HIV PreventionPhase 1NCT01813162
In Vivo Drug Interaction Pharmacokinetic Study of Tenofovir 1% Gel and Three Commonly Used Vaginal Products
A Phase 1 study testing Tenofovir 1% gel and Vaginal product in people with HIV Prevention, run by CONRAD at 2 sites in United States.
Trial summary
The purpose of the study is determine if the local release characteristics and systemic exposure to tenofovir (TFV) 1% gel and a given commonly used vaginal product are impacted by concomitant use Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- Tenofovir 1% gel and Vaginal product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2013to Dec 2014
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-50 years, inclusive
- General good health (by volunteer history and per investigator discretion)
- History of and currently regular menstrual cycles
- Willing to abstain from the use of vaginal products, other than the TFV gel and her assigned study vaginal product for the duration of the study.
- Willing to abstain from sex and other vaginal activity during each crossover period starting 72 hours prior to initiating product use, for the duration of use, and until the sixth day following sample collection
- At low risk for pregnancy due to surgical sterilization of participant and/or her sexual partner, use of copper IUD or male condom, abstinence, or same sex relationship
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- Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to easy genital tract sample collection
- History of Pap smears and follow-up consistent with ACOG practice guidelines
- Negative urine pregnancy test
- Willing to give voluntary consent, sign an informed consent form and comply with study procedures as required by the protocol
Who cannot join
- History of hysterectomy
- Currently pregnant/within 2 calendar months from the last pregnancy outcome.
- Use of Depo-Provera in the last 120 days or any hormonal contraceptives in the last month
- Currently breastfeeding or having breastfed an infant in the last 2 months, or planning to breastfeed during the course of the study
- History of sensitivity/allergy to any component of:
- TFV 1% gel; or
Show all 22Show fewer
- topical anesthetic, or allergy to both silver nitrate and Monsel's solution.
- Contraindication to any of 3 vaginal products (antifungal cream, antimicrobial gel, or the combination contraceptive vaginal ring) to which participants may be randomized
- In the last 6 months, diagnosed with or treated for any STI or pelvic inflammatory disease, by self report.
- Symptomatic BV
- Positive test for Trichomonas vaginalis at Visit 1
- Positive test for Neisseria gonorrhea or Chlamydia trachomatis
- Positive test for HIV
- Positive test for Hepatitis B surface antigen (HBsAg)
- Known bleeding disorder that could lead to prolonged or continuous bleeding with biopsy
- Chronic or acute vulvar or vaginal symptoms
- Known current drug or alcohol abuse which could impact study compliance
- Grade 2 or higher laboratory abnormality, per the August 2009 update of the DAIDS Table for Grading the Severity of Adverse Events
- Systemic use in the last 2 weeks or anticipated use during the study of any of the following: corticosteroids, antibiotics, anticoagulants or other drugs known to prolong bleeding and or clotting, antifungals, antivirals (e.g., acyclovir or valacyclovir) or antiretrovirals (e.g., Viread®).
- Participation in any other drug or device interventional investigational trial (device, drug, or vaginal trial) within 30 days of this study or planned participation in any other investigational trial during the study
- History of gynecological procedures (including genital piercing) on the external genitalia, vagina or cervix within the last 14 days
- Abnormal finding on laboratory or physical examination or a social or medical condition which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dept of OBGYN and Reproductive Sciences, UCSF
San Francisco, California
Bronx-Lebanon Hospital Center
The Bronx, New York
About this study
The purpose of the study is determine if the local release characteristics and systemic exposure to tenofovir (TFV) 1% gel and a given commonly used vaginal product are impacted by concomitant use
Read the detailed description
This study consists of three separate crossover studies, each evaluating if local release characteristics and systemic exposure to TFV 1% gel and a given vaginal product are impacted by concomitant use. Vaginal products to be assessed are: antifungal cream, antimicrobial gel, and the combination contraceptive vaginal ring (IVR). There will be no comparison between vaginal product groups.
Participants will be randomized to vaginal product. Participants in the cream and gel cohorts will be randomized to the order of treatment conditions (TFV gel alone, vaginal product alone, and TFV gel and vaginal product concomitantly). Participants in the IVR cohort will use TFV gel alone during the first crossover period; the order of the remaining treatment conditions (IVR alone, TFV and IVR concomitantly) for crossover periods 2 and 3 will be randomly assigned.
