CAPELLA: Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance
Study Details
Study Description
Brief Summary
The primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen (functional monotherapy) in people living with HIV (PLWH) with multi-drug resistance (MDR).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cohort 1A: Lenacapavir Participants with human-immunodeficiency virus-1 ribonucleic acid (HIV-1 RNA) ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at Cohort Selection visit compared with screening visit will receive oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, while continuing their failing regimen in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants will receive subcutaneous (SC) lenacapavir 927 mg and will initiate an OBR at Day 1 SC Visit (14 days after the first dose of oral lenacapavir). Participants will receive their subsequent SC lenacapavir injection at Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until product becomes accessible to participants through an access program or until Gilead elects to discontinue the study in the country. |
Drug: Oral Lenacapavir
Tablets administered without regard to food
Other Names:
Drug: Subcutaneous Lenacapavir
Administered in the abdomen via subcutaneous injections
Other Names:
Drug: Failing ARV Regimen
Failing antiretroviral (ARV) regimen defined by the lack of efficacy. Any combination of approved and unapproved agents that could potentially be part of the failing regimen.
Drug: Optimized Background Regimen (OBR)
Optimized background regimen as prescribed by the Investigator
|
Placebo Comparator: Cohort 1B: Placebo to Lenacapavir Participants with HIV-1 RNA ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit will receive oral lenacapavir placebo on Days 1, 2, and 8 while continuing their failing regimen in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants will receive oral lenacapavir 600 mg on Days 15 and 16 and 300 mg on Day 22, and will initiate an OBR on Day 15. At Day 1 SC (14 days after the first dose of oral lenacapavir), participants will receive SC lenacapavir 927 mg while continuing OBR. Participants will receive their next SC injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir every 6 months (26 weeks), while continuing their OBR, until the product becomes accessible to participants through an access program or until Gilead elects to discontinue study in the country. |
Drug: Oral Lenacapavir
Tablets administered without regard to food
Other Names:
Drug: Oral Lenacapavir Placebo
Tablets administered without regard to food
Drug: Subcutaneous Lenacapavir
Administered in the abdomen via subcutaneous injections
Other Names:
Drug: Failing ARV Regimen
Failing antiretroviral (ARV) regimen defined by the lack of efficacy. Any combination of approved and unapproved agents that could potentially be part of the failing regimen.
Drug: Optimized Background Regimen (OBR)
Optimized background regimen as prescribed by the Investigator
|
Experimental: Cohort 2: Lenacapavir Participants with a ≥ 0.5 log10 copies/mL HIV-1 RNA decline at the Cohort Selection Visit compared with the screening visit or with HIV-1 RNA < 400 copies/mL or if Cohort 1 is fully enrolled will receive oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, and will initiate an OBR on Day 1 in Oral Lead-in Period (Baseline to Day 14); followed by Maintenance Period where participants will receive SC lenacapavir 927 mg at Day 1 SC Visit (14 days after the first dose of oral lenacapavir) while continuing their OBR. Participants will receive their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given the option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product becomes accessible to participants through an access program or until Gilead elects to discontinue the study in the country. |
Drug: Oral Lenacapavir
Tablets administered without regard to food
Other Names:
Drug: Subcutaneous Lenacapavir
Administered in the abdomen via subcutaneous injections
Other Names:
Drug: Optimized Background Regimen (OBR)
Optimized background regimen as prescribed by the Investigator
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants in Cohort 1 Achieving a Reduction of ≥ 0.5 log10 Copies/mL in Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) From Baseline to the End of Functional Monotherapy Period [Baseline up to Day 1 SC Visit (14 days after the first dose of oral lencapavir) or Day 15]
