Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults
Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT03739866
Collaborator
(none)
53
12
8
18.6
4.4
0.2
Study Details
Study Description
Brief Summary
The primary objectives of this study are:
Part A: To evaluate the short-term antiviral activity of lenacapavir (formerly GS-6207) with respect to the maximum reduction of plasma HIV-1 RNA (log10 copies/mL) from Day 1 through Day 10 compared to placebo in HIV-1 infected adults who are antiretroviral treatment naive or are experienced but capsid inhibitor (CAI) naive.
Part B: To evaluate the short-term antiviral activity of tenofovir alafenamide (TAF) with respect to the maximum reduction of plasma HIV-1 RNA (log10 copies/mL) from Day 1 through Day 10 in HIV-1 infected adult subjects who are antiretroviral treatment naïve or are experienced but without resistance to TAF.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
53 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 1b Randomized, Double-Blinded, Placebo Controlled, Multi-Cohort Study of the Safety, Pharmacokinetics, and Antiviral Activity of GS-6207 Administered Subcutaneously in HIV-1 Infected Subjects
Actual Study Start Date
:
Nov 26, 2018
Actual Primary Completion Date
:
Nov 14, 2019
Actual Study Completion Date
:
Jun 15, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part A: Lenacapavir 20 mg Participants will receive single dose of lenacapavir 20 mg on Day 1 followed by bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) as per standard-care therapy starting on Day 10 through Day 225. |
Drug: Lenacapavir
Administered subcutaneously in the abdomen
Other Names:
Drug: B/F/TAF
50/200/25 mg tablets administered orally once daily
Other Names:
|
| Experimental: Part A: Lenacapavir 50 mg Participants will receive single dose of lenacapavir 50 mg on Day 1 followed by B/F/TAF as per standard-care therapy starting on Day 10 through Day 225. |
Drug: Lenacapavir
Administered subcutaneously in the abdomen
Other Names:
Drug: B/F/TAF
50/200/25 mg tablets administered orally once daily
Other Names:
|
| Experimental: Part A: Lenacapavir 150 mg Participants will receive single dose of lenacapavir 150 mg on Day 1 followed by B/F/TAF as per standard-care therapy starting on Day 10 through Day 225. |
Drug: Lenacapavir
Administered subcutaneously in the abdomen
Other Names:
Drug: B/F/TAF
50/200/25 mg tablets administered orally once daily
Other Names:
|
| Experimental: Part A: Lenacapavir 450 mg Participants will receive single dose of lenacapavir 450 mg on Day 1 followed by B/F/TAF as per standard-care therapy starting on Day 10 through Day 225. |
Drug: Lenacapavir
Administered subcutaneously in the abdomen
Other Names:
Drug: B/F/TAF
50/200/25 mg tablets administered orally once daily
Other Names:
|
| Experimental: Part A: Lenacapavir 750 mg Participants will receive single dose of lenacapavir 750 mg on Day 1 followed by B/F/TAF as per standard-care therapy starting on Day 10 through Day 225. |
Drug: Lenacapavir
Administered subcutaneously in the abdomen
Other Names:
Drug: B/F/TAF
50/200/25 mg tablets administered orally once daily
Other Names:
|
| Placebo Comparator: Part A: Placebo Participants will receive single dose of placebo matched to lenacapavir on Day 1 followed by B/F/TAF as per standard-care therapy starting on Day 10 through Day 225. |
Drug: Placebo
Administered subcutaneously in the abdomen
Drug: B/F/TAF
50/200/25 mg tablets administered orally once daily
Other Names:
|
| Experimental: Part B: TAF 200 mg Participants will receive a single dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy starting on Day 10 through Day 225. |
Drug: B/F/TAF
50/200/25 mg tablets administered orally once daily
Other Names:
Drug: TAF
Tablets administered orally
|
| Experimental: Part B: TAF 600 mg Participants will receive a single dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy starting on Day 10 through Day 225. |
Drug: B/F/TAF
50/200/25 mg tablets administered orally once daily
Other Names:
Drug: TAF
Tablets administered orally
|
Outcome Measures
Primary Outcome Measures
- Part A and Part B: Maximum Reduction From Day 1 (Baseline) Through Day 10 in Plasma HIV-1 RNA [Day 1 through Day 10]
Maximum reduction is defined as the minimum of change from baseline in plasma HIV-1 RNA (i.e. smallest change in HIV-RNA from baseline).
Secondary Outcome Measures
- Part A and Part B: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) [Day 1 through 225 days]
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE could therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as any AE with an onset date on or after the study drug start date.
- Part A and Part B: Percentage of Participants Experiencing Treatment Emergent Laboratory Abnormalities [Day 1 through 225 days]
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.
- Part A and Part B Pharmacokinetic (PK) Parameter: AUCinf of Lenacapavir, TAF and Its Metabolite TFV [Part A: 0 (predose),1,2,4,8,12,24 h postdose on Day 1, anytime on Days 3,4,7,8,9,10,14,29,43,57,85,113,141,169,197,225; Part B: 0 (predose),0.5,1,2,3,4,6,8,10,12,24 and 48 h postdose on Day 1, approximately Day 1 predose time on Days 4,5,6,7,8,9,10]
AUCinf is defined as area under the concentration versus time curve from time zero to infinity.
