↗Enrolled (actual)
96
Serious AEs
2.1%
Results posted
Oct 2022
Primary outcome: Primary: 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 — 8; 2; 3; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- placebo ring (Combination_product); dapivirine ring (Combination_product)
- Age
- Pediatric · 15+ yrs
- Sex
- Female
- Sponsor
- International Partnership for Microbicides, Inc.
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
8; 2; 3; 0 | — |
| SECONDARY 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 |
39; 12; 9; 1; 18; 7 | — |
| SECONDARY Adherence to the Study VR (Dapivirine or Placebo) in HIV Uninfected Adolescent Females, When Inserted Once Every 4 Weeks for a 24 Week Period |
29; 11 | — |
| SECONDARY The Systemic Dapivirine Exposure |
310.5; 255.5; 250.9; 243.1 | — |
| SECONDARY Local Dapivirine Exposure |
27.8; 45.0; 49.2; 51.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
- sterilization (of participant, as defined in site SOPs)
- 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.
- 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
- 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)
- 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
Data sourced from ClinicalTrials.gov (NCT02028338). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.