Secondary Outcome Measures
- Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 50 Copies/mL at Week 26 Based on the US FDA-defined Snapshot Algorithm [Week 26 (26 weeks after first dose of subcutaneous lenacapavir)]
The percentage of participants in cohort 1 with plasma HIV-1 RNA < 50 copies/mL at Week 26 was analyzed using the United States Food and Drug Administration (US FDA)-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
- Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 200 Copies/mL at Week 26 Based on the US FDA-defined Snapshot Algorithm [Week 26 (26 weeks after first dose of subcutaneous lenacapavir)]
The percentage of participants in cohort 1 with plasma HIV-1 RNA < 200 copies/mL at Week 26 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
- Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 50 Copies/mL at Week 52 Based on the US FDA-defined Snapshot Algorithm [Week 52]
- Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 200 Copies/mL at Week 52 Based on the US FDA-defined Snapshot Algorithm [Week 52]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
Adult aged ≥ 18 years (at all sites) or adolescent aged ≥ 12 and weighing ≥ 35 kg (at sites in North America and Dominican Republic)
-
Currently receiving a stable failing ARV regimen for > 8 weeks
-
Have HIV-1 RNA ≥ 400 copies/mL at screening
-
Have multidrug resistance (resistance to ≥2 agents from ≥3 of the 4 main classes of ARV)
-
Have no more than 2 fully active ARV remaining from the 4 main classes that can be effectively combined to form a viable regimen
-
Able and willing to receive an OBR together with lenacapavir
-
No Hepatitis C virus (HCV) ongoing infection
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 | Eisenhower Health Center at Rimrock | Palm Springs | California | United States | 92264 |
4 | One Community Health | Sacramento | California | United States | 95817 |
5 | Yale University; School of Medicine | New Haven | Connecticut | United States | 06510 |
6 | Washington Health Institute | Washington | District of Columbia | United States | 20017 |
7 | Midland Florida Clinical Research Center, LLC | DeLand | Florida | United States | 32720 |
8 | Gary J. Richmond, M.D., P.A. | Fort Lauderdale | Florida | United States | 33316 |
9 | Midway Immunology and Research Center | Fort Pierce | Florida | United States | 34982 |
10 | Floridian Clinical Research | Hialeah | Florida | United States | 33016 |
11 | AIDS Healthcare Foundation - South Beach | Miami Beach | Florida | United States | 33139 |
12 | Orlando Immunology Center | Orlando | Florida | United States | 32803 |
13 | St. Joseph's Hospital Comprehensive Research Institute | Tampa | Florida | United States | 33614 |
14 | Triple O Research Institute, P.A. | West Palm Beach | Florida | United States | 33401 |
15 | Emory Hospital Midtown Infectious Disease Clinic | Atlanta | Georgia | United States | 30308 |
16 | Atlanta ID Group, PC | Atlanta | Georgia | United States | 30309 |
17 | Chatham County Health Department | Savannah | Georgia | United States | 31401 |
18 | Howard Brown Health Center | Chicago | Illinois | United States | 60613 |
19 | Northstar Healthcare | Chicago | Illinois | United States | 60657 |
20 | Be Well Medical Center | Berkley | Michigan | United States | 48072 |
21 | Southampton Healthcare, Inc. | Saint Louis | Missouri | United States | 63139 |
22 | Jacobi Medical Center | Bronx | New York | United States | 10461 |
23 | New York-Presbyterian/Queens | Flushing | New York | United States | 11355 |
24 | North Shore University Hospital/Division of Infectious Diseases | Manhasset | New York | United States | 11030 |
25 | Atrium Health- Infectious Disease Consultants | Charlotte | North Carolina | United States | 28209 |
26 | Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
27 | The Miriam Hospital | Providence | Rhode Island | United States | 02906 |
28 | 1265 Union Avenue, 8 East | Memphis | Tennessee | United States | 38163 |
29 | Central Texas Clinical Research | Austin | Texas | United States | 78705 |
30 | St Hope Foundation | Bellaire | Texas | United States | 77401 |
