HIVPhase 1NCT01694407
Safety, Pharmacokinetics, Pharmacodynamics, and Disintegration Time of Vaginal Tablets Containing Tenofovir and/or Emtricitabine
A Phase 1 study testing Tenofovir (TFV) Alone Vaginal Tablet, Emtricitabine (FTC) Alone Vaginal Tablet and TFV and FTC Combined Vaginal Tablet in people with HIV, run by CONRAD at 2 sites in United States.
Trial summary
This prospective, double-blinded, randomized, parallel cohort study will examine the genital and systemic safety, pharmacokinetics (PK), pharmacodynamics (PD), disintegration and disappearance times, and acceptability of four vaginal tablets: 1) Tenofovir (TFV) alone; 2) Emtricitabine (FTC) alone; 3) TFV combined with… 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
- What is being tested?
- Tenofovir (TFV) Alone Vaginal Tablet, Emtricitabine (FTC) Alone Vaginal Tablet and TFV and FTC Combined Vaginal Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2013to Dec 2013
- 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
- General good health (by volunteer history and per investigator discretion) without any clinically significant systemic disease (including, but not limited to significant liver disease/hepatitis, gastrointestinal disease, kidney disease, thyroid disease, osteoporosis or bone disease, and diabetes)
- Currently having regular menstrual cycles of 25 - 35 days by participant report
- History of Pap smears and follow-up consistent with American Congress of Obstetricians and Gynecologist (ACOG) practice guidelines #99 and #109 or willing to undergo a Pap smear at Visit 1
- Protected from pregnancy, meaning one of the following:
- Sexually abstinent and planning to remain abstinent for the duration of the study;
- In a monogamous heterosexual relationship for at least four months with a partner who is not known to be HIV positive and has no known risks for sexually transmitted infections (STIs) and:
Show all 15Show fewer
- Couple is using condoms and is willing to use non-spermicidally lubricated condoms throughout the study or
- One partner is sterilized; or
- In a monogamous same sex relationship for at least four months with a partner who is not known to be HIV positive and has no known risks for STIs.
- Willing to abstain from vaginal activity as follows:
- Starting 48 hours before Visit 2 until the sixth day after Visit 2 Starting 48 hours before Visit 3 until the sixth day after Visit 3 Starting 48 hours before Visit 4 until the sixth day after Visit 6
- Willing to abstain from the use of any vaginal product other than the study product including spermicides, lubricants, and douches starting 48 hours before Visit 2 until the sixth day after Visit 6 (tampons may be used, but for menses only)
- Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to easy colposcopy and genital tract sample collection
- 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 or within two calendar months from the last pregnancy outcome. Note: If recently pregnant must have had at least two spontaneous menses since pregnancy outcome
- Use of any hormonal contraceptive method in the last 30 days (oral, transdermal, transvaginal, implant, or hormonal intrauterine contraceptive device)
- Injection of Depo-Provera in the last 6 months
- Current use of IUD
- Currently breastfeeding or having breastfed an infant in the last two months, or planning to breastfeed during the course of the study
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- History of sensitivity/allergy to any component of the study products, topical anesthetic, or allergy to both silver nitrate and Monsel's solution
- In the last six months, diagnosed with or treated for any STI or pelvic inflammatory disease. Note: Women with a history of genital herpes or condylomata who have been asymptomatic for at least six months may be considered for eligibility
- Nugent score greater than or equal to 7 at Visit 1 or symptomatic bacterial vaginosis (BV) as defined by Amsel's criteria at Visit 1 or 2
- Symptomatic vulvovaginal candidiasis or symptomatic urinary tract infection (UTI)
- Positive test for Trichomonas vaginalis, Neisseria gonorrhea or Chlamydia trachomatis
- Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or vesicles suspicious for an STI
- 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 (pain, irritation, spotting, etc.)
- Known current drug or alcohol abuse which could impact study compliance
- Grade 1 or higher laboratory abnormality, per the August 2009 update of the Division of AIDS, National Institute of Allergy and Infectious Disease (DAIDS) Table for Grading the Severity of Adverse Events (AEs)
- Systemic use in the last two weeks or anticipated use during the study of any of the following: corticosteroids, antibiotics, antifungals, antivirals (e.g., acyclovir or valacyclovir) or antiretrovirals (e.g., Viread, Atripla, Emtriva, Complera). Note: Participants should avoid non-steroidal anti-inflammatory drugs (NSAIDs) except for treatment of dysmenorrhea during menses. Participants may use Tylenol® on an as-needed but not daily basis during the study.
