Status:
COMPLETED
Project ADHERE: Clinical Proof-of-Concept of a Tenofovir (TFV) Aptamer-Based Biosensor
Lead Sponsor:
Eastern Virginia Medical School
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV/AIDS
Adherence, Medication
Eligibility:
FEMALE
18-50 years
Phase:
EARLY_PHASE1
Brief Summary
Truvada®, an oral pill comprised of two anti-retroviral compounds, emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), is currently the only drug combination approved for pre-exposure prophyl...
Detailed Description
Project ADHERE is a pilot, prospective, randomized study which will screen approximately 20 healthy, non-pregnant, HIV negative, premenopausal women (aged 18-50) at Eastern Virginia Medical School (EV...
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, osteoporosis or bone disease, and diabetes) and with an intact gastrointestinal tract, uterus and cervix.
- Estimated calculated creatinine clearance (eCcr) of at least 80 mL/min
- Body Mass Index (BMI) of ≥18 and \<35kg/m2; and a total body weight \>45 kg (99.2 lbs)
- Willing to give voluntary consent and sign an informed consent form
- Willing and able to comply with protocol requirements, including swallowing tablets
- Must be protected from pregnancy by:
- Condoms
- Hormonal contraceptives
- Copper or Levonorgestrel intrauterine device (IUD)
- Sterilization of either partner
- Heterosexual abstinence
- 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 STIs
Exclusion
- Currently pregnant
- Currently breastfeeding or planning to breastfeed during the course of the study
- In the last three months, diagnosed with or treated for any STI
- Positive test for HIV, or Hepatitis B surface antigen (HBsAg)
- Systemic use in the last two weeks or anticipated use during the study of any of the following: antiretrovirals (e.g. Viread®, Atripla®, Emtriva®, or Complera®), or drugs that may interact with TFV (e.g., protease inhibitors, anticonvulsants, antimycobacterials, St. John's Wort).
- 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 2014 update of 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 :
March 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04870671
Start Date
March 25 2021
End Date
January 31 2023
Last Update
January 30 2024
Active Locations (1)
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1
Clinical Research Center, Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507