A Phase 1 interventional study of Truvada and Genvoya in HIV Infections, 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 2019-09-17.
Sponsored by Emory University · Phase 1, Interventional, and Prevention
The purpose of this study is to determine the ability of new anti-HIV agents to penetrate different body compartments in HIV negative men who have sex with men and transgender women. These new agents might be considered for pre-exposure prophylaxis regimens in the future. This study will include 90 healthy, HIV-negative men who have sex with men and transgender women who are not taking hormones aged 18-49 years. Participant must be willing to participate in 1 of the 3 study phases, be willing to take Truvada® (PrEP) or Genvoya®, and willing to undergo blood draws, urethral swabs, and rectal biopsy procedures.
Men who have sex with men (MSM) and Transgender women (TGW) who have sex with men continue to be disproportionately affected by HIV. Over 60% of new HIV infections in the US occur among MSM. The majority of HIV infections among MSM and TGW occur through exposure to the rectal mucosa during receptive anal intercourse (RAI). Pre-exposure prophylaxis (PrEP) is a new HIV prevention method that is recommended by CDC and WHO for MSM at risk of HIV infection. PrEP entails taking an anti-HIV medication (Truvada®; tenofovir/emtricitabine) on a daily basis to prevent HIV infection. However, current tenofovir- based regimens have shown to have side effects that researchers are hoping to reduce in newly developed anti-HIV agents. This study is designed to examine the ability of these new agents to penetrate mucosal tissues and potentially prevent HIV infection during RAI exposure for MSM and TGW.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 48 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections 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.
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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:
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.
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.
Drug: Genvoya
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.
Drug: Truvada
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.
Drug: Genvoya
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.
Drug: Truvada
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.
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.
Changes in Intracellular Emtricitabine Triphosphate (FTC-TP)
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.
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Changes in Intracellular Tenofovir Diphosphate (TFV-DP)
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.
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Plasma Emtricitabine (FTC) Concentration
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.
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Plasma Tenofovir Disoproxil Fumarate (TDF) Concentration
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.
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Plasma Tenofovir Alafenamide (TAF) Concentration
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.
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Plasma Elvitegravir (EVG) Concentration
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.
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Rectal Emtricitabine (FTC) Concentration
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.
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Rectal Tenofovir Disoproxil Fumarate (TDF) Concentration
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.
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Rectal Tenofovir Alafenamide (TAF) Concentration
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.
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Rectal Elvitegravir (EVG) Concentration
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.
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Intracellular Tenofovir Alafenamide (TAF) Concentration in Peripheral Blood Mononuclear Cells (PBMCs)
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.
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Intracellular Elvitegravir (EVG) Concentration in Peripheral Blood Mononuclear Cells (PBMCs)
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.
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Intracellular Emtricitabine (FTC) Concentration in Rectal Tissue
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.
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Intracellular Tenofovir (TFV) Concentration in Rectal Tissue
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.
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Tenofovir Alafenamide (TAF) Concentration in Rectal Tissue
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.
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Elvitegravir (EVG) Concentration in Rectal Tissue
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.
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Emtricitabine (FTC) Concentration in Penile Secretions
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.
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Tenofovir Disoproxil Fumarate (TDF) Concentration in Penile Secretions
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.
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Tenofovir Alafenamide (TAF) Concentration in Penile Secretions
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.
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Elvitegravir (EVG) Concentration in Penile Secretions
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.
Time frame: Baseline, Visit 4 (Up to ten days post drug)
PrEP Efficacy as Measured by Inhibition of in Vitro Infection of Rectal Biopsies to HIV
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.
