Safety and Pharmacokinetic Trial in Healthy HIV-Negative Women to Assess the Delivery of Dapivirine From a Vaginal Ring

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02920827
• Date of registration: 29/09/2016
• Prospective Registration: No
• Primary sponsor: International Partnership for Microbicides, Inc.
• Public title: Safety and Pharmacokinetic Trial in Healthy HIV-Negative Women to Assess the Delivery of Dapivirine From a Vaginal Ring
• Scientific title: A Double-Blind, Randomised, Placebo-Controlled Safety and Pharmacokinetic Trial in Healthy HIV-Negative Women to Assess Delivery of Dapivirine From the Matrix Vaginal Ring Containing 25 MG of Dapivirine
• Date of first enrolment: August 2009
• Target sample size: 16
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02920827
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Belgium

Contacts

• Name: Annalene Nel, PhD
• Affiliation: IPM

Key inclusion & exclusion criteria

Inclusion Criteria:

- were females between 18 and 40 years of age, inclusive

- were willing and able to give written, informed consent

- were available for all visits and consented to follow all procedures scheduled for the
trial

- were healthy, based on medical history, vital signs, physical examination, urinalysis
(dipstick and microscopy), laboratory evaluations for genital infections (gonorrhea,
chlamydia and trichomonas), and laboratory evaluations for hematology and biochemistry

- were HIV-negative, as determined by an HIV test at screening

- were willing to abstain from sexual activity for the duration of the period of ring
use

- were on a stable form of contraception, defined as a stable oral contraceptive regimen
for at least two months prior to enrollment; OR a transdermal contraceptive patch for
at least three months prior to enrollment; OR long-acting progestins for at least six
months prior to enrollment; OR had an intra-uterine device (IUD) inserted (with no
vaginal or gynecological complaints associated with its use) at least three months
prior to enrollment; OR had undergone surgical sterilization at least three months
prior to enrollment; AND were willing to use oral contraceptives, if necessary, to
avoid menstruation while taking part in this trial

- were asymptomatic for genital infections at the time of enrollment, and the cervix and
vagina appeared normal upon pelvic examination and colposcopy, as determined by the
investigator

- were willing to refrain from the use of vaginal products or objects including, but not
limited to, tampons, cotton wool, rags, diaphragms, cervical caps (or any other
vaginal barrier method), douches, lubricants, vibrators/dildos, non-trial vaginal
rings and drying agents for 14 days prior to enrollment and for the duration of the
trial

- were willing to refrain from participation in any other research trial for the
duration of this trial

- were willing to provide adequate locator information for trial retention purposes and
were reachable per local standard procedures (e.g. by home visit or telephone, or via
family or close neighbor contacts (confidentiality was to be maintained))

- were hepatitis B and C negative at the time of screening.

Exclusion Criteria:

- had a history of anaphylaxis or severe allergy resulting in angioedema, or a history
of sensitivity/allergy to latex or silicone

- were pregnant or breast-feeding, or had their last pregnancy outcome within three
months prior to screening

- were participating in any other clinical research trial involving investigational or
marketed products at the time of this trial or within two months prior to screening

- had a history or diagnosis of and/or treatment for a sexually transmitted disease
within the previous three months

- had a history of genital tract surgery within the previous two months

- had a current diagnosis of sexually transmitted infections (STIs) (gonorrhea,
chlamydia and/or trichomonas)

- had current vulvar or vaginal symptoms/abnormalities that could influence the trial
results

- had a history of significant urogenital or uterine prolapse, undiagnosed vaginal
bleeding or urethral obstruction, incontinence or urge incontinence

- had symptomatic genital herpes simplex virus (HSV) infection or a history of genital
herpetic infection

- had current non-iatrogenic pelvic/colposcopic examination findings involving deep
epithelial disruption

- had any Grade 2, 3 or 4 hematology, biochemistry or urinalysis laboratory abnormality
at baseline (screening), according to the Division of Acquired Immunodeficiency
Syndrome (DAIDS) Table for Grading Adverse Events

- had a Pap test result at screening that required cryotherapy, biopsy, treatment (other
than for infection) or further evaluation; this included any findings of atypical
squamous cells of undetermined significance (ASCUS)

- had any condition(s) that, in the opinion of the investigator, could interfere with
adherence to trial requirements or evaluation of the trial objectives.



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Combination Product: Dapivirine Vaginal Ring

Combination Product: Placebo vaginal ring

Primary Outcome(s)

Safety: To assess the safety and tolerability of the dapivirine vaginal ring, the endpoint was the proportion of women on the dapivirine or placebo ring experiencing specific, protocol-defined safety events during the study (see description). [Time Frame: 28 days]

Pharmacokinetics: assessed by measurement of the concentrations of dapivirine in plasma and in vaginal fluids (collected by Tear Test Strips) before, during and after the trial period. [Time Frame: 28 days]

Secondary ID(s)

IPM024

Source(s) of Monetary Support

Please refer to primary and secondary sponsors