HIV/AIDS
Conditions
Keywords
HIV, MSM, Anti-retrovirals, Pharmacokinetics, Peri-exposure HIV prophylaxis
Brief summary
This study is being conducted to determine if the uptake of anti-HIV medication, called Genvoya®, at different time-frames, is different at several body sites, including mucosal tissues. This medication might be considered for on-demand PEP regimens in the future.
Detailed description
Men who have sex with men (MSM) continue to be disproportionately affected by HIV. The majority of MSM acquire HIV after exposure to the rectal mucosa through unprotected receptive anal intercourse. Post-exposure-prophylaxis (PEP) is an intervention that is used to prevent HIV infection soon (72 hours) after a potential exposure. HIV-negative people with a possible exposure to HIV are instructed to take 28 days of a combination anti-HIV medication regimen, Truvada® + Raltegravir. This study is being conducted to determine if the uptake of another anti-HIV medication, called Genvoya®, at different time-frames, is different at several body sites, including mucosal tissues. This medication might be considered for on-demand PEP regimens in the future.
Interventions
DRUGGenvoya
Genvoya is a fixed-dose combination anti-retroviral drug containing tenofovir alafenamide (TAF), emtricitabine (FTC), elvitegravir (EVG), and cobicistat. At the second study visit, participants will be provided with a single dose of Genvoya, and instructed to take the dose at home with documentation by digital, time-stamped photo or video. At the third study visit, which will occur 24 hours after home dosing, participants will be given another single dose of Genvoya at the clinic.
Sponsors
Centers for Disease Control and Prevention
Emory University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
1. HIV-negative man who reports receptive anal sex with another man in the last 6 months 2. Aged 18-49 years 3. Not currently taking PrEP and no plans to initiate during study 4. Not currently taking PEP 5. Able to provide informed consent in English 6. No plans for relocation in the next 3 months 7. Willing to undergo peripheral blood, penile swabs, urine, and rectal biopsy sampling 8. Willing to use study products as directed 9. 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. 10. Hepatitis B surface antigen (HBsAg) must be negative (screening lab test) 11. Creatine clearance \>60 ml/min
Exclusion criteria
1. 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 2. Currently infected with hepatitis virus and/ or have liver disease 3. Current or chronic history of kidney disease 4. Significant laboratory abnormalities at baseline visit, including but not limited to: 1. Hgb ≤ 10 g/dL 2. Partial thromboplastin time (PTT) \> 1.5x upper limit of normal (ULN) or international normalized ratio (INR) \> 1.5x ULN 3. Platelet count \<100,000 4. Creatinine clearance \<60 5. HBsAg reactive 5. 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: 1. Uncontrolled or severe cardiac arrhythmia 2. Recent major abdominal, cardiothoracic, or neurological surgery 3. History of uncontrolled bleeding diathesis 4. History of colonic, rectal, or vaginal perforation, fistula, or malignancy 5. History or evidence on clinical examination of ulcerative, suppurative, or proliferative lesions of the anorectal mucosa, or untreated sexually transmitted disease with mucosal involvement 6. Continued need for, or use during the 14 days prior to enrollment, of the following medications: 1. Aspirin or more than 4 doses of NSAIDs 2. Warfarin, heparin (low-molecular weight or unfractionated), platelet aggregation inhibitors, or fibrinolytic agents 3. Any form of rectally administered agent besides lubricants or douching used for sexual intercourse 7. Continued need for, or use during the 90 days prior to enrollment, of the following medications: 1. Systemic immunomodulatory agents 2. Supraphysiologic doses of steroids (short course steroids less than 7 days duration, allowable at the discretion of the investigators) 3. Experimental medications, vaccines, or biologicals 8. Intent to use HIV antiretroviral pre/post-exposure prophylaxis (PrEP or PEP) during the study, outside of the study procedures 9. Symptoms of an untreated rectal sexually transmitted infection (e.g. rectal pain, discharge, bleeding, etc.) 10. Current use of hormonal therapy 11. 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. 12. Participants taking potent inhibitors (e.g. itraconazole, diltiazem) or inducers (e.g. rifampin, phenytoin) of the CYP3A4 enzyme that also metabolizes Genvoya will be excluded from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration of Emtricitabine (FTC) | Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication | Median drug concentrations of the FTC component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. |
