HIV PreventionEarly Phase 1PrEP-Pod-IVRNCT03255915
PrEP-Pod-IVR (TDF-FTC/Placebo IVR 28 Day Crossover Study)
A Early Phase 1 study testing Tenofovir Disoproxil Fumarate (TDF)-Emtricitabine (FTC) in people with HIV Prevention, run by Oak Crest Institute of Science at 1 site in United States.
Trial summary
Participants will have a 28-day pre-ring baseline assessment period (Stage 1) followed by randomization to order with 5 participants per study arm. All participants will sequentially receive both study products for 28-days with at least a 2-week washout period between products. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- Tenofovir Disoproxil Fumarate (TDF)-Emtricitabine (FTC)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2018to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age of 18 through 45 years at screening, verified per site SOP
- Female participants, born female
- Not pregnant or breastfeeding
- Availability to return for all study visits, barring unforeseen circumstances
- Willing and able to
- communicate in English
Show all 34Show fewer
- provide written informed consent to take part in the study
- provide adequate locator information, as defined in site SOP
- complete all required study procedures, including phone surveys, daily vaginal swabs, and reliably store swabs in freezer
- Must agree
- not to participate in other concurrent interventional and/or drug trials
- to use study-provided condoms for vaginal or anal intercourse for the duration of the study
- to abstain from use of any vaginal products (e.g., lubricants, feminine hygiene products, vaginally administered contraceptive products, sex toys) other than study products for the duration of the study beginning at enrollment Note: Tampons may be used during menses, but must be discontinued 72 hours prior to study visits and for 7 days after biopsy procedures. Menstrual pads will be provided to participants.
- to abstain from receptive oral, vaginal, or anal intercourse during the first week after each pod-IVR insertion and for 2 days before and 7 days after biopsy procedures
- to abstain from insertion of anything in the vagina (e.g., tampon, finger, sex toy, lubricants, medication, douche) during the first week after each pod-IVR insertion and for 2 days before and 7 days after biopsy procedures
- Understands and agrees to local STI reporting requirements
- HIV-1 seronegative at screening
- Must be in general good health in the opinion of the investigator
- Regular menstrual cycles of approximately 21 to 35 days apart with no untreated intermenstrual menstrual bleeding Note: This criterion is not applicable to participants using continuous combination oral contraceptive pills or progestin-only methods (such as Depo-Provera or levonorgestrel-releasing IUD), as the absence of regular menstrual cycles is an expected, normal consequence in this context.
- Satisfactory cervical Pap result in the 36 calendar months prior to Enrollment consistent with Grade 0 according to the Female Genital Grading Table for Use in Microbicide Studies [Addendum 1, Dated November 2007], or if Grade 1 or higher Pap result has had a satisfactory evaluation with no treatment required per American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines in the 12 calendar months prior to Enrollment
- Using an effective method of contraception and intending to continue use of an effective method for the duration of study participation. Acceptable methods include:
- hormonal methods (except contraceptive vaginal rings)
- IUD
- sterilization of participant or partner
- In addition to the criteria listed above, participants who agree to have rectal biopsies collected must meet the following criteria:
- Must agree to abstain from insertion of anything in the rectum (e.g., finger, sex toy, lubricants, medication, enema) during the first week after each pod-IVR insertion and for 2 days before and 7 days after biopsy procedures
- Male sexual partner(s) who meet the following criteria are eligible for inclusion in the study:
- Age of 18 years or over
- Has a female sexual partner enrolled in the study
- Willing and able to
- communicate in English
- provide written informed consent to take part in the study
- provide adequate locator information, as defined in site SOP
- complete in-depth interview via video conference
Who cannot join
- Individuals who meet any of the following criteria will be excluded from the study:
- Undergoing or completed gender reassignment
- Participant reports any of the following at Screening:
- Has plans to relocate away from the study site area during the period of study participation
- Pregnant, less than 3 months post-partum, or lactating
- Intends to become pregnant during the period of study participation
Show all 45Show fewer
- Current or planned use of an IVR
- Known HIV-infected partners
- Non-therapeutic injection drug use in the 6 months prior to screening