31 | AIDS Arms, Inc. DBA Prism Health North Texas | Dallas | Texas | United States | 75215 |
32 | North Texas Infectious Diseases Consultants, P.A. | Dallas | Texas | United States | 75246 |
33 | The Crofoot Research Center, INC. | Houston | Texas | United States | 77098 |
34 | DCOL Center for Clinical Research | Longview | Texas | United States | 75605 |
35 | Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID) | Annandale | Virginia | United States | 22003 |
36 | Vancouver ID Research and Care Centre Society | Vancouver | British Columbia | Canada | V6Z 2C9 |
37 | Maple Leaf Research/Maple Leaf Medical Clinic | Toronto | Ontario | Canada | M5G 1K2 |
38 | Clinique de médecine urbaine du Quartier Latin | Montreal | Quebec | Canada | H2L 4E9 |
39 | The Ottawa Hospital | Ottawa | Canada | K1H 8L6 | |
40 | Instituto Dominicano de Estudios Virologicos (IDEV) | Santo Domingo | Dominican Republic | 10103 | |
41 | Hospital Dr. Salvador Bienvenido Gautier | Santo Domingo | Dominican Republic | 10514 | |
42 | Hôpital Sainte-Marguerite | Marseille | France | 13009 | |
43 | Hôpital Saint-Louis | Paris | France | 75010 | |
44 | Hôpital Saint-Antoine | Paris | France | 75012 | |
45 | Hôpital Bichat-Claude Bernard | Paris | France | 75018 | |
46 | Universitätsklinikum Frankfurt, Medizinische Klinik II | Frankfurt | Hesse | Germany | 60590 |
47 | Universitätsklinikum Essen, Klinik für Dermatologie und Venerologie | Essen | Germany | 45122 | |
48 | ICH Study Center GmbH & Co. KG | Hamburg | Germany | 20146 | |
49 | University of Naples Federico II | Bergamo | Italy | 24127 | |
50 | UOC Malattie Infettive - ASST Spedali Civili Di Brescia - Piazzale Spedali Civili 1 | Brescia | Italy | 25100 | |
51 | Divisione di Malattie Infettive, IRCCS Ospedale San Raffaele | Milano | Italy | 20127 | |
52 | U.O.C. IMMUNODEFICIENZE VIRALI - Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS | Roma | Italy | 00149 | |
53 | U.O.C. Malattie Infettive - Fondazione Policlinico Universitario A. Gemelli IRCCS | Rome | Italy | 00168 | |
54 | National Hospital Organization Nagoya Medical Center | Nagoya | Japan | 460-0001 | |
55 | National Hospital Organization Osaka National Hospital | Osaka | Japan | 540-0006 | |
56 | Tokyo Medical University Hospital | Tokyo | Japan | 1600023 | |
57 | Center Hospital of the National Center for Global Health and Medicine | Tokyo | Japan | 1628655 | |
58 | Durban International Clinical Research Site, Enhancing Care Foundation | Durban | South Africa | 4302 | |
59 | Helen Joseph Hospital | Johannesburg | South Africa | 2092 | |
60 | Vx Pharma | Pretoria | South Africa | 87 | |
61 | Perinatal HIV Research Unit (PHRU) | Soweto | South Africa | 2013 | |
62 | Hospital Universitari Germans Trías i Pujol | Badalona | Spain | 08916 | |
63 | Hospital Clinic de Barcelona | Barcelona | Spain | 08036 | |
64 | Hospital Universitario La Paz | Madrid | Spain | 28046 | |
65 | Hospital Universitario Virgen del Rocío | Sevilla | Spain | 41013 | |
66 | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung | Taiwan | 80756 | |
67 | Kaohsiung Veterans General Hospital | Kaohsiung | Taiwan | 81362 | |
68 | Far Eastern Memorial Hospital | New Taipei City | Taiwan | 22060 | |
69 | National Taiwan University Hospital | Taipei | Taiwan | 10048 | |
70 | Taoyuan General Hospital, Ministry of Health and Welfare | Taoyuan City | Taiwan | 33004 | |
71 | Thai Red Cross AIDS Research Center | Bangkok | Thailand | 10330 | |
72 | Faculty of Medicine Ramathibodi Hospital, Mahidol University | Bangkok | Thailand | 10400 | |
73 | Faculty of Medicine Siriraj Hospital, Mahidol University | Bangkok | Thailand | 10700 | |
74 | Faculty of Medicine, Khon Kaen University | Khon Kaen | Thailand | 40002 | |
75 | Bamrasnaradura Infectious Diseases Institute | Nonthaburi | Thailand | 11000 |
Sponsors and Collaborators
- Gilead Sciences
Investigators
- Study Director: Gilead Study Director, Gilead Sciences
Study Documents (Full-Text)
More Information
Publications
- GS-US-200-4625
- 2019-003814-16
Study Results
Participant Flow
Recruitment Details | Participants were enrolled at study sites in the United States, Thailand, Italy, Dominican Republic, Spain, France, Canada, Taiwan, South Africa, Japan, and Germany. The first participant was screened on 21 November 2019. Data submitted represent interim analysis performed on data collected by the Primary Completion Date 05 October 2020, and additional data collected after all participants in Cohort 1 completed Week 26 visit. |
