HIV PreventionPhase 1NCT02245945
Safety and Acceptability of Tenofovir 1% Gel in Adolescent Females
A Phase 1 study testing TFV 1% vaginal gel in people with HIV Prevention, run by CONRAD at 2 sites in United States.
Trial summary
The purpose of this trial is to assess the safety and acceptability of Tenofovir (TFV) 1% gel in adolescent females over 12 weeks of a minimum of twice weekly dosing following the BAT24 regimen. Read more about this study
- Who is it for?
- Ages 15 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- TFV 1% vaginal gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento Apr 2015
- 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 15 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 15 through 17 years, inclusive, as per site policy
- 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)
- Able to communicate in spoken and written English
- Willing to following instructions regarding vaginal activity and vaginal products as follows:
- Willing to abstain from all vaginal activity, including intercourse, for 48 hours prior to Visit 2 and 48 hours prior to Visit 7
- Willing to abstain from the use of vaginal products other than the study product including spermicides, lubricants, and douches for the duration of study participation.
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- Note: Tampons may be used for menses, but pads should be used for any other intermenstrual spotting or bleeding.
- Assessment of onset and progression of puberty as measured by Tanner Stage 4 or 5
- History of consensual penile-vaginal intercourse (at least one episode in participant's lifetime)
- Negative urine pregnancy test
- Use of an effective method of contraception for at least the past 30 days (per participant report) and intended use for the duration of study participation. Effective methods include:
- Hormonal methods (excluding contraceptive ring)
- Intrauterine contraception (IUC)
- Note: An IUC must be in place for at least 15 days prior to enrollment
- Willing to give voluntary assent, and comply with study procedures as required by the protocol assent and willing for parent/guardian to provide written informed consent for participation as per Institutional Review Board (IRB) requirements. Emancipated minors may give their own informed consent.
Who cannot join
- Known adverse reaction to study products (ever) or latex, per participant report
- Non-therapeutic injection drug use in the last 12 calendar months
- Post-exposure prophylaxis (PEP) for HIV-1 exposure within the last 6 calendar months
- Currently pregnant or within 30 days from the last pregnancy outcome.
- Note: If recently pregnant must have had at least two spontaneous menses since pregnancy outcome.
- History of gynecological procedures (including genital piercing) on the external genitalia, vagina or cervix within the last 14 days
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- Intention to become pregnant in the next 6 months
- Currently breastfeeding or having breastfed an infant in the last two months, or planning to breastfeed during the course of the study
- Positive for HIV
- Grade 2 or higher as per the Division of AIDS (DAIDS) Table for Grading Adult and Pediatric Adverse Events, Version 1.0, December 2004 (Clarification dated August 2009) of the following:
- Alanine transaminase (ALT), aspartate aminotransferase (AST)
- Creatinine
- Hemoglobin
- Platelet count
- Hepatitis B surface antigen (HBsAg)
- Note: Otherwise eligible participants with an exclusionary test result(s) listed above may be re-tested a maximum of one time and if a non-exclusionary result is documented within the 30 days of providing informed consent, they may be enrolled.
- Clinically apparent Grade 2 or higher pelvic examination finding (observed by study staff) per the Female Genital Grading Table for Use in Microbicide Studies (Addendum 1 to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 1.0, December 2004 (Clarification dated August 2009)
- Note: 1) Cervical bleeding associated with speculum insertion and/or specimen collection judged to be within the range of normal according to the clinical judgment of the Principal Investigator/designee is considered expected non-menstrual bleeding and is not exclusionary. 2) Otherwise eligible participants with exclusionary pelvic examination findings may be enrolled /randomized if improvement of findings to a non-exclusionary grade or to resolution can be documented within 30 days of providing informed consent for Screening.
- Current pelvic inflammatory disease (PID) or sexually transmitted infection requiring treatment per current Centers for Disease Control and Prevention (CDC) guidelines (e.g., Trichomonas vaginalis, Neisseria gonorrhea (GC), Chlamydia trachomatis (CT), or active herpes outbreak)
- Symptomatic vulvovaginal candidiasis, symptomatic bacterial vaginosis (BV) or urinary tract infection (UTI)
- Note: Otherwise eligible participants with symptomatic vulvovaginal candidiasis, BV or UTI prior to genital sampling at Visit 2 will be offered treatment and may be continue in the study after completing treatment and all symptoms and findings have resolved.
- 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®, Stribild®).
