HIV/AIDSNCT03218085
Role of Exogenous and Endogenous Sex Hormones on Tenofovir and Emtricitabine Disposition in Female Genital Tract
An observational study of HIV/AIDS and Menopause, run by University of Minnesota at 1 site in United States.
Trial summary
Cervical biopsies will be collected from women aged 18 and over whom are virally suppressed and taking tenofovir as part of their antiretroviral therapy regimen. Blood plasma, peripheral blood mononuclear cells (PBMC), and cervicovaginal swabs will also be collected. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV/AIDS, Menopause, Inflammation Vagina
- What is being tested?
- Tenofovir and Emtricitabine
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2017to 15 Feb 2024
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 1. Currently pregnant or previous pregnancy within 3 months of enrollment 2. Currently breast feeding 3. Symptomatic vaginal infection within 2 weeks prior to enrollment 4. Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior to enrollment 5. Use of oral and/or vaginal preparations of antibiotic or antifungal medications within 30 days prior to the enrollment visit
Who may be able to join
- Female, or transgender female with a cervix, age 18 years or older
- HIV-positive
- Stable on antiretroviral regimen containing tenofovir or emtricitabine for at least 2 weeks at time of enrollment.
- Virally suppressed (HIV-RNA copies <50 copies/mL) for at least 6 months at time of enrollment.
- Willing to refrain from vaginal intercourse and use of vaginal devices such as douches and sex toys within 72 hours of the biopsy visit.
- Willing and able to give signed informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Role of Exogenous and Endogenous Sex Hormones on Tenofovir and Emtricitabine
Cervical biopsies will be collected from women aged 18 and over whom are virally suppressed and taking tenofovir as part of their antiretroviral therapy regimen. Blood plasma, peripheral blood mononuclear cells (PBMC), and cervicovaginal swabs will also be collected. Drug concentrations, hormone concentrations, inflammatory cytokines, and vaginal microbiome will be evaluated to understand the role of hormones, inflammation, and the microbiome in modulating drug efficacy in the female genital tract.
- Conditions
- HIV/AIDS, Menopause, Inflammation Vagina
- Being tested
- Tenofovir, Emtricitabine
- Keywords
- tenofovir, prevention, microbiome, cervicovaginal, biopsy, swab, cytokines, inflammation, pharmacology
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Vaginitis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenofovirDrug
Two cervical biopsies, blood plasma, PBMC, and two cervicovaginal swabs will be collected at a single study visit
EmtricitabineDrug
Two cervical biopsies, blood plasma, PBMC, and two cervicovaginal swabs will be collected at a single study visit
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the influence of exogenous and endogenous sex hormones on tenofovir and emtricitabine concentrations in cervical tissues
Measured: Day 1
Secondary outcomes (5)
To assess the influence of endogenous and exogenous sex hormones on the expression of drug metabolizing enzymes and transporters in cervical tissue
Measured: Day 1
To determine the influence of endogenous and exogenous sex hormones on the endogenous nucleotide pool in cervical tissues
Measured: Day 1
To discriminate between local and systemic effects of hormonal use on antiretroviral disposition.
Measured: Day 1
To determine relationship between local inflammation and drug disposition in the female genital tract
Measured: Day 1
To identify potential role of the vaginal microbiome in local drug disposition,
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start14 Jul 2017
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Clinical Pharmacy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218085
- Sponsor's protocol ID
- PHARM-2016-24820
- Status last verified
- Apr 2024
- First submitted
- 10 Jul 2017
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Exogenous and Endogenous Sex Hormones on Tenofovir and Emtricitabine
- ClinicalTrials.gov ID
- NCT03218085
- Acronym / sponsor ID
- PHARM-2016-24820
- Conditions
- HIV/AIDS, Menopause, Inflammation Vagina
- Keywords
- tenofovir, prevention, microbiome, cervicovaginal, biopsy, swab, cytokines, inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- American College of Clinical Pharmacy
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 14 Jul 2017 (actual)
- 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.
Cervical biopsies will be collected from women aged 18 and over whom are virally suppressed and taking tenofovir as part of their antiretroviral therapy regimen. Blood plasma, peripheral blood mononuclear cells (PBMC), and cervicovaginal swabs will also be collected. Drug concentrations, hormone concentrations, inflammatory cytokines, and vaginal microbiome will be evaluated to understand the role of hormones, inflammation, and the microbiome in modulating drug efficacy in the female genital tract.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Currently pregnant or previous pregnancy within 3 months of enrollment 2. Currently breast feeding 3. Symptomatic vaginal infection within 2 weeks prior to enrollment 4. Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior to enrollment 5. Use of oral and/or vaginal preparations of antibiotic or antifungal medications within 30 days prior to the enrollment visit
Key inclusion criteria (6 listed)
- Female, or transgender female with a cervix, age 18 years or older
- HIV-positive
- Stable on antiretroviral regimen containing tenofovir or emtricitabine for at least 2 weeks at time of enrollment.
- Virally suppressed (HIV-RNA copies <50 copies/mL) for at least 6 months at time of enrollment.
- Willing to refrain from vaginal intercourse and use of vaginal devices such as douches and sex toys within 72 hours of the biopsy visit.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| TenofovirTwo cervical biopsies, blood plasma, PBMC, and two cervicovaginal swabs will be collected at a single study visit | Drug | – |
| EmtricitabineTwo cervical biopsies, blood plasma, PBMC, and two cervicovaginal swabs will be collected at a single study visit | Drug | – |
Primary outcome
Assess the influence of exogenous and endogenous sex hormones on tenofovir and emtricitabine concentrations in cervical tissues
Time frame: Day 1
5 secondary outcomes
To assess the influence of endogenous and exogenous sex hormones on the expression of drug metabolizing enzymes and transporters in cervical tissue
Time frame: Day 1
To determine the influence of endogenous and exogenous sex hormones on the endogenous nucleotide pool in cervical tissues
Time frame: Day 1
To discriminate between local and systemic effects of hormonal use on antiretroviral disposition.
Time frame: Day 1
To determine relationship between local inflammation and drug disposition in the female genital tract
Time frame: Day 1
To identify potential role of the vaginal microbiome in local drug disposition,
Time frame: Day 1
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 16 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS and Menopause, run by University of Minnesota 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 6 inclusion and 0 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 16 Apr 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Assess the influence of exogenous and endogenous sex hormones on tenofovir and emtricitabine concentrations in cervical tissues (time frame: Day 1). 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 16 Apr 2024.