- Part A and Part B PK Parameter: AUClast of Lenacapavir, TAF and Its Metabolite TFV [Part A: 0 (predose),1,2,4,8,12,24 h postdose on Day 1, anytime on Days 3,4,7,8,9,10,14,29,43,57,85,113,141,169,197,225; Part B: 0 (predose),0.5,1,2,3,4,6,8,10,12,24 and 48 h postdose on Day 1, approximately Day 1 predose time on Days 4,5,6,7,8,9,10]
AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration.
- Part A and Part B PK Parameter: Cmax of Lenacapavir, TAF and Its Metabolite TFV [Part A: 0 (predose),1,2,4,8,12,24 h postdose on Day 1, anytime on Days 3,4,7,8,9,10,14,29,43,57,85,113,141,169,197,225; Part B: 0 (predose),0.5,1,2,3,4,6,8,10,12,24 and 48 h postdose on Day 1, approximately Day 1 predose time on Days 4,5,6,7,8,9,10]
Cmax is defined as the maximum observed concentration of drug.
- Part B PK Parameter: AUCinf of TFV-DP Metabolite of TAF [Part B: 0 (predose), 1, 2, 4, 6, 8, 12, 24 and 48 hours post dose on Day 1, approximately Day 1 predose time on Days 4, 5 (if possible), 6 (if possible), 7, 8, 9, 10]
AUCinf is defined as area under the concentration versus time curve from time zero to infinity.
- Part B PK Parameter: AUClast of TFV-DP Metabolite of TAF [Part B: 0 (predose), 1, 2, 4, 6, 8, 12, 24 and 48 hours post dose on Day 1, approximately Day 1 predose time on Days 4, 5 (if possible), 6 (if possible), 7, 8, 9, 10]
AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration.
- Part B PK Parameter: Cmax of TFV-DP Metabolite of TAF [Part B: 0 (predose), 1, 2, 4, 6, 8, 12, 24 and 48 hours post dose on Day 1, approximately Day 1 predose time on Days 4, 5 (if possible), 6 (if possible), 7, 8, 9, 10]
Cmax is defined as the maximum observed concentration of drug.
- Part A: Percentage of Participants Ever Achieving HIV-1 RNA < 50 Copies/mL by Day 10 [Day 10]
- Part A: Number of Participants Experiencing Any Emergence of Capsid Inhibitor Resistance [Day 10]
- Part A: Number of Participants Experiencing Any Emergence of Capsid Inhibitor Resistance [Day 10 through Day 225]
Post-Monotherapy Resistance Analysis Population analyzed for this outcome measure included any participant who received at least 1 dose of study drug/placebo, maintained their study drug regimen, & met one of following virologic failure criteria: HIV-1 RNA ≥ 50 copies/mL & < 1 log10 HIV-1 RNA reduction from Day 10 at Day 57 visit, confirmed at a scheduled or unscheduled visit at least 2 weeks following Day 57 At any visit following Day 10, after achieving HIV-1 RNA < 50 copies/mL, a rebound in HIV-1 RNA to ≥ 50 copies/mL, which was subsequently confirmed at following scheduled or unscheduled visit; OR At any visit, a > 1 log10 increase in HIV-1 RNA from nadir, which was subsequently confirmed at following scheduled or unscheduled visit; Any participant with HIV-1 RNA ≥ 50 copies/mL at study endpoint or study discontinuation who didn't meet any of criteria above also had protease (PR)/reverse transcriptase (RT), integrase (IN), &capsid (CA) genotyping & phenotyping performed.
- Part B: Number of Participants Experiencing Any Emergence of TAF Resistance [Day 10]
- Part B: Number of Participants Experiencing Any Emergence of TAF Resistance [Day 10 through Day 225]
TAF Resistance testing was performed for any participant meeting Post-Monotherapy Resistance Analysis Population criteria - it included any participant who received at least 1 dose of study drug/placebo, maintained their study drug regimen, & met one of the following virologic failure criteria: HIV-1 RNA ≥50 copies/mL & < 1 log10 HIV-1 RNA reduction from D10 at the D57 visit, confirmed at scheduled or unscheduled visit at least 2 weeks following D57 At any visit following D10, after achieving HIV-1 RNA< 50 copies/mL, a rebound in HIV-1 RNA to ≥50 copies/mL, which was subsequently confirmed at the following scheduled/unscheduled visit; OR At any visit, a > 1 log10 increase in HIV-1 RNA from nadir, which was subsequently confirmed at the following scheduled or unscheduled visit; Any participant with HIV-1 RNA ≥50 copies/mL at study endpoint or study discontinuation who didn't meet any of the criteria above also had PR/RT, IN, and CA genotyping & phenotyping performed. D = Day
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
-
Plasma HIV-1 RNA ≥ 5,000 copies/mL but ≤ 400,000 copies/mL and CD4+ cell count > 200 cells/mm^3
-
Treatment naive or experienced but CAI (for Part A only) and integrase strand transfer inhibitor (INSTI) naïve, and have not received any antiretroviral therapy (ART) within 12 weeks of screening
-
Screening genotype report must show sensitivity to B/F/TAF to allow its initiation on Day 10
-
Screening genotype report must show sensitivity to at least one agent in either non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI) class to allow its use as part of standard of care oral antiretroviral treatment in the future
-
Have adequate renal function (estimated glomerular filtration rate ≥ 70 mL/min)
-
No clinically significant abnormalities in electrocardiography (ECG) at Screening
-
Willing to initiate B/F/TAF on Day 10 after completion of all assessments
Key Exclusion Criteria:
- Pregnant or lactating females
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ruane Clinical Research Group, Inc. | Los Angeles | California | United States | 90036 |