- Participation in any other investigational trial (device, drug, or vaginal trial) within the last 30 days 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
Clinical Research Center, Eastern Virginia Medical School
Norfolk, Virginia, 23507
Albert Einstein College of Medicine
The Bronx, New York, 10451
About this study
Official title: A Phase I Clinical Trial Assessing the Safety, Pharmacokinetics, Pharmacodynamics, and Disintegration Time of Vaginal Tablets Containing Tenofovir and/or Emtricitabine
This prospective, double-blinded, randomized, parallel cohort study will examine the genital and systemic safety, pharmacokinetics (PK), pharmacodynamics (PD), disintegration and disappearance times, and acceptability of four vaginal tablets: 1) Tenofovir (TFV) alone; 2) Emtricitabine (FTC) alone; 3) TFV combined with FTC; and 4) placebo. Participants will be randomized to treatment group, to number of tablets to be inserted in the Single Use Phase (1 tablet or 1 tablet followed by a second tablet two hours later to mimic the BAT24 dosing regimen), and to one of four collection time points (2, 4, 6, or 24 hours after tablet insertion) for assessments only after the last dose of the Multiple Use Phase.
In the Single Use Phase of the study, the participant will insert one tablet in the clinic to estimate times to disintegration and disappearance. Those randomized to two tablets will insert a second tablet 2 hours later. In all women, sample collection will occur 5 hours after the initial tablet insertion.
In the Multiple Use Phase of the study, participants will insert a tablet once daily for 14 days. The 1st, 7th, and 14th tablets will be inserted in the clinic; the remaining tablets will be inserted at home. The clinic will call the participant on day 3 of the multiple use phase to ask about any symptoms the participant may be experiencing. Each insertion in the clinic will be followed by sample collection and, at Visits 4 and 6, colposcopy at the participant's assigned time point.
Read the detailed description
Objectives:
Primary:
- To assess genital safety after a single use (consisting of one tablet in half of participants and one tablet followed by a second tablet two hours later in the other half) and during and after two weeks of daily tablet use
- To assess systemic safety after two weeks of daily tablet use
- To assess the pharmacokinetics (PK) of TFV and FTC after a single use (as defined above) and during and after two weeks of daily tablet use
Secondary:
- To estimate the time needed for tablet disintegration and the time needed for full tablet disappearance
- To assess acceptability of the tablet
- To assess indicators of the pharmacodynamics (PD) of TFV and FTC in vitro using biological samples (fluids) from study participants obtained before use, after a single (use as define above), and after two weeks of daily tablet use
Exploratory:
•To assess exploratory indicators of the PD of TFV and FTC in vitro using biological samples (tissues) from study participants obtained before use, after a single use (as defined above), and after two weeks of daily tablet use
- Conditions
- HIV
- Being tested
- Tenofovir (TFV) Alone Vaginal Tablet, Emtricitabine (FTC) Alone Vaginal Tablet, TFV and FTC Combined Vaginal Tablet, Placebo Vaginal Tablet
- Keywords
- Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir (TFV) Alone Vaginal TabletDrug
vaginal tablet containing 40 mg of TFV
Emtricitabine (FTC) Alone Vaginal TabletDrug
Vaginal Tablet containing 40 mg of TFV
TFV and FTC Combined Vaginal TabletDrug
vaginal tablet with 40 mg TFV and 40 mg FTC
Placebo Vaginal TabletDrug
Vaginal Tablet containing no drug
| Study group | Role | What they receive |
|---|---|---|
| TFV Alone Vaginal Tablet | Active comparator | Not described Receives: Drug: Tenofovir (TFV) Alone Vaginal Tablet |
| Emtricitabine (FTC) Alone Vaginal Tablet | Active comparator | Not described Receives: Drug: Emtricitabine (FTC) Alone Vaginal Tablet |
| TFV Combined with FTC Vaginal Tablet | Active comparator | Not described Receives: Drug: TFV and FTC Combined Vaginal Tablet |
| Placebo Vaginal Tablet | Placebo comparator | Not described Receives: Drug: Placebo Vaginal Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Genitourinary AEs
Genitourinary AEs, moderate to severe
Measured: 5 hours after first tablet insertion and after 7th and 14th daily tablet
Changes on physical examination and colposcopy
Changes on physical examination and colposcopy
Measured: 5 hours after first tablet insertion and after 7th and 14th daily tablet
Changes Soluble markers of mucosal immunity, immune cell numbers, & characteristics in CVL
Changes Soluble markers of mucosal immunity, immune cell numbers, \& characteristics in CVL
Measured: 5 hours after first tablet insertion and after 7th and 14th daily tablet
Changes in Number, phenotype and activation status of immune cells in cervicovaginal mucosa
