HIV/AIDSNCT03377608
Modifiers of Tenofovir in the Female Genital Tract
An observational study of HIV/AIDS and Contraception, run by University of Minnesota at 1 site in Uganda.
Trial summary
Two-armed, single visit, pharmacokinetic study to compare tenofovir diphosphate concentrations in cervical tissues of women on Depo-Provera contraception vs non-hormonal contraception. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- HIV/AIDS, Contraception
- What is being tested?
- Tenofovir Disoproxil Fumarate and Depo-Provera
- How many people
- 50 participants
- Where
- 1 siteUganda
- Study dates
- 17 Nov 2017to 2 Apr 2018
- 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 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Women will be recruited from an existing cohort.
Who may be able to join
- Female, or transgender female with a cervix, aged 18-35 years old
- HIV-positive
- Stable on antiretroviral regimen containing TDF 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
- Currently pregnant or previous pregnancy within 3 months of enrollment
- Currently breast feeding
- Symptomatic vaginal infection within 2 weeks prior to enrollment
- Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior to enrollment
- History of vulvar/vaginal/ cervical dysplasia, neoplasia or cancer, atypical squamous cells of undetermined significance, condyloma, or human papilloma virus (HPV) in the past year
- Use of oral and/or vaginal preparations of antibiotic or antifungal medications within 30 days prior to the enrollment visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modifiers of Tenofovir Exposure in the Female Genital Tract of African Women on Depo-provera
Two-armed, single visit, pharmacokinetic study to compare tenofovir diphosphate concentrations in cervical tissues of women on Depo-Provera contraception vs non-hormonal contraception.
- Conditions
- HIV/AIDS, Contraception
- Being tested
- Tenofovir Disoproxil Fumarate, Depo-Provera
- Keywords
- tenofovir, microbiome, inflammation
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Disoproxil FumarateDrug
Two cervical biopsies, blood plasma, PBMC, urine, and two cervicovaginal swabs will be collected at a single study visit
Depo-ProveraDrug
Two cervical biopsies, blood plasma, PBMC, urine, and two cervicovaginal swabs will be collected at a single study visit
| Study group | Role | What they receive |
|---|---|---|
| Depo-Provera | Not described Receives: Drug: Tenofovir Disoproxil Fumarate; Drug: Depo-Provera | |
| Non-hormonal contraception | Not described Receives: Drug: Tenofovir Disoproxil Fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Tissue Concentrations
Assess the influence of hormonal contraception on tenofovir concentrations in cervical tissues
Measured: Day 1
Secondary outcomes (3)
Proinflammatory cytokines
To determine relationship between local inflammation and drug disposition in the female genital tract
Measured: Day 1
Gene expression of drug metabolizing enzymes and transporters
To assess the influence of hormonal contraception on the expression of drug metabolizing enzymes and transporters in cervical tissue
Measured: Day 1
Vaginal microbiome
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 posted19 Dec 2017
- Study start17 Nov 2017
- Primary completion29 Mar 2018
- Study completion2 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- MU-JHU CARE
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377608
- Sponsor's protocol ID
- STUDY00000171
- Status last verified
- Apr 2018
- First submitted
- 8 Dec 2017
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nicol MR, Eneh P, Nakalega R, Kaiser T, Kabwigu S, Isingel E, Beksinska M, Sykes C, Fowler MG, Brown TT, Staley C, Kiweewa Matovu F. Depot Medroxyprogesterone Acetate and the Vaginal Microbiome as Modifiers of Tenofovir Diphosphate and Lamivudine Triphosphate Concentrations in the Female Genital Tract of Ugandan Women: Implications for Tenofovir Disoproxil Fumarate/Lamivudine in Preexposure Prophylaxis. Clin Infect Dis. 2020 Apr 10;70(8):1717-1724. doi: 10.1093/cid/ciz443.
PubMed 31131846
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifiers of Tenofovir Exposure in the Female Genital Tract of African Women on Depo-provera
- ClinicalTrials.gov ID
- NCT03377608
- Acronym / sponsor ID
- STUDY00000171
- Conditions
- HIV/AIDS, Contraception
- Keywords
- tenofovir, microbiome, inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- MU-JHU CARE
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 29 Mar 2018 (actual)
- Study completion
- 2 Apr 2018 (actual)
- First posted
- 19 Dec 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.
Two-armed, single visit, pharmacokinetic study to compare tenofovir diphosphate concentrations in cervical tissues of women on Depo-Provera contraception vs non-hormonal contraception.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depo-Provera | – | Drug: Tenofovir Disoproxil Fumarate, Drug: Depo-Provera |
| Non-hormonal contraception | – | Drug: Tenofovir Disoproxil Fumarate |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women will be recruited from an existing cohort.
Key inclusion criteria (6 listed)
- Female, or transgender female with a cervix, aged 18-35 years old
- HIV-positive
- Stable on antiretroviral regimen containing TDF 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 (6 listed)
- Currently pregnant or previous pregnancy within 3 months of enrollment
- Currently breast feeding
- Symptomatic vaginal infection within 2 weeks prior to enrollment
- Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior to enrollment
- History of vulvar/vaginal/ cervical dysplasia, neoplasia or cancer, atypical squamous cells of undetermined significance, condyloma, or human papilloma virus (HPV) in the past year
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 |
|---|---|---|
| Tenofovir Disoproxil FumarateTwo cervical biopsies, blood plasma, PBMC, urine, and two cervicovaginal swabs will be collected at a single study visit | Drug | Depo-Provera, Non-hormonal contraception |
| Depo-ProveraTwo cervical biopsies, blood plasma, PBMC, urine, and two cervicovaginal swabs will be collected at a single study visit | Drug | Depo-Provera |
Primary outcome
Cervical Tissue Concentrations
Time frame: Day 1
Assess the influence of hormonal contraception on tenofovir concentrations in cervical tissues
3 secondary outcomes
Proinflammatory cytokines
Time frame: Day 1
Gene expression of drug metabolizing enzymes and transporters
Time frame: Day 1
Vaginal microbiome
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 1 May 2018.
- Derived from this study: PubMed 31131846Nicol MR, Eneh P, Nakalega R, Kaiser T, Kabwigu S, Isingel E, Beksinska M, Sykes C, Fowler MG, Brown TT, Staley C, Kiweewa Matovu F. Depot Medroxyprogesterone Acetate and the Vaginal Microbiome as Modifiers of Tenofovir Diphosphate and Lamivudine Triphosphate Concentrations in the Female Genital Tract of Ugandan Women: Implications for Tenofovir Disoproxil Fumarate/Lamivudine in Preexposure Prophylaxis. Clin Infect Dis. 2020 Apr 10;70(8):1717-1724. doi: 10.1093/cid/ciz443.
- Individual participant dataSharing planned: No
Related trials for HIV/AIDS
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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 Contraception, run by University of Minnesota at 1 site in Uganda.
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 6 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 1 May 2018. 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 Uganda. 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?
Cervical Tissue Concentrations (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03377608, which also lists 1 linked publication.
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 1 May 2018; AzTrials last refreshed its copy on 8 Nov 2026.