Each participant will attend a total of at least 7 visits. At the first visit, volunteers will be consented and will undergo procedures to assess whether they are eligible to continue in the study. If eligible, they will undergo 3 crossover treatment periods. Within each crossover treatment period there will be 2 visits, which will be scheduled to occur within the same menstrual cycle; the first visit will be in the follicular phase of the menstrual cycle such that product use is initiated on cycle day 9 to 18 and the second visit will be on cycle day 16 to 24.
At the start of crossover period 1, after it has been confirmed that the participant meets all of the inclusion criteria and none of the exclusion criteria, she will be randomized to a vaginal product cohort and to a sequence of the treatment conditions for the 3 crossover periods. Crossover periods 2 and 3 will be scheduled in the subsequent menstrual cycles, with the first visit of each crossover period occurring approximately 2 weeks after the completion of the previous crossover period.
Product usage during the 3 crossover periods is as follows:
- Treatment Condition (vaginal product alone): The participant will be instructed to use her assigned product for 5 to 21 days, depending on the dosing instructions for the particular product cohort to which she has been assigned . The second visit of the crossover period will occur after product use is complete. For participants using antifungal cream or antimicrobial gel, blood specimens will be collected approximately 6 hours after the last gel or cream use. In the IVR cohort, blood specimens will be collected after 21 days of use at 0/4, 6, 10, and 24 hours. The 0/4 hour collection time point is the time of the first plasma draw. It is meant to mimic the 4 hour post-TFV gel insertion collection time point described below for the TFV gel alone and the vaginal product/TFV gel treatment conditions. No biopsies will be collected during the vaginal product treatment condition for all cohorts.
- Treatment Condition (TFV gel alone): The participant will be instructed to use TFV gel for 7 days, inserted twice a day with each dose approximately 12 hours apart. The second visit of the crossover period will occur after product use is complete. Blood specimens will be collected approximately 4 hours after the last dose of TFV gel. In the IVR cohort, participants will have blood specimens collected 4, 6, 10 and 24 hours after the last dose of TFV gel. Vaginal biopsy will be scheduled to take place approximately 6 hours after the last dose of TFV gel for all cohorts.
- Treatment Condition (vaginal product and TFV gel): The participant will be instructed to use her assigned product for 5 to 21 days, depending on the dosing instructions for the particular product cohort to which she has been assigned. TFV gel will be used for 7 days, inserted twice a day with each dose approximately 12 hours apart; the morning insertion of TFV gel will occur approximately two hours after insertion of the vaginal product (for the gel and cream cohorts). The second visit of the crossover period will occur after product use is complete. In the gel and or cream cohorts, blood specimens will be collected approximately 4 hours after the last TFV gel use. In the IVR cohort, blood specimens will be collected 4, 6, 10 and 24 hours after the last dose of TFV gel. Vaginal biopsy will be scheduled to take place approximately 6 hours after the last dose of TFV gel for all cohorts.
Each participant will be contacted by phone approximately 1-2 weeks after completion of crossover period 3 to confirm that there have been no additional adverse experiences. If necessary, she may be seen in an unscheduled visit for follow-up. She will then be exited from the study.
- Conditions
- HIV Prevention
- Being tested
- Tenofovir 1% gel, Vaginal product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir 1% gelDrug
Vaginal productDrug
Also called Terconazole 0.4%, Metronidazole gel, Contraceptive IVR
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir 1% gel | Active comparator | Participants will vaginally insert 1 applicator of TFV gel twice a day for 7 days, with each dose inserted approximately 12 hours after the previous dose (for a total of 13 doses). Each applicator contains 4.4 gm of TFV 1% gel. Receives: Drug: Tenofovir 1% gel |
| Vaginal product alone | Active comparator | Participants will use their assigned vaginal product for 5 to 21 days depending on the dosing instructions for the particular product:
1. Terconazole 0.4% vaginal cream: once a day for seven days. 1 applicator (5 gm) of terconazole cream contains 20 mg terconazole.
2. Metronidazole gel: once a day for 5 days. 1 applicator (5 gm)of metronidazole gel contains 37.5 mg metronidazole.
3. Contraceptive IVR: insert ring and leave in place for 21 days; return to clinic for removal on day 21. The IVR contains two active components, etonogestrel (progestin) and ethinyl estradiol (estrogen). Receives: Drug: Vaginal product |
| Vaginal product and Tenofovir 1% gel | Experimental | Tenofovir gel: Participants will vaginally insert 1 applicator of TFV gel twice a day for 7 days, with each dose inserted approximately 12 hours after the previous dose (for a total of 13 doses). Each applicator contains 4.4 gm of TFV 1% gel.
