Status:
COMPLETED
In Vivo Drug Interaction Pharmacokinetic Study of Tenofovir 1% Gel and Three Commonly Used Vaginal Products
Lead Sponsor:
CONRAD
Conditions:
HIV Prevention
Eligibility:
FEMALE
18-50 years
Phase:
PHASE1
Brief 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
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 us...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01813162
Start Date
December 1 2013
End Date
December 1 2014
Last Update
May 22 2015
Active Locations (2)
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1
Dept of OBGYN and Reproductive Sciences, UCSF
San Francisco, California, United States
2
Bronx-Lebanon Hospital Center
The Bronx, New York, United States