| Plasma Concentration of Tenofovir (TFV) | Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication | Median drug concentrations of the TFV component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. |
| Plasma Concentration of Elvitegravir (EVG) | Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication | Median drug concentrations of the EVG component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP) | Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication | A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, natural killer (NK) cells) and monocytes. Median drug concentrations were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. |
| Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP) | Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication | A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, NK cells) and monocytes. Median drug levels were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP) | Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication | Median drug concentrations of TFV-DP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. |
| Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP) | Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication | Median drug concentrations of FTC-TP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. |
| Rectal Tissue Concentration of Elvitegravir (EVG) | Baseline, and 2, 4, 8, 24, 72, 96 hours after taking the second dose of medication | Median drug concentrations in rectal tissue of the EVG component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. |
| Rectal Tissue Concentration of Emtricitabine (FTC) | Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication | Median drug concentrations in rectal tissue of the FTC component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. |
| Rectal Tissue Concentration of Tenofovir (TFN) | Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication | Median drug concentrations in rectal tissue of the TFN component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the Hope Clinic in Atlanta, Georgia, USA. Participant enrollment began on March 13, 2019 and all follow up was completed September 20, 2019.
Pre-assignment details
After the completion of enrollment in the Pre-drug arm, enrollment began sequentially in Arm A, followed by Arm B and Arm C. Arms A, B, and C were further broken down into two different sub-groups, determining the timing of the rectal swab and biopsy procedure. Arm D was enrolled last and included a single time point specimen collection. Participants were able to take part in more than one study arm, with at least a 6 week period after completion of one study arm before beginning another one.
Participants by arm
| Arm | Count |
|---|---|
| Pre-drug Participants enrolled in the pre-drug arm did not receive any drug. At visit 2, they underwent blood, urine, penile swab, cheek swab, rectal swab and rectal biopsy collection. | 4 |
| Genvoya Genvoya is a fixed-dose combination anti-retroviral drug containing tenofovir alafenamide (TAF), emtricitabine (FTC), elvitegravir (EVG), and cobicistat. At the second study visit, participants will be provided with a single dose of Genvoya, and instructed to take the dose at home with documentation by digital, time-stamped photo or video. At the third study visit, which will occur 24 hours after home dosing, participants will be given another single dose of Genvoya at the clinic.
