A Phase 1 interventional study of Genvoya in HIV/AIDS, sponsored by Emory University. Completed at 1 site in United States. Open to male participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2021-08-13.
Sponsored by Emory University · Phase 1, Interventional, and Prevention
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.
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.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 41 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Significant laboratory abnormalities at baseline visit, including but not limited to:
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:
Continued need for, or use during the 14 days prior to enrollment, of the following medications:
Continued need for, or use during the 90 days prior to enrollment, of the following medications:
Participants enrolled in the pre-drug arm will not receive any drug. At visit 2, they will undergo blood, urine, penile swab, cheek swab, rectal swab and rectal biopsy collection.
Specimen collection 2 hours after taking the medication in the clinic (visit 4), and 48 hours after taking the medication in the clinic (visit 5).
Drug: Genvoya
Specimen collection 4 hours after taking the medication in the clinic (visit 4), and 72 hours after taking the medication in the clinic (visit 5).
Drug: Genvoya
Specimen collection 24 hours after taking the medication in the clinic (visit 4), and 96 hours after taking the medication in the clinic (visit 5).
Drug: Genvoya
Specimen collection 8 hours after taking the medication in the clinic (visit 4).
Drug: 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.
Also known as: Cobicistat/Elvitegravir/Emtricitabine/Tenofovir alafenamide
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
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
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
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
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
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
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
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
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
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
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.
| Milestone | Pre-drug | Genvoya |
|---|---|---|
| Started | 4 | 37 |
| Started study arm a | 0 | 14 |
| Completed study arm a | 0 | 8 |
| Started study arm b | 0 | 8 |
| Completed study arm b | 0 | 8 |
| Started study arm c | 0 | 11 |
| Completed study arm c | 0 | 8 |
| Started study arm d | 0 | 6 |
| Completed study arm d | 0 | 4 |
| Completed | 3 | 28 |
| Not completed | 1 | 9 |
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.
| ng/mL | Genvoya - 2 and 48 Hours Specimen Collection | Genvoya - 4 and 72 Hours Specimen Collection | Genvoya - 24 and 96 Hours Specimen Collection | Genvoya - Single Time Point Specimen Collection |
|---|---|---|---|---|
| Baseline | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| 2 hours | 0 (0 to 0) | — | — | — |
| 4 hours | — | 0 (0 to 0) | — | — |
| 8 hours | — | — | — | 0 (0 to 0) |
| 24 hours | — | — | 0 (0 to 13) | — |
| 48 hours | 0 (0 to 0) | — | — | — |
| 72 hours | — | 0 (0 to 0) | — | — |
| 96 hours | — | — | 0 (0 to 60) | — |
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.
| ng/mL | Genvoya - 2 and 48 Hours Specimen Collection | Genvoya - 4 and 72 Hours Specimen Collection | Genvoya - 24 and 96 Hours Specimen Collection | Genvoya - Single Time Point Specimen Collection |
|---|---|---|---|---|
| Baseline | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| 2 hours | 2710 (1765 to 3345) | — | — | — |
| 4 hours | — | 1725 (747 to 2565) | — | — |
| 8 hours | — | — | — | 300 (225 to 351) |
| 24 hours | — | — | 113 (37 to 258) | — |
| 48 hours | 0 (0 to 768) | — | — | — |
| 72 hours | — | 0 (0 to 0) | — | — |
| 96 hours | — | — | 0 (0 to 107) | — |
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.
| ng/mL | Genvoya - 2 and 48 Hours Specimen Collection | Genvoya - 4 and 72 Hours Specimen Collection | Genvoya - 24 and 96 Hours Specimen Collection | Genvoya - Single Time Point Specimen Collection |
|---|---|---|---|---|
| Baseline | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| 2 hours | 2243 (916 to 3455) | — | — | — |
| 4 hours | — | 1818 (1230 to 4095) | — | — |
| 8 hours | — | — | — | 283 (105 to 421) |
| 24 hours | — | — | 232 (22 to 527) | — |
| 48 hours | 0 (0 to 69) | — | — | — |
| 72 hours | — | 0 (0 to 0) | — | — |
| 96 hours | — | — | 0 (0 to 18) | — |
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.
| fmol/10^6 cells | Genvoya - 2 and 48 Hours Specimen Collection | Genvoya - 4 and 72 Hours Specimen Collection | Genvoya - 24 and 96 Hours Specimen Collection | Genvoya - Single Time Point Specimen Collection |
|---|---|---|---|---|
| Baseline | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| 2 hours | 569 (262 to 1287) | — | — | — |
| 4 hours | — | 621 (156 to 1375) | — | — |
| 8 hours | — | — | — | 375 (270 to 1294) |
| 24 hours | — | — | 429 (276 to 659) | — |
| 48 hours | 291 (202 to 421) | — | — | — |
| 72 hours | — | 158 (81 to 436) | — | — |
| 96 hours | — | — | 117 (92 to 227) | — |
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.
| fmol/10^6 cells | Genvoya - 2 and 48 Hours Specimen Collection | Genvoya - 4 and 72 Hours Specimen Collection | Genvoya - 24 and 96 Hours Specimen Collection | Genvoya - Single Time Point Specimen Collection |
|---|---|---|---|---|
| Baseline | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| 2 hours | 7705 (5230 to 8750) | — | — | — |
| 4 hour | — | 7800 (3200 to 11650) | — | — |
| 8 hours | — | — | — | 6855 (5380 to 7710) |
| 24 hours | — | — | 5140 (3110 to 7740) | — |
| 48 hours | 2120 (1517 to 3390) | — | — | — |
| 72 hours | — | 955 (648 to 2210) | — | — |
| 96 hours | — | — | 714 (333 to 6000) | — |
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.
