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Master protocol: The goal of this master clinical trial study is to learn how novel antiretrovirals (medicines that stop the virus from multiplying) affect the human immunodeficiency virus-1 (HIV-1) infection in people living with HIV (PWH).
Substudy-01 (GS-US-544-5905-01) will evaluate bavtavirine in PWH.
Substudy-02 (GS-US-544-5905-02) will evaluate GS-1720 in PWH.
Substudy-03 (GS-US-544-5905-03) will evaluate GS-6212 in PWH.
This umbrella study will begin with a substudy of bavtavirine (Substudy-01), and later substudies GS-1720 (Substudy-02) and GS-6212 (Substudy-03) will be added. Substudies evaluating additional study drugs will be added in a staggered manner when relevant nonclinical and/or clinical data become available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal) | Experimental | Participants receive a single dose of bavtavirine 675 mg tablet with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiate a regimen of B/F/TAF, or an alternative standard of care (SOC) antiretroviral (ART) regimen (example INSTI + NRTIs: dolutegravir (DTG)/abacavir (ABC)/3TC or DTG/3TC) up to Day 39. |
|
| Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal) | Experimental | Participants receive a single dose of bavtavirine 1200 mg tablet with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiate a regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC) up to Day 39. |
|
| Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal) | Experimental | Participants receive bavtavirine 900 mg tablet with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiate a regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC) up to Day 39. |
|
| Substudy 02: Cohort 1: GS-1720 450 mg | Experimental | Participants receive a single dose of GS-1720 450 mg tablet on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiate a regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC) up to Day 60. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bavtavirine | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Substudies 01, 02 and 03: Change From Baseline in Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (log10 Copies/mL) at Day 11 Relative to Historical Placebo Data | Baseline, Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Substudies 01, 02 and 03: Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Day 8 Relative to Historical Placebo Data | Baseline, Day 8 | |
| Substudies 01, 02 and 03: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were defined as any AEs with an onset date on or after the study drug start date. Percentages were rounded-off. |
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Key Inclusion Criteria:
All Substudies:
Substudy-01, Substudy-02, and Substudy-03:
Key Exclusion Criteria:
All Substudies:
Known historical genotypic or phenotypic resistance to 4 major ARV classes (nucleoside reverse transcriptase inhibitor (NRTI), nonnucleoside reverse transcriptase inhibitor (NNRTI), protease inhibitor (PI), integrase strand-transfer inhibitor (INSTI)).
History of an AIDS-defining condition including present at the time of screening.
Active, serious infections (other than HIV-1) requiring therapy and including active tuberculosis infection < 30 days prior to randomization.
History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
Any other serious or active clinical condition or prior therapy that, in the opinion of the investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements.
Hepatitis C virus (HCV) antibody positive and detectable HCV RNA.
Chronic hepatitis B virus (HBV) infection, as determined by either:
Hepatic transaminases (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) > 5 x upper limit of normal (ULN).
Current alcohol or substance use judged by the investigator to potentially interfere with individual study compliance.
Positive serum pregnancy test at screening or a positive pregnancy test prior to Day 1.
Individuals with plan to breastfeed during the study period including the protocol-defined follow-up period.
Requirement for ongoing therapy with or prior use of any prohibited medications listed in the protocol. Any prescription medications or over the counter medications, including herbal products, within 28 days prior to start of study drug dosing must be reviewed and approved by the sponsor, with the exception of vitamins and/or acetaminophen and/or ibuprofen.
Any current or prior receipt of LA parenteral ARVs such as mAbs targeting HIV-1, injectable CAB, or injectable RPV, for treatment or prophylaxis (PrEP, PEP).
Substudy-01, Substudy-02, Substudy-03:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Beach Education and Research Consultants,Substudy-03 | Long Beach | California | 90813 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Carl J. Fichtenbaum, Mezgebe Berhe, Jose Bordon, et al, Antiviral Activity, Safety, and Pharmacokinetics of GS-1720: A Novel Weekly Oral INSTI. Conference on Retroviruses and Opportunistic Infections, 2024, 3-6 March. |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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Efficacy outcome measures (OM) included an additional cohort of Placebo. In this study, none of the participants received placebo. Placebo arm included 21 participants with HIV-1 from 3 other Gilead Phase 1b studies (GS-US-120-0104, GS-US-141-1219 (NCT02275065), and GS-US-200-4072 (NCT03739866)).