Participants took Genvoya and had specimens collected at different time points. Arm A: specimen collection occurred 2 hours and after taking the medication in the clinic (visit 4), and 48 hours after taking the medication in the clinic (visit 5) Arm B: specimen collection occurred 4 hours and after taking the medication in the clinic (visit 4), and 72 hours after taking the medication in the clinic (visit 5) Arm C: specimen collection occurred 24 hours and after taking the medication in the clinic (visit 4), and 96 hours after taking the medication in the clinic (visit 5) Arm D: specimen collection occurred 8 hours after taking the medication in the clinic (visit 4), for a single time point of specimen collection | 37 |
| Total | 41 |
Baseline characteristics
| Characteristic | Pre-drug | Genvoya | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 36 Participants | 40 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 26 Participants | 30 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 0 Participants | 7 Participants | 7 Participants |
| Region of Enrollment United States | 4 Participants | 37 Participants | 41 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 4 Participants | 37 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 14 | 0 / 8 | 0 / 11 | 0 / 6 |
| other Total, other adverse events | 0 / 4 | 0 / 14 | 0 / 8 | 0 / 11 | 0 / 6 |
| serious Total, serious adverse events | 0 / 4 | 0 / 14 | 0 / 8 | 0 / 11 | 0 / 6 |
Outcome results
Primary
Plasma Concentration of Elvitegravir (EVG)
Median drug concentrations of the EVG component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Time frame: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Population: Data are reported per intervention, based on the time points of sample collection for each study arm (two participants were in multiple study arms). Analysis of drug concentrations in participants in the Pre-drug arm was not performed as no drugs were administered to this study arm.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Genvoya - 2 and 48 Hours Specimen Collection | Plasma Concentration of Elvitegravir (EVG) | 2 hours | 2243 ng/mL |
| Genvoya - 2 and 48 Hours Specimen Collection | Plasma Concentration of Elvitegravir (EVG) | 48 hours | 0 ng/mL |
| Genvoya - 2 and 48 Hours Specimen Collection | Plasma Concentration of Elvitegravir (EVG) | Baseline | 0 ng/mL |
| Genvoya - 4 and 72 Hours Specimen Collection | Plasma Concentration of Elvitegravir (EVG) | 4 hours | 1818 ng/mL |
| Genvoya - 4 and 72 Hours Specimen Collection | Plasma Concentration of Elvitegravir (EVG) | 72 hours | 0 ng/mL |
| Genvoya - 4 and 72 Hours Specimen Collection | Plasma Concentration of Elvitegravir (EVG) | Baseline | 0 ng/mL |
| Genvoya - 24 and 96 Hours Specimen Collection | Plasma Concentration of Elvitegravir (EVG) | 96 hours | 0 ng/mL |
| Genvoya - 24 and 96 Hours Specimen Collection | Plasma Concentration of Elvitegravir (EVG) | 24 hours | 232 ng/mL |
| Genvoya - 24 and 96 Hours Specimen Collection | Plasma Concentration of Elvitegravir (EVG) | Baseline | 0 ng/mL |
| Genvoya - Single Time Point Specimen Collection | Plasma Concentration of Elvitegravir (EVG) | 8 hours | 283 ng/mL |
| Genvoya - Single Time Point Specimen Collection | Plasma Concentration of Elvitegravir (EVG) | Baseline | 0 ng/mL |
Primary
Plasma Concentration of Emtricitabine (FTC)
Median drug concentrations of the FTC component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Time frame: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Population: Data are reported per intervention, based on the time points of sample collection for each study arm (two participants were in multiple study arms). Analysis of drug concentrations in participants in the Pre-drug arm was not performed as no drugs were administered to this study arm.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Genvoya - 2 and 48 Hours Specimen Collection | Plasma Concentration of Emtricitabine (FTC) | Baseline | 0 ng/mL |
| Genvoya - 2 and 48 Hours Specimen Collection | Plasma Concentration of Emtricitabine (FTC) | 2 hours | 2710 ng/mL |
| Genvoya - 2 and 48 Hours Specimen Collection | Plasma Concentration of Emtricitabine (FTC) | 48 hours | 0 ng/mL |
| Genvoya - 4 and 72 Hours Specimen Collection | Plasma Concentration of Emtricitabine (FTC) | 4 hours | 1725 ng/mL |
