Safety, Pharmacokinetics and Acceptability of PC-1005 for Vaginal Use

NCT02033109 | Completed Phase 1 DMC

• 1 other identifier: Population Council #558
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase 1 clinical trial will evaluate MIV-150, a third generation non-nucleoside reverse transcriptase inhibitor, co-formulated with a potentially potent agent, zinc acetate for the prevention of HIV infection in women. This is the first in-human of PC-1005 (MIV-150/zinc acetate in a carrageenan gel), the first study in which females will be exposed to MIV-150, the first time MIV-150 will be administered topically, and the first time MIV-150 will be administered intravaginally.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Safety: adverse events, serious adverse events, physical exams, and clinical laboratory parameters

  * Number and percent of participants with treatment emergent adverse events and adverse events, and medical significance of adverse events and serious adverse events * Number, percent and medical significance of abnormalities in physical exams, pelvic exams, and biopsies once product has been administered * Number, percent and medical significance of abnormalities in clinical laboratory parameters once product has been administered

  5 weeks for safety run-in study; 7 weeks for main study

Secondary Outcomes (1)

• Assessment of acceptability and adherence of PC-1005 use in seronegative women (main study only)

  14 days

Other Outcomes (4)

• Exploratory: pharmacodynamics and immune mediators

  Day 1 (baseline, both run-in and main); Day 14 (post-dose, main study only)

• Exploratory: MIV-150 and zinc levels in cervical tissue biopsies (main study only)

  Day 14 (post-dose)

• Exploratory: dye stain assay analysis

  Post-dose

Study Arms (2)

PC-1005

EXPERIMENTAL

* 4.00 g dosed once daily for 3 days (safety run-in) * 4.00 g dosed once daily for 14 days (main study)

Drug: PC-1005

HEC gel

PLACEBO COMPARATOR

4.00 g dosed once daily for 14 days (main study only)

Drug: HEC gel

Interventions

PC-1005 DRUG

Intravaginal use

Also known as: MIV-150/zinc acetate in a carrageenan gel

PC-1005

HEC gel DRUG

Also known as: hydroxyethylcellulose gel, placebo gel

HEC gel

Eligibility Criteria

• Age: 19 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Population Council: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Study Officials

• Craig J Hoesley, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• George W Creasy, MD

  Population Council

  STUDY CHAIR

• Barbara Friedland, MPH

  Population Council

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 10, 2014
• Study Start: May 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 15, 2017

Record last verified: 2017-08

Locations

US (1)