HIVPhase 1NCT02033109
Safety, Pharmacokinetics and Acceptability of PC-1005 for Vaginal Use
A Phase 1 study testing PC-1005 and HEC gel in people with HIV, run by Population Council at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- PC-1005 and HEC gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jun 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: 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
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.
Read the 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.
- Conditions
- HIV
- Being tested
- PC-1005, HEC gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC-1005Drug
Also called MIV-150/zinc acetate in a carrageenan gel
Intravaginal use
HEC gelDrug
Also called hydroxyethylcellulose gel, placebo gel
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: PC-1005 |
| HEC gel | Placebo comparator | 4.00 g dosed once daily for 14 days (main study only) Receives: Drug: HEC gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Questionnaire, self-report, and applicators returned empty
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startMay 2014
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Council
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Craig J Hoesley, MD, Principal investigator, University of Alabama at BirminghamGeorge W Creasy, MD, Study chair, Population CouncilBarbara Friedland, MPH, Study director, Population Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033109
- Sponsor's protocol ID
- Population Council #558
- Status last verified
- Aug 2017
- First submitted
- 8 Jan 2014
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02033109
- Acronym / sponsor ID
- Population Council #558
- Conditions
- HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Population CouncilUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PC-1005 | Experimental | Drug: PC-1005* 4.00 g dosed once daily for 3 days (safety run-in) * 4.00 g dosed once daily for 14 days (main study) |
| HEC gel | Placebo comparator | Drug: HEC gel4.00 g dosed once daily for 14 days (main study only) |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PC-1005Also: MIV-150/zinc acetate in a carrageenan gelIntravaginal use | Drug | PC-1005 |
| HEC gelAlso: hydroxyethylcellulose gel, placebo gel | Drug | HEC gel |
Primary outcome
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
* 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
1 secondary outcome
Assessment of acceptability and adherence of PC-1005 use in seronegative women (main study only)
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig J Hoesley, MD principal investigator
University of Alabama at Birmingham
George W Creasy, MD study chair
Population Council
Barbara Friedland, MPH study director
Population Council
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PC-1005 and HEC gel in people with HIV, run by Population Council at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2017.