Each bavtavirine, GS-1720, and GS-6212 cohort was compared to the pooled placebo cohort in the efficacy OMs #1, 2, and 17.
100 participants were screened. Participants were enrolled at study sites in the United States, Thailand, and Dominican Republic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal) | Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF), or an alternative standard of care (SOC) antiretroviral therapy (ART) regimen (example integrase strand-transfer inhibitor (INSTI) + nucleoside reverse transcriptase inhibitor (NRTIs): Dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) or DTG/3TC), orally up to Day 39. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Substudy 01 Protocol Amendment 01 | Sep 27, 2022 |
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The Substudies were conducted in parallel. However, the cohorts within the Substudies received drug assignment sequentially.
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| Substudy 02: Cohort 2: GS-1720 150 mg | Experimental | Participants receive a single dose of GS-1720 150 mg tablet on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiate a regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC) up to Day 60. |
|
| Substudy 02: Cohort 3: GS-1720 30 mg | Experimental | Participants receive a single dose of GS-1720 30 mg tablet on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiate a regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC) up to Day 60. |
|
| Substudy 02: Cohort 4: GS-1720 900 mg | Experimental | Participants receive a single dose of GS-1720 900 mg tablet on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiate a regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC) up to Day 60. |
|
| Substudy 03: Cohort 1: GS- 6212 100 mg | Experimental | Participants receive GS-6212 100 mg tablet twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiate a regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC) up to Day 25. |
|
|
| B/F/TAF | Drug | Administered orally |
|
|
| Standard of Care (Substudy 01) | Drug | Antiretroviral therapy, administered orally Non-NNRTIs, examples: ABC/DTG/3TC; DTG plus (TAF or TDF) plus (FTC or 3TC) |
|
| GS-1720 | Drug | Administered orally |
|
| Standard of Care (Substudy 02) | Drug | Antiretroviral therapy, administered orally Example INSTIs: DTG/ABC/3TC or DTG/3TC |
|
| GS-6212 | Drug | Administered orally |
|
| Standard of Care (Substudy 03) | Drug | Antiretroviral therapy, administered orally |
|
| First dose up to last dose (Substudy 01: Up to Day 39; Substudy 02: Up to Day 60; Substudy 03: Up to Day 25) |
| Substudies 01, 02 and 03: Percentage of Participants With Graded Laboratory Abnormalities | Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any time postbaseline. Laboratory abnormalities were graded using Division of AIDS (DAIDS) scale with grade 0 to 4 where 0 = no grade; 1 = mild, 2 = moderate, 3 = severe; 4 = potentially life-threatening. Participants with at least a 1 grade increased from baseline for an individual laboratory test where the maximum post baseline laboratory abnormality was 1) grade 1 or higher and 2) grade 3 or higher were reported. The maximum postbaseline toxicity grade across all tests for an individual participant was used in analysis. Percentages were rounded-off. | First dose up to last dose (Substudy 01: Up to Day 39; Substudy 02: Up to Day 60; Substudy 03: Up to Day 25) |
| Substudy 01: Pharmacokinetic (PK) Parameter: Cmax of Bavtavirine | Cmax was defined as the maximum observed concentration of drug. | Cohorts 1, 2 and 3 (Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, and 12 hours postdose); Cohort 3: Day 2: Predose, 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose |
| Substudy 01: PK Parameter: AUC of Bavtavirine | AUC was defined as the area under the concentration versus time curve. | Day 1 up to Day 11 |
| Substudy 01: PK Parameter: Plasma Concentration of Bavtavirine | Days 8 and 11 |
| Substudy 02: PK Parameter: Cmax of GS-1720 | Cmax was defined as the maximum observed concentration of drug. | Days 1 and 2: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8 and (optional) 12 hours postdose |
