- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02033109
Safety, Pharmacokinetics and Acceptability of PC-1005 for Vaginal Use
A Phase 1, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Acceptability of PC-1005 Microbicide Gel Formulation in HIV-seronegative Women
Study Overview
Detailed Description
This study will begin with a safety run-in, which is an open label, single-arm safety run-in with 5 women receiving PC-1005 once daily for 3 consecutive days. Safety and pharmacokinetics will take place after each dose. the participants from the run-in will not be eligible for the main study.
The main study participants will be randomized 4:1 to the study gels: 24 randomized to PC-1005 (active) and 6 randomized to HEC gel (placebo). The study product will be applied vaginally once daily for 14 days with clinical and laboratory assessments at baseline (enrollment) and after the 1st, 2nd, 8th, 9th, and 14th doses, and a safety follow-up visit 7 days after the 14th dose.
Participants in the run-in and main study will be requested to be sexually abstinent starting immediately after the Screening Visit until study exit.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women between 19 and 49 years of age, inclusive
- Willing and able to provide written informed consent
- Healthy, based on medical history, vital signs, physical examination, urinalysis, laboratory evaluations for genital infections and laboratory evaluations for hematology, liver and renal function with a BMI ≥18 kg/m^2 and ≤32 kg/m^2
- HIV-negative as determined by HIV ELISA test at screening
- Hepatitis B and C negative at screening
- Rapid plasma reagin negative at screening
- If HSV-2 positive, must be free from outbreaks for at least 6 months prior to screening
- In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle, defined as having a minimum of 21 days and a maximum of 35 days between menses
- Normal Pap test at screening
- Agrees to use one form of effective contraception for the duration of the trial
- Willing to abstain from sexual intercourse/activity including receptive vaginal, oral, digital, and anal intercourse, and the use of any vaginal products including tampons, male and female condoms, contraceptive sponges, diaphragms, cervical caps, douches, lubricants, and vibrators/dildos starting from the Screening Visit through Study Exit
- Agrees to not participate in any other clinical research trial for the duration of this trial
Exclusion Criteria:
- History of or known sensitivity/allergy to any component of either study product
- Currently pregnant or breast-feeding, or within 3 months of last pregnancy outcome
- Participation in any other clinical research trial involving investigational or marketed products currently or within two months of participation prior to screening, including any trial of a spermicide, microbicide and/or drug
- Diagnosed with or treated for any STI (other than HSV) or pelvic inflammatory disease in the last 3 months
- Positive test for Neisseria gonorrhea, Chlamydia trachomatis, or Trichomonas vaginalis
- Symptomatic vulvovaginal candidiasis, bacterial vaginosis (BV), or urinary tract infection (UTI) at screening
- Presence of any clinically significant genital epithelial findings such as abrasions, ulcerations, lacerations, or vesicles suspicious for STIs at screening
- Presence of any other clinically significant abnormal physical finding on the vulva, vaginal walls or cervix at screening
- Any clinically significant abnormal hematology, chemistry or urinalysis findings at screening
- Any chronic (excluding HSV-2) or progressive disease (including any known history of cancer, diabetes, cardiac disease, autoimmune disease, blood dyscrasias, or Wilson's disease), or signs of cardiovascular disease, or renal failure, even controlled with medication
- History of hysterectomy or menopause
- Use of excluded contraceptive methods including Nuvaring®, condoms (male or female), contraceptive sponge, diaphragm, or cervical cap (Safety Run-in and Main study)
- History of gynecological surgery or procedure within past 2 months
- History of uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction within the last 3 months, including break-through bleeding requiring sanitary protection
- Known current drug abuse, including illicit drugs, or alcohol abuse
- Any other condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives
- Unable to comply with study requirements, including but not limited to, attending all study visits, using the gel as directed, observing abstinence throughout the study and use of effective contraceptives, limiting alcoholic beverages to 2 per day and caffeine to no more than 6 servings per day
- History of latex allergy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PC-1005
|
Intravaginal use
Other Names:
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Placebo Comparator: HEC gel
4.00 g dosed once daily for 14 days (main study only)
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety: adverse events, serious adverse events, physical exams, and clinical laboratory parameters
Time Frame: 5 weeks for safety run-in study; 7 weeks for main study
|
|
5 weeks for safety run-in study; 7 weeks for main study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of acceptability and adherence of PC-1005 use in seronegative women (main study only)
Time Frame: 14 days
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Questionnaire, self-report, and applicators returned empty
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14 days
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exploratory: pharmacodynamics and immune mediators
Time Frame: Day 1 (baseline, both run-in and main); Day 14 (post-dose, main study only)
|
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Day 1 (baseline, both run-in and main); Day 14 (post-dose, main study only)
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Exploratory: MIV-150 and zinc levels in cervical tissue biopsies (main study only)
Time Frame: Day 14 (post-dose)
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Additional cervical biopsy after the last dose
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Day 14 (post-dose)
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Exploratory: dye stain assay analysis
Time Frame: Post-dose
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Post-dose
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Exploratory: pharmacokinetics evaluation of zinc in resum
Time Frame: Days 1, 2 and 3 (run-in) / Days 1, 8 and 14 (main study)
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Days 1, 2 and 3 (run-in) / Days 1, 8 and 14 (main study)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Craig J Hoesley, MD, University of Alabama at Birmingham
- Study Chair: George W Creasy, MD, Population Council
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Population Council #558
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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