- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02985996
Body Compartment PK for New HIV Pre-exposure Prophylaxis Modalities
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- HIV-negative man who reports receptive anal sex with another man in the last 6 months
- Male to female transgender women who have sex with men who report receptive anal intercourse with another man in the last 6 months and are not currently taking hormonal therapy or plan to take hormonal therapy for the duration of the study
- Not currently taking PrEP and no plans to initiate during study
- Able to provide informed consent in English
- No plans for relocation in the next 3 months
- Willing to undergo peripheral blood and rectal biopsy sampling
- Willing to use study products as directed
- Willing to abstain from receptive anal intercourse 3 days prior to starting study product and for the duration of the study and for 7 days after any rectal biopsy procedure.
Exclusion Criteria:
- History of inflammatory bowel disease or other inflammatory, infiltrative, infectious or vascular condition involving the lower gastrointestinal tract that, in the judgment of the investigators, may be worsened by study procedures or may significantly distort the anatomy of the distal large bowel
Significant laboratory abnormalities at baseline visit, including but not limited to:
- Hgb ≤ 10 g/dL
- PTT > 1.5x ULN or INR > 1.5x ULN
- Platelet count <100,000
- Creatinine clearance <60
Any known medical condition that, in the judgment of the investigators, increases the risk of local or systemic complications of endoscopic procedures or pelvic examination, including but not limited to:
- Uncontrolled or severe cardiac arrhythmia
- Recent major abdominal, cardiothoracic, or neurological surgery
- History of uncontrolled bleeding diathesis
- History of colonic, rectal, or vaginal perforation, fistula, or malignancy
- History or evidence on clinical examination of ulcerative, suppurative, or proliferative lesions of the anorectal or vaginal mucosa, or untreated sexually transmitted disease with mucosal involvement
Continued need for, or use during the 14 days prior to enrollment, of the following medications:
- Aspirin or more than 4 doses of NSAIDs
- Warfarin, heparin (low-molecular weight or unfractionated), platelet aggregation inhibitors, or fibrinolytic agents
- Any form of rectally administered agent besides products lubricants or douching used for sexual intercourse
Continued need for, or use during the 90 days prior to enrollment, of the following medications:
- Systemic immunomodulatory agents
- Supraphysiologic doses of steroids
- Experimental medications, vaccines, or biologicals
- Intent to use HIV antiretroviral pre-exposure prophylaxis (PrEP) during the study, outside of the study procedures
- Symptoms of an untreated rectal sexually transmitted infection (e.g. rectal pain, discharge, bleeding, etc.)
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Phase I/Pre-Drug
Ten participants will be asked to complete study phase 1. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs.
Up to 12 rectal biopsies will be taken.
|
|
Experimental: Phase II/Genvoya
Participants will receive one dose Genvoya.
Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs.
Up to 12 rectal biopsies will be taken.
|
Genvoya is a 1-pill, once-a-day prescription medicine used to treat HIV-1.
Genvoya is a combination of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamid in one tablet.
|
Experimental: Phase II/Truvada
Participants will receive one dose of Truvada.
Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs.
Up to 12 rectal biopsies will be taken.
|
Truvada is intended for the treatment of HIV-1 infection.
Truvada is a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg in one tablet.
|
Experimental: Phase III/Genvoya
Participants will receive Genvoya once daily for ten days.
Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs.
Up to 12 rectal biopsies will be taken.
|
Genvoya is a 1-pill, once-a-day prescription medicine used to treat HIV-1.
Genvoya is a combination of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamid in one tablet.
|
Experimental: Phase III/Truvada
Participants will receive Truvada once daily for ten days.
Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs.
Up to 12 rectal biopsies will be taken.
|
Truvada is intended for the treatment of HIV-1 infection.
Truvada is a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg in one tablet.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Intracellular Emtricitabine Triphosphate (FTC-TP)
Time Frame: Baseline, Visit 4 (Up to ten days post drug)
|
Intracellular emtricitabine triphosphate (FTC-TP) is measured and compared from blood specimen in both arms from baseline to visit 4. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
|
Baseline, Visit 4 (Up to ten days post drug)
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Changes in Intracellular Tenofovir Diphosphate (TFV-DP)
Time Frame: Baseline, Visit 4 (Up to ten days post drug)
|
Intracellular tenofovir diphosphate (TFV-DP) is measured and compared from blood specimen in both arms from baseline to visit 4. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
|
Baseline, Visit 4 (Up to ten days post drug)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Plasma Emtricitabine (FTC) Concentration
Time Frame: Baseline, Visit 4 (Up to ten days post drug)
|
Plasma emtricitabine (FTC) concentration is measured from blood specimen.
For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
|
Baseline, Visit 4 (Up to ten days post drug)
|
Change in Plasma Tenofovir Disoproxil Fumarate (TDF) Concentration
Time Frame: Baseline, Visit 4 (Up to ten days post drug)
|
Plasma tenofovir disoproxil fumarate (TDF) concentration is measured from blood specimen.
For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
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Baseline, Visit 4 (Up to ten days post drug)
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Change in Plasma Tenofovir Alafenamide (TAF) Concentration
Time Frame: Baseline, Visit 4 (Up to ten days post drug)
|
Plasma tenofovir alafenamide (TAF) concentration is measured from blood specimen.
For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
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Baseline, Visit 4 (Up to ten days post drug)
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Change in Plasma Elvitegravir (EVG) Concentration
Time Frame: Baseline, Visit 4 (Up to ten days post drug)
|
Plasma elvitegravir (EVG) concentration is measured from blood specimen.