In addition, Participants will use their assigned vaginal product for 5 to 21 days depending on the dosing instructions for the particular product:
1. Terconazole 0.4% vaginal cream: once a day for seven days. 1 applicator (5 gm) of terconazole cream contains 20 mg terconazole.
2. Metronidazole gel: once a day for 5 days. 1 applicator (5 gm)of metronidazole gel contains 37.5 mg metronidazole.
3. Contraceptive IVR: insert ring and leave in place for 21 days; return to clinic for removal on day 21. The IVR contains two active components, etonogestrel (progestin) and ethinyl estradiol (estrogen). Use of TFV gel will begin on day 15 of IVR use. Receives: Drug: Tenofovir 1% gel; Drug: Vaginal product |
What is being measured
The primary outcome is the main question the study is designed to answer.
TFV concentrations in plasma and genital tissue and TFV-DP concentrations in genital tissue
Vaginal product alone: Participant will use assigned product per dosing instructions (antifungal cream: 7 days; antimicrobial gel: 5 days; IVR: 21 days). In cream or gel cohorts, blood will be drawn 6 hrs after last use. In contraceptive ring cohort, blood will be drawn after 21 days of use at 0/4,6,10\&24 hrs.
TFV gel alone: Participant will use TFV gel for 7 days, inserted 2X a day. In cream/gel cohorts blood will be drawn 4 hrs after last TFV gel use. In contraceptive ring cohort blood will be drawn 4,6,10\&24 hrs after last TFV gel use. Vaginal biopsy will occur 6 hrs after last TFV gel use for all.
Vaginal product \& TFV gel: Participant will use assigned product per dosing instructions. TFV gel will be used for 7 days, 2X a day. In gel/cream cohorts blood will be drawn 4 hrs after last TFV gel use. In contraceptive ring cohort blood will be drawn 4,6,10\&24 hrs after last dose of TFV gel. Vaginal biopsy will occur 6 hrs after the last dose of TFV gel for all.
Measured: Assessments will be after product use (see description)
Secondary outcomes (2)
Vaginal product concentration in plasma
Vaginal product alone: Participant will use assigned product per dosing instructions (antifungal cream: 7 days; antimicrobial gel: 5 days; IVR: 21 days). In cream or gel cohorts, blood will be drawn 6 hrs after last use. In contraceptive ring cohort, blood will be drawn after 21 days of use at 0/4,6,10\&24 hrs.
TFV gel alone: Participant will use TFV gel for 7 days, inserted 2X a day. In cream/gel cohorts blood will be drawn 4 hrs after last TFV gel use. In contraceptive ring cohort blood will be drawn 4,6,10\&24 hrs after last TFV gel use.
Vaginal product \& TFV gel: Participant will use assigned product per dosing instructions. TFV gel will be used for 7 days, 2X a day. In gel/cream cohorts blood will be drawn 4 hrs after last TFV gel use. In contraceptive ring cohort blood will be drawn 4,6,10\&24 hrs after last dose of TFV gel.
Measured: Assessments will be after product use (see description)
Genitourinary adverse events (AEs)
Vaginal product alone: Participant will use assigned product per dosing instructions (antifungal cream: 7 days; antimicrobial gel: 5 days; IVR: 21 days). Genitourinary AEs will be assessed by participant report and exam after completion of dosing.
TFV gel alone: Participant will use TFV gel for 7 days, inserted 2X a day. Genitourinary AEs will be assessed by participant report and exam after completion of dosing.
Vaginal product \& TFV gel: Participant will use assigned product per dosing instructions. TFV gel will be used for 7 days, 2X a day. Genitourinary AEs will be assessed by participant report and exam after completion of dosing.
Measured: Assessments will be after product use (see description)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- CONRAD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jill Schwartz, M.D., Study chair, CONRAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813162
- Sponsor's protocol ID
- A11-118
- Status last verified
- May 2015
- First submitted
- 11 Mar 2013
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Drug Interaction Pharmacokinetic Study of Tenofovir 1% Gel and Three Commonly Used Vaginal Products
- ClinicalTrials.gov ID
- NCT01813162
- Acronym / sponsor ID
- A11-118
- Conditions
- HIV Prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- CONRADUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Mar 2013 (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.