| 2 | Mills Clinical Research | Los Angeles | California | United States | 90069 |
| 3 | One Community | Sacramento | California | United States | 95817 |
| 4 | The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Center | Torrance | California | United States | 90502 |
| 5 | Midway Immunology and Research Center | Fort Pierce | Florida | United States | 34982 |
| 6 | Orlando Immunology Center PA | Orlando | Florida | United States | 32803-1851 |
| 7 | Triple O Research Institute, P.A. | West Palm Beach | Florida | United States | 33401 |
| 8 | Be Well Medical Center | Berkley | Michigan | United States | 48072-3436 |
| 9 | AIDS Arms, Inc., DBA Prism Health North Texas | Dallas | Texas | United States | 75208 |
| 10 | North Texas Infectious Diseases Consultants, P.A. | Dallas | Texas | United States | 75246 |
| 11 | Tarrant County Infectious Disease Associates | Fort Worth | Texas | United States | 76104 |
| 12 | The Crofoot Research Center, INC (dba Gordon E. Crofoot MD PA) | Houston | Texas | United States | 77098 |
Sponsors and Collaborators
- Gilead Sciences
Investigators
- Study Director: Gilead Study Director, Gilead Sciences
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT03739866
Other Study ID Numbers:
- GS-US-200-4072
First Posted:
Nov 14, 2018
Last Update Posted:
Apr 9, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled at study sites in the United States. The first participant was screened on 26 November 2018. The last study visit occurred on 15 June 2020. |
|---|---|
| Pre-assignment Detail | 89 participants were screened. |
| Arm/Group Title | Part A: Lenacapavir 20 mg | Part A: Lenacapavir 50 mg | Part A: Lenacapavir 150 mg | Part A: Lenacapavir 450 mg | Part A: Lenacapavir 750 mg | Part A: Placebo | Part B: Tenofovir Alafenamide (TAF) 200 mg | Part B: TAF 600 mg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. |
| Period Title: Overall Study | ||||||||
| STARTED | 6 | 6 | 7 | 6 | 6 | 10 | 7 | 5 |
| COMPLETED | 6 | 6 | 6 | 5 | 5 | 10 | 7 | 5 |
| NOT COMPLETED | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Part A: Lenacapavir 20 mg | Part A: Lenacapavir 50 mg | Part A: Lenacapavir 150 mg | Part A: Lenacapavir 450 mg | Part A: Lenacapavir 750 mg | Part A: Placebo | Part B: TAF 200 mg | Part B: TAF 600 mg | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy on started on Day 10 through Day 225. | Total of all reporting groups |
| Overall Participants | 6 | 6 | 6 | 6 | 5 | 10 | 7 | 5 | 51 |
| Age (years) [Mean (Standard Deviation) ] | |||||||||
| Mean (Standard Deviation) [years] |
33
(4.4)
|
36
(14.4)
|
39
(11.5)
|
36
(15.5)
|
37
(17.7)
|
29
(9.3)
|
29
(8.7)
|
40
(8.7)
|
34
(11.5)
|
| Sex: Female, Male (Count of Participants) | |||||||||
| Female |
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
2
40%
|
1
10%
|
0
0%
|
0
0%
|
4
7.8%
|
| Male |
6
100%
|
6
100%
|
5
83.3%
|
6
100%
|
3
60%
|
9
90%
|
7
100%
|
5
100%
|
47
92.2%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||||||
| Hispanic or Latino |
1
16.7%
|
0
0%
|
0
0%
|
1
16.7%
|
3
60%
|
1
10%
|
5
71.4%
|
2
40%
|
13
25.5%
|
| Not Hispanic or Latino |
5
83.3%
|
6
100%
|
6
100%
|
5
83.3%
|
2
40%
|
9
90%
|
2
28.6%
|
3
60%
|
38
74.5%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race/Ethnicity, Customized (Count of Participants) | |||||||||
| Asian |
1
16.7%
|
1
16.7%
|
0
0%
|
0
0%
|
0
0%
|
1
10%
|
0
0%
|
0
0%
|
3
5.9%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
14.3%
|
0
0%
|
1
2%
|
| Black |
0
0%
|
2
33.3%
|
3
50%
|
2
33.3%
|
1
20%
|
4
40%
|
1
14.3%
|
0
0%
|
13
25.5%
|
| White |
4
66.7%
|
3
50%
|
2
33.3%
|
4
66.7%
|
3
60%
|
5
50%
|
5
71.4%
|
5
100%
|
31
60.8%
|
| Other |
1
16.7%
|
0
0%
|
1
16.7%
|
0
0%
|
1
20%
|
0
0%
|
0
0%
|
0
0%
|
3
5.9%
|
| HIV-1 RNA (log10 copies/mL) [Mean (Standard Deviation) ] | |||||||||
| Mean (Standard Deviation) [log10 copies/mL] |
4.46
(0.428)
|
4.44
(0.328)
|
4.48
(0.161)
|
4.52
(0.190)
|
4.56
(0.305)
|
4.50
(0.371)
|
4.23
(0.621)
|
4.97
(0.439)
|
4.50
(0.403)
|
Outcome Measures
| Title | Part A and Part B: Maximum Reduction From Day 1 (Baseline) Through Day 10 in Plasma HIV-1 RNA |
|---|---|
| Description | Maximum reduction is defined as the minimum of change from baseline in plasma HIV-1 RNA (i.e. smallest change in HIV-RNA from baseline). |
| Time Frame | Day 1 through Day 10 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set (FAS) included all participants who were randomized/enrolled and received at least 1 full dose of study drug. |
| Arm/Group Title | Part A: Lenacapavir 20 mg | Part A: Lenacapavir 50 mg | Part A: Lenacapavir 150 mg | Part A: Lenacapavir 450 mg | Part A: Lenacapavir 750 mg | Part A: Placebo | Part B: TAF 200 mg | Part B: TAF 600 mg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. |
| Measure Participants | 6 | 6 | 6 | 6 | 5 | 10 | 7 | 5 |
| Mean (Standard Deviation) [log10 copies/mL] |
-1.35
(0.318)
|
-1.79
(0.476)
|
-1.76
(0.203)
|
-2.20
(0.468)
|
-2.26
(0.662)
|
-0.17
(0.128)
|
-0.75
(0.270)
|
-0.91
(0.294)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Part A: Lenacapavir 20 mg, Part A: Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Part A: Lenacapavir 50 mg, Part A: Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Part A: Lenacapavir 150 mg, Part A: Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Part A: Lenacapavir 450 mg, Part A: Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Part A: Lenacapavir 750 mg, Part A: Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Part A and Part B: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) |