| Genvoya - 4 and 72 Hours Specimen Collection | Plasma Concentration of Emtricitabine (FTC) | Baseline | 0 ng/mL |
| Genvoya - 4 and 72 Hours Specimen Collection | Plasma Concentration of Emtricitabine (FTC) | 72 hours | 0 ng/mL |
| Genvoya - 24 and 96 Hours Specimen Collection | Plasma Concentration of Emtricitabine (FTC) | 24 hours | 113 ng/mL |
| Genvoya - 24 and 96 Hours Specimen Collection | Plasma Concentration of Emtricitabine (FTC) | Baseline | 0 ng/mL |
| Genvoya - 24 and 96 Hours Specimen Collection | Plasma Concentration of Emtricitabine (FTC) | 96 hours | 0 ng/mL |
| Genvoya - Single Time Point Specimen Collection | Plasma Concentration of Emtricitabine (FTC) | 8 hours | 300 ng/mL |
| Genvoya - Single Time Point Specimen Collection | Plasma Concentration of Emtricitabine (FTC) | Baseline | 0 ng/mL |
Primary
Plasma Concentration of Tenofovir (TFV)
Median drug concentrations of the TFV component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Time frame: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Population: Data are reported per intervention, based on the time points of sample collection for each study arm (two participants were in multiple study arms). Analysis of drug concentrations in participants in the Pre-drug arm was not performed as no drugs were administered to this study arm.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Genvoya - 2 and 48 Hours Specimen Collection | Plasma Concentration of Tenofovir (TFV) | Baseline | 0 ng/mL |
| Genvoya - 2 and 48 Hours Specimen Collection | Plasma Concentration of Tenofovir (TFV) | 2 hours | 0 ng/mL |
| Genvoya - 2 and 48 Hours Specimen Collection | Plasma Concentration of Tenofovir (TFV) | 48 hours | 0 ng/mL |
| Genvoya - 4 and 72 Hours Specimen Collection | Plasma Concentration of Tenofovir (TFV) | 4 hours | 0 ng/mL |
| Genvoya - 4 and 72 Hours Specimen Collection | Plasma Concentration of Tenofovir (TFV) | Baseline | 0 ng/mL |
| Genvoya - 4 and 72 Hours Specimen Collection | Plasma Concentration of Tenofovir (TFV) | 72 hours | 0 ng/mL |
| Genvoya - 24 and 96 Hours Specimen Collection | Plasma Concentration of Tenofovir (TFV) | 24 hours | 0 ng/mL |
| Genvoya - 24 and 96 Hours Specimen Collection | Plasma Concentration of Tenofovir (TFV) | Baseline | 0 ng/mL |
| Genvoya - 24 and 96 Hours Specimen Collection | Plasma Concentration of Tenofovir (TFV) | 96 hours | 0 ng/mL |
| Genvoya - Single Time Point Specimen Collection | Plasma Concentration of Tenofovir (TFV) | 8 hours | 0 ng/mL |
| Genvoya - Single Time Point Specimen Collection | Plasma Concentration of Tenofovir (TFV) | Baseline | 0 ng/mL |
Secondary
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)
A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, NK cells) and monocytes. Median drug levels were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Time frame: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Population: Data are reported per intervention, based on the time points of sample collection for each study arm (two participants were in multiple study arms). Analysis of drug concentrations in participants in the Pre-drug arm was not performed as no drugs were administered to this study arm.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Genvoya - 2 and 48 Hours Specimen Collection | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP) | 48 hours | 2120 fmol/10^6 cells |
| Genvoya - 2 and 48 Hours Specimen Collection | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP) | 2 hours | 7705 fmol/10^6 cells |
| Genvoya - 2 and 48 Hours Specimen Collection | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP) | Baseline | 0 fmol/10^6 cells |
| Genvoya - 4 and 72 Hours Specimen Collection | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP) | 72 hours | 955 fmol/10^6 cells |
| Genvoya - 4 and 72 Hours Specimen Collection | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP) | Baseline | 0 fmol/10^6 cells |
| Genvoya - 4 and 72 Hours Specimen Collection | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP) | 4 hour | 7800 fmol/10^6 cells |
| Genvoya - 24 and 96 Hours Specimen Collection | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP) | 96 hours | 714 fmol/10^6 cells |
