HIV PreventionPhase 1NCT01810315
Influence of Reproductive Cycle and Menopause on HIV-1 Infection and TFV Gel Activity
A Phase 1 study testing TFV 1% gel and Estradiol vaginal cream in people with HIV Prevention, run by CONRAD at 1 site in United States.
Trial summary
Purpose of the study is to assess tenofovir (TFV) PK and PD endpoints, cervicovaginal safety parameters, susceptibility to HIV-1 infection, and objective measures of vaginal applicator use in premenopausal and postmenopausal women. Read more about this study
- Who is it for?
- Ages 21 to 89 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- TFV 1% gel and Estradiol vaginal cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Oct 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 21 to 89 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In good healthsignificant systemic disease
- Not at risk of an STI, meaning: In a monogamous heterosexual or same sex relationship for at least the last four months with a partner who is not known to be HIV positive and has no known risks for STIs OR sexually abstinent
- Willing and able to comply with study procedures
- Normal Pap smear (by written report) in the past year.
- 21-to-45 years of age
- Not at risk for pregnancy, meaning:
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- Regular menstrual cycles (every 24 - 35 days)
- Luteal phase P level of greater than or equal to 3 ng/ml
- 46-89 years of age OR both ovaries removed at least 30 days prior to Visit 1
- No menstrual periods/vaginal bleeding in the past 12 months OR both ovaries removed at least 30 days prior to Visit 1
- FSH level of greater than or equal to 20 MIU/ml
Who cannot join
- Clinically significant history of an abnormal Pap smear in the past year
- Surgery or biopsy of the vagina or cervix within 30 days
- Current STI or lower genital tract infection
- Current use of chronic immunosuppressants
- Current presence of vulvar, anal and/or vaginal genital warts
- Current tobacco use of any amount
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- History of sensitivity/allergy to any component of the study product, topical anesthetic, or allergy to silver nitrate and/or Monsel's solution
- Known bleeding disorder that could lead to prolonged or continuous bleeding
- 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 any of the following: corticosteroids, antibiotics, anticoagulants or other drugs known to prolong bleeding and/or clotting, antifungals, antivirals or antiretrovirals.
- Investigator discretion
- Current participation in any other drug or device study
- Use of DMPA in last six months
- Use of any other hormonal contraceptive method without 2 subsequent, normal menses since stopping hormonal contraceptives
- Current use of copper IUD
- Currently pregnant or pregnancy within the past 3 months
- Currently breastfeeding/having breastfed an infant in the last 2 months
- Use of any hormonal medications in the past 30 days
- Contraindications to vaginal estrogen cream
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Center, Eastern Virginia Medical School
Norfolk, Virginia, 23507
About this study
Official title: Influence of Female Reproductive Cycle and Menopause on Cervicovaginal Tissue Susceptibility to HIV-1 Infections and Tenofovir 1% Gel Activity
Purpose of the study is to assess tenofovir (TFV) PK and PD endpoints, cervicovaginal safety parameters, susceptibility to HIV-1 infection, and objective measures of vaginal applicator use in premenopausal and postmenopausal women.
Read the detailed description
Premenopausal women: Baseline blood and genital samples will be taken in the follicular and luteal phase (visits 2 and 3). The participant will be given TFV gel and instructed to insert two doses, separated by 2 hours, and return to the clinic 3 hours after the second insertion for blood and genital samples (visits 4/4a and 5/5a).
Postmenopausal women: Premenopausal women: Baseline blood and genital samples will be taken (visit 2). The participant will be given TFV gel and instructed to insert two doses, separated by 2 hours, and return to the clinic 3 hours after the second insertion for blood and genital samples (visit 3/3a). Estradiol cream will be distributed at visit 4. Post estradiol blood and genital samples will be taken at Visit 5. The participant will given TFV gel and instructed to insert 2 doses as before, while continuing to use the estradiol cream. Post TFV gel and estradiol cream blood and genital samples will be taken (visit 6/6a).
- Conditions
- HIV Prevention
- Being tested
- TFV 1% gel, Estradiol vaginal cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TFV 1% gelDrug
Estradiol vaginal creamDrug
| Study group | Role | What they receive |
|---|---|---|
| Baseline | No intervention | Premenopausal women will undergo baseline sampling in each the follicular and luteal phase. Postmenopausal women will undergo baseline sampling one time. |
| TFV 1% Gel | Experimental | Participants will vaginally insert 1 applicator of TFV gel followed by a 2nd applicator 2 hours later. Each applicator contains 4.4 gm of TFV 1% gel.