| Substudy 02: PK Parameter: AUC of GS-1720 | AUC was defined as the area under the concentration versus time curve. | Day 1 up to Day 11 |
| Substudy 02: PK Parameter: Plasma Concentration of GS-1720 | Days 8 and 11 |
| Substudy 03: PK Parameter: Cmax of GS-6212 | Cmax was defined as the maximum observed concentration of drug. | Days 1 and 10 (Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8 and (optional) 12 hours postdose) |
| Substudy 03: PK Parameter: AUC0-8h of GS-6212 | AUC0-8h was defined as the area under the concentration versus time curve spanning from 0 to 8 hours post dose. | Days 1 and 10 (Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8 and (optional) 12 hours postdose) |
| Substudy 03: PK Parameter: AUCtau of GS-6212 | AUCtau was defined as the area under the curve from time zero to end of dosing interval. | Day 10 (Parameter estimated based on observed data from 0 to 8 hours postdose) |
| Substudy 03: PK Parameter: Plasma Concentration of GS-6212 | Days 1 and 10: 8 hours postdose |
| Substudy 03: PK Parameter: Ctrough of GS-6212 (Day 10) | Ctrough was defined as concentration at the end of the dosing interval. | Day 10 (Parameter estimated based on observed data from 0 to 8 hours postdose) |
| Substudy 03: PK Parameter: Cavg of GS-6212 (Day 10) | Cavg was defined as average plasma concentration during dose administration. | Day 10 (predose to 8 hours postdose) |
| Substudies 01, 02 and 03: Percentage of Participants at Any Measurement Achieving HIV-1 RNA < 50 Copies/mL by Day 11 at Each Dose Level | Percentages were rounded-off. | Up to Day 11 |
| Substudies 01, 02 and 03: Percentage of Participants With Emergence of Viral Resistance to the ARV Class of the Given Drug | The antiretroviral (ARV) class of given drugs would be BVY or NNRTIs (Substudy 01) or INSTIs (Substudy 02) or INSTIs (Substudy 03). Percentages were rounded-off. | Up to Day 11 |
| Substudy 01: Maximum Inhibitory Quotient (IQ) of Bavtavirine by Mean Plasma Concentration (Ct) up to Day 11 | Inhibitory quotient was calculated as the ratio of bavtavirine in vivo exposure to in vitro plasma concentration. IQ is defined as paEC95. paEC95 = protein-adjusted effective concentration to achieve 95% effective inhibition. The IQ ≥ 2 indicated higher reduction in viral load with less rebound. | Up to Day 11 |
| Substudy 02: Inhibitory Quotient (IQ) of GS-1720 by Mean Plasma Concentration (Ct) at Day 11 | Inhibitory quotient was calculated as the ratio of GS-1720 in vivo exposure to in vitro plasma concentration. IQ is defined as paEC95. paEC95 = protein-adjusted effective concentration to achieve 95% effective inhibition. The IQ ≥ 2 indicated higher reduction in viral load with less rebound. | Day 11 |
| Substudy 03: Inhibitory Quotient (IQ) of GS-6212 by Ctrough at Day 11 | Ctrough is the plasma concentration of the drug just before the next dose. Inhibitory quotient was calculated as the ratio of GS-1720 in vivo exposure to in vitro Ctrough. IQ is defined as paEC95. paEC95 = protein-adjusted effective concentration to achieve 95% effective inhibition. The IQ ≥ 2 indicated higher reduction in viral load with less rebound. | Day 11 |
| Mills Clinical Research,Substudy-02 |
| Los Angeles |
| California |
| 90069 |
| United States |
| Mills Clinical Research,Substudy-03 | Los Angeles | California | 90069 | United States |
| Quest Clinical Research,Substudy-01 | San Francisco | California | 94115 | United States |
| Quest Clinical Research,Substudy-02 | San Francisco | California | 94115 | United States |
| Quest Clinical Research,Substudy-03 | San Francisco | California | 94115 | United States |
| Yale University; School of Medicine; AIDS Program (Administrative & Study Supplies),Substudy-03 | New Haven | Connecticut | 06510 | United States |
| Yale University,Substudy-02 | New Haven | Connecticut | 06520 | United States |
| Washington Health Institute,Substudy-01 | Washington D.C. | District of Columbia | 20017 | United States |
| Washington Health Institute,Substudy-02 | Washington D.C. | District of Columbia | 20017 | United States |