Changes in Number, phenotype and activation status of immune cells in cervicovaginal mucosa
Measured: 5 hours after first tablet insertion and after 7th and 14th daily tablet
Changes in Mucosal histology in cervicovaginal tissue
Changes in Mucosal histology in cervicovaginal tissue
Measured: 5 hours after first tablet insertion and after 7th and 14th daily tablet
Changes in Changes in microflora
Changes in Changes in microflora (semiquantitative cultures and unculturable species)
Measured: 5 hours after first tablet insertion and after 7th and 14th daily tablet
Changes in Systemic laboratory tests
Changes in Systemic laboratory tests
Measured: 5 hours after first tablet insertion and after 7th and 14th daily tablet
TFV & FTC concentrations in plasma, vaginal aspirate, & genital tissue
TFV \& FTC concentrations in plasma, vaginal aspirate, \& genital tissue Pharmacokinetics Mean (SD) and Median (Min, Max, C-Max, T-Max) of TFV and FTC in blood, vaginal aspirate,and genital tissue at Visit 2, 3, 4, 5, 6
Measured: 5 hours after first tablet insertion
TFV-DP and FTC-TP concentrations in PBMCs, endocervical cells, & genital tissue
TFV-DP and FTC-TP concentrations in PBMCs, endocervical cells, \& genital tissue Pharmacokinetics C-Max and T-Max of Blood TFV and FTC levels at single dose phase, by site and overall, Evaluable Population
Measured: 5 hours after first tablet insertion
TFV & FTC concentrations in plasma, vaginal aspirate, & genital tissue
TFV \& FTC concentrations in plasma, vaginal aspirate, \& genital tissue Pharmacokinetics Mean (SD) and Median (Min, Max, C-Max, T-Max) of TFV and FTC in blood, vaginal aspirate,and genital tissue at Visit 2, 3, 4, 5, 6
Measured: after 7th daily tablet
TFV & FTC concentrations in plasma, vaginal aspirate, & genital tissue
TFV \& FTC concentrations in plasma, vaginal aspirate, \& genital tissue Pharmacokinetics Mean (SD) and Median (Min, Max, C-Max, T-Max) of TFV and FTC in blood, vaginal aspirate,and genital tissue at Visit 2, 3, 4, 5, 6
Measured: after 14 daily tablet insertion
TFV-DP and FTC-TP concentrations in PBMCs, endocervical cells, & genital tissue
TFV-DP and FTC-TP concentrations in PBMCs, endocervical cells, \& genital tissue Pharmacokinetics C-Max and T-Max of Blood TFV and FTC levels at single dose phase, by site and overall, Evaluable Population
Measured: after 7th daily tablet
TFV-DP and FTC-TP concentrations in PBMCs, endocervical cells, & genital tissue
TFV-DP and FTC-TP concentrations in PBMCs, endocervical cells, \& genital tissue Pharmacokinetics C-Max and T-Max of Blood TFV and FTC levels at single dose phase, by site and overall, Evaluable Population
Measured: after 14th daily tablet
Secondary outcomes (3)
Pharmacodynamics
Anti-HIV and anti-HSV activity in CVL
Anti-HIV and anti-HSV activity as a percent of anti-HIV and anti-HSV activity before exposure to test product
Measured: 5 hours after first tablet insertion and after 7th and 14th daily tablet
Disintegration
Medians and interquartile ranges of (a) time to disintegration (tablet no longer coherent but residual product is visible) and (b) time to complete disappearance
Measured: 5 hours after first tablet insertion and after 7th and 14th daily tablet
Acceptability
Responses on acceptability questionnaires
Measured: 5 hours after first tablet insertion and after 7th and 14th daily tablet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startFeb 2013
- Primary completionDec 2013
- Study completionDec 2013
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- CONRAD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jill Schwartz, MD, Study director, CONRAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694407
- Sponsor's protocol ID
- A11-117
- Status last verified
- Mar 2015
- First submitted
- 17 Jul 2012
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial Assessing the Safety, Pharmacokinetics, Pharmacodynamics, and Disintegration Time of Vaginal Tablets Containing Tenofovir and/or Emtricitabine
- ClinicalTrials.gov ID
- NCT01694407
- Acronym / sponsor ID
- A11-117
- Conditions
- HIV
- Keywords
- Prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- CONRADUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Sep 2012 (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 prospective, double-blinded, randomized, parallel cohort study will examine the genital and systemic safety, pharmacokinetics (PK), pharmacodynamics (PD), disintegration and disappearance times, and acceptability of four vaginal tablets: 1) Tenofovir (TFV) alone; 2) Emtricitabine (FTC) alone; 3) TFV combined with FTC; and 4) placebo. Participants will be randomized to treatment group, to number of tablets to be inserted in the Single Use Phase (1 tablet or 1 tablet followed by a second tablet two hours later to mimic the BAT24 dosing regimen), and to one of four collection time points (2, 4, 6, or 24 hours after tablet insertion) for assessments only after the last dose of the Multiple Use Phase.
