- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03202511
Assessment of a New "Boosting" Strategy for HIV Pre-exposure Prophylaxis in Healthy Volunteers
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University Clinical Research Center at University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 to 55 years old healthy (as decided from a pre-enrollment screening session described above) male participants within 32% of their ideal body weight.
- Individuals who agree to refrain from taking any prescriptions medications, over-the-counter medications (including salicylates/aspirin), hormonal agents, and herbal, dietary, and alternative supplements that may interact with the metabolism of those study drugs at least 2 weeks prior to the start of the study and until study completion.
- Nonsmoker or individuals willing to refrain from smoking or use of tobacco or marijuana for at least one month prior to and until the completion of the study (the entire study lasts for approximately 49 days).
Exclusion Criteria:
1. Are underweight (weigh less than 52 kg or 114 lb) or overweight [body mass index (BMI) greater than 32].
2. Females will be excluded to reduce study variability for this first proof of concept study.
3. Have insufficient renal function (estimated Creatinine Clearance ≤ 90 mL/min).
4. Have history of current alcohol or drug abuse (more than 4 alcoholic drinks per day on a regular basis).
5. Have history of intolerance, allergic reactions (e.g. rash) or other forms of hypersensitivities to any of the study medications (tenofovir disoproxil fumarate/ emtricitabine, probenecid).
6. Have taken TDF or FTC as part of pre-exposure prophylaxis within the past 6 weeks.
7. Any current major illness or chronic illness such as (but not limited to) kidney disease, hepatic disease, diabetes mellitus, gout, hypertension, coronary artery disease, chronic obstructive pulmonary disease, cancer, chronic active hepatitis B virus (HBV) infection, or HIV.
8. History of anemia or any other significant hematologic disorder. 9. Have history or current gastrointestinal disorders such as persistent diarrhea or malabsorption that would interfere with the absorption of orally administered drugs.
10. Have a serious infection within the last week before study enrollment. 11. Have donated blood within the past two months. 12. Have blood results that do not fall in a healthy range (e.g., blood hemoglobin less than 12.0 mg/dl).
13. Are taking on regular basis substances that may interfere with the metabolism (breakdown) of study medications by the body, including prescription medications, over-the-counter, herbal or dietary supplements, alternative medications, or hormonal agents (i.e. oral contraceptives, intra-uterine device with hormones).
14. Have a life style that places subjects at a higher risk for contracting HIV during the study period (e.g. active illicit drug use, excessive alcohol drinking, sexually transmitted infection (including gonorrhea, chlamydia, syphilis, herpes, human papilloma virus) within the past one year, or having more than one sexual partner in the past 6 months).
15. Positive HIV antibody test. 16. Positive HBV surface antigen test. 17. Have participation in a research study or use of an investigational drug in the last one month.
18. Are employed or are student under supervision of any of the investigators of this study.
19. Cannot state a good understanding of this study including risks and requirements; are unable to follow the rules of this study.
20. Cannot commit the time requested for this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
The control phase will consist of subjects taking 600/400 mg oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) on day 1 (2 tablets) followed by 300/200 mg (1 tablet) doses on days 2 and 3.
|
Included in arm/group descriptions.
Other Names:
|
Experimental: Treatment
The treatment phase will consist of subjects taking 600/400 mg oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) (2 tablets) along with a 2 gram oral probenecid (PRO) dose (4 tablets, 500 mg each) on day 1.
|
Included in arm/group descriptions.
Other Names:
Included in arm/group descriptions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma TFV AUC0-INF GMR
Time Frame: The first 72 hours of each phase.
|
The geometric mean ratio (GMR) of the plasma TFV area under the curve (AUC) comparing the test phase (T) to control phase (C) was assessed.
PK samples were collected from 0 to 72 hours post-dose.
|
The first 72 hours of each phase.
|
PBMC TFV-DP AUC GMR
Time Frame: The first 72 hours of each phase.
|
The geometric mean ratio (GMR) of the PBMC TFV-DP area under the curve (AUC) comparing the test phase (T) to control phase (C) was assessed.
PK samples were collected from 0 to 72 hours post-dose.
|
The first 72 hours of each phase.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brandon T Gufford, PharmD, PhD, Indiana Unversity School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antirheumatic Agents
- Gout Suppressants
- Renal Agents
- Uricosuric Agents
- Tenofovir
- Emtricitabine
- Probenecid
Other Study ID Numbers
- 1705315090
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pre-Exposure Prophylaxis
-
Penn State UniversityRecruiting
-
Fenway Community HealthHarvard UniversityCompletedPre-Exposure ProphylaxisUnited States
-
University of Illinois at ChicagoNational Institute of Nursing Research (NINR)RecruitingSex Work | Pre-Exposure ProphylaxisUnited States
-
Massachusetts General HospitalNational Institute of Allergy and Infectious Diseases (NIAID); AIDS Healthcare...RecruitingSTI | Contraceptive Usage | Pre-Exposure ProphylaxisSouth Africa
-
University of Massachusetts, WorcesterEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingPre-Exposure ProphylaxisThailand
-
Medstar Health Research InstituteCompletedPre-Exposure ProphylaxisUnited States
-
George Washington UniversityNational Institute of Allergy and Infectious Diseases (NIAID); Gilead SciencesCompletedPre-Exposure ProphylaxisUnited States
-
University of Massachusetts, WorcesterNational Institute of Mental Health (NIMH); Wayne State University; Institute...RecruitingPre-Exposure ProphylaxisThailand
-
Beth Israel Deaconess Medical CenterNational Institute of Mental Health (NIMH); The Fenway InstituteCompleted
-
University of North Carolina, Chapel HillNational Institute of Allergy and Infectious Diseases (NIAID)CompletedHIV | Pre-exposure ProphylaxisChina
Clinical Trials on Tenofovir disoproxil fumarate/Emtricitabine
-
National Institute of Allergy and Infectious Diseases...Microbicide Trials NetworkCompleted
-
National Institute of Allergy and Infectious Diseases...Microbicide Trials NetworkCompletedHIV InfectionsSouth Africa, Uganda, Zimbabwe
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedHIV InfectionsUnited States, Puerto Rico
-
University of WashingtonBill and Melinda Gates FoundationCompletedHIV Infections | HIV-1 InfectionsKenya, Uganda
-
CONRADEastern Virginia Medical School; University of North Carolina; Agility Clinical...Completed
-
University of KwaZuluMedical Research Council, South Africa; Centre for the AIDS Programme of Research...Completed
-
University of ManitobaWorld Health Organization; DMSC; Ashodaya SamithiCompleted
-
University of HawaiiGilead SciencesUnknown
-
Merck Sharp & Dohme LLCActive, not recruitingProphylaxis | Human Immunodeficiency Virus Type 1 | HIV-IUnited States, South Africa, Uganda
-
University of California, San DiegoGilead Sciences; University at BuffaloCompleted