PreventionPhase 1NCT01369303
Pharmacokinetic and Pharmacodynamic Study of Tenofovir 1% Gel
A Phase 1 study testing Tenofovir 1% vaginal gel in people with Prevention, run by CONRAD at 5 sites in 2 countries.
Trial summary
The purpose of the study is to obtain data on the pharmacokinetics (PK) and pharmacodynamics (PD) and immune system effect of the BAT24 dosing regimen versus daily and pericoital dosing regimens with vaginal use of tenofovir 1% gel after a single sex act and after multiple sex acts. 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
- Prevention
- What is being tested?
- Tenofovir 1% vaginal gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jan 2012to May 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
- Age 18-50 years, inclusive;
- 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 type 2 diabetes);
- Currently having regular menstrual cycles, if not on hormonal (including continuous) contraception, by volunteer report and per investigator discretion;
- History of Pap smears and follow-up consistent with American Congress of Obstetricians and Gynecologist (ACOG) practice guideline #109 (see study manual) or willing to undergo a Pap smear at Visit 1. (Note: See study manual for clarification of eligibility criteria specific to Pap smear results.)
- Willing to abstain from the use of any vaginal product other than the study gel including spermicides, lubricants, vaginal hygiene products, contraceptive intravaginal ring, diaphragms, and cervical caps (non-hormonal IUC if used as her method of contraception, is allowed) for the duration of the study;
- In a monogamous relationship for at least the last four months with a male partner, at least 18 years old with no known risks for STIs, and not known to be HIV positive, who is willing and able to comply with the study requirements, and with whom condoms are not typically used;
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- Protected from pregnancy by sterilization of either partner, use of combination oral contraceptives or patch for at least two cycles, or non-hormonal intrauterine contraception throughout the study. Continuous oral contraceptives are allowable if the patient is at low risk for breakthrough bleeding;
- Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to easy genital tract sample collection;
- Negative urine pregnancy test; and
- 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 Depo-Provera in the last 120 days;
- Currently breastfeeding or having breastfed an infant in the last two months, or planning to breastfeed during the course of the study;
- History of sensitivity/allergy to any component of the study product, 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;
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- Symptomatic vulvovaginal candidiasis, Nugent score greater than equal to 7 at screening or symptomatic bacterial vaginosis (BV) at Visit 2, 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 a sexually transmitted infection;
- 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 DAIDS Table for Grading the Severity of Adverse Events;
- Systemic use in the last two weeks or anticipated use during the study of drugs on a daily basis that may reduce renal function (e.g., ibuprofen) or liver function (e.g., Tylenol®), or that may affect anti-HSV activity (e.g., acyclovir or valacyclovir) of any of the following: corticosteroids, antibiotics, antifungals, antivirals (e.g. acyclovir or valacylovir) or antiretrovirals (e.g. Viread®). Note: Participants should avoid nonsteroidal 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 for 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; and
- 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
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Advances in Health, Inc.
Houston, Texas, 77030
Eastern Virginia Medical School
Norfolk, Virginia, 23507
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213
Dominican Republic1 site
Profamilia
Santo Domingo, Dominican Republic
About this study
Official title: Pharmacokinetic and Pharmacodynamic Study of Tenofovir 1% Gel Using the Bat 24 Regimen Versus Daily and Pericoital Dosing
The purpose of the study is to obtain data on the pharmacokinetics (PK) and pharmacodynamics (PD) and immune system effect of the BAT24 dosing regimen versus daily and pericoital dosing regimens with vaginal use of tenofovir 1% gel after a single sex act and after multiple sex acts.