| Washington Health Institute,Substudy-03 | Washington D.C. | District of Columbia | 20017 | United States |
| Midland Florida Clinical Research Center, LLC,Substudy-02 | DeLand | Florida | 32720 | United States |
| Midland Florida Clinical Research, LLC,Substudy-03 | DeLand | Florida | 32720 | United States |
| Midway Immunology and Research Center,Substudy-01 | Ft. Pierce | Florida | 34982 | United States |
| Midway Immunology and Research Center,Substudy-02 | Ft. Pierce | Florida | 34982 | United States |
| Midway Immunology and Research Center,Substudy-03 | Ft. Pierce | Florida | 34982 | United States |
| Bliss Health,Substudy-02 | Orlando | Florida | 32803 | United States |
| Bliss Health,Substudy-03 | Orlando | Florida | 32803 | United States |
| Orlando Immunology Center,Substudy-01 | Orlando | Florida | 32803 | United States |
| Orlando Immunology Center,Substudy-03 | Orlando | Florida | 32803 | United States |
| Triple O Research Institute, P.A.,Substudy-01 | West Palm Beach | Florida | 33407 | United States |
| Triple O Research Institute, P.A.,Substudy-03 | West Palm Beach | Florida | 33407 | United States |
| Infectious Disease Specialists of Atlanta,Substudy-01 | Decatur | Georgia | 30033 | United States |
| Indiana CTSI Clinical Research Center,Substudy-01 | Indianapolis | Indiana | 46202 | United States |
| University of Cincinnati College of Medicine,Substudy-02 | Cincinnati | Ohio | 45267 | United States |
| University of Cincinnati College of Medicine,Substudy-03 | Cincinnati | Ohio | 45267 | United States |
| Central Texas Clinical Research,Substudy-01 | Austin | Texas | 78705 | United States |
| Central Texas Clinical Research,Substudy-03 | Austin | Texas | 78705 | United States |
| Prism Health North Texas,Substudy-02 | Dallas | Texas | 75208 | United States |
| Prism Health North Texas,Substudy-03 | Dallas | Texas | 75215 | United States |
| North Texas Infectious Diseases Consultant, P.A.,Substudy-02 | Dallas | Texas | 75246 | United States |
| North Texas Infectious Diseases Consultants, P.A.,Substudy-03 | Dallas | Texas | 75246 | United States |
| AXCES Research,Substudy-02 | El Paso | Texas | 79902 | United States |
| AXES Research Group LLC,Substudy-03 | El Paso | Texas | 79902 | United States |
| Therapeutic Concepts, PA,Substudy-02 | Houston | Texas | 77004 | United States |
| Therapeutic Concepts, PA,Substudy-03 | Houston | Texas | 77004 | United States |
| The Crofoot Research Center, Inc.,Substudy-01 | Houston | Texas | 77098 | United States |
| MultiCare Rockwood Main Clinic- Research,Substudy-03 | Spokane | Washington | 99202 | United States |
| Instituto Dominicano de Estudio Virologicos - IDEV,Substudy-02 | Santo Domingo | 10103 | Dominican Republic |
| The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),Substudy-02 | Bangkok | 10330 | Thailand |
| The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),Substudy-03 | Bangkok | 10330 | Thailand |
| Faculty of Medicine, Srinagarind Hospital, Khon Kaen University,Substudy-03 | Khon Kaen | 40002 | Thailand |
| FG001 | Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal) | Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39. |
| FG002 | Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal) | Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39. |
| FG003 | Substudy 02: Cohort 1: GS-1720 450 mg | Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| FG004 | Substudy 02: Cohort 2: GS-1720 150 mg | Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| FG005 | Substudy 02: Cohort 3: GS-1720 30 mg | Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| FG006 | Substudy 02: Cohort 4: GS-1720 900 mg | Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| FG007 | Substudy 03: Cohort 1: GS- 6212 100 mg | Participants received GS-6212 100 mg tablet orally, twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25. |
| COMPLETED |
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| NOT COMPLETED |
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|
The Safety Analysis Set included all participants who took at least 1 dose of the following: bavtavirine in Substudy 01; GS-1720 in Substudy 02 and GS-6212 in Substudy 03.