| Genvoya - 24 and 96 Hours Specimen Collection | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP) | 24 hours | 5140 fmol/10^6 cells |
| Genvoya - 24 and 96 Hours Specimen Collection | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP) | Baseline | 0 fmol/10^6 cells |
| Genvoya - Single Time Point Specimen Collection | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP) | 8 hours | 6855 fmol/10^6 cells |
| Genvoya - Single Time Point Specimen Collection | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP) | Baseline | 0 fmol/10^6 cells |
Secondary
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)
A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, natural killer (NK) cells) and monocytes. Median drug concentrations were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Time frame: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Population: Data are reported per intervention, based on the time points of sample collection for each study arm (two participants were in multiple study arms). Analysis of drug concentrations in participants in the Pre-drug arm was not performed as no drugs were administered to this study arm.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Genvoya - 2 and 48 Hours Specimen Collection | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP) | Baseline | 0 fmol/10^6 cells |
| Genvoya - 2 and 48 Hours Specimen Collection | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP) | 2 hours | 569 fmol/10^6 cells |
| Genvoya - 2 and 48 Hours Specimen Collection | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP) | 48 hours | 291 fmol/10^6 cells |
| Genvoya - 4 and 72 Hours Specimen Collection | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP) | 4 hours | 621 fmol/10^6 cells |
| Genvoya - 4 and 72 Hours Specimen Collection | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP) | Baseline | 0 fmol/10^6 cells |
| Genvoya - 4 and 72 Hours Specimen Collection | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP) | 72 hours | 158 fmol/10^6 cells |
| Genvoya - 24 and 96 Hours Specimen Collection | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP) | 24 hours | 429 fmol/10^6 cells |
| Genvoya - 24 and 96 Hours Specimen Collection | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP) | Baseline | 0 fmol/10^6 cells |
| Genvoya - 24 and 96 Hours Specimen Collection | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP) | 96 hours | 117 fmol/10^6 cells |
| Genvoya - Single Time Point Specimen Collection | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP) | 8 hours | 375 fmol/10^6 cells |
| Genvoya - Single Time Point Specimen Collection | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP) | Baseline | 0 fmol/10^6 cells |
Other Pre-specified
Rectal Tissue Concentration of Elvitegravir (EVG)
Median drug concentrations in rectal tissue of the EVG component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Time frame: Baseline, and 2, 4, 8, 24, 72, 96 hours after taking the second dose of medication
Population: Data are reported per intervention, based on the time points of sample collection for each study arm (two participants were in multiple study arms). Analysis of drug concentrations in participants in the Pre-drug arm was not performed as no drugs were administered to this study arm.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Genvoya - 2 and 48 Hours Specimen Collection | Rectal Tissue Concentration of Elvitegravir (EVG) | Baseline | 0 ng/mg |
| Genvoya - 2 and 48 Hours Specimen Collection | Rectal Tissue Concentration of Elvitegravir (EVG) | 2 hours | 51.23 ng/mg |
| Genvoya - 2 and 48 Hours Specimen Collection | Rectal Tissue Concentration of Elvitegravir (EVG) | 48 hours | 1.03 ng/mg |
| Genvoya - 4 and 72 Hours Specimen Collection | Rectal Tissue Concentration of Elvitegravir (EVG) | 4 hours | 41.47 ng/mg |
| Genvoya - 4 and 72 Hours Specimen Collection | Rectal Tissue Concentration of Elvitegravir (EVG) | Baseline | 0 ng/mg |
| Genvoya - 4 and 72 Hours Specimen Collection | Rectal Tissue Concentration of Elvitegravir (EVG) | 72 hours | 0 ng/mg |
| Genvoya - 24 and 96 Hours Specimen Collection | Rectal Tissue Concentration of Elvitegravir (EVG) | 24 hours | 0.60 ng/mg |
