Phase 4
N=43
Biomarkers for Event-driven PrEP Adherence
Human Immunodeficiency Virus
Bottom Line
View on ClinicalTrials.gov: NCT04298697 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Tenofovir-diphosphate (TFV-DP) Concentration — 217; 1041; 578; 789 femtomoles
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Emory University
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tenofovir-diphosphate (TFV-DP) Concentration |
217; 1041; 578; 789 | — |
Summary
This study aims to recruit 40 participants who will take the combination anti-HIV drug tenofovir+emtricitabine (TDF/FTC) at specified times. Participants will then provide biologic samples for the measurement of anti-retroviral drug concentrations in various body compartment sites. Participants will be involved in the study for up to 24 weeks.
Eligibility Criteria
Inclusion Criteria
- HIV-negative person, who was assigned male at birth, who reports sex with another man in the last year, and is in good general health.
- Not currently taking PrEP and no plans to initiate during study
- Not currently taking PEP
- Consistent condom use and willing to use condoms for the duration of the study
- Able to provide informed consent in English
- No plans for relocation in the next 4 months
- Willing to undergo peripheral blood, urine, hair, finger stick, and optional hair sampling
- Willing to use study products as directed
- Hepatitis B surface antigen (HBsAg) must be negative (screening lab test)
- Creatinine clearance (CrCl) >60 ml/min
Exclusion Criteria
- Currently infected with hepatitis virus and/ or has liver disease
- Current or chronic history of kidney disease or CrCl<60 ml/min
- Continued need for, or use during the 90 days prior to enrollment, of the following medications:
- Systemic immunomodulatory agents
- Supraphysiologic doses of steroids (short course steroids less than 7 days duration, allowable at the discretion of the investigators)
- Chemotherapy or radiation for treatment of malignancy
- Experimental medications, vaccines, or biologicals
- Intent to use HIV antiretroviral pre/post-exposure prophylaxis (PrEP or PEP) during the study, outside of the study procedures
- Current use of hormonal therapy
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements
Data sourced from ClinicalTrials.gov (NCT04298697). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.