---|---|
Pre-assignment Detail | 144 participants were screened. |
Arm/Group Title | Cohort 1A: Lenacapavir | Cohort 1B: Placebo to Lenacapavir | Cohort 2: Lenacapavir |
---|---|---|---|
Arm/Group Description | Participants with human-immunodeficiency virus-1 ribonucleic acid (HIV-1 RNA) ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit received oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, while continuing their failing regimen (previous anti-retroviral [ARV] regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received subcutaneous (SC) lenacapavir 927 mg and initiated an optimized background regimen (OBR; as prescribed by the Investigator) at Day 1 SC Visit (14 days after the first dose of oral lenacapavir). Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country. | Participants with HIV-1 RNA ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit received oral lenacapavir placebo on Days 1, 2, and 8 while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received oral lenacapavir 600 mg tablet on Days 15 and 16 and 300 mg on Day 22, and initiated an OBR (as prescribed by the Investigator) on Day 15. At Day 1 SC (14 days after the first dose of oral lenacapavir), participants received SC lenacapavir 927 mg while continuing their OBR. Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country. | Participants were enrolled in Cohort 2 if Cohort 1 was fully enrolled or if they did not meet the criteria for randomization in Cohort 1 (ie, they had ≥ 0.5 log10 HIV-1 RNA decline compared to the Screening visit and/or HIV-1 RNA < 400 copies/mL at the Cohort Selection visit). Participants received oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, and will initiate an OBR on Day 1 in Oral Lead-in Period (Baseline to Day 14); followed by Maintenance Period where participants received SC lenacapavir 927 mg at Day 1 SC Visit (14 days after the first dose of oral lenacapavir) while continuing their OBR. Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given the option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country. |
Period Title: Functional Mono/Oral Lead-in (14 Days) | |||
STARTED | 24 | 12 | 36 |
COMPLETED | 24 | 12 | 36 |
NOT COMPLETED | 0 | 0 | 0 |
Period Title: Functional Mono/Oral Lead-in (14 Days) | |||
STARTED | 24 | 12 | 36 |
COMPLETED | 0 | 0 | 0 |
NOT COMPLETED | 24 | 12 | 36 |
Baseline Characteristics
Arm/Group Title | Cohort 1A: Lenacapavir | Cohort 1B: Placebo to Lenacapavir | Cohort 2: Lenacapavir | Total |
---|---|---|---|---|
Arm/Group Description | Participants with HIV-1 RNA ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit received oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received SC lenacapavir 927 mg and initiated an OBR (as prescribed by the Investigator) at Day 1 SC Visit (14 days after the first dose of oral lenacapavir). Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country. | Participants with HIV-1 RNA ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit received oral lenacapavir placebo on Days 1, 2, and 8 while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received oral lenacapavir 600 mg tablet on Days 15 and 16 and 300 mg on Day 22, and initiated an OBR (as prescribed by the Investigator) on Day 15. At Day 1 SC (14 days after the first dose of oral lenacapavir), participants received SC lenacapavir 927 mg while continuing their OBR. Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country. | Participants were enrolled in Cohort 2 if Cohort 1 was fully enrolled or if they did not meet the criteria for randomization in Cohort 1 (ie, they had ≥ 0.5 log10 HIV-1 RNA decline compared to the Screening visit and/or HIV-1 RNA < 400 copies/mL at the Cohort Selection visit). Participants received oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, and will initiate an OBR on Day 1 in Oral Lead-in Period (Baseline to Day 14); followed by Maintenance Period where participants received SC lenacapavir 927 mg at Day 1 SC Visit (14 days after the first dose of oral lenacapavir) while continuing their OBR. Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given the option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country. | Total of all reporting groups |