|---|---|
| Description | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE could therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as any AE with an onset date on or after the study drug start date. |
| Time Frame | Day 1 through 225 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug. |
| Arm/Group Title | Part A: Lenacapavir 20 mg | Part A: Lenacapavir 50 mg | Part A: Lenacapavir 150 mg | Part A: Lenacapavir 450 mg | Part A: Lenacapavir 750 mg | Part A: Placebo | Part B: TAF 200 mg | Part B: TAF 600 mg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. |
| Measure Participants | 6 | 6 | 6 | 6 | 5 | 10 | 7 | 5 |
| Number [percentage of participants] |
83.3
1388.3%
|
100
1666.7%
|
83.3
1388.3%
|
100
1666.7%
|
80
1600%
|
70
700%
|
85.7
1224.3%
|
100
2000%
|
| Title | Part A and Part B: Percentage of Participants Experiencing Treatment Emergent Laboratory Abnormalities |
|---|---|
| Description | Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. |
| Time Frame | Day 1 through 225 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Safety Analysis Set were analyzed. |
| Arm/Group Title | Part A: Lenacapavir 20 mg | Part A: Lenacapavir 50 mg | Part A: Lenacapavir 150 mg | Part A: Lenacapavir 450 mg | Part A: Lenacapavir 750 mg | Part A: Placebo | Part B: TAF 200 mg | Part B: TAF 600 mg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. |
| Measure Participants | 6 | 6 | 6 | 6 | 5 | 10 | 7 | 5 |
| Number [percentage of participants] |
83.3
1388.3%
|
83.3
1388.3%
|
100.0
1666.7%
|
66.7
1111.7%
|
100.0
2000%
|
80.0
800%
|
100.0
1428.6%
|
80.0
1600%
|
| Title | Part A and Part B Pharmacokinetic (PK) Parameter: AUCinf of Lenacapavir, TAF and Its Metabolite TFV |
|---|---|
| Description | AUCinf is defined as area under the concentration versus time curve from time zero to infinity. |
| Time Frame | Part A: 0 (predose),1,2,4,8,12,24 h postdose on Day 1, anytime on Days 3,4,7,8,9,10,14,29,43,57,85,113,141,169,197,225; Part B: 0 (predose),0.5,1,2,3,4,6,8,10,12,24 and 48 h postdose on Day 1, approximately Day 1 predose time on Days 4,5,6,7,8,9,10 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the PK Analysis Set were analyzed. |
| Arm/Group Title | Part A: Lenacapavir 20 mg | Part A: Lenacapavir 50 mg | Part A: Lenacapavir 150 mg | Part A: Lenacapavir 450 mg | Part A: Lenacapavir 750 mg | Part B: TAF 200 mg | Part B: TAF 600 mg |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. |
| Measure Participants | 6 | 6 | 6 | 6 | 5 | 7 | 5 |
| Part A: Lenacapavir |
6564.3
(2562.02)
|
9124.1
(4443.03)
|
31537.0
(6811.74)
|
106041.1
(19939.41)
|
181861.0
(73100.91)
|
||
| Part B: TAF |
1270.3
(346.47)
|
3556.1
(1396.81)
|
|||||
| Part B: TFV |
2807.9
(904.23)
|
13435.4
(1748.60)
|
| Title | Part A and Part B PK Parameter: AUClast of Lenacapavir, TAF and Its Metabolite TFV |
|---|---|
| Description | AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. |
| Time Frame | Part A: 0 (predose),1,2,4,8,12,24 h postdose on Day 1, anytime on Days 3,4,7,8,9,10,14,29,43,57,85,113,141,169,197,225; Part B: 0 (predose),0.5,1,2,3,4,6,8,10,12,24 and 48 h postdose on Day 1, approximately Day 1 predose time on Days 4,5,6,7,8,9,10 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the PK Analysis Set were analyzed. |
| Arm/Group Title | Part A: Lenacapavir 20 mg | Part A: Lenacapavir 50 mg | Part A: Lenacapavir 150 mg | Part A: Lenacapavir 450 mg | Part A: Lenacapavir 750 mg | Part B: TAF 200 mg | Part B: TAF 600 mg |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. |
| Measure Participants | 6 | 6 | 6 | 6 | 5 | 7 | 5 |
| Part A: Lenacapavir |
5084.3
(2143.03)
|
7524.4
(4140.40)
|
28866.4
(8247.37)
|
102919.0
(19984.50)
|
171173.9
(80524.85)
|
||
| Part B: TAF |
1265.8
(350.75)
|
3553.0
(1396.14)
|
|||||
| Part B: TFV |
2706.7
(877.05)
|
12682.5
(1780.31)
|
| Title | Part A and Part B PK Parameter: Cmax of Lenacapavir, TAF and Its Metabolite TFV |
|---|---|
| Description | Cmax is defined as the maximum observed concentration of drug. |
| Time Frame | Part A: 0 (predose),1,2,4,8,12,24 h postdose on Day 1, anytime on Days 3,4,7,8,9,10,14,29,43,57,85,113,141,169,197,225; Part B: 0 (predose),0.5,1,2,3,4,6,8,10,12,24 and 48 h postdose on Day 1, approximately Day 1 predose time on Days 4,5,6,7,8,9,10 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the PK Analysis Set were analyzed. |
| Arm/Group Title | Part A: Lenacapavir 20 mg | Part A: Lenacapavir 50 mg | Part A: Lenacapavir 150 mg | Part A: Lenacapavir 450 mg | Part A: Lenacapavir 750 mg | Part B: TAF 200 mg | Part B: TAF 600 mg |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. |
| Measure Participants | 6 | 6 | 6 | 6 | 5 | 7 | 5 |
| Part A: Lenacapavir |
3.0
(1.00)
|
5.4
(4.00)
|
17.1
(7.33)
|
60.1
(16.92)
|
116.6
(40.38)
|
||
| Part B: TAF |
1919.0
(822.57)
|
3934.0
(742.85)
|
|||||
| Part B: TFV |
93.0
(36.97)
|
371.0
(72.76)
|
| Title | Part B PK Parameter: AUCinf of TFV-DP Metabolite of TAF |
|---|---|
| Description | AUCinf is defined as area under the concentration versus time curve from time zero to infinity. |
