In Vivo Drug Interaction Pharmacokinetic Study of Tenofovir 1% Gel and Three Commonly Used Vaginal Products
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ClinicalTrials.gov Identifier: NCT01813162 |
Recruitment Status
:
Completed
First Posted
: March 18, 2013
Last Update Posted
: May 22, 2015
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Condition or disease | Intervention/treatment | Phase |
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HIV Prevention | Drug: Tenofovir 1% gel Drug: Vaginal product | Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 101 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Official Title: | In Vivo Drug Interaction Pharmacokinetic Study of Tenofovir 1% Gel and Three Commonly Used Vaginal Products |
Study Start Date : | December 2013 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Tenofovir 1% gel
Participants will vaginally insert 1 applicator of TFV gel twice a day for 7 days, with each dose inserted approximately 12 hours after the previous dose (for a total of 13 doses). Each applicator contains 4.4 gm of TFV 1% gel.
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Drug: Tenofovir 1% gel |
Active Comparator: Vaginal product alone
Participants will use their assigned vaginal product for 5 to 21 days depending on the dosing instructions for the particular product:
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Drug: Vaginal product
Other Names:
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Experimental: Vaginal product and Tenofovir 1% gel
Tenofovir gel: Participants will vaginally insert 1 applicator of TFV gel twice a day for 7 days, with each dose inserted approximately 12 hours after the previous dose (for a total of 13 doses). Each applicator contains 4.4 gm of TFV 1% gel. In addition, Participants will use their assigned vaginal product for 5 to 21 days depending on the dosing instructions for the particular product:
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Drug: Tenofovir 1% gel
Drug: Vaginal product
Other Names:
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- TFV concentrations in plasma and genital tissue and TFV-DP concentrations in genital tissue [ Time Frame: Assessments will be after product use (see description) ]
Vaginal product alone: Participant will use assigned product per dosing instructions (antifungal cream: 7 days; antimicrobial gel: 5 days; IVR: 21 days). In cream or gel cohorts, blood will be drawn 6 hrs after last use. In contraceptive ring cohort, blood will be drawn after 21 days of use at 0/4,6,10&24 hrs.
TFV gel alone: Participant will use TFV gel for 7 days, inserted 2X a day. In cream/gel cohorts blood will be drawn 4 hrs after last TFV gel use. In contraceptive ring cohort blood will be drawn 4,6,10&24 hrs after last TFV gel use. Vaginal biopsy will occur 6 hrs after last TFV gel use for all.
Vaginal product & TFV gel: Participant will use assigned product per dosing instructions. TFV gel will be used for 7 days, 2X a day. In gel/cream cohorts blood will be drawn 4 hrs after last TFV gel use. In contraceptive ring cohort blood will be drawn 4,6,10&24 hrs after last dose of TFV gel. Vaginal biopsy will occur 6 hrs after the last dose of TFV gel for all.
- Vaginal product concentration in plasma [ Time Frame: Assessments will be after product use (see description) ]
Vaginal product alone: Participant will use assigned product per dosing instructions (antifungal cream: 7 days; antimicrobial gel: 5 days; IVR: 21 days). In cream or gel cohorts, blood will be drawn 6 hrs after last use. In contraceptive ring cohort, blood will be drawn after 21 days of use at 0/4,6,10&24 hrs.
TFV gel alone: Participant will use TFV gel for 7 days, inserted 2X a day. In cream/gel cohorts blood will be drawn 4 hrs after last TFV gel use. In contraceptive ring cohort blood will be drawn 4,6,10&24 hrs after last TFV gel use.
Vaginal product & TFV gel: Participant will use assigned product per dosing instructions. TFV gel will be used for 7 days, 2X a day. In gel/cream cohorts blood will be drawn 4 hrs after last TFV gel use. In contraceptive ring cohort blood will be drawn 4,6,10&24 hrs after last dose of TFV gel.
- Genitourinary adverse events (AEs) [ Time Frame: Assessments will be after product use (see description) ]
Vaginal product alone: Participant will use assigned product per dosing instructions (antifungal cream: 7 days; antimicrobial gel: 5 days; IVR: 21 days). Genitourinary AEs will be assessed by participant report and exam after completion of dosing.
TFV gel alone: Participant will use TFV gel for 7 days, inserted 2X a day. Genitourinary AEs will be assessed by participant report and exam after completion of dosing.
Vaginal product & TFV gel: Participant will use assigned product per dosing instructions. TFV gel will be used for 7 days, 2X a day. Genitourinary AEs will be assessed by participant report and exam after completion of dosing.

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 Criteria:
- 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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01813162
United States, California | |
Dept of OBGYN and Reproductive Sciences, UCSF | |
San Francisco, California, United States | |
United States, New York | |
Bronx-Lebanon Hospital Center | |
Bronx, New York, United States |
Study Chair: | Jill Schwartz, M.D. | CONRAD |
Responsible Party: | CONRAD |
ClinicalTrials.gov Identifier: | NCT01813162 History of Changes |
Other Study ID Numbers: |
A11-118 |
First Posted: | March 18, 2013 Key Record Dates |
Last Update Posted: | May 22, 2015 |
Last Verified: | May 2015 |
Additional relevant MeSH terms:
Tenofovir Terconazole Metronidazole Contraceptive Agents Ethinyl Estradiol Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Anti-Retroviral Agents Anti-HIV Agents Reproductive Control Agents Physiological Effects of Drugs Antiprotozoal Agents Antiparasitic Agents Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antifungal Agents |