- History of autoimmune disease
- History of toxic shock syndrome
- History of adverse reaction to TDF, FTC, silicone, or microcrystalline cellulose
- PrEP or Post-exposure prophylaxis for HIV exposure within 6 months prior to screening
- Use of systemic immunomodulatory medications within the 4 weeks prior to the Enrollment
- Use of vaginally or rectally administered medications or products (including condoms) containing Nonoxynol-9 (N-9) within the 4 weeks prior to the Enrollment
- Participating in another research study involving drugs or medical devices within the 4 weeks or 5 half-lives (if known) prior to the Enrollment
- Gynecologic or genital procedure (e.g., tubal ligation, dilation and curettage, piercing) within 60 days prior to Enrollment
- Note: Colposcopy and cervical biopsies for evaluation of an abnormal Pap smear as well as IUD removal are not exclusionary
- Per participant report at screening, anticipated use and/or unwillingness to abstain from the following medications during the period of study participation:
- Heparin, including Lovenox® (enoxaparin sodium)
- Warfarin
- Plavix® (clopidogrel bisulfate)
- Any other drugs that are associated with increased likelihood of bleeding following mucosal biopsy (e.g., daily high dose aspirin, Pradaxa®)
- NSAID use for 5 half-lives prior to biopsy (e.g. ibuprofen for 1 day, naproxen for 4 days).
- Rectally or vaginally administered medications (including over-the-counter products)
- History of significant gastrointestinal bleeding in the opinion of the investigator
- Abnormalities of the cervical, vaginal, or colorectal mucosa, or significant symptom(s), which in the opinion of the clinician represents a contraindication to protocol-required biopsies (including but not limited to presence of any unresolved injury, infectious or inflammatory condition of the local mucosa, and presence of symptomatic external hemorrhoids). Erythema is not exclusionary.
- Includes any clinically apparent Grade 2 or higher pelvic examination finding (observed by study staff) at Screening or Enrollment, as per the Female Genital Grading Table for Use in Microbicide Studies [Addendum 1, Dated November 2007]
- At screening: participant-reported symptoms and/or clinical or laboratory diagnosis of active rectal or reproductive tract infection requiring treatment per current CDC guidelines or symptomatic urinary tract infection (UTI). Infections requiring treatment include symptomatic bacterial vaginosis, symptomatic vaginal candidiasis, trichomoniasis, chlamydia (CT), gonorrhea (GC), syphilis, active HSV lesions, chancroid, pelvic inflammatory disease, genital sores or ulcers, cervicitis, or symptomatic genital warts requiring treatment (i.e., those that cause undue burden or discomfort to the participant).
- Note:
- An HSV-1 or HSV-2 seropositive diagnosis with no active lesions is allowed, since treatment is not required
- One re-screening after documented treatment will be allowed
- Has any of the following laboratory abnormalities at Screening:
- Note: Grade is per Version 2.1 of the DAIDS Toxicity Table
- Hemoglobin Grade 1 or higher
- Platelet count Grade 1 or higher
- International Normalized Ratio (INR) Grade 2 or higher
- White blood cell count Grade 2 or higher
- Calculated creatinine clearance ≤ 80 mL/minute using the Cockcroft-Gault equation
- Grade 2 or higher ALT and/or AST (i.e., ≥ 2.5x the site laboratory upper limit of normal [ULN])
- Positive for Hepatitis B surface antigen (HBsAg)
- Positive for Hepatitis C antibody (HCV Ab)
- Has any other condition that, in the opinion of the Principal Investigator or designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives
- Male sexual partner(s) who meet the following criteria are not eligible for inclusion in the study:
- 1) Female partner did not utilize study product
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: Randomized Order, Controlled, Double Blind, Crossover Early Phase 1 Pilot Study to Assess Safety and Pharmacokinetics of a Tenofovir Disoproxil Fumarate and Emtricitabine (TDF-FTC) Releasing IVR Over 28 Days Compared to Placebo
Participants will have a 28-day pre-ring baseline assessment period (Stage 1) followed by randomization to order with 5 participants per study arm. All participants will sequentially receive both study products for 28-days with at least a 2-week washout period between products. Arm 1 will receive the TDF-FTC pod-IVR for Stage 2 followed by the placebo pod-IVR during Stage 3. Arm 2 will receive the placebo pod-IVR for Stage 2 followed by the TDF-FTC pod-IVR during Stage 3. During Stages 2 \& 3 participants will also complete brief phone surveys (<3 min), computer-assisted self-interviews (CASIs), and in-depth interviews (IDIs) regarding perceptibility and acceptability. If willing, participants' male sexual partners will be invited to complete IDIs as well.
