Development of a Urine-Based Point-of-Care Test for Adherence to Antiretroviral Drugs

• Status: Active, not recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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 saliva following abrupt drug cessation in HIV-negative adults. Results from this study may provide support for development of a point of care urine testing device to monitor drug adherence.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rhonda Brand
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Anti-Retroviral Agents; Dolutegravir; Emtricitabine; Emtricitabine tenofovir alafenamide; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lamivudine; Tenofovir

Criteria

Inclusion Criteria:

1. At least 18 years of age at screening, verified per site standard operating procedure (SOP)

2. Not pregnant or breastfeeding

3. Availability to return for all study visits, barring unforeseen circumstances

4. 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

5. Must agree not to participate in other concurrent interventional and/or drug trials

6. Understands and agrees to local sexually transmitted infections (STI) reporting requirements

7. HIV-1 seronegative at screening

8. Must be in general good health in the opinion of the investigator

9. 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 Criteria:

1. Participant reports any of the following at Screening:

1. Has plans to relocate away from the study site area during the period of study participation

2. Pregnant, less than 3 months post-partum, or lactating

3. Intends to become pregnant during the period of study participation

4. History of adverse reaction to study drugs

5. History of osteoporosis or osteopenia

6. PrEP (pre-exposure prophylaxis) or (PEP) post-exposure prophylaxis for HIV exposure within 3 months - prior to screening

7. Participating in another research study involving drugs or medical devices within 3 months or 5 half-lives (if known) prior to enrollment

8. History of gastric bypass

9. History of inflammatory bowel disease

10. Currently taking or anticipation of taking any medications on list of prohibited medications as specified in section 4.10.

11. Unwilling or unable to comply with study procedures, medications and visits

12. Allergies to dyes, excipients and components of drugs

13. Condomless insertive or receptive anal intercourse with more than one partner in the past six months

14. Known HIV-positive sexual partner within the last 6 months

15. History of STI in the last 3 months

2. Has any of the following laboratory abnormalities at Screening:

Note: Grade is per Version 2.1 of the Division of AIDS (DAIDS) Toxicity Table

1. Hemoglobin Grade 1 or higher

2. Platelet count Grade 1 or higher

3. White blood cell count Grade 2 or higher

4. Calculated creatinine clearance ≤ 70 mL/minute using the Cockcroft-Gault equation

5. Grade 2 or higher ALT and/or AST (i.e., ≥ 2.5x the site laboratory upper limit of normal [ULN])

6. Total bilirubin Grade 3 or higher

7. Positive for Hepatitis B surface antigen (HBsAg)

8. Confirmed positive for Hepatitis C antibody (HCV Ab)

3. 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