- Conditions
- Prevention
- Being tested
- Tenofovir 1% vaginal gel
- Keywords
- HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir 1% vaginal gelDrug
Tenofovir 1% gel is supplied as a clear, transparent, viscous gel packaged in pre-filled single use applicators. Each applicator contains 4.0 mL of tenofovir gel (equal to 4.4 gm) at a concentration of 1% (weight for weight) formulated in purified water with edetate disodium, citric acid, glycerin, methylparaben, propylparaben and hydroxyethylcellulose, and is pH adjusted to 4-5.
| Study group | Role | What they receive |
|---|---|---|
| Daily dosing | Experimental | Tenofovir 1% gel will be inserted each day or evening at about the same time with the last study-sex 12 hours after the final dose Receives: Drug: Tenofovir 1% vaginal gel |
| BAT24 dosing | Experimental | Tenofovir 1% gel will be inserted 1 hour before and 1 hour after sex Receives: Drug: Tenofovir 1% vaginal gel |
| Pericoital dosing | Experimental | Tenofovir 1% gel will be inserted either 1 hour before sex OR 1 hour after sex Receives: Drug: Tenofovir 1% vaginal gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
TFV concentrations in blood plasma, aspirate and tissue and TFV-DP concentrations in PBMCs, endocervical cells and tissue to evaluate if a single precoital or postcoital dose provides concentrations similar to BAT24 after a single sex act.
Each participant will be randomized to one of nine groups: (dosing regimen: BAT24, precoital or postcoital) x (sample collection time-point: 4, 12 or 72 hours after the single act of study-related sex). Approximately 30 women will be assigned to each dosing regimen.
Measured: Assigned time-point after a single act of study-related sex
TFV concentrations in blood plasma, aspirate and tissue and TFV-DP concentrations in PBMCs, endocervical cells and tissue to evaluate if daily or intermittent pericoital dosing provides concentrations similar to BAT24 after two weeks of twice weekly sex
Participants will be randomized to 1 of 12 groups: (dosing regimen: BAT24, precoital, postcoital or daily) x (sample collection time-point: 4, 12 or 72 hrs after the last act of study-related sex). 30 women will be assigned to each the BAT24 and daily dosing regimens; 15 will be assigned to each the pre- and postcoital dosing regimens. Those assigned to the BAT24 or a pericoital regimen will have study-related sex twice weekly for 2 weeks. Those assigned to the daily regimen will use the gel at about the same time each day for 2 weeks and to have sex at least twice each week.
Measured: Assigned time-point after the last act of study-related sex
Secondary outcomes (3)
Characterize anti-HIV and anti-HSV activity of cervicovaginal lavages (CVLs) at baseline and after a single sex act using BAT24 and a single precoital or postcoital dose of TFV gel
Measured: Assigned time-point after a single act of study-related sex
Anti-HIV and anti-HSV activity of CVLs after two weeks of twice weekly sex using BAT24, daily and pericoital dosing of TFV gel
Measured: Assigned time-point after the last act of study-related sex
Compare genitourinary adverse events (AEs) after administration of TFV gel
Measured: Assigned time-point after study-related sex (single act and two weeks of twice weekly study-related sex)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startJan 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- CONRAD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jill Schwartz, M.D., Study director, CONRAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369303
- Sponsor's protocol ID
- A10-113
- Status last verified
- Dec 2013
- First submitted
- 7 Jun 2011
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic and Pharmacodynamic Study of Tenofovir 1% Gel Using the Bat 24 Regimen Versus Daily and Pericoital Dosing
- ClinicalTrials.gov ID
- NCT01369303
- Acronym / sponsor ID
- A10-113
- Conditions
- Prevention
- Keywords
- HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- CONRADUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 8 Jun 2011 (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 to obtain data on the pharmacokinetics (PK) and pharmacodynamics (PD) and immune system effect of the BAT24 dosing regimen versus daily and pericoital dosing regimens with vaginal use of tenofovir 1% gel after a single sex act and after multiple sex acts.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Daily dosing | Experimental | Drug: Tenofovir 1% vaginal gelTenofovir 1% gel will be inserted each day or evening at about the same time with the last study-sex 12 hours after the final dose |
| BAT24 dosing | Experimental | Drug: Tenofovir 1% vaginal gelTenofovir 1% gel will be inserted 1 hour before and 1 hour after sex |
| Pericoital dosing | Experimental | Drug: Tenofovir 1% vaginal gelTenofovir 1% gel will be inserted either 1 hour before sex OR 1 hour after sex |
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) 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 type 2 diabetes);
- Currently having regular menstrual cycles, if not on hormonal (including continuous) contraception, by volunteer report and per investigator discretion;
- History of Pap smears and follow-up consistent with American Congress of Obstetricians and Gynecologist (ACOG) practice guideline #109 (see study manual) or willing to undergo a Pap smear at Visit 1. (Note: See study manual for clarification of eligibility criteria specific to Pap smear results.)
