Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Lenacapavir 20 mg | Experimental | 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. |
|
| Part A: Lenacapavir 50 mg | Experimental | 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. |
|
| Part A: Lenacapavir 150 mg | Experimental | 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. |
|
| Part A: Lenacapavir 450 mg | Experimental | 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. |
|
| Part A: Lenacapavir 750 mg | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenacapavir | Drug | Administered subcutaneously in the abdomen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A and Part B: Maximum Reduction From Day 1 (Baseline) Through Day 10 in Plasma HIV-1 RNA | 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). | Day 1 through Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A and Part B: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) | 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. |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruane Clinical Research Group, Inc. | Los Angeles | California | 90036 | United States | ||
| Mills Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Daar ES, McDonald C, Crofoot G, Ruane P, Sinclair G, Begley R, et al. Dose-response relationship of subcutaneous long-acting HIV capsid inhibitor GS-6207 [Poster]. Presented at: Conference on Retroviruses and Opportunistic Infections; 2020 March 8-11; Boston, MA, USA | ||
| Result | Daar ES, McDonald C, Crofoot G, Ruane P, Sinclair G, Patel H, et al. Single doses of long acting capsid inhibitor GS-6207 administered by subcutaneous injection are safe and efficacious in people living with HIV [Poster]. Presented at: 17th European AIDS Conference; 2019 November 6-9; Basel, Switzerland. | ||
| Result | Daar ES, McDonald C, Crofoot G, Ruane P, Sinclair G, Patel H, et al. Safety and antiviral activity over 10 days following a single dose of subcutaneous GS-6207, a first-in-class, long acting HIV capsid inhibitor in people living with HIV [Poster]. Presented at: 10th IAS Conference on HIV Science; 2019 21-24 July; Mexico City, Mexico. | ||
| 32612233 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
89 participants were screened.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Lenacapavir 20 mg | 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. |
| FG001 | Part A: Lenacapavir 50 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 13, 2019 | Oct 13, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Part A: Placebo | Placebo Comparator | 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. |
|
| Part B: TAF 200 mg | Experimental | 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. |
|
| Part B: TAF 600 mg | Experimental | 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. |
|
|
| Placebo | Drug | Administered subcutaneously in the abdomen |
|
| B/F/TAF | Drug | 50/200/25 mg tablets administered orally once daily |
|
|
| TAF | Drug | Tablets administered orally |
|
| Day 1 through 225 days |
| Part A and Part B: Percentage of Participants Experiencing Treatment Emergent Laboratory Abnormalities | 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. | Day 1 through 225 days |
| Part A and Part B Pharmacokinetic (PK) Parameter: AUCinf of Lenacapavir, TAF and Its Metabolite TFV | AUCinf is defined as area under the concentration versus time curve from time zero to infinity. | 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 |
| Part A and Part B PK Parameter: AUClast of Lenacapavir, TAF and Its Metabolite TFV | AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. | 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 |
| Part A and Part B PK Parameter: Cmax of Lenacapavir, TAF and Its Metabolite TFV | Cmax is defined as the maximum observed concentration of drug. | 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 |
| Part B PK Parameter: AUCinf of TFV-DP Metabolite of TAF | AUCinf is defined as area under the concentration versus time curve from time zero to infinity. | 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 |
| Part B PK Parameter: AUClast of TFV-DP Metabolite of TAF | AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. | 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 |
| Part B PK Parameter: Cmax of TFV-DP Metabolite of TAF | Cmax is defined as the maximum observed concentration of drug. | 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 |
| 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 | 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:
| Day 10 through Day 225 |
| Part B: Number of Participants Experiencing Any Emergence of TAF Resistance | Day 10 |
| Part B: Number of Participants Experiencing Any Emergence of TAF Resistance | 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:
D = Day | Day 10 through Day 225 |
| Los Angeles |
| California |
| 90069 |
| United States |
| One Community | Sacramento | California | 95817 | United States |
| The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34982 | United States |
| Orlando Immunology Center PA | Orlando | Florida | 32803-1851 | United States |
| Triple O Research Institute, P.A. | West Palm Beach | Florida | 33401 | United States |
| Be Well Medical Center | Berkley | Michigan | 48072-3436 | United States |
| AIDS Arms, Inc., DBA Prism Health North Texas | Dallas | Texas | 75208 | United States |
| North Texas Infectious Diseases Consultants, P.A. | Dallas | Texas | 75246 | United States |
| Tarrant County Infectious Disease Associates | Fort Worth | Texas | 76104 | United States |
| The Crofoot Research Center, INC (dba Gordon E. Crofoot MD PA) | Houston | Texas | 77098 | United States |
| Result |
| Link JO, Rhee MS, Tse WC, Zheng J, Somoza JR, Rowe W, Begley R, Chiu A, Mulato A, Hansen D, Singer E, Tsai LK, Bam RA, Chou CH, Canales E, Brizgys G, Zhang JR, Li J, Graupe M, Morganelli P, Liu Q, Wu Q, Halcomb RL, Saito RD, Schroeder SD, Lazerwith SE, Bondy S, Jin D, Hung M, Novikov N, Liu X, Villasenor AG, Cannizzaro CE, Hu EY, Anderson RL, Appleby TC, Lu B, Mwangi J, Liclican A, Niedziela-Majka A, Papalia GA, Wong MH, Leavitt SA, Xu Y, Koditek D, Stepan GJ, Yu H, Pagratis N, Clancy S, Ahmadyar S, Cai TZ, Sellers S, Wolckenhauer SA, Ling J, Callebaut C, Margot N, Ram RR, Liu YP, Hyland R, Sinclair GI, Ruane PJ, Crofoot GE, McDonald CK, Brainard DM, Lad L, Swaminathan S, Sundquist WI, Sakowicz R, Chester AE, Lee WE, Daar ES, Yant SR, Cihlar T. Clinical targeting of HIV capsid protein with a long-acting small molecule. Nature. 2020 Aug;584(7822):614-618. doi: 10.1038/s41586-020-2443-1. Epub 2020 Jul 1. |