- 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
- Any other condition that, in the opinion of the Principal Investigator (PI) or designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Utah
Salt Lake City, Utah, 84112
Albert Einstein College of Medicine
The Bronx, New York, 10451
About this study
Official title: Phase I Safety and Acceptability of Tenofovir 1% Gel in Adolescent Females
The purpose of this trial is to assess the safety and acceptability of Tenofovir (TFV) 1% gel in adolescent females over 12 weeks of a minimum of twice weekly dosing following the BAT24 regimen.
- Conditions
- HIV Prevention
- Being tested
- TFV 1% vaginal gel, HEC Placebo Gel
- Keywords
- HIV, prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TFV 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.
HEC Placebo GelDrug
Placebo gel contains hydroxyethylcellulose (HEC) as the gel thickener, purified water, sodium chloride, sorbic acid and sodium hydroxide. The gel is isotonic and formulated at a pH of 4.4. Each pre-filled applicator will contain approximately 4 mL of placebo gel for delivery.
| Study group | Role | What they receive |
|---|---|---|
| TFV 1% gel | Experimental | Participants will be instructed to use TFV 1% vaginal gel according to the BAT 24 regimen (2 gel doses) at least twice per week, regardless of sexual frequency.
The BAT24 dosing regimen when used with sex is defined as one dose of gel within 12 hours before sex and a second dose of gel as soon as possible within 12 hours after sex and no more than two doses in a 24 hour period. Participants who do engage in sexual intercourse should use the BAT24 regimen with each sex act.
If used without sex, the BAT24 dosing regimen is defined as 2 doses of gel administered 2-24 hours apart, with no more than two doses in a 24 hour period. Receives: Drug: TFV 1% vaginal gel |
| hydroxyethylcellulose (HEC) placebo gel | Placebo comparator | Participants will be instructed to use HEC placebo gel according to the BAT 24 regimen (2 gel doses) at least twice per week, regardless of sexual frequency.
The BAT24 dosing regimen when used with sex is defined as one dose of gel within 12 hours before sex and a second dose of gel as soon as possible within 12 hours after sex and no more than two doses in a 24 hour period. Participants who do engage in sexual intercourse should use the BAT24 regimen with each sex act.
If used without sex, the BAT24 dosing regimen is defined as 2 doses of gel administered 2-24 hours apart, with no more than two doses in a 24 hour period. Receives: Drug: HEC Placebo Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in genitourinary adverse events (AEs)
Number of genitourinary adverse events (AEs)
Measured: 24 hours after single dose; 1, 2, 4, 8 and 12 weeks during/after repeat dosing
Changes in soluble markers of inflammation in cervicovaginal fluid (CVF)
changes in soluble markers of inflammation in cervicovaginal fluid (CVF)
Measured: Baseline; 24 hours after single dose; 12 weeks after repeat dosing
Changes in vaginal microflora as assessed by Gram stain and semi-quantitative vaginal culture
Changes in vaginal microflora as assessed by Gram stain and semi-quantitative vaginal culture
Measured: Baseline and 12 weeks after repeat dosing
Secondary outcomes (6)
Responses to key questions on acceptability questionnaire
Responses to key questions on acceptability questionnaire
Measured: 2, 8 and 12 weeks during/after repeat dosing
TFV concentration in plasma
TFV concentration in plasma
Measured: 2 and 24 hours after single dose
TFV concentration in CVF
TFV concentration in CVF
Measured: 24 hours after single does; 2, 4, 8, and 12 weeks during/after repeat dosing
Anti-HIV and anti-herpes simplex virus (HSV)-2 activity in the CVF
Anti-HIV and anti-HSV-2 activity in the CVF
Measured: Baseline; 24 hours after single-dose; 12 weeks after repeat dosing
Real time adherence via internet-based diary
Real time adherence via internet-based diary
Measured: 12 weeks
Biologic markers of adherence via returned empty applicators
Biologic markers of adherence via returned empty applicators
Measured: 2, 4, 8 and 12 weeks during/after repeat dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Primary completionApr 2015
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 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
- NCT02245945
- Sponsor's protocol ID
- A14-130
- Status last verified
- Apr 2015
- First submitted
- 16 Sep 2014
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Safety and Acceptability of Tenofovir 1% Gel in Adolescent Females
- ClinicalTrials.gov ID
- NCT02245945
- Acronym / sponsor ID
- A14-130
- Conditions
- HIV Prevention
- Keywords
- HIV, prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CONRADUniversity, hospital or other
- Primary completion
- Apr 2015 (actual)
- First posted