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| ID | Title | Description |
|---|---|---|
| BG000 | Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal) | Participants received a single dose of bavtavirine 675 mg tablet, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39. |
| BG001 | Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal) | Participants received a single dose of bavtavirine 1200 mg tablet, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39. |
| BG002 | Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal) | Participants received a single dose of bavtavirine 900 mg tablet, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39. |
| BG003 | Substudy 02: Cohort 1: GS-1720 450 mg | Participants received a single dose of GS-1720 450 mg tablet, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| BG004 | Substudy 02: Cohort 2: GS-1720 150 mg | Participants received a single dose of GS-1720 150 mg tablet, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| BG005 | Substudy 02: Cohort 3: GS-1720 30 mg | Participants received a single dose of GS-1720 30 mg tablet, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| BG006 | Substudy 02: Cohort 4: GS-1720 900 mg | Participants received a single dose of GS-1720 900 mg tablet, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| BG007 | Substudy 03: Cohort 1: GS- 6212 100 mg | Participants received GS-6212 100 mg tablet, orally, twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25. |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Substudies 01, 02 and 03: Change From Baseline in Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (log10 Copies/mL) at Day 11 Relative to Historical Placebo Data | Participants in the Full Analysis Set with data available were analyzed. The Full Analysis Set included all participants who were enrolled and received full dose(s) of study drugs bavtavirine, GS-1720 and GS-6212 in these substudies. The placebo arm included pooled data from participants who received placebo in 3 historical Gilead HIV-1 phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) for HIV-1 efficacy parameters only. | Posted | Mean | Standard Deviation | log10 copies/mL | Baseline, Day 11 |
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| Secondary | Substudies 01, 02 and 03: Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Day 8 Relative to Historical Placebo Data | Participants in the Full Analysis Set with available data were analyzed. The placebo arm included pooled data from participants who received placebo in 3 historical Gilead HIV-1 phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) for HIV-1 efficacy parameters only. | Posted | Mean | Standard Deviation | log10 copies/mL | Baseline, Day 8 |
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| Secondary | Substudies 01, 02 and 03: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were defined as any AEs with an onset date on or after the study drug start date. Percentages were rounded-off. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose up to last dose (Substudy 01: Up to Day 39; Substudy 02: Up to Day 60; Substudy 03: Up to Day 25) |
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| Secondary | Substudies 01, 02 and 03: Percentage of Participants With Graded Laboratory Abnormalities | Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any time postbaseline. Laboratory abnormalities were graded using Division of AIDS (DAIDS) scale with grade 0 to 4 where 0 = no grade; 1 = mild, 2 = moderate, 3 = severe; 4 = potentially life-threatening. Participants with at least a 1 grade increased from baseline for an individual laboratory test where the maximum post baseline laboratory abnormality was 1) grade 1 or higher and 2) grade 3 or higher were reported. The maximum postbaseline toxicity grade across all tests for an individual participant was used in analysis. Percentages were rounded-off. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose up to last dose (Substudy 01: Up to Day 39; Substudy 02: Up to Day 60; Substudy 03: Up to Day 25) |
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| Secondary | Substudy 01: Pharmacokinetic (PK) Parameter: Cmax of Bavtavirine | Cmax was defined as the maximum observed concentration of drug. | Participants in PK Analysis Set in Substudy 01 were analyzed. The PK Analysis Set included all participants who were enrolled in the study, received at least 1 dose of study drug, and had at least 1 non-missing post baseline concentration value for bavtavirine. Per pre-specified analysis, Cmax at Day 2 was calculated only for Cohort 3. | Posted | Mean | Standard Deviation | ng/mL | Cohorts 1, 2 and 3 (Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, and 12 hours postdose); Cohort 3: Day 2: Predose, 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose |
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| Secondary | Substudy 01: PK Parameter: AUC of Bavtavirine | AUC was defined as the area under the concentration versus time curve. | Participants in the PK Analysis Set in Substudy 01 were analyzed. | Posted | Mean | Standard Deviation | h*ng/mL | Day 1 up to Day 11 |
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| Secondary | Substudy 01: PK Parameter: Plasma Concentration of Bavtavirine | Participants in the PK Analysis Set in Substudy 01 with available data were analyzed. | Posted | Mean | Standard Deviation | ng/mL | Days 8 and 11 |
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| Secondary | Substudy 02: PK Parameter: Cmax of GS-1720 | Cmax was defined as the maximum observed concentration of drug. | Participants in the PK Analysis Set in Substudy 02 with available data were analyzed. | Posted | Mean | Standard Deviation | µg/mL | Days 1 and 2: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8 and (optional) 12 hours postdose |