| Result | Margot N, Ram R, Parvangada P, Martin R, Hyland R, Rhee M, Callebaut C. Lenacapavir resistance analysis in a phase Ib clinical proof-of-concept study [oral]. Presented at: HIV Glasgow; 2020 October 5 - 8; Virtual. |
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. |
| FG002 | Part A: Lenacapavir 150 mg | 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. |
| FG003 | Part A: Lenacapavir 450 mg | 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. |
| FG004 | Part A: Lenacapavir 750 mg | 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. |
| FG005 | Part A: Placebo | 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. |
| FG006 | Part B: Tenofovir Alafenamide (TAF) 200 mg | 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. |
| FG007 | Part B: TAF 600 mg | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Lenacapavir 20 mg | 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. |
| BG001 | Part A: Lenacapavir 50 mg | 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. |
| BG002 | Part A: Lenacapavir 150 mg | 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. |
| BG003 | Part A: Lenacapavir 450 mg | 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. |
| BG004 | Part A: Lenacapavir 750 mg | 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. |
| BG005 | Part A: Placebo | 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. |
| BG006 | Part B: TAF 200 mg | 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. |
| BG007 | Part B: TAF 600 mg | 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. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| HIV-1 RNA | Mean | Standard Deviation | log10 copies/mL |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part A and Part B: Maximum Reduction From Day 1 (Baseline) Through Day 10 in Plasma HIV-1 RNA | 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). | The Full Analysis Set (FAS) included all participants who were randomized/enrolled and received at least 1 full dose of study drug. | Posted | Mean | Standard Deviation | log10 copies/mL | Day 1 through Day 10 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part A and Part B: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) | 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. | The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Day 1 through 225 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part A and Part B: Percentage of Participants Experiencing Treatment Emergent Laboratory Abnormalities | 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. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | Day 1 through 225 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part A and Part B Pharmacokinetic (PK) Parameter: AUCinf of Lenacapavir, TAF and Its Metabolite TFV | AUCinf is defined as area under the concentration versus time curve from time zero to infinity. | Participants in the PK Analysis Set were analyzed. | Posted | Mean | Standard Deviation | h*ng/mL | 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part A and Part B PK Parameter: AUClast of Lenacapavir, TAF and Its Metabolite TFV | AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. | Participants in the PK Analysis Set were analyzed. | Posted | Mean | Standard Error | h*ng/mL | 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part A and Part B PK Parameter: Cmax of Lenacapavir, TAF and Its Metabolite TFV | Cmax is defined as the maximum observed concentration of drug. | Participants in the PK Analysis Set were analyzed. | Posted | Mean | Standard Deviation | ng/mL | 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part B PK Parameter: AUCinf of TFV-DP Metabolite of TAF | AUCinf is defined as area under the concentration versus time curve from time zero to infinity. | 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. | Posted | Mean | Standard Deviation | h*uM | 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 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part B PK Parameter: AUClast of TFV-DP Metabolite of TAF | AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. | Participants in the PBMC PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | h*uM | 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 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part B PK Parameter: Cmax of TFV-DP Metabolite of TAF | Cmax is defined as the maximum observed concentration of drug. | Participants in the PBMC PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | uM | 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 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part A: Percentage of Participants Ever Achieving HIV-1 RNA < 50 Copies/mL by Day 10 | Participants in the FAS Analysis Set were analyzed. | Posted | Number | percentage of participants | Day 10 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part A: Number of Participants Experiencing Any Emergence of Capsid Inhibitor Resistance | 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. | Posted | Count of Participants | Participants | No | Day 10 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part A: Number of Participants Experiencing Any Emergence of Capsid Inhibitor Resistance | 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:
| Participants in the Post-Monotherapy Resistance Analysis Population were analyzed. | Posted | Count of Participants | Participants | No | Day 10 through Day 225 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part B: Number of Participants Experiencing Any Emergence of TAF Resistance | 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. | Posted | Count of Participants | Participants | No | Day 10 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part B: Number of Participants Experiencing Any Emergence of TAF Resistance | 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:
D = Day | Data was not collected as no participants met the specified Post-Monotherapy Resistance Analysis Population criteria. | Posted | No | Day 10 through Day 225 |
|
Day 1 through 225 days
The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A: Lenacapavir 20 mg | 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. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG001 | Part A: Lenacapavir 50 mg | 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. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG002 | Part A: Lenacapavir 150 mg | 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. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG003 | Part A: Lenacapavir 450 mg | 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. | 0 | 6 | 1 | 6 | 6 | 6 |
| EG004 | Part A: Lenacapavir 750 mg | 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. | 0 | 5 | 0 | 5 | 4 | 5 |
| EG005 | Part A: Placebo | 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. | 0 | 10 | 1 | 10 | 7 | 10 |
| EG006 | Part B: TAF 200 mg | 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. | 0 | 7 | 0 | 7 | 6 | 7 |
| EG007 | Part B: TAF 600 mg | 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. | 0 | 5 | 0 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA Version 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Excessive cerumen production | Ear and labyrinth disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Retinal tear | Eye disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Anogenital dysplasia | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Rectal discharge | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Injection site mass | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Injection site nodule | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Suprapubic pain | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Anal chlamydia infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Latent tuberculosis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Oropharyngeal gonococcal infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Pharyngeal chlamydia infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Proctitis gonococcal | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Syphilis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
| |
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
| |
| Exposure to communicable disease | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Systematic Assessment |
| |
| Lymphoplasmacytoid lymphoma/immunocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Stress | Psychiatric disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Crystalluria | Renal and urinary disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Sterile pyuria | Renal and urinary disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Seborrhoea | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 23.0 | Systematic Assessment |
|
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:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 14, 2020 | Oct 13, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000730993 | lenacapavir |
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black |
|
| White |
|
| Other |
|
| Superiority |
| t-test, 2 sided | <0.0001 | Superiority |
| t-test, 2 sided | <0.0001 | Superiority |
| t-test, 2 sided | <0.0001 | Superiority |
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.
| OG003 | Part A: Lenacapavir 450 mg | 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. |
| OG004 | Part A: Lenacapavir 750 mg | 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. |
| OG005 | Part A: Placebo | 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. |
| OG006 | Part B: TAF 200 mg | 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. |
| OG007 | Part B: TAF 600 mg | 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. |
|
|
| OG003 |
| Part A: Lenacapavir 450 mg |
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. |
| OG004 | Part A: Lenacapavir 750 mg | 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. |
| OG005 | Part A: Placebo | 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. |
| OG006 | Part B: TAF 200 mg | 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. |
| OG007 | Part B: TAF 600 mg | 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. |
|
|
| OG003 | Part A: Lenacapavir 450 mg | 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. |
| OG004 | Part A: Lenacapavir 750 mg | 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. |
| OG005 | Part B: TAF 200 mg | 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. |
| OG006 | Part B: TAF 600 mg | 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. |
|
|
| OG003 | Part A: Lenacapavir 450 mg | 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. |
| OG004 | Part A: Lenacapavir 750 mg | 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. |
| OG005 | Part B: TAF 200 mg | 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. |
| OG006 | Part B: TAF 600 mg | 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. |
|
|
| OG003 | Part A: Lenacapavir 450 mg | 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. |
| OG004 | Part A: Lenacapavir 750 mg | 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. |
| OG005 | Part B: TAF 200 mg | 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. |
| OG006 | Part B: TAF 600 mg | 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. |
|
|
|
|
|
| OG004 | Part A: Lenacapavir 750 mg | 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. |
| OG005 | Part A: Placebo | 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 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. |
| OG004 | Part A: Lenacapavir 750 mg | 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. |
| OG005 | Part A: Placebo | 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 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. |
| OG002 | Part A: Lenacapavir 150 mg | 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. |
| OG003 | Part A: Lenacapavir 450 mg | 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. |
| OG004 | Part A: Lenacapavir 750 mg | 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. |
| OG005 | Part A: Placebo | 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. |
|
|
|
|
|
|
|
|
|
|