| Time Frame | Part B: 0 (predose), 1, 2, 4, 6, 8, 12, 24 and 48 hours post dose on Day 1, approximately Day 1 predose time on Days 4, 5 (if possible), 6 (if possible), 7, 8, 9, 10 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The peripheral blood mononuclear cell (PBMC) PK Analysis Set included all participants who are enrolled in Part B of the study, received at least 1 dose of study drug, and had at least 1 nonmissing TFV-DP concentration. Participants with available data were analyzed. |
| Arm/Group Title | Part B: TAF 200 mg | Part B: TAF 600 mg |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. |
| Measure Participants | 4 | 5 |
| Mean (Standard Deviation) [h*uM] |
599.7
(299.36)
|
7981.4
(3852.75)
|
| Title | Part B PK Parameter: AUClast of TFV-DP Metabolite of TAF |
|---|---|
| Description | AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. |
| Time Frame | Part B: 0 (predose), 1, 2, 4, 6, 8, 12, 24 and 48 hours post dose on Day 1, approximately Day 1 predose time on Days 4, 5 (if possible), 6 (if possible), 7, 8, 9, 10 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the PBMC PK Analysis Set with available data were analyzed. |
| Arm/Group Title | Part B: TAF 200 mg | Part B: TAF 600 mg |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. |
| Measure Participants | 6 | 5 |
| Mean (Standard Deviation) [h*uM] |
390.9
(372.31)
|
7749.3
(3731.57)
|
| Title | Part B PK Parameter: Cmax of TFV-DP Metabolite of TAF |
|---|---|
| Description | Cmax is defined as the maximum observed concentration of drug. |
| Time Frame | Part B: 0 (predose), 1, 2, 4, 6, 8, 12, 24 and 48 hours post dose on Day 1, approximately Day 1 predose time on Days 4, 5 (if possible), 6 (if possible), 7, 8, 9, 10 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the PBMC PK Analysis Set with available data were analyzed. |
| Arm/Group Title | Part B: TAF 200 mg | Part B: TAF 600 mg |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. |
| Measure Participants | 6 | 5 |
| Mean (Standard Deviation) [uM] |
8.5
(9.94)
|
163.0
(118.75)
|
| Title | Part A: Percentage of Participants Ever Achieving HIV-1 RNA < 50 Copies/mL by Day 10 |
|---|---|
| Description | |
| Time Frame | Day 10 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the FAS Analysis Set were analyzed. |
| Arm/Group Title | Part A: Lenacapavir 20 mg | Part A: Lenacapavir 50 mg | Part A: Lenacapavir 150 mg | Part A: Lenacapavir 450 mg | Part A: Lenacapavir 750 mg | Part A: Placebo |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. |
| Measure Participants | 6 | 6 | 6 | 6 | 5 | 10 |
| Number [percentage of participants] |
0
0%
|
16.7
278.3%
|
0
0%
|
16.7
278.3%
|
20.0
400%
|
0
0%
|
| Title | Part A: Number of Participants Experiencing Any Emergence of Capsid Inhibitor Resistance |
|---|---|
| Description | |
| Time Frame | Day 10 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the End of Monotherapy Resistance Analysis Population who had received 1 dose of study drug or placebo, regardless of virologic status were analyzed. One participant in 'Part A: Lenacapavir 750 mg' group had assay failure and thus was not included in the analysis. |
| Arm/Group Title | Part A: Lenacapavir 20 mg | Part A: Lenacapavir 50 mg | Part A: Lenacapavir 150 mg | Part A: Lenacapavir 450 mg | Part A: Lenacapavir 750 mg | Part A: Placebo |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. |
| Measure Participants | 6 | 6 | 6 | 6 | 4 | 10 |
| Count of Participants [Participants] |
1
16.7%
|
1
16.7%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Part A: Number of Participants Experiencing Any Emergence of Capsid Inhibitor Resistance |
|---|---|
| Description | Post-Monotherapy Resistance Analysis Population analyzed for this outcome measure included any participant who received at least 1 dose of study drug/placebo, maintained their study drug regimen, & met one of following virologic failure criteria: HIV-1 RNA ≥ 50 copies/mL & < 1 log10 HIV-1 RNA reduction from Day 10 at Day 57 visit, confirmed at a scheduled or unscheduled visit at least 2 weeks following Day 57 At any visit following Day 10, after achieving HIV-1 RNA < 50 copies/mL, a rebound in HIV-1 RNA to ≥ 50 copies/mL, which was subsequently confirmed at following scheduled or unscheduled visit; OR At any visit, a > 1 log10 increase in HIV-1 RNA from nadir, which was subsequently confirmed at following scheduled or unscheduled visit; Any participant with HIV-1 RNA ≥ 50 copies/mL at study endpoint or study discontinuation who didn't meet any of criteria above also had protease (PR)/reverse transcriptase (RT), integrase (IN), &capsid (CA) genotyping & phenotyping performed. |
| Time Frame | Day 10 through Day 225 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Post-Monotherapy Resistance Analysis Population were analyzed. |
| Arm/Group Title | Part A: Lenacapavir 20 mg | Part A: Lenacapavir 50 mg | Part A: Lenacapavir 150 mg | Part A: Lenacapavir 450 mg | Part A: Lenacapavir 750 mg | Part A: Placebo |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. |
| Measure Participants | 0 | 0 | 1 | 0 | 0 | 1 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Part B: Number of Participants Experiencing Any Emergence of TAF Resistance |
|---|---|
| Description | |
| Time Frame | Day 10 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Post-Monotherapy Resistance Analysis Population were analyzed. One participant in 'Part B: TAF 200 mg' group and one participant in 'Part B: TAF 600 mg' group had assay failure and thus were not included in the analysis. |
