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Body Compartment PK for New HIV Pre-exposure Prophylaxis Modalities

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02985996
Recruitment Status : Completed
First Posted : December 7, 2016
Results First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Colleen Kelley, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition HIV Infections
Interventions Drug: Truvada
Drug: Genvoya
Enrollment 48
Recruitment Details  
Pre-assignment Details

24 participants were recruited in Phase II, but only 18 were randomized to either Genvoya or Truvada due to lost to follow up.

19 participants were recruited in Phase III, but only 16 were randomized to either Genvoya or Truvada due to lost to follow up.

Arm/Group Title Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Overall Study
Started 5 8 10 7 9
Completed 5 7 9 7 9
Not Completed 0 1 1 0 0
Reason Not Completed
Withdrawal by Subject             0             0             1             0             0
Protocol Violation             0             1             0             0             0
Arm/Group Title Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada Total
Hide Arm/Group Description 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. 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 5 8 10 7 9 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 8 participants 10 participants 7 participants 9 participants 39 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
8
 100.0%
10
 100.0%
7
 100.0%
9
 100.0%
39
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 8 participants 10 participants 7 participants 9 participants 39 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
5
 100.0%
8
 100.0%
10
 100.0%
7
 100.0%
9
 100.0%
39
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 8 participants 10 participants 7 participants 9 participants 39 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  40.0%
3
  37.5%
7
  70.0%
6
  85.7%
4
  44.4%
22
  56.4%
White
3
  60.0%
5
  62.5%
2
  20.0%
1
  14.3%
4
  44.4%
15
  38.5%
More than one race
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
1
   2.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
1
   2.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 8 participants 10 participants 7 participants 9 participants 39 participants
5 8 10 7 9 39
1.Primary Outcome
Title Changes in Intracellular Emtricitabine Triphosphate (FTC-TP)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 5 7 9 7 9
Median (Full Range)
Unit of Measure: fmol/1000000 PBMC
0
(0 to 0)
3380
(2091 to 4320)
2580
(1531 to 5340)
6470
(3030 to 15,380)
7660
(3170 to 10,470)
2.Primary Outcome
Title Changes in Intracellular Tenofovir Diphosphate (TFV-DP)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada
Hide Arm/Group Description:
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
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.
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.
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.
Overall Number of Participants Analyzed 5 7 9 7 9
Median (Full Range)
Unit of Measure: fmol/1000000 PBMC
0
(0 to 0)
213
(111 to 323)
28
(0 to 32)
453
(138 to 897)
80
(0 to 156)
3.Secondary Outcome
Title Change in Plasma Emtricitabine (FTC) Concentration
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada
Hide Arm/Group Description:
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.
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.
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
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.
Overall Number of Participants Analyzed 5 7 9 7 9
Median (Full Range)
Unit of Measure: ng/mL
0
(0 to 0)
30
(12 to 46)
34
(20 to 206)
152
(31 to 613)
280
(66 to 518)
4.Secondary Outcome
Title Change in Plasma Tenofovir Disoproxil Fumarate (TDF) Concentration
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I/Pre-Drug Phase II/Short Course Phase III/Steady State Phase III/Genvoya Phase III/Truvada
Hide Arm/Group Description:
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 be randomized to receive one dose of Truvada or 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.

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: 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.

Participants will be randomized to receive Truvada or Genvoya to be taken 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: 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: 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.