Overall Participants | 24 | 12 | 36 | 72 |
Age (years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [years] |
54
(11.3)
|
49
(10.9)
|
48
(13.7)
|
50
(12.6)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
7
29.2%
|
3
25%
|
8
22.2%
|
18
25%
|
Male |
17
70.8%
|
9
75%
|
28
77.8%
|
54
75%
|
Race/Ethnicity, Customized (Count of Participants) | ||||
Asian |
2
8.3%
|
1
8.3%
|
12
33.3%
|
15
20.8%
|
Black |
10
41.7%
|
6
50%
|
11
30.6%
|
27
37.5%
|
White |
12
50%
|
4
33.3%
|
13
36.1%
|
29
40.3%
|
Not Permitted |
0
0%
|
1
8.3%
|
0
0%
|
1
1.4%
|
Race/Ethnicity, Customized (Count of Participants) | ||||
Hispanic or Latino |
6
25%
|
4
33.3%
|
5
13.9%
|
15
20.8%
|
Not Hispanic or Latino |
18
75%
|
7
58.3%
|
31
86.1%
|
56
77.8%
|
Not Permitted |
0
0%
|
1
8.3%
|
0
0%
|
1
1.4%
|
Region of Enrollment (Count of Participants) | ||||
Canada |
0
0%
|
0
0%
|
2
5.6%
|
2
2.8%
|
Dominican Republic |
0
0%
|
1
8.3%
|
0
0%
|
1
1.4%
|
France |
0
0%
|
1
8.3%
|
2
5.6%
|
3
4.2%
|
Italy |
1
4.2%
|
0
0%
|
6
16.7%
|
7
9.7%
|
South Africa |
0
0%
|
0
0%
|
1
2.8%
|
1
1.4%
|
Spain |
1
4.2%
|
0
0%
|
0
0%
|
1
1.4%
|
Taiwan |
0
0%
|
0
0%
|
1
2.8%
|
1
1.4%
|
Thailand |
2
8.3%
|
1
8.3%
|
8
22.2%
|
11
15.3%
|
United States |
20
83.3%
|
9
75%
|
13
36.1%
|
42
58.3%
|
Japan |
0
0%
|
0
0%
|
2
5.6%
|
2
2.8%
|
Germany |
0
0%
|
0
0%
|
1
2.8%
|
1
1.4%
|
HIV-1 RNA (log10 copies/mL) (log10 copies/mL) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [log10 copies/mL] |
3.97
(0.922)
|
4.87
(0.393)
|
4.06
(1.164)
|
4.17
(1.034)
|
HIV-1 RNA Categories (Count of Participants) | ||||
≤ 100000 copies/mL |
23
95.8%
|
6
50%
|
29
80.6%
|
58
80.6%
|
> 100000 copies/mL |
1
4.2%
|
6
50%
|
7
19.4%
|
14
19.4%
|
Outcome Measures
Title | Percentage of Participants in Cohort 1 Achieving a Reduction of ≥ 0.5 log10 Copies/mL in Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) From Baseline to the End of Functional Monotherapy Period |
---|---|
Description | |
Time Frame | Baseline up to Day 1 SC Visit (14 days after the first dose of oral lencapavir) or Day 15 |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set for the Functional Monotherapy Period analysis included participants who were randomized in the Functional Monotherapy Period and received at least 1 dose of blinded study drug. |
Arm/Group Title | Cohort 1A: Lenacapavir | Cohort 1B: Placebo to Lenacapavir |
---|---|---|
Arm/Group Description | Participants with HIV-1 RNA ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit received oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received SC lenacapavir 927 mg and initiated an OBR (as prescribed by the Investigator) at Day 1 SC Visit (14 days after the first dose of oral lenacapavir). Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country. | Participants with HIV-1 RNA ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit received oral lenacapavir placebo on Days 1, 2, and 8 while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received oral lenacapavir 600 mg tablet on Days 15 and 16 and 300 mg on Day 22, and initiated an OBR (as prescribed by the Investigator) on Day 15. At Day 1 SC (14 days after the first dose of oral lenacapavir), participants received SC lenacapavir 927 mg while continuing their OBR. Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country. |
Measure Participants | 24 | 12 |
Number [percentage of participants] |
87.5
364.6%
|
16.7
139.2%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Cohort 1A: Lenacapavir, Cohort 1B: Placebo to Lenacapavir |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | The difference in percentage between 2 treatment groups was compared using an unconditional exact method using 2 invert 1-sided tests with an alpha level at 0.05 to evaluate superiority. | |
Statistical Test of Hypothesis | p-Value | < 0.0001 |
Comments | The P value and 95% confidence interval (CI) for the point estimate of treatment difference in proportions was estimated and constructed using the Chan and Zhang method. | |
Method | Chan & Zhang method | |
Comments | ||
Method of Estimation | Estimation Parameter | Percentage Difference |
Estimated Value | 70.8 | |
Confidence Interval |