- Conditions
- HIV Prevention
- Being tested
- Tenofovir Disoproxil Fumarate (TDF)-Emtricitabine (FTC), Placebo
- Keywords
- HIV Prevention, Intravaginal Ring, Tenofovir Disoproxil Fumarate, Emtricitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Disoproxil Fumarate (TDF)-Emtricitabine (FTC)Drug
TDF-FTC pod-IVR designed to deliver TDF at a target rate of 1 mg d-1 and FTC at a target rate of 2 mg d-1.
PlaceboOther
A placebo pod-IVR containing microcrystalline cellulose pods.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Arm 1 will receive the Tenofovir Disoproxil Fumarate (TDF)-Emtricitabine (FTC) pod-IVR for Stage 2 followed by the placebo pod-IVR during Stage 3. Receives: Drug: Tenofovir Disoproxil Fumarate (TDF)-Emtricitabine (FTC); Other: Placebo |
| Arm 2 | Experimental | Arm 2 will receive the placebo pod-IVR for Stage 2 followed by the Tenofovir Disoproxil Fumarate (TDF)-Emtricitabine (FTC) pod-IVR during Stage 3. Receives: Drug: Tenofovir Disoproxil Fumarate (TDF)-Emtricitabine (FTC); Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Vaginal IVRs releasing TDF-FTC by reports of Adverse Events
Adverse events Grade 2 or higher as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017, Addendum 1 Female Genital Grading Tables for Use in Microbicide Studies (November 2007), and/or Addendum 3 Rectal Grading Table for Use in Microbicide Studies (Clarification dated May 2012) to this table
Measured: From date of enrollment until the date of study completion or date of study withdrawal from any cause, whichever came first, assessed up to 6 months
Characterization of pharmacokinetics of TDF-FTC released by an IVR - plasma
To characterize the local and systemic pharmacokinetics (PK) of TDF-FTC delivered via a pod-IVR, including drug concentration in plasma.
Measured: From date of enrollment until the date of study completion or date of study withdrawal from any cause, whichever came first, assessed up to 6 months
Characterization of pharmacokinetics of TDF-FTC released by an IVR - vagina
To characterize the local and systemic pharmacokinetics (PK) of TDF-FTC delivered via a pod-IVR, including drug concentration in vaginal secretions and tissue.
Measured: From date of enrollment until the date of study completion or date of study withdrawal from any cause, whichever came first, assessed up to 6 months
Characterization of pharmacokinetics of TDF-FTC released by an IVR - rectum
To characterize the local and systemic pharmacokinetics (PK) of TDF-FTC delivered via a pod-IVR, including drug concentration in rectal secretions.
Measured: From date of enrollment until the date of study completion or date of study withdrawal from any cause, whichever came first, assessed up to 6 months
Secondary outcomes (4)
Acceptability of IVR assessed via computer assisted self interviews
Self-reported attitudes of participants about experience and product attributes via computer assisted self interviews
Measured: 28 days after use of each IVR
Acceptability of IVR assessed via in depth interviews
Self-reported attitudes of participants about experience and product attributes via in depth interviews
Measured: 28 days after use of each IVR
Adherence
Measured by vaginal fluid PK drug levels, vaginal tissue PK drug and drug metabolite levels, and residual drug levels in returned, used pod-IVRs.
Measured: From date of IVR insertion until the date of IVR removal or date of study withdrawal from any cause, whichever came first, assessed up to 6 months
Acceptability of IVR assessed via in depth interviews - male partners
Self-reported attitudes of participant's male sexual partner(s) about experience and product attributes via in-depth interviews.