- Willing to abstain from the use of any vaginal product other than the study gel including spermicides, lubricants, vaginal hygiene products, contraceptive intravaginal ring, diaphragms, and cervical caps (non-hormonal IUC if used as her method of contraception, is allowed) for the duration of the study;
Key exclusion criteria (19 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 Depo-Provera in the last 120 days;
- Currently breastfeeding or having breastfed an infant in the last two months, or planning to breastfeed during the course of the study;
- History of sensitivity/allergy to any component of the study product, topical anesthetic, or allergy to both silver nitrate and Monsel's solution;
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% vaginal gelTenofovir 1% gel is supplied as a clear, transparent, viscous gel packaged in pre-filled single use applicators. Each applicator contains 4.0 mL of tenofovir gel (equal to 4.4 gm) at a concentration of 1% (weight for weight) formulated in purified water with edetate disodium, citric acid, glycerin, methylparaben, propylparaben and hydroxyethylcellulose, and is pH adjusted to 4-5. | Drug | BAT24 dosing, Daily dosing, Pericoital dosing |
Primary outcome
TFV concentrations in blood plasma, aspirate and tissue and TFV-DP concentrations in PBMCs, endocervical cells and tissue to evaluate if a single precoital or postcoital dose provides concentrations similar to BAT24 after a single sex act.
Time frame: Assigned time-point after a single act of study-related sex
Each participant will be randomized to one of nine groups: (dosing regimen: BAT24, precoital or postcoital) x (sample collection time-point: 4, 12 or 72 hours after the single act of study-related sex). Approximately 30 women will be assigned to each dosing regimen.
TFV concentrations in blood plasma, aspirate and tissue and TFV-DP concentrations in PBMCs, endocervical cells and tissue to evaluate if daily or intermittent pericoital dosing provides concentrations similar to BAT24 after two weeks of twice weekly sex
Time frame: Assigned time-point after the last act of study-related sex
Participants will be randomized to 1 of 12 groups: (dosing regimen: BAT24, precoital, postcoital or daily) x (sample collection time-point: 4, 12 or 72 hrs after the last act of study-related sex). 30 women will be assigned to each the BAT24 and daily dosing regimens; 15 will be assigned to each the pre- and postcoital dosing regimens. Those assigned to the BAT24 or a pericoital regimen will have study-related sex twice weekly for 2 weeks. Those assigned to the daily regimen will use the gel at about the same time each day for 2 weeks and to have sex at least twice each week.
3 secondary outcomes
Characterize anti-HIV and anti-HSV activity of cervicovaginal lavages (CVLs) at baseline and after a single sex act using BAT24 and a single precoital or postcoital dose of TFV gel
Time frame: Assigned time-point after a single act of study-related sex
Anti-HIV and anti-HSV activity of CVLs after two weeks of twice weekly sex using BAT24, daily and pericoital dosing of TFV gel
Time frame: Assigned time-point after the last act of study-related sex
Compare genitourinary adverse events (AEs) after administration of TFV gel
Time frame: Assigned time-point after study-related sex (single act and two weeks of twice weekly study-related sex)
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 12 Dec 2013.
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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 director
CONRAD
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tenofovir 1% vaginal gel in people with Prevention, run by CONRAD at 5 sites in 2 countries.
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 19 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 12 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Dominican Republic. 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 blood plasma, aspirate and tissue and TFV-DP concentrations in PBMCs, endocervical cells and tissue to evaluate if a single precoital or postcoital dose provides concentrations similar to BAT24 after a single sex act. (time frame: Assigned time-point after a single act of study-related sex). The study lists 2 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 12 Dec 2013.