| ng/mg | Genvoya - 2 and 48 Hours Specimen Collection | Genvoya - 4 and 72 Hours Specimen Collection | Genvoya - 24 and 96 Hours Specimen Collection | Genvoya - Single Time Point Specimen Collection |
|---|---|---|---|---|
| Baseline | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| 2 hours | 0 (0 to 0.48) | — | — | — |
| 4 hours | — | 0.30 (0 to 1.23) | — | — |
| 8 hours | — | — | — | 0.01 (0 to 0.01) |
| 24 hours | — | — | 0.03 (0 to 1.20) | — |
| 48 hours | 0 (0 to 0) | — | — | — |
| 72 hours | — | 0 (0 to 0) | — | — |
| 96 hours | — | — | 0 (0 to 0) | — |
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.
| ng/mg | Genvoya - 2 and 48 Hours Specimen Collection | Genvoya - 4 and 72 Hours Specimen Collection | Genvoya - 24 and 96 Hours Specimen Collection | Genvoya - Single Time Point Specimen Collection |
|---|---|---|---|---|
| Baseline | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| 2 hours | 9.54 (6.23 to 10.43) | — | — | — |
| 4 hours | — | 9.25 (0 to 12.11) | — | — |
| 8 hours | — | — | — | 0.17 (0.11 to 0.19) |
| 24 hours | — | — | 1.23 (0.29 to 12.86) | — |
| 48 hours | 0.02 (0 to 4.93) | — | — | — |
| 72 hours | — | 0 (0 to 0) | — | — |
| 96 hours | — | — | 0.02 (0.02 to 0.03) | — |
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.
| ng/mg | Genvoya - 2 and 48 Hours Specimen Collection | Genvoya - 4 and 72 Hours Specimen Collection | Genvoya - 24 and 96 Hours Specimen Collection | Genvoya - Single Time Point Specimen Collection |
|---|---|---|---|---|
| Baseline | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| 2 hours | 51.23 (28.19 to 69.04) | — | — | — |
| 4 hours | — | 41.47 (8.95 to 66.17) | — | — |
| 8 hours | — | — | — | 0.31 (0.05 to 0.51) |
| 24 hours | — | — | 0.60 (0.29 to 40.02) | — |
| 48 hours | 1.03 (0 to 2.46) | — | — | — |
| 72 hours | — | 0 (0 to 0) | — | — |
| 96 hours | — | — | 0.02 (0.02 to 0.03) | — |
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.
| fmol/mg | Genvoya - 2 and 48 Hours Specimen Collection | Genvoya - 4 and 72 Hours Specimen Collection | Genvoya - 24 and 96 Hours Specimen Collection | Genvoya - Single Time Point Specimen Collection |
|---|---|---|---|---|
| Baseline | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| 2 hours | 39.1 (34.2 to 74.6) | — | — | — |
| 4 hours | — | 45.9 (15.7 to 135.4) | — | — |
| 8 hours | — | — | — | 23.7 (14.7 to 27.4) |
| 24 hours | — | — | 20.2 (5.0 to 35.7) | — |
| 48 hours | 18.2 (15.9 to 22.1) | — | — | — |
| 72 hours | — | 11.9 (6.7 to 22.2) | — | — |
| 96 hours | — | — | 14.7 (4.6 to 1926.0) | — |
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.
| fmol/mg | Genvoya - 2 and 48 Hours Specimen Collection | Genvoya - 4 and 72 Hours Specimen Collection | Genvoya - 24 and 96 Hours Specimen Collection | Genvoya - Single Time Point Specimen Collection |
|---|---|---|---|---|
| Baseline | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| 2 hours | 187.5 (146.6 to 255.9) | — | — | — |
| 4 hours | — | 198.2 (68.9 to 365.8) | — | — |
| 8 hours | — | — | — | 116.5 (62.3 to 176.6) |
| 24 hours | — | — | 104.3 (19.5 to 184.5) | — |
| 48 hours | 56.3 (18.1 to 91.7) | — | — | — |
| 72 hours | — | 15.1 (7.3 to 52.3) | — | — |
| 96 hours | — | — | 12.5 (6.3 to 141.3) | — |
Collected over Data on adverse events were collected from the time of study enrollment, at the screening visit, through two days after the biopsy (up to seven weeks total).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pre-drug | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Genvoya - 2 and 48 Hours Specimen Collection | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Genvoya - 4 and 72 Hours Specimen Collection | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Genvoya - 24 and 96 Hours Specimen Collection | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Genvoya - Single Time Point Specimen Collection | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Categorical(Participants) | Pre-drug | Genvoya | Total |
|---|---|---|---|
| <=18 years | 0 | 1 | 1 |
| Between 18 and 65 years | 4 | 36 | 40 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Pre-drug | Genvoya | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 4 | 37 | 41 |
| Race (NIH/OMB)(Participants) | Pre-drug | Genvoya | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 26 | 30 |
| White | 0 | 7 | 7 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 4 | 4 |
| Region of Enrollment(Participants) | Pre-drug | Genvoya | Total |
|---|---|---|---|
| United States | 4 | 37 | 41 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after de-identification (e.g., text, tables, figures, and appendices), will be available. The study protocol will be available. Data will become available Beginning 9 months and ending at 36 months following publication to researchers who provide a methodologically sound proposal.
Supporting information: Study protocol
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Acquired Immunodeficiency Syndrome→
Emory University