(2-Sided) 95% 34.9 to 90.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 50 Copies/mL at Week 26 Based on the US FDA-defined Snapshot Algorithm |
---|---|
Description | The percentage of participants in cohort 1 with plasma HIV-1 RNA < 50 copies/mL at Week 26 was analyzed using the United States Food and Drug Administration (US FDA)-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
Time Frame | Week 26 (26 weeks after first dose of subcutaneous lenacapavir) |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set for the All Lenacapavir Analysis included participants who were enrolled into the study and received at least 1 dose of SC lenacapavir. |
Arm/Group Title | Cohort 1A: Lenacapavir | Cohort 1B: Placebo to Lenacapavir |
---|---|---|
Arm/Group Description | Participants with HIV-1 RNA ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit received oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received SC lenacapavir 927 mg and initiated an OBR (as prescribed by the Investigator) at Day 1 SC Visit (14 days after the first dose of oral lenacapavir). Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country. | Participants with HIV-1 RNA ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit received oral lenacapavir placebo on Days 1, 2, and 8 while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received oral lenacapavir 600 mg tablet on Days 15 and 16 and 300 mg on Day 22, and initiated an OBR (as prescribed by the Investigator) on Day 15. At Day 1 SC (14 days after the first dose of oral lenacapavir), participants received SC lenacapavir 927 mg while continuing their OBR. Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country. |
Measure Participants | 24 | 12 |
Number (95% Confidence Interval) [percentage of participants] |
87.5
364.6%
|
66.7
555.8%
|
Title | Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 200 Copies/mL at Week 26 Based on the US FDA-defined Snapshot Algorithm |
---|---|
Description | The percentage of participants in cohort 1 with plasma HIV-1 RNA < 200 copies/mL at Week 26 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
Time Frame | Week 26 (26 weeks after first dose of subcutaneous lenacapavir) |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the Full Analysis set for the All Lenacapavir Analysis were analyzed. |
Arm/Group Title | Cohort 1A: Lenacapavir | Cohort 1B: Placebo to Lenacapavir |
---|---|---|
Arm/Group Description | Participants with HIV-1 RNA ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit received oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received SC lenacapavir 927 mg and initiated an OBR (as prescribed by the Investigator) at Day 1 SC Visit (14 days after the first dose of oral lenacapavir). Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country. | Participants with HIV-1 RNA ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit received oral lenacapavir placebo on Days 1, 2, and 8 while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received oral lenacapavir 600 mg tablet on Days 15 and 16 and 300 mg on Day 22, and initiated an OBR (as prescribed by the Investigator) on Day 15. At Day 1 SC (14 days after the first dose of oral lenacapavir), participants received SC lenacapavir 927 mg while continuing their OBR. Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country. |
Measure Participants | 24 | 12 |
Number (95% Confidence Interval) [percentage of participants] |
95.8
399.2%
|
75.0
625%
|
Title | Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 50 Copies/mL at Week 52 Based on the US FDA-defined Snapshot Algorithm |
---|---|
Description | |
Time Frame | Week 52 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 200 Copies/mL at Week 52 Based on the US FDA-defined Snapshot Algorithm |
---|---|
Description | |
Time Frame | Week 52 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Adverse Events
Time Frame | All-Cause Mortality: Enrollment up to Week 26 (26 weeks after first dose of subcutaneous lenacapavir); Adverse Events: First dose date up to Week 26 (26 weeks after first dose of subcutaneous lenacapavir) | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | All-Cause Mortality: All Enrolled Analysis Set included participants who were randomized into Cohort 1 or enrolled into Cohort 2. Adverse events: Safety Analysis Set included participants who were enrolled and received at least 1 dose of study drug. | |||||
