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

Population Council

Status and phase

Completed

Phase 1

Conditions

HIV

Treatments

Drug: HEC gel

Drug: PC-1005

Study type

Interventional

Funder types

Other

Identifiers

NCT02033109

Population Council #558

Details and patient eligibility

About

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.

Full 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.

Enrollment

35 patients

Sex

Female

Ages

19 to 49 years old

Volunteers

Accepts Healthy Volunteers

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