- 22 Sep 2014 (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 this trial is to assess the safety and acceptability of Tenofovir (TFV) 1% gel in adolescent females over 12 weeks of a minimum of twice weekly dosing following the BAT24 regimen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TFV 1% gel | Experimental | Drug: TFV 1% vaginal gelParticipants will be instructed to use TFV 1% vaginal gel according to the BAT 24 regimen (2 gel doses) at least twice per week, regardless of sexual frequency. The BAT24 dosing regimen when used with sex is defined as one dose of gel within 12 hours before sex and a second dose of gel as soon as possible within 12 hours after sex and no more than two doses in a 24 hour period. Participants who do engage in sexual intercourse should use the BAT24 regimen with each sex act. If used without sex, the BAT24 dosing regimen is defined as 2 doses of gel administered 2-24 hours apart, with no more than two doses in a 24 hour period. |
| hydroxyethylcellulose (HEC) placebo gel | Placebo comparator | Drug: HEC Placebo GelParticipants will be instructed to use HEC placebo gel according to the BAT 24 regimen (2 gel doses) at least twice per week, regardless of sexual frequency. The BAT24 dosing regimen when used with sex is defined as one dose of gel within 12 hours before sex and a second dose of gel as soon as possible within 12 hours after sex and no more than two doses in a 24 hour period. Participants who do engage in sexual intercourse should use the BAT24 regimen with each sex act. If used without sex, the BAT24 dosing regimen is defined as 2 doses of gel administered 2-24 hours apart, with no more than two doses in a 24 hour period. |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Age 15 through 17 years, inclusive, as per site policy
- 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)
- Able to communicate in spoken and written English
- Willing to following instructions regarding vaginal activity and vaginal products as follows:
- Note: Tampons may be used for menses, but pads should be used for any other intermenstrual spotting or bleeding.
Key exclusion criteria (25 listed)
- Known adverse reaction to study products (ever) or latex, per participant report
- Non-therapeutic injection drug use in the last 12 calendar months
- Post-exposure prophylaxis (PEP) for HIV-1 exposure within the last 6 calendar months
- Currently pregnant or within 30 days from the last pregnancy outcome.
- Note: If recently pregnant must have had at least two spontaneous menses since pregnancy outcome.
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% 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 | TFV 1% gel |
| HEC Placebo GelPlacebo gel contains hydroxyethylcellulose (HEC) as the gel thickener, purified water, sodium chloride, sorbic acid and sodium hydroxide. The gel is isotonic and formulated at a pH of 4.4. Each pre-filled applicator will contain approximately 4 mL of placebo gel for delivery. | Drug | hydroxyethylcellulose (HEC) placebo gel |
Primary outcome
Changes in genitourinary adverse events (AEs)
Time frame: 24 hours after single dose; 1, 2, 4, 8 and 12 weeks during/after repeat dosing
Number of genitourinary adverse events (AEs)
Changes in soluble markers of inflammation in cervicovaginal fluid (CVF)
Time frame: Baseline; 24 hours after single dose; 12 weeks after repeat dosing
changes in soluble markers of inflammation in cervicovaginal fluid (CVF)
Changes in vaginal microflora as assessed by Gram stain and semi-quantitative vaginal culture
Time frame: Baseline and 12 weeks after repeat dosing
Changes in vaginal microflora as assessed by Gram stain and semi-quantitative vaginal culture
6 secondary outcomes
Responses to key questions on acceptability questionnaire
Time frame: 2, 8 and 12 weeks during/after repeat dosing
TFV concentration in plasma
Time frame: 2 and 24 hours after single dose
TFV concentration in CVF
Time frame: 24 hours after single does; 2, 4, 8, and 12 weeks during/after repeat dosing
Anti-HIV and anti-herpes simplex virus (HSV)-2 activity in the CVF
Time frame: Baseline; 24 hours after single-dose; 12 weeks after repeat dosing
Real time adherence via internet-based diary
Time frame: 12 weeks
Biologic markers of adherence via returned empty applicators
Time frame: 2, 4, 8 and 12 weeks during/after repeat dosing
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 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, 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 TFV 1% vaginal gel 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 15 inclusion and 25 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: withdrawn, as of the sponsor's last update on 1 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. 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 was withdrawn before enrolling participants, so there are no results.
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 adverse events (AEs) (time frame: 24 hours after single dose; 1, 2, 4, 8 and 12 weeks during/after repeat dosing). The study lists 3 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 1 May 2015.