Time frame: Up to 10 months post-baseline
| Milestone | Phase I/Pre-Drug | Phase II/Genvoya | Phase II/Truvada | Phase III/Genvoya | Phase III/Truvada |
|---|---|---|---|---|---|
| Started | 5 | 8 | 10 | 7 | 9 |
| Completed | 5 | 7 | 9 | 7 | 9 |
| Not completed | 0 | 1 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Protocol violation | 0 | 1 | 0 | 0 | 0 |
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.
| fmol/1000000 PBMC | Phase I/Pre-Drug | Phase II/Genvoya | Phase II/Truvada | Phase III/Genvoya | Phase III/Truvada |
|---|---|---|---|---|---|
| Changes in Intracellular Emtricitabine Triphosphate (FTC-TP) | 0 (0 to 0) | 3380 (2091 to 4320) | 2580 (1531 to 5340) | 6470 (3030 to 15,380) | 7660 (3170 to 10,470) |
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.
| fmol/1000000 PBMC | Phase I/Pre-Drug | Phase II/Genvoya | Phase II/Truvada | Phase III/Genvoya | Phase III/Truvada |
|---|---|---|---|---|---|
| Changes in Intracellular Tenofovir Diphosphate (TFV-DP) | 0 (0 to 0) | 213 (111 to 323) | 28 (0 to 32) | 453 (138 to 897) | 80 (0 to 156) |
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.
| ng/mL | Phase I/Pre-Drug | Phase II/Genvoya | Phase II/Truvada | Phase III/Genvoya | Phase III/Truvada |
|---|---|---|---|---|---|
| Change in Plasma Emtricitabine (FTC) Concentration | 0 (0 to 0) | 30 (12 to 46) | 34 (20 to 206) | 152 (31 to 613) | 280 (66 to 518) |
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.
| ng/mL | Phase I/Pre-Drug | Phase II/Short Course | Phase III/Steady State | Phase III/Genvoya | Phase III/Truvada |
|---|---|---|---|---|---|
| Change in Plasma Tenofovir Disoproxil Fumarate (TDF) Concentration | 0 (0 to 0) | 0 (0 to 0) | 28 (20 to 59) | 0 (0 to 0) | 59 (38 to 89) |
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.
No measurements were reported for this outcome.
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.
| ng/mL | Phase I/Pre-Drug | Phase II/Genvoya | Phase II/Truvada | Phase III/Genvoya | Phase III/Truvada |
|---|---|---|---|---|---|
| Change in Plasma Elvitegravir (EVG) Concentration | 0 (0 to 0) | 102 (0 to 295) | 0 (0 to 0) | 384 (99 to 705) | 0 (0 to 0) |
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.
| ng/swab | Phase I/Pre-Drug | Phase II/Genvoya | Phase II/Truvada | Phase III/Genvoya | Phase III/Truvada |
|---|---|---|---|---|---|
| Change in Rectal Emtricitabine (FTC) Concentration | 0 (0 to 0) | 288 (0 to 42,450) | 419 (64 to 6935) | 371 (0 to 3830) | 109 (0 to 3900) |
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.
| ng/swab | Phase I/Pre-Drug | Phase II/Genvoya | Phase II/Truvada | Phase III/Genvoya | Phase III/Truvada |
|---|---|---|---|---|---|
| Change in Rectal Tenofovir Disoproxil Fumarate (TDF) Concentration | 0 (0 to 0) | 58 (0 to 1195) | 45 (0 to 263) | 533 (0 to 18,400) | 1325 (0 to 6145) |
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.
No measurements were reported for this outcome.
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.
| ng/swab | Phase I/Pre-Drug | Phase II/Genvoya | Phase II/Truvada | Phase III/Genvoya | Phase III/Truvada |
|---|---|---|---|---|---|
| Change in Rectal Elvitegravir (EVG) Concentration | 0 (0 to 0) | 405 (55 to 7975) | 0 (0 to 0) | 219 (0 to 54,100) | 0 (0 to 0) |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
| fmol/mg tissue | Phase I/Pre-Drug | Phase II/Genvoya | Phase II/Truvada | Phase III/Genvoya | Phase III/Truvada |
|---|---|---|---|---|---|
| Change in Intracellular Emtricitabine (FTC) Concentration in Rectal Tissue | 0 (0 to 0) | 0 (0 to 11) | 0 (0 to 51) | 27 (0 to 79) | 41 (0 to 110) |
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.
| fmol/mg tissue | Phase I/Pre-Drug | Phase II/Genvoya | Phase II/Truvada | Phase III/Genvoya | Phase III/Truvada |
|---|---|---|---|---|---|
| Change in Intracellular Tenofovir (TFV) Concentration in Rectal Tissue | 0 (0 to 0) | 17 (0 to 65) | 11 (0 to 74) | 0 (0 to 102) | 0 (0 to 17) |
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.