The purpose of the study is determine if the local release characteristics and systemic exposure to tenofovir (TFV) 1% gel and a given commonly used vaginal product are impacted by concomitant use
Detailed description
This study consists of three separate crossover studies, each evaluating if local release characteristics and systemic exposure to TFV 1% gel and a given vaginal product are impacted by concomitant use. Vaginal products to be assessed are: antifungal cream, antimicrobial gel, and the combination contraceptive vaginal ring (IVR). There will be no comparison between vaginal product groups.
Participants will be randomized to vaginal product. Participants in the cream and gel cohorts will be randomized to the order of treatment conditions (TFV gel alone, vaginal product alone, and TFV gel and vaginal product concomitantly). Participants in the IVR cohort will use TFV gel alone during the first crossover period; the order of the remaining treatment conditions (IVR alone, TFV and IVR concomitantly) for crossover periods 2 and 3 will be randomly assigned.
Each participant will attend a total of at least 7 visits. At the first visit, volunteers will be consented and will undergo procedures to assess whether they are eligible to continue in the study. If eligible, they will undergo 3 crossover treatment periods. Within each crossover treatment period there will be 2 visits, which will be scheduled to occur within the same menstrual cycle; the first visit will be in the follicular phase of the menstrual cycle such that product use is initiated on cycle day 9 to 18 and the second visit will be on cycle day 16 to 24.
At the start of crossover period 1, after it has been confirmed that the participant meets all of the inclusion criteria and none of the exclusion criteria, she will be randomized to a vaginal product cohort and to a sequence of the treatment conditions for the 3 crossover periods. Crossover periods 2 and 3 will be scheduled in the subsequent menstrual cycles, with the first visit of each crossover period occurring approximately 2 weeks after the completion of the previous crossover period.
Product usage during the 3 crossover periods is as follows:
- Treatment Condition (vaginal product alone): The participant will be instructed to use her assigned product for 5 to 21 days, depending on the dosing instructions for the particular product cohort to which she has been assigned . The second visit of the crossover period will occur after product use is complete. For participants using antifungal cream or antimicrobial gel, blood specimens will be collected approximately 6 hours after the last gel or cream use. In the IVR cohort, blood specimens will be collected after 21 days of use at 0/4, 6, 10, and 24 hours. The 0/4 hour collection time point is the time of the first plasma draw. It is meant to mimic the 4 hour post-TFV gel insertion collection time point described below for the TFV gel alone and the vaginal product/TFV gel treatment conditions. No biopsies will be collected during the vaginal product treatment condition for all cohorts.
- Treatment Condition (TFV gel alone): The participant will be instructed to use TFV gel for 7 days, inserted twice a day with each dose approximately 12 hours apart. The second visit of the crossover period will occur after product use is complete. Blood specimens will be collected approximately 4 hours after the last dose of TFV gel. In the IVR cohort, participants will have blood specimens collected 4, 6, 10 and 24 hours after the last dose of TFV gel. Vaginal biopsy will be scheduled to take place approximately 6 hours after the last dose of TFV gel for all cohorts.
- Treatment Condition (vaginal product and TFV gel): The participant will be instructed to use her assigned product for 5 to 21 days, depending on the dosing instructions for the particular product cohort to which she has been assigned. TFV gel will be used for 7 days, inserted twice a day with each dose approximately 12 hours apart; the morning insertion of TFV gel will occur approximately two hours after insertion of the vaginal product (for the gel and cream cohorts). The second visit of the crossover period will occur after product use is complete. In the gel and or cream cohorts, blood specimens will be collected approximately 4 hours after the last TFV gel use. In the IVR cohort, blood specimens will be collected 4, 6, 10 and 24 hours after the last dose of TFV gel. Vaginal biopsy will be scheduled to take place approximately 6 hours after the last dose of TFV gel for all cohorts.