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| Secondary | Substudy 02: PK Parameter: AUC of GS-1720 | AUC was defined as the area under the concentration versus time curve. | Participants in the PK Analysis Set in Substudy 02 were analyzed. | Posted | Mean | Standard Deviation | h*µg/mL | Day 1 up to Day 11 |
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| Secondary | Substudy 02: PK Parameter: Plasma Concentration of GS-1720 | Participants in the PK Analysis Set in Substudy 02 were analyzed. | Posted | Mean | Standard Deviation | µg/mL | Days 8 and 11 |
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| Secondary | Substudy 03: PK Parameter: Cmax of GS-6212 | Cmax was defined as the maximum observed concentration of drug. | Participants in the PK Analysis Set in Substudy 03 with available data were analyzed. | Posted | Mean | Standard Deviation | ng/mL | Days 1 and 10 (Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8 and (optional) 12 hours postdose) |
|
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| Secondary | Substudy 03: PK Parameter: AUC0-8h of GS-6212 | AUC0-8h was defined as the area under the concentration versus time curve spanning from 0 to 8 hours post dose. | Participants in the PK Analysis Set in Substudy 03 with available data were analyzed. | Posted | Mean | Standard Deviation | h*ng/mL | Days 1 and 10 (Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8 and (optional) 12 hours postdose) |
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| Secondary | Substudy 03: PK Parameter: AUCtau of GS-6212 | AUCtau was defined as the area under the curve from time zero to end of dosing interval. | Participants in the PK Analysis Set in Substudy 03 with available data were analyzed. | Posted | Mean | Standard Deviation | h*ng/mL | Day 10 (Parameter estimated based on observed data from 0 to 8 hours postdose) |
|
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| Secondary | Substudy 03: PK Parameter: Plasma Concentration of GS-6212 | Participants in the PK Analysis Set in Substudy 03 with available data were analyzed. | Posted | Mean | Standard Deviation | ng/mL | Days 1 and 10: 8 hours postdose |
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| Secondary | Substudy 03: PK Parameter: Ctrough of GS-6212 (Day 10) | Ctrough was defined as concentration at the end of the dosing interval. | Participants in the PK Analysis Set in Substudy 03 with available data were analyzed. | Posted | Mean | Standard Deviation | ng/mL | Day 10 (Parameter estimated based on observed data from 0 to 8 hours postdose) |
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| Secondary | Substudy 03: PK Parameter: Cavg of GS-6212 (Day 10) | Cavg was defined as average plasma concentration during dose administration. | Participants in the PK Analysis Set in Substudy 03 with available data were analyzed. | Posted | Mean | Standard Deviation | ng/mL | Day 10 (predose to 8 hours postdose) |
|
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| Secondary | Substudies 01, 02 and 03: Percentage of Participants at Any Measurement Achieving HIV-1 RNA < 50 Copies/mL by Day 11 at Each Dose Level | Percentages were rounded-off. | Participants in the Full Analysis Set were analyzed. The placebo arm included pooled data from participants who received placebo in 3 historical Gilead HIV-1 phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) for HIV-1 efficacy parameters only. | Posted | Number | percentage of participants | Up to Day 11 |
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| Secondary | Substudies 01, 02 and 03: Percentage of Participants With Emergence of Viral Resistance to the ARV Class of the Given Drug | The antiretroviral (ARV) class of given drugs would be BVY or NNRTIs (Substudy 01) or INSTIs (Substudy 02) or INSTIs (Substudy 03). Percentages were rounded-off. | Participant in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Up to Day 11 |
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| Secondary | Substudy 01: Maximum Inhibitory Quotient (IQ) of Bavtavirine by Mean Plasma Concentration (Ct) up to Day 11 | Inhibitory quotient was calculated as the ratio of bavtavirine in vivo exposure to in vitro plasma concentration. IQ is defined as paEC95. paEC95 = protein-adjusted effective concentration to achieve 95% effective inhibition. The IQ ≥ 2 indicated higher reduction in viral load with less rebound. | The PK/PD Analysis Set included all participants who were in the Full Analysis Set and have both nonmissing Ct (and/or AUC) of study drug and the change from baseline at Day 11 in plasma HIV-1 RNA (log10 copies/mL). | Posted | Number | ratio | Up to Day 11 |
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| Secondary | Substudy 02: Inhibitory Quotient (IQ) of GS-1720 by Mean Plasma Concentration (Ct) at Day 11 | Inhibitory quotient was calculated as the ratio of GS-1720 in vivo exposure to in vitro plasma concentration. IQ is defined as paEC95. paEC95 = protein-adjusted effective concentration to achieve 95% effective inhibition. The IQ ≥ 2 indicated higher reduction in viral load with less rebound. | Participants in the PK/PD Analysis Set were analyzed. | Posted | Number | ratio | Day 11 |
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| Secondary | Substudy 03: Inhibitory Quotient (IQ) of GS-6212 by Ctrough at Day 11 | Ctrough is the plasma concentration of the drug just before the next dose. Inhibitory quotient was calculated as the ratio of GS-1720 in vivo exposure to in vitro Ctrough. IQ is defined as paEC95. paEC95 = protein-adjusted effective concentration to achieve 95% effective inhibition. The IQ ≥ 2 indicated higher reduction in viral load with less rebound. | Participants in the PK/PD Analysis Set with available data were analyzed. | Posted | Number | ratio | Day 11 |
|
|
Substudy 01: Up to Day 39; Substudy 02: Up to Up to Day 60; Substudy 03: Up to Day 25
All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant ID number in the study after screening.
Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of bavtavirine, GS-1720, and GS-6212 in this study.
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 | Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal) | Participants received a single dose of bavtavirine 675 mg, tablets, orally, with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG001 | Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal) | Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39. | 0 | 6 | 1 | 6 | 0 | 6 |
| EG002 | Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal) | Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG003 | Substudy 02: Cohort 1: GS-1720 450 mg | Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. | 0 | 7 | 0 | 7 | 3 | 7 |
| EG004 | Substudy 02: Cohort 2: GS-1720 150 mg | Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. | 0 | 7 | 1 | 7 | 6 | 7 |
| EG005 | Substudy 02: Cohort 3: GS-1720 30 mg | Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. | 0 | 7 | 0 | 7 | 6 | 7 |
| EG006 | Substudy 02: Cohort 4: GS-1720 900 mg | Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. | 0 | 7 | 0 | 7 | 5 | 7 |
| EG007 | Substudy 03: Cohort 1: GS- 6212 100 mg | Participants received GS-6212 100 mg, tablet, orally, twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25. | 0 | 8 | 0 | 8 | 6 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Suicidal behaviour | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hangover | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anal fistula infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Conjunctivitis bacterial | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pyuria | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Syphilis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Procedural headache | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Creatinine renal clearance abnormal | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Electrocardiogram ST segment abnormal | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Electrocardiogram T wave abnormal | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Neisseria test positive | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Sars-cov-2 test positive | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Device loosening | Product Issues | MedDRA 27.0 | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Terminal insomnia | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lower respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | 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 |
| Feb 4, 2025 |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Substudy 02 Protocol Amendment 02 | May 5, 2023 | Feb 4, 2025 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Substudy 03 Protocol Amendment 01 | Aug 18, 2023 | Mar 5, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Substudy 01 Statistical Analysis Plan | Sep 15, 2023 | Feb 4, 2025 | SAP_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Substudy 02 Statistical Analysis Plan | May 16, 2024 | Feb 4, 2025 | SAP_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Substudy 03 Statistical Analysis Plan | Aug 27, 2024 | Mar 5, 2025 | SAP_005.pdf |
| ID | Term |
|---|---|
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Dominican Republic |
|
| Thailand |
|
|
| Change from Baseline at Day 11 |
|
|
P-value was calculated from two-sided t-test. |
| Superiority |
| t-test, 2 sided | 0.0013 | P-value was calculated from two-sided t-test. | Superiority |
| t-test, 2 sided | <0.0001 | P-value was calculated from two-sided t-test. | Superiority |
| t-test, 2 sided | <0.0001 | P-value was calculated from two-sided t-test. | Superiority |
| t-test, 2 sided | <0.0001 | P-value was calculated from two-sided t-test. | Superiority |
| t-test, 2 sided | <0.0001 | P-value was calculated from two-sided t-test. | Superiority |
| t-test, 2 sided | <0.0001 | P-value was calculated from two-sided t-test. | Superiority |
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39. |
| OG003 | Substudy 02: Cohort 1: GS-1720 450 mg | Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| OG004 | Substudy 02: Cohort 2: GS-1720 150 mg | Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| OG005 | Substudy 02: Cohort 3: GS-1720 30 mg | Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| OG006 | Substudy 02: Cohort 4: GS-1720 900 mg | Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| OG007 | Substudy 03: Cohort 1: GS- 6212 100 mg | Participants received GS-6212 100 mg tablet orally twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25. |
| OG008 | Placebo | Historical data for the placebo participants from 3 sponsor Phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) were combined to form a single placebo group for the purpose of analysis. For Study GS-US-200-4072, HIV-1 RNA (log10 copies/mL) collected on Day 10 was used for "Day 11", since HIV-1 RNA was not collected on Day 11 for this study. Each GS-1720 cohort was compared to the pooled placebo group with respect to the change from baseline in plasma HIV-1 RNA (log10 copies/mL) on Day 11. |