No measurements were reported for this outcome.
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.
| ng/mg tissue | Phase I/Pre-Drug | Phase II/Genvoya | Phase II/Truvada | Phase III/Genvoya | Phase III/Truvada |
|---|---|---|---|---|---|
| Change in Elvitegravir (EVG) Concentration in Rectal Tissue | 0 (0 to 0) | 2.7 (1.2 to 9.8) | 0 (0 to 0) | 6.8 (4.5 to 11.1) | 0 (0 to 0) |
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.
| ng/swab | Phase I/Pre-Drug | Phase II/Short Course | Phase III/Steady State | Phase III/Genvoya | Phase III/Truvada |
|---|---|---|---|---|---|
| Change in Emtricitabine (FTC) Concentration in Penile Secretions | 0 (0 to 0) | 32 (0 to 77) | 30 (0 to 406) | 175 (0 to 1775) | 54 (0 to 9685) |
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.
| ng/swab | Phase I/Pre-Drug | Phase II/Genvoya | Phase II/Truvada | Phase III/Genvoya | Phase III/Truvada |
|---|---|---|---|---|---|
| Change in Tenofovir Disoproxil Fumarate (TDF) Concentration in Penile Secretions | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 385) | 0 (0 to 30) | 17 (0 to 818) |
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.
No measurements were reported for this outcome.
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.
| ng/swab | Phase I/Pre-Drug | Phase II/Genvoya | Phase II/Truvada | Phase III/Genvoya | Phase III/Truvada |
|---|---|---|---|---|---|
| Change in Elvitegravir (EVG) Concentration in Penile Secretions | 0 (0 to 0) | 0 (0 to 28) | 0 (0 to 0) | 0 (0 to 12) | 0 (0 to 0) |
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.
| ng p24 | Phase I/Pre-Drug | Phase II/Genvoya | Phase II/Truvada | Phase III/Genvoya | Phase III/Truvada |
|---|---|---|---|---|---|
| PrEP Efficacy as Measured by Inhibition of in Vitro Infection of Rectal Biopsies to HIV | 740 (271 to 2319) | 225 (128 to 535) | 298 (224 to 381) | 348 (159 to 504) | 327 (94 to 465) |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase I/Pre-Drug | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Phase II/Genvoya | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Phase II/Truvada | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Phase III/Genvoya | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Phase III/Truvada | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Categorical(Participants) | Phase I/Pre-Drug | Phase II/Genvoya | Phase II/Truvada | Phase III/Genvoya | Phase III/Truvada | Total |
|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 8 | 10 | 7 | 9 | 39 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Phase I/Pre-Drug | Phase II/Genvoya | Phase II/Truvada | Phase III/Genvoya | Phase III/Truvada | Total |
|---|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 | 0 | 0 |
| Male | 5 | 8 | 10 | 7 | 9 | 39 |
| Race (NIH/OMB)(Participants) | Phase I/Pre-Drug | Phase II/Genvoya | Phase II/Truvada | Phase III/Genvoya | Phase III/Truvada | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 3 | 7 | 6 | 4 | 22 |
| White | 3 | 5 | 2 | 1 | 4 | 15 |
| More than one race | 0 | 0 | 1 | 0 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 1 | 1 |
| Region of Enrollment(participants) | Phase I/Pre-Drug | Phase II/Genvoya | Phase II/Truvada | Phase III/Genvoya | Phase III/Truvada | Total |
|---|---|---|---|---|---|---|
| United States | 5 | 8 | 10 | 7 | 9 | 39 |
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