Each participant will be contacted by phone approximately 1-2 weeks after completion of crossover period 3 to confirm that there have been no additional adverse experiences. If necessary, she may be seen in an unscheduled visit for follow-up. She will then be exited from the study.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tenofovir 1% gel | Active comparator | Drug: Tenofovir 1% gelParticipants will vaginally insert 1 applicator of TFV gel twice a day for 7 days, with each dose inserted approximately 12 hours after the previous dose (for a total of 13 doses). Each applicator contains 4.4 gm of TFV 1% gel. |
| Vaginal product alone | Active comparator | Drug: Vaginal productParticipants will use their assigned vaginal product for 5 to 21 days depending on the dosing instructions for the particular product: 1. Terconazole 0.4% vaginal cream: once a day for seven days. 1 applicator (5 gm) of terconazole cream contains 20 mg terconazole. 2. Metronidazole gel: once a day for 5 days. 1 applicator (5 gm)of metronidazole gel contains 37.5 mg metronidazole. 3. Contraceptive IVR: insert ring and leave in place for 21 days; return to clinic for removal on day 21. The IVR contains two active components, etonogestrel (progestin) and ethinyl estradiol (estrogen). |
| Vaginal product and Tenofovir 1% gel | Experimental | Drug: Tenofovir 1% gel, Drug: Vaginal productTenofovir gel: Participants will vaginally insert 1 applicator of TFV gel twice a day for 7 days, with each dose inserted approximately 12 hours after the previous dose (for a total of 13 doses). Each applicator contains 4.4 gm of TFV 1% gel. In addition, Participants will use their assigned vaginal product for 5 to 21 days depending on the dosing instructions for the particular product: 1. Terconazole 0.4% vaginal cream: once a day for seven days. 1 applicator (5 gm) of terconazole cream contains 20 mg terconazole. 2. Metronidazole gel: once a day for 5 days. 1 applicator (5 gm)of metronidazole gel contains 37.5 mg metronidazole. 3. Contraceptive IVR: insert ring and leave in place for 21 days; return to clinic for removal on day 21. The IVR contains two active components, etonogestrel (progestin) and ethinyl estradiol (estrogen). Use of TFV gel will begin on day 15 of IVR use. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age 18-50 years, inclusive
- General good health (by volunteer history and per investigator discretion)
- History of and currently regular menstrual cycles
- Willing to abstain from the use of vaginal products, other than the TFV gel and her assigned study vaginal product for the duration of the study.
- Willing to abstain from sex and other vaginal activity during each crossover period starting 72 hours prior to initiating product use, for the duration of use, and until the sixth day following sample collection
Key exclusion criteria (22 listed)
- History of hysterectomy
- Currently pregnant/within 2 calendar months from the last pregnancy outcome.
- Use of Depo-Provera in the last 120 days or any hormonal contraceptives in the last month
- Currently breastfeeding or having breastfed an infant in the last 2 months, or planning to breastfeed during the course of the study
- History of sensitivity/allergy to any component of:
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 1% gel | Drug | Tenofovir 1% gel, Vaginal product and Tenofovir 1% gel |
| Vaginal productAlso: Terconazole 0.4%, Metronidazole gel, Contraceptive IVR | Drug | Vaginal product alone, Vaginal product and Tenofovir 1% gel |
Primary outcome
TFV concentrations in plasma and genital tissue and TFV-DP concentrations in genital tissue
Time frame: Assessments will be after product use (see description)
Vaginal product alone: Participant will use assigned product per dosing instructions (antifungal cream: 7 days; antimicrobial gel: 5 days; IVR: 21 days). In cream or gel cohorts, blood will be drawn 6 hrs after last use. In contraceptive ring cohort, blood will be drawn after 21 days of use at 0/4,6,10\&24 hrs. TFV gel alone: Participant will use TFV gel for 7 days, inserted 2X a day. In cream/gel cohorts blood will be drawn 4 hrs after last TFV gel use. In contraceptive ring cohort blood will be drawn 4,6,10\&24 hrs after last TFV gel use. Vaginal biopsy will occur 6 hrs after last TFV gel use for all. Vaginal product \& TFV gel: Participant will use assigned product per dosing instructions. TFV gel will be used for 7 days, 2X a day. In gel/cream cohorts blood will be drawn 4 hrs after last TFV gel use. In contraceptive ring cohort blood will be drawn 4,6,10\&24 hrs after last dose of TFV gel. Vaginal biopsy will occur 6 hrs after the last dose of TFV gel for all.
2 secondary outcomes
Vaginal product concentration in plasma
Time frame: Assessments will be after product use (see description)
Genitourinary adverse events (AEs)
Time frame: Assessments will be after product use (see description)
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 22 May 2015.
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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.
Jill Schwartz, M.D. study chair
CONRAD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tenofovir 1% gel and Vaginal product in people with HIV Prevention, run by CONRAD at 2 sites 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 10 inclusion and 22 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 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
TFV concentrations in plasma and genital tissue and TFV-DP concentrations in genital tissue (time frame: Assessments will be after product use (see description)). 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 22 May 2015; AzTrials last refreshed its copy on 8 Nov 2026.