| Arm/Group Title | Part B: TAF 200 mg | Part B: TAF 600 mg |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. |
| Measure Participants | 6 | 4 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Part B: Number of Participants Experiencing Any Emergence of TAF Resistance |
|---|---|
| Description | TAF Resistance testing was performed for any participant meeting Post-Monotherapy Resistance Analysis Population criteria - it included any participant who received at least 1 dose of study drug/placebo, maintained their study drug regimen, & met one of the following virologic failure criteria: HIV-1 RNA ≥50 copies/mL & < 1 log10 HIV-1 RNA reduction from D10 at the D57 visit, confirmed at scheduled or unscheduled visit at least 2 weeks following D57 At any visit following D10, after achieving HIV-1 RNA< 50 copies/mL, a rebound in HIV-1 RNA to ≥50 copies/mL, which was subsequently confirmed at the following scheduled/unscheduled visit; OR At any visit, a > 1 log10 increase in HIV-1 RNA from nadir, which was subsequently confirmed at the following scheduled or unscheduled visit; Any participant with HIV-1 RNA ≥50 copies/mL at study endpoint or study discontinuation who didn't meet any of the criteria above also had PR/RT, IN, and CA genotyping & phenotyping performed. D = Day |
| Time Frame | Day 10 through Day 225 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was not collected as no participants met the specified Post-Monotherapy Resistance Analysis Population criteria. |
| Arm/Group Title | Part B: TAF 200 mg | Part B: TAF 600 mg |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. |
| Measure Participants | 0 | 0 |
Adverse Events
| Time Frame | Day 1 through 225 days | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug. | |||||||||||||||
| Arm/Group Title | Part A: Lenacapavir 20 mg | Part A: Lenacapavir 50 mg | Part A: Lenacapavir 150 mg | Part A: Lenacapavir 450 mg | Part A: Lenacapavir 750 mg | Part A: Placebo | Part B: TAF 200 mg | Part B: TAF 600 mg | ||||||||
| Arm/Group Description | Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225. | ||||||||
All Cause Mortality |
||||||||||||||||
| Part A: Lenacapavir 20 mg | Part A: Lenacapavir 50 mg | Part A: Lenacapavir 150 mg | Part A: Lenacapavir 450 mg | Part A: Lenacapavir 750 mg | Part A: Placebo | Part B: TAF 200 mg | Part B: TAF 600 mg | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
Serious Adverse Events |
||||||||||||||||
| Part A: Lenacapavir 20 mg | Part A: Lenacapavir 50 mg | Part A: Lenacapavir 150 mg | Part A: Lenacapavir 450 mg | Part A: Lenacapavir 750 mg | Part A: Placebo | Part B: TAF 200 mg | Part B: TAF 600 mg | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 1/10 (10%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Cardiac disorders | ||||||||||||||||
| Acute myocardial infarction | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Atrial fibrillation | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Coronary artery disease | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| Small intestinal obstruction | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 1/10 (10%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| General disorders | ||||||||||||||||
| Non-cardiac chest pain | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||
| Part A: Lenacapavir 20 mg | Part A: Lenacapavir 50 mg | Part A: Lenacapavir 150 mg | Part A: Lenacapavir 450 mg | Part A: Lenacapavir 750 mg | Part A: Placebo | Part B: TAF 200 mg | Part B: TAF 600 mg | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/6 (83.3%) | 6/6 (100%) | 5/6 (83.3%) | 6/6 (100%) | 4/5 (80%) | 7/10 (70%) | 6/7 (85.7%) | 5/5 (100%) | ||||||||
| Blood and lymphatic system disorders | ||||||||||||||||
| Anaemia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Cardiac disorders | ||||||||||||||||
| Atrioventricular block first degree | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Sinus tachycardia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 1/7 (14.3%) | 0/5 (0%) | ||||||||
| Tachycardia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Ear and labyrinth disorders | ||||||||||||||||
| Excessive cerumen production | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Eye disorders | ||||||||||||||||
| Conjunctivitis allergic | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Eye pain | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Retinal tear | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Vision blurred | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| Abdominal pain upper | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 2/7 (28.6%) | 1/5 (20%) | ||||||||
| Anogenital dysplasia | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Constipation | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 1/7 (14.3%) | 0/5 (0%) | ||||||||
| Diarrhoea | 1/6 (16.7%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Eructation | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Flatulence | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 1/7 (14.3%) | 0/5 (0%) | ||||||||
| Haemorrhoids | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 1/10 (10%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Lip dry | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 1/5 (20%) | ||||||||