| Genvoya - 24 and 96 Hours Specimen Collection | Rectal Tissue Concentration of Elvitegravir (EVG) | Baseline | 0 ng/mg |
| Genvoya - 24 and 96 Hours Specimen Collection | Rectal Tissue Concentration of Elvitegravir (EVG) | 96 hours | 0.02 ng/mg |
| Genvoya - Single Time Point Specimen Collection | Rectal Tissue Concentration of Elvitegravir (EVG) | 8 hours | 0.31 ng/mg |
| Genvoya - Single Time Point Specimen Collection | Rectal Tissue Concentration of Elvitegravir (EVG) | Baseline | 0 ng/mg |
Other Pre-specified
Rectal Tissue Concentration of Emtricitabine (FTC)
Median drug concentrations in rectal tissue of the FTC component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Time frame: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Population: Data are reported per intervention, based on the time points of sample collection for each study arm (two participants were in multiple study arms). Analysis of drug concentrations in participants in the Pre-drug arm was not performed as no drugs were administered to this study arm.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Genvoya - 2 and 48 Hours Specimen Collection | Rectal Tissue Concentration of Emtricitabine (FTC) | Baseline | 0 ng/mg |
| Genvoya - 2 and 48 Hours Specimen Collection | Rectal Tissue Concentration of Emtricitabine (FTC) | 2 hours | 9.54 ng/mg |
| Genvoya - 2 and 48 Hours Specimen Collection | Rectal Tissue Concentration of Emtricitabine (FTC) | 48 hours | 0.02 ng/mg |
| Genvoya - 4 and 72 Hours Specimen Collection | Rectal Tissue Concentration of Emtricitabine (FTC) | 4 hours | 9.25 ng/mg |
| Genvoya - 4 and 72 Hours Specimen Collection | Rectal Tissue Concentration of Emtricitabine (FTC) | Baseline | 0 ng/mg |
| Genvoya - 4 and 72 Hours Specimen Collection | Rectal Tissue Concentration of Emtricitabine (FTC) | 72 hours | 0 ng/mg |
| Genvoya - 24 and 96 Hours Specimen Collection | Rectal Tissue Concentration of Emtricitabine (FTC) | 24 hours | 1.23 ng/mg |
| Genvoya - 24 and 96 Hours Specimen Collection | Rectal Tissue Concentration of Emtricitabine (FTC) | Baseline | 0 ng/mg |
| Genvoya - 24 and 96 Hours Specimen Collection | Rectal Tissue Concentration of Emtricitabine (FTC) | 96 hours | 0.02 ng/mg |
| Genvoya - Single Time Point Specimen Collection | Rectal Tissue Concentration of Emtricitabine (FTC) | 8 hours | 0.17 ng/mg |
| Genvoya - Single Time Point Specimen Collection | Rectal Tissue Concentration of Emtricitabine (FTC) | Baseline | 0 ng/mg |
Other Pre-specified
Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)
Median drug concentrations of FTC-TP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Time frame: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Population: Data are reported per intervention, based on the time points of sample collection for each study arm (two participants were in multiple study arms). Analysis of drug concentrations in participants in the Pre-drug arm was not performed as no drugs were administered to this study arm.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Genvoya - 2 and 48 Hours Specimen Collection | Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP) | 48 hours | 56.3 fmol/mg |
| Genvoya - 2 and 48 Hours Specimen Collection | Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP) | 2 hours | 187.5 fmol/mg |
| Genvoya - 2 and 48 Hours Specimen Collection | Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP) | Baseline | 0 fmol/mg |
| Genvoya - 4 and 72 Hours Specimen Collection | Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP) | 72 hours | 15.1 fmol/mg |
| Genvoya - 4 and 72 Hours Specimen Collection | Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP) | Baseline | 0 fmol/mg |
| Genvoya - 4 and 72 Hours Specimen Collection | Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP) | 4 hours | 198.2 fmol/mg |
| Genvoya - 24 and 96 Hours Specimen Collection | Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP) | Baseline | 0 fmol/mg |
| Genvoya - 24 and 96 Hours Specimen Collection | Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP) | 96 hours | 12.5 fmol/mg |
| Genvoya - 24 and 96 Hours Specimen Collection | Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP) | 24 hours | 104.3 fmol/mg |
