Status:
COMPLETED
Safety, PK, and PD Study of a Vaginal Insert Containing TAF and EVG
Lead Sponsor:
CONRAD
Collaborating Sponsors:
Eastern Virginia Medical School
United States Agency for International Development (USAID)
Conditions:
Hiv
HSV
Eligibility:
FEMALE
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this Phase I study is to assess the safety, pharmacokinetics, and pharmacodynamics of a combination vaginal insert containing tenofovir alafenamide (TAF) and elvitegravir (EVG). This s...
Detailed Description
This Phase I study aims to complete at least 16 healthy, non-pregnant, HIV-uninfected women aged 18-50 years who are not at risk for pregnancy and are at low risk for sexually transmitted infections (...
Eligibility Criteria
Inclusion
- Age 18 to 50 years, inclusive
- General good health (by volunteer history and per investigator judgment) without any clinically significant systemic disease (including, but not limited to significant liver disease/hepatitis, gastrointestinal disease, kidney disease, thyroid disease, bone disease, and diabetes) and with an intact uterus and cervix.
- History of regular menstrual cycles, by volunteer report (for cycling women)
- History of Pap smears and follow-up consistent with standard clinical practice as outlined in the Study Manual or willing to undergo a Pap smear at Visit 1
- Able to communicate in spoken and written English
- Willing to give voluntary consent and sign an informed consent form
- Willing and able to comply with protocol requirements, including abstaining from vaginal activity and product use at specified times
- Must be protected from pregnancy by one of the following:
- Hormonal methods, except vaginal rings and DMPA
- Copper IUD
- Sterilization of participant or partner
- Consistent condom use
- Abstinence from penile-vaginal intercourse
- Same sex relationship
- If in a relationship, must be in a mutually monogamous relationship with a partner who is not known to be HIV positive and has no known risk of sexually transmitted infections (STIs)
Exclusion
- Positive pregnancy test or plans to become pregnant during the course of the study
- Currently breastfeeding or planning to breastfeed during the course of the study
- History of sensitivity/allergy to any component of the study product, topical anesthetic, or to both silver nitrate and Monsel's solution
- In the last three months, diagnosed with or treated for any STI (For HSV, ideally no outbreaks in the past year. More than two outbreaks in previous 12 month period is exclusionary.)
- Positive test for Trichomonas vaginalis (TV), Neisseria gonorrhea (GC), Chlamydia trachomatis (CT), HIV, or Hepatitis B surface antigen (HBsAg)
- Symptomatic bacterial vaginosis (BV)
- Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting/bleeding, discharge, etc.)
- Known blood disorder, including deep vein thrombosis (DVT) and pulmonary embolism (PE), or those that could lead to prolonged or continuous bleeding with biopsy
- NSAIDS, systemic corticosteroids (e.g. dexamethasone), Endothelin Receptor Antagonists (e.g bosentan), antibiotics, Anticonvulsants (e.g. carbamazepine, oxcarbazepine, phenobarbital, phenytoin), Antimycobacterials (Rifbutin, Rifampin, Rifapentine) anticoagulants or other drugs known to prolong bleeding and/or clotting, antifungals (i.e ketoconazole), or antivirals or antiretroviral (e.g. acyclovir, valacyclovir, Viread®, Atripla®, Emtriva®, or Complera®), St. John's Wort or drugs that may interact with TAF or EVG as specified in the Vitekta and Vemlidy Investigator Brochure, should not be used during the study.
- Current or anticipated chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) or acetominophen for the duration of the study.
- Participation in any other investigational trial with use of a drug/device within the last 30 days or planned participation in any other investigational trial with use of a drug/device during the study
- Grade 2 or higher laboratory abnormality, per the Division of AIDS, National Institute of Allergy and Infectious Disease (DAIDS) Table for Grading the Severity of Adverse Events, or clinically significant laboratory abnormality as determined by the clinician
- Abnormal finding on laboratory or physical examination or a social or medical condition in the volunteer 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 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03762772
Start Date
December 10 2018
End Date
March 20 2019
Last Update
July 16 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Research Center at Eastern Virginia Medical School (NOT RECRUITING ADDITIONAL SITES)
Norfolk, Virginia, United States, 23507