In the Single Use Phase of the study, the participant will insert one tablet in the clinic to estimate times to disintegration and disappearance. Those randomized to two tablets will insert a second tablet 2 hours later. In all women, sample collection will occur 5 hours after the initial tablet insertion.
In the Multiple Use Phase of the study, participants will insert a tablet once daily for 14 days. The 1st, 7th, and 14th tablets will be inserted in the clinic; the remaining tablets will be inserted at home. The clinic will call the participant on day 3 of the multiple use phase to ask about any symptoms the participant may be experiencing. Each insertion in the clinic will be followed by sample collection and, at Visits 4 and 6, colposcopy at the participant's assigned time point.
Detailed description
Objectives:
Primary:
- To assess genital safety after a single use (consisting of one tablet in half of participants and one tablet followed by a second tablet two hours later in the other half) and during and after two weeks of daily tablet use
- To assess systemic safety after two weeks of daily tablet use
- To assess the pharmacokinetics (PK) of TFV and FTC after a single use (as defined above) and during and after two weeks of daily tablet use
Secondary:
- To estimate the time needed for tablet disintegration and the time needed for full tablet disappearance
- To assess acceptability of the tablet
- To assess indicators of the pharmacodynamics (PD) of TFV and FTC in vitro using biological samples (fluids) from study participants obtained before use, after a single (use as define above), and after two weeks of daily tablet use
Exploratory:
•To assess exploratory indicators of the PD of TFV and FTC in vitro using biological samples (tissues) from study participants obtained before use, after a single use (as defined above), and after two weeks of daily tablet use
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TFV Alone Vaginal Tablet | Active comparator | Drug: Tenofovir (TFV) Alone Vaginal Tablet |
| Emtricitabine (FTC) Alone Vaginal Tablet | Active comparator | Drug: Emtricitabine (FTC) Alone Vaginal Tablet |
| TFV Combined with FTC Vaginal Tablet | Active comparator | Drug: TFV and FTC Combined Vaginal Tablet |
| Placebo Vaginal Tablet | Placebo comparator | Drug: Placebo Vaginal Tablet |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- General good health (by volunteer history and per investigator discretion) without any clinically significant systemic disease (including, but not limited to significant liver disease/hepatitis, gastrointestinal disease, kidney disease, thyroid disease, osteoporosis or bone disease, and diabetes)
- Currently having regular menstrual cycles of 25 - 35 days by participant report
- History of Pap smears and follow-up consistent with American Congress of Obstetricians and Gynecologist (ACOG) practice guidelines #99 and #109 or willing to undergo a Pap smear at Visit 1
- Protected from pregnancy, meaning one of the following:
- Couple is using condoms and is willing to use non-spermicidally lubricated condoms throughout the study or
Key exclusion criteria (22 listed)
- History of hysterectomy
- Currently pregnant or within two calendar months from the last pregnancy outcome. Note: If recently pregnant must have had at least two spontaneous menses since pregnancy outcome
- Use of any hormonal contraceptive method in the last 30 days (oral, transdermal, transvaginal, implant, or hormonal intrauterine contraceptive device)
- Injection of Depo-Provera in the last 6 months
- Current use of IUD
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 (TFV) Alone Vaginal Tabletvaginal tablet containing 40 mg of TFV | Drug | TFV Alone Vaginal Tablet |
| Emtricitabine (FTC) Alone Vaginal TabletVaginal Tablet containing 40 mg of TFV | Drug | Emtricitabine (FTC) Alone Vaginal Tablet |
| TFV and FTC Combined Vaginal Tabletvaginal tablet with 40 mg TFV and 40 mg FTC | Drug | TFV Combined with FTC Vaginal Tablet |
| Placebo Vaginal TabletVaginal Tablet containing no drug | Drug | Placebo Vaginal Tablet |
Primary outcome
Changes in Genitourinary AEs
Time frame: 5 hours after first tablet insertion and after 7th and 14th daily tablet
Genitourinary AEs, moderate to severe
Changes on physical examination and colposcopy