For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
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Baseline, Visit 4 (Up to ten days post drug)
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Change in Rectal Emtricitabine (FTC) Concentration
Time Frame: Baseline, Visit 4 (Up to ten days post drug)
|
Emtricitabine (FTC) concentration is measured from rectal secretion specimen.
For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
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Baseline, Visit 4 (Up to ten days post drug)
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Change in Rectal Tenofovir Disoproxil Fumarate (TDF) Concentration
Time Frame: Baseline, Visit 4 (Up to ten days post drug)
|
Tenofovir disoproxil fumarate (TDF), concentration is measured from rectal secretion specimen.
For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
|
Baseline, Visit 4 (Up to ten days post drug)
|
Change in Rectal Tenofovir Alafenamide (TAF) Concentration
Time Frame: Baseline, Visit 4 (Up to ten days post drug)
|
Tenofovir alafenamide (TAF) concentration is measured from rectal secretion specimen.
For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
|
Baseline, Visit 4 (Up to ten days post drug)
|
Change in Rectal Elvitegravir (EVG) Concentration
Time Frame: Baseline, Visit 4 (Up to ten days post drug)
|
Elvitegravir (EVG) concentration is measured from rectal secretion specimen.
For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
|
Baseline, Visit 4 (Up to ten days post drug)
|
Change in Intracellular Tenofovir Alafenamide (TAF) Concentration in Peripheral Blood Mononuclear Cells (PBMCs)
Time Frame: Baseline, Visit 4 (Up to ten days post drug)
|
Intracellular tenofovir alafenamide (TAF) concentration is measured from isolated PBMCs collected via blood draw.
For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
|
Baseline, Visit 4 (Up to ten days post drug)
|
Change in Intracellular Elvitegravir (EVG) Concentration in Peripheral Blood Mononuclear Cells (PBMCs)
Time Frame: Baseline, Visit 4 (Up to ten days post drug)
|
Intracellular elvitegravir (EVG) concentration is measured from isolated PBMCs collected via blood draw.
For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
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Baseline, Visit 4 (Up to ten days post drug)
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Change in Intracellular Emtricitabine (FTC) Concentration in Rectal Tissue
Time Frame: Baseline, Visit 4 (Up to ten days post drug)
|
Tissue emtricitabine (FTC) concentration is measured from rectal biopsies and isolated cells.
For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
|
Baseline, Visit 4 (Up to ten days post drug)
|
Change in Intracellular Tenofovir (TFV) Concentration in Rectal Tissue
Time Frame: Baseline, Visit 4 (Up to ten days post drug)
|
Intracellular tenofovir (TFV) Concentration in Rectal Tissue is measured from rectal biopsies and isolated cells.
For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
|
Baseline, Visit 4 (Up to ten days post drug)
|
Change in Tenofovir Alafenamide (TAF) Concentration in Rectal Tissue
Time Frame: Baseline, Visit 4 (Up to ten days post drug)
|
Tissue tenofovir alafenamide (TAF) concentration is measured from rectal biopsies and isolated cells.
For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
|
Baseline, Visit 4 (Up to ten days post drug)
|
Change in Elvitegravir (EVG) Concentration in Rectal Tissue
Time Frame: Baseline, Visit 4 (Up to ten days post drug)
|
Tissue elvitegravir (EVG) concentration is measured from rectal biopsies and isolated cells.
For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
|
Baseline, Visit 4 (Up to ten days post drug)
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Change in Emtricitabine (FTC) Concentration in Penile Secretions
Time Frame: Baseline, Visit 4 (Up to ten days post drug)
|
Emtricitabine (FTC) concentrations is measured from urethral and penile specimen.
For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
|
Baseline, Visit 4 (Up to ten days post drug)
|
Change in Tenofovir Disoproxil Fumarate (TDF) Concentration in Penile Secretions
Time Frame: Baseline, Visit 4 (Up to ten days post drug)
|
Tenofovir disoproxil fumarate (TDF) concentrations is measured from urethral and penile specimen.
For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
|
Baseline, Visit 4 (Up to ten days post drug)
|
Change in Tenofovir Alafenamide (TAF) Concentration in Penile Secretions
Time Frame: Baseline, Visit 4 (Up to ten days post drug)
|
Tenofovir alafenamide (TAF) concentrations is measured from urethral and penile specimen.
For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
|
Baseline, Visit 4 (Up to ten days post drug)
|
Change in Elvitegravir (EVG) Concentration in Penile Secretions
Time Frame: Baseline, Visit 4 (Up to ten days post drug)
|
Elvitegravir (EVG) concentrations is measured from urethral and penile specimen.
For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
|
Baseline, Visit 4 (Up to ten days post drug)
|
PrEP Efficacy as Measured by Inhibition of in Vitro Infection of Rectal Biopsies to HIV
Time Frame: Up to 10 months post-baseline
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Rectal biopsies will be subjected to in vitro infection with HIV to test for changes in susceptibility to virus infection. Concentrations of cumulative p24 production in supernatants following in vitro infection of rectal biopsies correlate with viral infection and replication in rectal biopsies. Therefore, lower concentrations of p24 production in biopsies collected from men receiving PrEP compared to controls indicates a potential greater protection from infection and potential increased PrEP efficacy. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration. |
Up to 10 months post-baseline
|
Collaborators and Investigators
Sponsor
Collaborators
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 (Estimate)
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
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- 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
- Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
- Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Other Study ID Numbers
- IRB00092488
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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