| Nausea | 1/6 (16.7%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 1/10 (10%) | 2/7 (28.6%) | 3/5 (60%) | ||||||||
| Proctalgia | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Proctitis | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Rectal discharge | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Rectal haemorrhage | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Toothache | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Umbilical hernia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Vomiting | 1/6 (16.7%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 1/10 (10%) | 1/7 (14.3%) | 1/5 (20%) | ||||||||
| General disorders | ||||||||||||||||
| Chills | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 1/10 (10%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Fatigue | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 1/7 (14.3%) | 1/5 (20%) | ||||||||
| Influenza like illness | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 1/7 (14.3%) | 1/5 (20%) | ||||||||
| Injection site bruising | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Injection site erythema | 1/6 (16.7%) | 1/6 (16.7%) | 4/6 (66.7%) | 2/6 (33.3%) | 2/5 (40%) | 1/10 (10%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Injection site induration | 0/6 (0%) | 1/6 (16.7%) | 3/6 (50%) | 2/6 (33.3%) | 1/5 (20%) | 1/10 (10%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Injection site mass | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/5 (20%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Injection site nodule | 0/6 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 2/6 (33.3%) | 2/5 (40%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Injection site pain | 0/6 (0%) | 4/6 (66.7%) | 4/6 (66.7%) | 4/6 (66.7%) | 4/5 (80%) | 3/10 (30%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Injection site swelling | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/5 (20%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Non-cardiac chest pain | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 1/5 (20%) | ||||||||
| Oedema peripheral | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Pain | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/5 (20%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Peripheral swelling | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Pyrexia | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Suprapubic pain | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 1/5 (20%) | ||||||||
| Hepatobiliary disorders | ||||||||||||||||
| Hepatic steatosis | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 1/7 (14.3%) | 0/5 (0%) | ||||||||
| Immune system disorders | ||||||||||||||||
| Drug hypersensitivity | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 1/10 (10%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Infections and infestations | ||||||||||||||||
| Acute sinusitis | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/5 (20%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Anal chlamydia infection | 0/6 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 1/7 (14.3%) | 0/5 (0%) | ||||||||
| Bronchitis | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/5 (20%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Cellulitis | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Gastroenteritis | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 1/7 (14.3%) | 0/5 (0%) | ||||||||
| Gastroenteritis viral | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 1/7 (14.3%) | 0/5 (0%) | ||||||||
| Hordeolum | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 1/10 (10%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Influenza | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 1/5 (20%) | ||||||||
| Latent tuberculosis | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/5 (20%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Nasopharyngitis | 1/6 (16.7%) | 1/6 (16.7%) | 2/6 (33.3%) | 2/6 (33.3%) | 0/5 (0%) | 1/10 (10%) | 1/7 (14.3%) | 0/5 (0%) | ||||||||
| Oral candidiasis | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Oropharyngeal gonococcal infection | 0/6 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Pharyngeal chlamydia infection | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 1/10 (10%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Pharyngitis | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Pharyngitis streptococcal | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 1/7 (14.3%) | 0/5 (0%) | ||||||||
| Proctitis gonococcal | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 1/10 (10%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Subcutaneous abscess | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Syphilis | 0/6 (0%) | 2/6 (33.3%) | 0/6 (0%) | 2/6 (33.3%) | 0/5 (0%) | 0/10 (0%) | 1/7 (14.3%) | 1/5 (20%) | ||||||||
| Upper respiratory tract infection | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 4/6 (66.7%) | 0/5 (0%) | 0/10 (0%) | 1/7 (14.3%) | 2/5 (40%) | ||||||||
| Urinary tract infection | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Urinary tract infection bacterial | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 1/10 (10%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||