Premenopausal women will undergo sampling after TFV gel use in each the follicular and luteal phase. Postmenopausal women will undergo sampling after TFV gel use one time. Receives: Drug: TFV 1% gel |
| Estradiol Vaginal Cream | Experimental | Post menopausal women only: Participants will insert 2 grams of estradiol cream into the vagina every night for 14 days and then one gram of estradiol cream into the vagina every other night Receives: Drug: Estradiol vaginal cream |
| TFV 1% gel and estradiol cream | Experimental | Postmenopausal women only: Participants will vaginally insert 1 applicator of TFV gel followed by a 2nd applicator 2 hours later. Each applicator contains 4.4 gm of TFV 1% gel. In addition, participants will one gram of estradiol cream into the vagina every other night. Receives: Drug: TFV 1% gel; Drug: Estradiol vaginal cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of tenofovir in plasma, vaginal aspirate, and genital tissue
Measured: 3 hours after dosing
Concentrations of TFV-DP in genital tissue
Measured: 3 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2014
- Study completionOct 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CONRAD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810315
- Sponsor's protocol ID
- A12-124
- Status last verified
- Apr 2015
- First submitted
- 11 Mar 2013
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Female Reproductive Cycle and Menopause on Cervicovaginal Tissue Susceptibility to HIV-1 Infections and Tenofovir 1% Gel Activity
- ClinicalTrials.gov ID
- NCT01810315
- Acronym / sponsor ID
- A12-124
- Conditions
- HIV Prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CONRADUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 13 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.
Purpose of the study is to assess tenofovir (TFV) PK and PD endpoints, cervicovaginal safety parameters, susceptibility to HIV-1 infection, and objective measures of vaginal applicator use in premenopausal and postmenopausal women.
Detailed description
Premenopausal women: Baseline blood and genital samples will be taken in the follicular and luteal phase (visits 2 and 3). The participant will be given TFV gel and instructed to insert two doses, separated by 2 hours, and return to the clinic 3 hours after the second insertion for blood and genital samples (visits 4/4a and 5/5a).
Postmenopausal women: Premenopausal women: Baseline blood and genital samples will be taken (visit 2). The participant will be given TFV gel and instructed to insert two doses, separated by 2 hours, and return to the clinic 3 hours after the second insertion for blood and genital samples (visit 3/3a). Estradiol cream will be distributed at visit 4. Post estradiol blood and genital samples will be taken at Visit 5. The participant will given TFV gel and instructed to insert 2 doses as before, while continuing to use the estradiol cream. Post TFV gel and estradiol cream blood and genital samples will be taken (visit 6/6a).
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Baseline | No intervention | –Premenopausal women will undergo baseline sampling in each the follicular and luteal phase. Postmenopausal women will undergo baseline sampling one time. |
| TFV 1% Gel | Experimental | Drug: TFV 1% gelParticipants will vaginally insert 1 applicator of TFV gel followed by a 2nd applicator 2 hours later. Each applicator contains 4.4 gm of TFV 1% gel. Premenopausal women will undergo sampling after TFV gel use in each the follicular and luteal phase. Postmenopausal women will undergo sampling after TFV gel use one time. |
| Estradiol Vaginal Cream | Experimental | Drug: Estradiol vaginal creamPost menopausal women only: Participants will insert 2 grams of estradiol cream into the vagina every night for 14 days and then one gram of estradiol cream into the vagina every other night |
| TFV 1% gel and estradiol cream | Experimental | Drug: TFV 1% gel, Drug: Estradiol vaginal creamPostmenopausal women only: Participants will vaginally insert 1 applicator of TFV gel followed by a 2nd applicator 2 hours later. Each applicator contains 4.4 gm of TFV 1% gel. In addition, participants will one gram of estradiol cream into the vagina every other night. |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- In good healthsignificant systemic disease
- Not at risk of an STI, meaning: In a monogamous heterosexual or same sex relationship for at least the last four months with a partner who is not known to be HIV positive and has no known risks for STIs OR sexually abstinent
- Willing and able to comply with study procedures
- Normal Pap smear (by written report) in the past year.
- 21-to-45 years of age
Key exclusion criteria (19 listed)
- Clinically significant history of an abnormal Pap smear in the past year
- Surgery or biopsy of the vagina or cervix within 30 days
- Current STI or lower genital tract infection
- Current use of chronic immunosuppressants
- Current presence of vulvar, anal and/or vaginal genital warts
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 |
|---|---|---|
| TFV 1% gel | Drug | TFV 1% Gel, TFV 1% gel and estradiol cream |
| Estradiol vaginal cream | Drug | Estradiol Vaginal Cream, TFV 1% gel and estradiol cream |
Primary outcome
Concentrations of tenofovir in plasma, vaginal aspirate, and genital tissue
Time frame: 3 hours after dosing
Concentrations of TFV-DP in genital tissue
Time frame: 3 hours after dosing
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 10 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TFV 1% gel and Estradiol vaginal cream in people with HIV Prevention, run by CONRAD 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 11 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 10 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 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?
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?
Concentrations of tenofovir in plasma, vaginal aspirate, and genital tissue (time frame: 3 hours after dosing). 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 10 Apr 2015.