Biomarkers for Event-driven PrEP Adherence

NCT04298697 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: IRB00116781CDC-IRB00116781
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Human Immunodeficiency Virus

Keywords

Pre-exposure prophylaxis (PrEP); Post-exposure prophylaxis (PEP)

Outcome Measures

Primary Outcomes (1)

• Tenofovir-diphosphate (TFV-DP) Concentration

  Concentration of TFV-DP was measured 24 hours after the last dose to compare accumulation of drug following weekly event-driven PrEP (ED-PrEP) dosing. Dried blood spot samples were collected from participants using a 6 millimeter (mm) dried blood spot card punch system.

  24 Hours After Last Dose (Week 1 for Arm A, Week 13 for Arms B, C, and D)

Study Arms (4)

TDF/FTC for 1 week

EXPERIMENTAL

The first 10 participants (Arm A) will take TDF/FTC for three consecutive days of one week, taking 2 pills on the first day and one pill on the second and third day, for a total of 4 doses.

Drug: Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)

TDF/FTC for 13 weeks

EXPERIMENTAL

The second 10 participants (Arm B) will take TDF/FTC for three consecutive days for thirteen weeks, taking 2 pills on the first day and one pill on the second and third day of each week, for a total of 52 doses.

Drug: Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)

TDF/FTC for 13 weeks with weekly alternating schedule

EXPERIMENTAL

The third 10 participants (Arm C) will take TDF/FTC for three consecutive days, alternating weeks over a 13-week period, taking 2 pills on the first day and one pill on the second and third day of each dosing week, for a total of 28 doses.

Drug: Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)

TDF/FTC for 13 weeks with weekly alternating schedule every two weeks

EXPERIMENTAL

The fourth 10 participants (Arm D) will take TDF/FTC for three consecutive days over a 13-week period, alternating two weeks of study medication followed by two weeks with no medication, taking 2 pills on the first day and one pill on the second and third day of dosing each week, for a total of 28 doses.

Drug: Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)

Interventions

Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) DRUG

TDF/FTC is a combination anti-HIV medication that contains the drugs tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Participants will take 2 pills on the first day of the week and one pill per day on the second and third days of the week, according to the dosing schedule of the study arm they are in. Participants will have biologic specimens collected at specific time points until 28 days after the last dose.

Also known as: Truvada

TDF/FTC for 1 week; TDF/FTC for 13 weeks; TDF/FTC for 13 weeks with weekly alternating schedule; TDF/FTC for 13 weeks with weekly alternating schedule every two weeks

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Hope Clinic

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Colleen Kelley, MD, MPH
• Organization: Emory University

colleen.kelley@emory.edu

404-712-1823

Study Officials

• Colleen Kelley, MD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 6, 2020
• Study Start: February 28, 2020
• Primary Completion: August 9, 2022
• Study Completion: August 9, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will become available to researchers who provide a methodologically sound proposal, beginning 9 months and ending at 36 months following publication.
• Access Criteria: Proposals should be directed to colleen.kelley@emory.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)