Arm/Group Title | Cohort 1A: Lenacapavir | Cohort 1B: Placebo to Lenacapavir | Cohort 2: Lenacapavir | |||
Arm/Group Description | Participants with HIV-1 RNA ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit received oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received SC lenacapavir 927 mg and initiated an OBR (as prescribed by the Investigator) at Day 1 SC Visit (14 days after the first dose of oral lenacapavir). Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country. | Participants with HIV-1 RNA ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit received oral lenacapavir placebo on Days 1, 2, and 8 while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received oral lenacapavir 600 mg tablet on Days 15 and 16 and 300 mg on Day 22, and initiated an OBR (as prescribed by the Investigator) on Day 15. At Day 1 SC (14 days after the first dose of oral lenacapavir), participants received SC lenacapavir 927 mg while continuing their OBR. Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country. | Participants were enrolled in Cohort 2 if Cohort 1 was fully enrolled or if they did not meet the criteria for randomization in Cohort 1 (ie, they had ≥ 0.5 log10 HIV-1 RNA decline compared to the Screening visit and/or HIV-1 RNA < 400 copies/mL at the Cohort Selection visit). Participants received oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, and will initiate an OBR on Day 1 in Oral Lead-in Period (Baseline to Day 14); followed by Maintenance Period where participants received SC lenacapavir 927 mg at Day 1 SC Visit (14 days after the first dose of oral lenacapavir) while continuing their OBR. Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given the option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country. | |||
All Cause Mortality |
||||||
Cohort 1A: Lenacapavir | Cohort 1B: Placebo to Lenacapavir | Cohort 2: Lenacapavir | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/24 (0%) | 0/12 (0%) | 1/36 (2.8%) | |||
Serious Adverse Events |
||||||
Cohort 1A: Lenacapavir | Cohort 1B: Placebo to Lenacapavir | Cohort 2: Lenacapavir | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/24 (4.2%) | 1/12 (8.3%) | 2/36 (5.6%) | |||
Gastrointestinal disorders | ||||||
Abdominal pain | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Pancreatic mass | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Proctalgia | 1/24 (4.2%) | 0/12 (0%) | 0/36 (0%) | |||
Infections and infestations | ||||||
Clostridium difficile infection | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Injury, poisoning and procedural complications | ||||||
Femoral neck fracture | 0/24 (0%) | 0/12 (0%) | 1/36 (2.8%) | |||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
Neoplasm malignant | 0/24 (0%) | 0/12 (0%) | 1/36 (2.8%) | |||
Nervous system disorders | ||||||
Dizziness | 0/24 (0%) | 0/12 (0%) | 1/36 (2.8%) | |||
Other (Not Including Serious) Adverse Events |
||||||
Cohort 1A: Lenacapavir | Cohort 1B: Placebo to Lenacapavir | Cohort 2: Lenacapavir | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 20/24 (83.3%) | 11/12 (91.7%) | 30/36 (83.3%) | |||
Blood and lymphatic system disorders | ||||||
Lymphadenopathy | 0/24 (0%) | 2/12 (16.7%) | 0/36 (0%) | |||
Thrombocytopenia | 0/24 (0%) | 1/12 (8.3%) | 1/36 (2.8%) | |||
Ear and labyrinth disorders | ||||||
Cerumen impaction | 1/24 (4.2%) | 1/12 (8.3%) | 0/36 (0%) | |||
Ear swelling | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Endocrine disorders | ||||||
Hypogonadism | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Eye disorders | ||||||
Eye pruritus | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Gastrointestinal disorders | ||||||
Abdominal distension | 3/24 (12.5%) | 0/12 (0%) | 1/36 (2.8%) | |||
Abdominal pain upper | 0/24 (0%) | 2/12 (16.7%) | 0/36 (0%) | |||
Anal fissure | 0/24 (0%) | 1/12 (8.3%) | 1/36 (2.8%) | |||
Constipation | 2/24 (8.3%) | 2/12 (16.7%) | 0/36 (0%) | |||
Diarrhoea | 3/24 (12.5%) | 2/12 (16.7%) | 1/36 (2.8%) | |||
Nausea | 4/24 (16.7%) | 1/12 (8.3%) | 1/36 (2.8%) | |||
Toothache | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Vomiting | 0/24 (0%) | 1/12 (8.3%) | 3/36 (8.3%) | |||