| Genvoya - Single Time Point Specimen Collection | Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP) | 8 hours | 116.5 fmol/mg |
| Genvoya - Single Time Point Specimen Collection | Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP) | Baseline | 0 fmol/mg |
Other Pre-specified
Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)
Median drug concentrations of TFV-DP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Time frame: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Population: Data are reported per intervention, based on the time points of sample collection for each study arm (two participants were in multiple study arms). Analysis of drug concentrations in participants in the Pre-drug arm was not performed as no drugs were administered to this study arm.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Genvoya - 2 and 48 Hours Specimen Collection | Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP) | Baseline | 0 fmol/mg |
| Genvoya - 2 and 48 Hours Specimen Collection | Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP) | 2 hours | 39.1 fmol/mg |
| Genvoya - 2 and 48 Hours Specimen Collection | Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP) | 48 hours | 18.2 fmol/mg |
| Genvoya - 4 and 72 Hours Specimen Collection | Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP) | 4 hours | 45.9 fmol/mg |
| Genvoya - 4 and 72 Hours Specimen Collection | Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP) | Baseline | 0 fmol/mg |
| Genvoya - 4 and 72 Hours Specimen Collection | Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP) | 72 hours | 11.9 fmol/mg |
| Genvoya - 24 and 96 Hours Specimen Collection | Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP) | 24 hours | 20.2 fmol/mg |
| Genvoya - 24 and 96 Hours Specimen Collection | Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP) | Baseline | 0 fmol/mg |
| Genvoya - 24 and 96 Hours Specimen Collection | Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP) | 96 hours | 14.7 fmol/mg |
| Genvoya - Single Time Point Specimen Collection | Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP) | 8 hours | 23.7 fmol/mg |
| Genvoya - Single Time Point Specimen Collection | Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP) | Baseline | 0 fmol/mg |
Other Pre-specified
Rectal Tissue Concentration of Tenofovir (TFN)
Median drug concentrations in rectal tissue of the TFN component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Time frame: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Population: Data are reported per intervention, based on the time points of sample collection for each study arm (two participants were in multiple study arms). Analysis of drug concentrations in participants in the Pre-drug arm was not performed as no drugs were administered to this study arm.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Genvoya - 2 and 48 Hours Specimen Collection | Rectal Tissue Concentration of Tenofovir (TFN) | Baseline | 0 ng/mg |
| Genvoya - 2 and 48 Hours Specimen Collection | Rectal Tissue Concentration of Tenofovir (TFN) | 2 hours | 0 ng/mg |
| Genvoya - 2 and 48 Hours Specimen Collection | Rectal Tissue Concentration of Tenofovir (TFN) | 48 hours | 0 ng/mg |
| Genvoya - 4 and 72 Hours Specimen Collection | Rectal Tissue Concentration of Tenofovir (TFN) | 4 hours | 0.30 ng/mg |
| Genvoya - 4 and 72 Hours Specimen Collection | Rectal Tissue Concentration of Tenofovir (TFN) | Baseline | 0 ng/mg |
| Genvoya - 4 and 72 Hours Specimen Collection | Rectal Tissue Concentration of Tenofovir (TFN) | 72 hours | 0 ng/mg |
| Genvoya - 24 and 96 Hours Specimen Collection | Rectal Tissue Concentration of Tenofovir (TFN) | 24 hours | 0.03 ng/mg |
| Genvoya - 24 and 96 Hours Specimen Collection | Rectal Tissue Concentration of Tenofovir (TFN) | Baseline | 0 ng/mg |
| Genvoya - 24 and 96 Hours Specimen Collection | Rectal Tissue Concentration of Tenofovir (TFN) | 96 hours | 0 ng/mg |
| Genvoya - Single Time Point Specimen Collection | Rectal Tissue Concentration of Tenofovir (TFN) | 8 hours | 0.01 ng/mg |
| Genvoya - Single Time Point Specimen Collection | Rectal Tissue Concentration of Tenofovir (TFN) | Baseline | 0 ng/mg |