| Contusion | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 1/5 (20%) | ||||||||
| Corneal abrasion | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Exposure to communicable disease | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 1/7 (14.3%) | 0/5 (0%) | ||||||||
| Ligament sprain | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 1/7 (14.3%) | 0/5 (0%) | ||||||||
| Limb injury | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Road traffic accident | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 1/5 (20%) | ||||||||
| Skin abrasion | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 1/7 (14.3%) | 0/5 (0%) | ||||||||
| Skin laceration | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Investigations | ||||||||||||||||
| Liver function test increased | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Transaminases increased | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 1/7 (14.3%) | 0/5 (0%) | ||||||||
| Weight increased | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 1/7 (14.3%) | 0/5 (0%) | ||||||||
| Metabolism and nutrition disorders | ||||||||||||||||
| Decreased appetite | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Gout | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Hypokalaemia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Increased appetite | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Vitamin D deficiency | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| Arthralgia | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) | 1/6 (16.7%) | 0/5 (0%) | 1/10 (10%) | 0/7 (0%) | 2/5 (40%) | ||||||||
| Back pain | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 1/10 (10%) | 1/7 (14.3%) | 0/5 (0%) | ||||||||
| Joint range of motion decreased | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Joint swelling | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Muscle spasms | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 1/5 (20%) | ||||||||
| Musculoskeletal chest pain | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Musculoskeletal stiffness | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 1/7 (14.3%) | 0/5 (0%) | ||||||||
| Neck pain | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 1/5 (20%) | ||||||||
| Osteoarthritis | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||
| Anogenital warts | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 1/10 (10%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Lymphoplasmacytoid lymphoma/immunocytoma | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 1/5 (20%) | ||||||||
| Nervous system disorders | ||||||||||||||||
| Headache | 2/6 (33.3%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 2/10 (20%) | 2/7 (28.6%) | 3/5 (60%) | ||||||||
| Presyncope | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 1/7 (14.3%) | 0/5 (0%) | ||||||||
| Psychiatric disorders | ||||||||||||||||
| Anxiety | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 2/5 (40%) | ||||||||
| Depression | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Insomnia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 1/7 (14.3%) | 1/5 (20%) | ||||||||
| Stress | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 1/7 (14.3%) | 0/5 (0%) | ||||||||
| Renal and urinary disorders | ||||||||||||||||
| Crystalluria | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Proteinuria | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Sterile pyuria | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Cough | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 1/10 (10%) | 1/7 (14.3%) | 1/5 (20%) | ||||||||
| Dyspnoea | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Nasal congestion | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 1/5 (20%) | ||||||||
| Oropharyngeal pain | 1/6 (16.7%) | 1/6 (16.7%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 1/7 (14.3%) | 1/5 (20%) | ||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| Acne | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Dry skin | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 1/5 (20%) | ||||||||
| Eczema | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 1/7 (14.3%) | 0/5 (0%) | ||||||||
| Hyperhidrosis | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Night sweats | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Rash | 1/6 (16.7%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 1/5 (20%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Rash maculo-papular | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Seborrhoea | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Urticaria | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
| Vascular disorders | ||||||||||||||||
| Hypotension | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/10 (0%) | 0/7 (0%) | 0/5 (0%) | ||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years
Results Point of Contact
| Name/Title | Gilead Clinical Study Information Center |
|---|---|
| Organization | Gilead Sciences |
| Phone | 1-833-445-3230 (GILEAD-0) |
| GileadClinicalTrials@gilead.com |
Responsible Party:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT03739866
Other Study ID Numbers:
- GS-US-200-4072
First Posted:
Nov 14, 2018
Last Update Posted:
Apr 9, 2021
Last Verified:
Mar 1, 2021