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.
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.
Overall Number of Participants Analyzed 5 7 9 7 9
Median (Full Range)
Unit of Measure: ng/mL
0
(0 to 0)
0
(0 to 0)
28
(20 to 59)
0
(0 to 0)
59
(38 to 89)
5.Secondary Outcome
Title Change in Plasma Tenofovir Alafenamide (TAF) Concentration
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
TAF was not measured, only the metabolite TFV was measured
Arm/Group Title Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change in Plasma Elvitegravir (EVG) Concentration
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 5 7 9 7 9
Median (Full Range)
Unit of Measure: ng/mL
0
(0 to 0)
102
(0 to 295)
0
(0 to 0)
384
(99 to 705)
0
(0 to 0)
7.Secondary Outcome
Title Change in Rectal Emtricitabine (FTC) Concentration
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 5 7 9 7 9
Median (Full Range)
Unit of Measure: ng/swab
0
(0 to 0)
288
(0 to 42,450)
419
(64 to 6935)
371
(0 to 3830)
109
(0 to 3900)
8.Secondary Outcome
Title Change in Rectal Tenofovir Disoproxil Fumarate (TDF) Concentration
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 5 7 9 7 9
Median (Full Range)
Unit of Measure: ng/swab
0
(0 to 0)
58
(0 to 1195)
45
(0 to 263)
533
(0 to 18,400)
1325
(0 to 6145)
9.Secondary Outcome
Title Change in Rectal Tenofovir Alafenamide (TAF) Concentration
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The study didn't measure TAF, only the metabolite TFV
Arm/Group Title Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Change in Rectal Elvitegravir (EVG) Concentration
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 5 7 9 7 9
Median (Full Range)
Unit of Measure: ng/swab
0
(0 to 0)
405
(55 to 7975)
0
(0 to 0)
219
(0 to 54,100)
0
(0 to 0)
11.Secondary Outcome
Title Change in Intracellular Tenofovir Alafenamide (TAF) Concentration in Peripheral Blood Mononuclear Cells (PBMCs)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The study didn't measure TAF, only the metabolite TFV
Arm/Group Title Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Change in Intracellular Elvitegravir (EVG) Concentration in Peripheral Blood Mononuclear Cells (PBMCs)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
EVG is very difficult to measure intracellularly, therefore the study only measured plasma or extracellular concentrations.
Arm/Group Title Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Change in Intracellular Emtricitabine (FTC) Concentration in Rectal Tissue
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 5 7 9 7 9
Median (Full Range)
Unit of Measure: fmol/mg tissue
0
(0 to 0)
0
(0 to 11)
0
(0 to 51)
27
(0 to 79)
41
(0 to 110)
14.Secondary Outcome
Title Change in Intracellular Tenofovir (TFV) Concentration in Rectal Tissue
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 5 7 9 7 9
Median (Full Range)
Unit of Measure: fmol/mg tissue
0
(0 to 0)
17
(0 to 65)
11
(0 to 74)
0
(0 to 102)
0
(0 to 17)
15.Secondary Outcome
Title Change in Tenofovir Alafenamide (TAF) Concentration in Rectal Tissue
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The study didn't measure TAF, only the metabolite TFV
Arm/Group Title Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Change in Elvitegravir (EVG) Concentration in Rectal Tissue
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 5 7 9 7 9
Median (Full Range)
Unit of Measure: ng/mg 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)
17.Secondary Outcome
Title Change in Emtricitabine (FTC) Concentration in Penile Secretions
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I/Pre-Drug Phase II/Short Course Phase III/Steady State Phase III/Genvoya Phase III/Truvada
Hide Arm/Group Description:
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 be randomized to receive one dose of Truvada or 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.

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: 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.

Participants will be randomized to receive Truvada or Genvoya to be taken 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: 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: 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.

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.
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.
Overall Number of Participants Analyzed 5 7 9 7 9
Median (Full Range)
Unit of Measure: ng/swab
0
(0 to 0)
32
(0 to 77)
30
(0 to 406)
175
(0 to 1775)
54
(0 to 9685)
18.Secondary Outcome
Title Change in Tenofovir Disoproxil Fumarate (TDF) Concentration in Penile Secretions
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 5 7 9 7 9
Median (Full Range)
Unit of Measure: ng/swab
0
(0 to 0)
0
(0 to 0)
0
(0 to 385)
0
(0 to 30)
17
(0 to 818)
19.Secondary Outcome
Title Change in Tenofovir Alafenamide (TAF) Concentration in Penile Secretions
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The study did not measure TAF, only the metabolite TFV
Arm/Group Title Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
20.Secondary Outcome
Title Change in Elvitegravir (EVG) Concentration in Penile Secretions
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 5 7 9 7 9
Median (Full Range)
Unit of Measure: ng/swab
0
(0 to 0)
0
(0 to 28)
0
(0 to 0)
0
(0 to 12)
0
(0 to 0)
21.Secondary Outcome
Title PrEP Efficacy as Measured by Inhibition of in Vitro Infection of Rectal Biopsies to HIV
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 5 7 9 7 9
Median (Full Range)
Unit of Measure: ng p24
740
(271 to 2319)
225
(128 to 535)
298
(224 to 381)
348
(159 to 504)
327
(94 to 465)
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/8 (0.00%)   0/10 (0.00%)   0/7 (0.00%)   0/9 (0.00%) 
Hide Serious Adverse Events
Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/8 (0.00%)   0/10 (0.00%)   0/7 (0.00%)   0/9 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phase I/Pre-Drug Phase II/Genvoya Phase II/Truvada Phase III/Genvoya Phase III/Truvada
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/8 (0.00%)   0/10 (0.00%)   0/7 (0.00%)   0/9 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Colleen Kelley
Organization: Emory University
Phone: 404-712-1823
EMail: colleen.kelley@emory.edu
Layout table for additonal information
Responsible Party: Colleen Kelley, Emory University
ClinicalTrials.gov Identifier: NCT02985996    
Other Study ID Numbers: IRB00092488
First Submitted: December 5, 2016
First Posted: December 7, 2016
Results First Submitted: January 22, 2019
Results First Posted: September 17, 2019
Last Update Posted: September 17, 2019