Status:
COMPLETED
Development of a Urine-Based Point-of-Care Test for Adherence to Antiretroviral Drugs
Lead Sponsor:
Rhonda Brand
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Medication Adherence
HIV
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This is a single-center, open label study to identify adherence levels of commonly prescribed FDA-approved antiretroviral agents by tracking the decline of drug concentrations in plasma, urine and sal...
Detailed Description
Poor adherence to antiretroviral (ARV) therapy and HIV pre-exposure prophylaxis (PrEP) incurs costs for patients, health systems, and society. Non-adherence to ARV precedes viral breakthrough and offe...
Eligibility Criteria
Inclusion
- At least 18 years of age at screening, verified per site standard operating procedure (SOP)
- Not pregnant or breastfeeding
- Availability to return for all study visits, barring unforeseen circumstances
- Willing and able to
- communicate in English
- provide written informed consent to take part in the study
- provide adequate locator information, as defined in site SOP
- follow the assigned dosing protocol and maintain an accurate dosing log
- Must agree not to participate in other concurrent interventional and/or drug trials
- Understands and agrees to local sexually transmitted infections (STI) reporting requirements
- HIV-1 seronegative at screening
- Must be in general good health in the opinion of the investigator
- For female participants of reproductive potential: Using an effective method of contraception and intending to continue use of an effective method for the duration of study participation and for 8 weeks after the last dose of study drug. Acceptable methods include:
- hormonal methods
- IUD (intrauterine device)
- sterilization of participant or partner
Exclusion
- Participant reports any of the following at Screening:
- Has plans to relocate away from the study site area during the period of study participation
- Pregnant, less than 3 months post-partum, or lactating
- Intends to become pregnant during the period of study participation
- History of adverse reaction to study drugs
- History of osteoporosis or osteopenia
- PrEP (pre-exposure prophylaxis) or (PEP) post-exposure prophylaxis for HIV exposure within 3 months - prior to screening
- Participating in another research study involving drugs or medical devices within 3 months or 5 half-lives (if known) prior to enrollment
- History of gastric bypass
- History of inflammatory bowel disease
- Currently taking or anticipation of taking any medications on list of prohibited medications as specified in section 4.10.
- Unwilling or unable to comply with study procedures, medications and visits
- Allergies to dyes, excipients and components of drugs
- Condomless insertive or receptive anal intercourse with more than one partner in the past six months
- Known HIV-positive sexual partner within the last 6 months
- History of STI in the last 3 months
- Has any of the following laboratory abnormalities at Screening:
- Note: Grade is per Version 2.1 of the Division of AIDS (DAIDS) Toxicity Table
- Hemoglobin Grade 1 or higher
- Platelet count Grade 1 or higher
- White blood cell count Grade 2 or higher
- Calculated creatinine clearance ≤ 70 mL/minute using the Cockcroft-Gault equation
- Grade 2 or higher ALT and/or AST (i.e., ≥ 2.5x the site laboratory upper limit of normal \[ULN\])
- Total bilirubin Grade 3 or higher
- Positive for Hepatitis B surface antigen (HBsAg)
- Confirmed positive for Hepatitis C antibody (HCV Ab)
- Has any other condition that, in the opinion of the Principal Investigator or designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives
Key Trial Info
Start Date :
August 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04302896
Start Date
August 31 2020
End Date
September 30 2021
Last Update
March 3 2022
Active Locations (1)
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1
HIV/AIDS Clinical Research Unit / University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213