Measured: 28 days after subject use of each IVR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start20 Sep 2018
- Primary completion30 Sep 2020
- Study completion31 Dec 2026 (estimated)
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 PreventionStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized order, placebo-controlled, double blind, crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oak Crest Institute of Science
- Sponsor type
- University, hospital or other
- Collaborators
- The Miriam Hospital, Johns Hopkins University, University of California, Los Angeles, University of California, San Diego, Vanderbilt University, The University of Texas Medical Branch, Galveston, National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Kathleen L Vincent, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255915
- Sponsor's protocol ID
- 17-0131
- Other IDs
- 1U19AI113048-01
- Acronym
- PrEP-Pod-IVR
- Status last verified
- Aug 2026
- First submitted
- 26 Jul 2017
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vincent KL, Moss JA, Marzinke MA, Pyles RB, Dawson L, Olive TJ, Butkyavichene I, Castonguay AE, Cortez JM Jr, Remedios-Chan M, Galvan P, Rivera S, Webster S, Gunawardana M, Adler AP, Ramirez CM, Spiegel HML, Hendrix CW, Anton PA, Baum MM. An intravaginal ring for HIV pre-exposure prophylaxis: assessment of safety and pharmacokinetics in a randomized, placebo-controlled clinical trial. Front Cell Infect Microbiol. 2026 Oct 6;16:1955105. doi: 10.3389/fcimb.2026.1955105. eCollection 2026.
PubMed 42903070
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Order, Controlled, Double Blind, Crossover Early Phase 1 Pilot Study to Assess Safety and Pharmacokinetics of a Tenofovir Disoproxil Fumarate and Emtricitabine (TDF-FTC) Releasing IVR Over 28 Days Compared to Placebo
- ClinicalTrials.gov ID
- NCT03255915
- Acronym / sponsor ID
- PrEP-Pod-IVR / 17-0131
- Conditions
- HIV Prevention
- Keywords
- HIV Prevention, Intravaginal Ring, Tenofovir Disoproxil Fumarate, Emtricitabine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Oak Crest Institute of ScienceUniversity, hospital or other
- Collaborators
- The Miriam Hospital, Johns Hopkins University, University of California, Los Angeles, University of California, San Diego, Vanderbilt University, The University of Texas Medical Branch, Galveston, National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Aug 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.
Participants will have a 28-day pre-ring baseline assessment period (Stage 1) followed by randomization to order with 5 participants per study arm. All participants will sequentially receive both study products for 28-days with at least a 2-week washout period between products. Arm 1 will receive the TDF-FTC pod-IVR for Stage 2 followed by the placebo pod-IVR during Stage 3. Arm 2 will receive the placebo pod-IVR for Stage 2 followed by the TDF-FTC pod-IVR during Stage 3. During Stages 2 \& 3 participants will also complete brief phone surveys (<3 min), computer-assisted self-interviews (CASIs), and in-depth interviews (IDIs) regarding perceptibility and acceptability. If willing, participants' male sexual partners will be invited to complete IDIs as well.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized order, placebo-controlled, double blind, crossover
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Tenofovir Disoproxil Fumarate (TDF)-Emtricitabine (FTC), Other: PlaceboArm 1 will receive the Tenofovir Disoproxil Fumarate (TDF)-Emtricitabine (FTC) pod-IVR for Stage 2 followed by the placebo pod-IVR during Stage 3. |
| Arm 2 | Experimental | Drug: Tenofovir Disoproxil Fumarate (TDF)-Emtricitabine (FTC), Other: PlaceboArm 2 will receive the placebo pod-IVR for Stage 2 followed by the Tenofovir Disoproxil Fumarate (TDF)-Emtricitabine (FTC) pod-IVR during Stage 3. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (34 listed)
- Age of 18 through 45 years at screening, verified per site SOP
- Female participants, born female
- Not pregnant or breastfeeding
- Availability to return for all study visits, barring unforeseen circumstances
- Willing and able to
Key exclusion criteria (45 listed)
- Undergoing or completed gender reassignment
- Participant reports any of the following at Screening:
- Note: Colposcopy and cervical biopsies for evaluation of an abnormal Pap smear as well as IUD removal are not exclusionary
- Per participant report at screening, anticipated use and/or unwillingness to abstain from the following medications during the period of study participation:
- History of significant gastrointestinal bleeding in the opinion of the investigator
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 Fumarate (TDF)-Emtricitabine (FTC)TDF-FTC pod-IVR designed to deliver TDF at a target rate of 1 mg d-1 and FTC at a target rate of 2 mg d-1. | Drug | Arm 1, Arm 2 |
| PlaceboA placebo pod-IVR containing microcrystalline cellulose pods. | Other | Arm 1, Arm 2 |
Primary outcome
Safety of Vaginal IVRs releasing TDF-FTC by reports of Adverse Events
Time frame: From date of enrollment until the date of study completion or date of study withdrawal from any cause, whichever came first, assessed up to 6 months
Adverse events Grade 2 or higher as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017, Addendum 1 Female Genital Grading Tables for Use in Microbicide Studies (November 2007), and/or Addendum 3 Rectal Grading Table for Use in Microbicide Studies (Clarification dated May 2012) to this table
Characterization of pharmacokinetics of TDF-FTC released by an IVR - plasma
Time frame: From date of enrollment until the date of study completion or date of study withdrawal from any cause, whichever came first, assessed up to 6 months
To characterize the local and systemic pharmacokinetics (PK) of TDF-FTC delivered via a pod-IVR, including drug concentration in plasma.
Characterization of pharmacokinetics of TDF-FTC released by an IVR - vagina
Time frame: From date of enrollment until the date of study completion or date of study withdrawal from any cause, whichever came first, assessed up to 6 months
To characterize the local and systemic pharmacokinetics (PK) of TDF-FTC delivered via a pod-IVR, including drug concentration in vaginal secretions and tissue.
Characterization of pharmacokinetics of TDF-FTC released by an IVR - rectum
Time frame: From date of enrollment until the date of study completion or date of study withdrawal from any cause, whichever came first, assessed up to 6 months
To characterize the local and systemic pharmacokinetics (PK) of TDF-FTC delivered via a pod-IVR, including drug concentration in rectal secretions.
4 secondary outcomes
Acceptability of IVR assessed via computer assisted self interviews
Time frame: 28 days after use of each IVR
Acceptability of IVR assessed via in depth interviews
Time frame: 28 days after use of each IVR
Adherence
Time frame: From date of IVR insertion until the date of IVR removal or date of study withdrawal from any cause, whichever came first, assessed up to 6 months
Acceptability of IVR assessed via in depth interviews - male partners
Time frame: 28 days after subject use of each IVR
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Derived from this study: PubMed 42903070Vincent KL, Moss JA, Marzinke MA, Pyles RB, Dawson L, Olive TJ, Butkyavichene I, Castonguay AE, Cortez JM Jr, Remedios-Chan M, Galvan P, Rivera S, Webster S, Gunawardana M, Adler AP, Ramirez CM, Spiegel HML, Hendrix CW, Anton PA, Baum MM. An intravaginal ring for HIV pre-exposure prophylaxis: assessment of safety and pharmacokinetics in a randomized, placebo-controlled clinical trial. Front Cell Infect Microbiol. 2026 Oct 6;16:1955105. doi: 10.3389/fcimb.2026.1955105. eCollection 2026.
- Individual participant dataSharing planned: No
Related trials for HIV Prevention
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
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
Not yet recruiting
HC-HMP: Healthy Choices Implementation Trial
Alcohol Drinking, HIV Infections
Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Active, not recruitingPhase 3
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
HIV Infections
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.
Kathleen L Vincent, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tenofovir Disoproxil Fumarate (TDF)-Emtricitabine (FTC) in people with HIV Prevention, run by Oak Crest Institute of Science 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 34 inclusion and 45 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: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 of Vaginal IVRs releasing TDF-FTC by reports of Adverse Events (time frame: From date of enrollment until the date of study completion or date of study withdrawal from any cause, whichever came first, assessed up to 6 months). The study lists 4 primary outcomes in all. 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 NCT03255915, 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 26 Aug 2026.