General disorders | ||||||
Asthenia | 0/24 (0%) | 1/12 (8.3%) | 2/36 (5.6%) | |||
Fatigue | 3/24 (12.5%) | 0/12 (0%) | 0/36 (0%) | |||
Injection site erythema | 7/24 (29.2%) | 2/12 (16.7%) | 10/36 (27.8%) | |||
Injection site induration | 2/24 (8.3%) | 0/12 (0%) | 7/36 (19.4%) | |||
Injection site nodule | 8/24 (33.3%) | 4/12 (33.3%) | 2/36 (5.6%) | |||
Injection site oedema | 1/24 (4.2%) | 0/12 (0%) | 2/36 (5.6%) | |||
Injection site pain | 7/24 (29.2%) | 2/12 (16.7%) | 9/36 (25%) | |||
Injection site pruritus | 2/24 (8.3%) | 0/12 (0%) | 1/36 (2.8%) | |||
Injection site swelling | 9/24 (37.5%) | 3/12 (25%) | 9/36 (25%) | |||
Pain | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Pyrexia | 1/24 (4.2%) | 2/12 (16.7%) | 2/36 (5.6%) | |||
Infections and infestations | ||||||
Abscess limb | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Covid-19 | 1/24 (4.2%) | 0/12 (0%) | 2/36 (5.6%) | |||
Ear infection | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Gastroenteritis | 2/24 (8.3%) | 1/12 (8.3%) | 0/36 (0%) | |||
Infected skin ulcer | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Nasopharyngitis | 0/24 (0%) | 1/12 (8.3%) | 1/36 (2.8%) | |||
Oesophageal candidiasis | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Oral candidiasis | 1/24 (4.2%) | 2/12 (16.7%) | 1/36 (2.8%) | |||
Oral herpes | 0/24 (0%) | 2/12 (16.7%) | 0/36 (0%) | |||
Osteomyelitis | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Tinea versicolour | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Urinary tract infection | 2/24 (8.3%) | 0/12 (0%) | 3/36 (8.3%) | |||
Investigations | ||||||
Weight decreased | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Metabolism and nutrition disorders | ||||||
Decreased appetite | 2/24 (8.3%) | 0/12 (0%) | 0/36 (0%) | |||
Hyperglycaemia | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Hyperlipidaemia | 2/24 (8.3%) | 0/12 (0%) | 0/36 (0%) | |||
Musculoskeletal and connective tissue disorders | ||||||
Arthralgia | 4/24 (16.7%) | 0/12 (0%) | 0/36 (0%) | |||
Back pain | 0/24 (0%) | 1/12 (8.3%) | 3/36 (8.3%) | |||
Muscular weakness | 2/24 (8.3%) | 0/12 (0%) | 0/36 (0%) | |||
Myalgia | 1/24 (4.2%) | 0/12 (0%) | 2/36 (5.6%) | |||
Neck pain | 1/24 (4.2%) | 2/12 (16.7%) | 0/36 (0%) | |||
Nervous system disorders | ||||||
Dizziness | 1/24 (4.2%) | 0/12 (0%) | 2/36 (5.6%) | |||
Headache | 2/24 (8.3%) | 0/12 (0%) | 3/36 (8.3%) | |||
Neuropathy peripheral | 2/24 (8.3%) | 0/12 (0%) | 0/36 (0%) | |||
Somnolence | 0/24 (0%) | 0/12 (0%) | 2/36 (5.6%) | |||
Psychiatric disorders | ||||||
Insomnia | 0/24 (0%) | 0/12 (0%) | 2/36 (5.6%) | |||
Sleep disorder | 0/24 (0%) | 1/12 (8.3%) | 1/36 (2.8%) | |||
Renal and urinary disorders | ||||||
Glycosuria | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Haematuria | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Pollakiuria | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Proteinuria | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Reproductive system and breast disorders | ||||||
Vaginal discharge | 0/24 (0%) | 0/12 (0%) | 3/36 (8.3%) | |||
Respiratory, thoracic and mediastinal disorders | ||||||
Cough | 2/24 (8.3%) | 2/12 (16.7%) | 1/36 (2.8%) | |||
Dyspnoea | 1/24 (4.2%) | 1/12 (8.3%) | 1/36 (2.8%) | |||
Epistaxis | 1/24 (4.2%) | 1/12 (8.3%) | 0/36 (0%) | |||
Haemoptysis | 2/24 (8.3%) | 0/12 (0%) | 0/36 (0%) | |||
Nasal congestion | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Wheezing | 1/24 (4.2%) | 1/12 (8.3%) | 0/36 (0%) | |||
Skin and subcutaneous tissue disorders | ||||||
Bullous haemorrhagic dermatosis | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Dry skin | 0/24 (0%) | 1/12 (8.3%) | 1/36 (2.8%) | |||
Prurigo | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Pruritus | 1/24 (4.2%) | 1/12 (8.3%) | 1/36 (2.8%) | |||
Rash | 2/24 (8.3%) | 0/12 (0%) | 2/36 (5.6%) | |||
Rash macular | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Rash papular | 0/24 (0%) | 2/12 (16.7%) | 0/36 (0%) | |||
Rash pruritic | 0/24 (0%) | 0/12 (0%) | 2/36 (5.6%) | |||
Skin ulcer | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) | |||
Surgical and medical procedures | ||||||
Tooth extraction | 0/24 (0%) | 1/12 (8.3%) | 0/36 (0%) |
Limitations/Caveats
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 |
- GS-US-200-4625
- 2019-003814-16