Time frame: 5 hours after first tablet insertion and after 7th and 14th daily tablet
Changes on physical examination and colposcopy
Changes Soluble markers of mucosal immunity, immune cell numbers, & characteristics in CVL
Time frame: 5 hours after first tablet insertion and after 7th and 14th daily tablet
Changes Soluble markers of mucosal immunity, immune cell numbers, \& characteristics in CVL
Changes in Number, phenotype and activation status of immune cells in cervicovaginal mucosa
Time frame: 5 hours after first tablet insertion and after 7th and 14th daily tablet
Changes in Number, phenotype and activation status of immune cells in cervicovaginal mucosa
Changes in Mucosal histology in cervicovaginal tissue
Time frame: 5 hours after first tablet insertion and after 7th and 14th daily tablet
Changes in Mucosal histology in cervicovaginal tissue
Changes in Changes in microflora
Time frame: 5 hours after first tablet insertion and after 7th and 14th daily tablet
Changes in Changes in microflora (semiquantitative cultures and unculturable species)
Changes in Systemic laboratory tests
Time frame: 5 hours after first tablet insertion and after 7th and 14th daily tablet
Changes in Systemic laboratory tests
TFV & FTC concentrations in plasma, vaginal aspirate, & genital tissue
Time frame: 5 hours after first tablet insertion
TFV \& FTC concentrations in plasma, vaginal aspirate, \& genital tissue Pharmacokinetics Mean (SD) and Median (Min, Max, C-Max, T-Max) of TFV and FTC in blood, vaginal aspirate,and genital tissue at Visit 2, 3, 4, 5, 6
TFV-DP and FTC-TP concentrations in PBMCs, endocervical cells, & genital tissue
Time frame: 5 hours after first tablet insertion
TFV-DP and FTC-TP concentrations in PBMCs, endocervical cells, \& genital tissue Pharmacokinetics C-Max and T-Max of Blood TFV and FTC levels at single dose phase, by site and overall, Evaluable Population
TFV & FTC concentrations in plasma, vaginal aspirate, & genital tissue
Time frame: after 7th daily tablet
TFV \& FTC concentrations in plasma, vaginal aspirate, \& genital tissue Pharmacokinetics Mean (SD) and Median (Min, Max, C-Max, T-Max) of TFV and FTC in blood, vaginal aspirate,and genital tissue at Visit 2, 3, 4, 5, 6
TFV & FTC concentrations in plasma, vaginal aspirate, & genital tissue
Time frame: after 14 daily tablet insertion
TFV \& FTC concentrations in plasma, vaginal aspirate, \& genital tissue Pharmacokinetics Mean (SD) and Median (Min, Max, C-Max, T-Max) of TFV and FTC in blood, vaginal aspirate,and genital tissue at Visit 2, 3, 4, 5, 6
TFV-DP and FTC-TP concentrations in PBMCs, endocervical cells, & genital tissue
Time frame: after 7th daily tablet
TFV-DP and FTC-TP concentrations in PBMCs, endocervical cells, \& genital tissue Pharmacokinetics C-Max and T-Max of Blood TFV and FTC levels at single dose phase, by site and overall, Evaluable Population
TFV-DP and FTC-TP concentrations in PBMCs, endocervical cells, & genital tissue
Time frame: after 14th daily tablet
TFV-DP and FTC-TP concentrations in PBMCs, endocervical cells, \& genital tissue Pharmacokinetics C-Max and T-Max of Blood TFV and FTC levels at single dose phase, by site and overall, Evaluable Population
3 secondary outcomes
Pharmacodynamics
Time frame: 5 hours after first tablet insertion and after 7th and 14th daily tablet
Disintegration
Time frame: 5 hours after first tablet insertion and after 7th and 14th daily tablet
Acceptability
Time frame: 5 hours after first tablet insertion and after 7th and 14th daily tablet
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 3 Apr 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, MD study director
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 (TFV) Alone Vaginal Tablet, Emtricitabine (FTC) Alone Vaginal Tablet and TFV and FTC Combined Vaginal Tablet in people with HIV, 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 15 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 3 Apr 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. 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?
Changes in Genitourinary AEs (time frame: 5 hours after first tablet insertion and after 7th and 14th daily tablet). The study lists 13 primary outcomes in all. 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 3 Apr 2015.