|
|
|
| OG002 |
| Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal) |
Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39. |
| OG003 | Substudy 02: Cohort 1: GS-1720 450 mg | Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| OG004 | Substudy 02: Cohort 2: GS-1720 150 mg | Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| OG005 | Substudy 02: Cohort 3: GS-1720 30 mg | Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| OG006 | Substudy 02: Cohort 4: GS-1720 900 mg | Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| OG007 | Substudy 03: Cohort 1: GS- 6212 100 mg | Participants received GS-6212 100 mg tablets orally twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25. |
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Participants received a single dose of bavtavirine 1200 mg, tablets, orally, with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
| OG002 | Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal) | Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39. |
| OG003 | Substudy 02: Cohort 1: GS-1720 450 mg | Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| OG004 | Substudy 02: Cohort 2: GS-1720 150 mg | Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| OG005 | Substudy 02: Cohort 3: GS-1720 30 mg | Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| OG006 | Substudy 02: Cohort 4: GS-1720 900 mg | Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| OG007 | Substudy 03: Cohort 1: GS- 6212 100 mg | Participants received GS-6212 100 mg, tablet, orally, twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25. |
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| OG002 | Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal) | Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39. |
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| OG003 | Substudy 02: Cohort 4: GS-1720 900 mg | Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
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| OG003 | Substudy 02: Cohort 4: GS-1720 900 mg | Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
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| OG003 | Substudy 02: Cohort 4: GS-1720 900 mg | Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
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Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39. |
| OG003 | Substudy 02: Cohort 1: GS-1720 450 mg | Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| OG004 | Substudy 02: Cohort 2: GS-1720 150 mg | Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| OG005 | Substudy 02: Cohort 3: GS-1720 30 mg | Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| OG006 | Substudy 02: Cohort 4: GS-1720 900 mg | Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| OG007 | Substudy 03: Cohort 1: GS- 6212 100 mg BID | Participants received GS-6212 100 mg, tablet, orally, twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25. |
| OG008 | Placebo | Historical data for the placebo participants from 3 sponsor Phase 1b studies (GS-US-120-0104, GS-US-141-1219, and GS-US-200-4072) were combined to form a single placebo group for the purpose of analysis. For Study GS-US-200-4072, HIV-1 RNA (log10 copies/mL) collected on Day 10 was used for "Day 11", since HIV-1 RNA was not collected on Day 11 for this study. Each GS-1720 cohort was compared to the pooled placebo group with respect to the change from baseline in plasma HIV-1 RNA (log10 copies/mL) on Day 11. |
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Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39.
| OG003 | Substudy 02: Cohort 1: GS-1720 450 mg | Participants received a single dose of GS-1720 450 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| OG004 | Substudy 02: Cohort 2: GS-1720 150 mg | Participants received a single dose of GS-1720 150 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| OG005 | Substudy 02: Cohort 3: GS-1720 30 mg | Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| OG006 | Substudy 02: Cohort 4: GS-1720 900 mg | Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| OG007 | Substudy 03: Cohort 1: GS- 6212 100 mg BID | Participants received GS-6212 100 mg, tablet, orally, twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 25. |
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| OG002 | Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal) | Participants received a single dose of bavtavirine 900 mg, tablets, orally, with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 39. |
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Participants received a single dose of GS-1720 30 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
| OG003 | Substudy 02: Cohort 4: GS-1720 900 mg | Participants received a single dose of GS-1720 900 mg, tablets, orally, on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiated an oral regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC), orally up to Day 60. |
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