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GS-9131 did not meet the targeted antiviral response
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The primary objective of this study is to evaluate the short-term antiviral potency of GS-9131 functional monotherapy compared to placebo-to-match (PTM) GS-9131, each administered once daily with the existing failing antiretroviral (ARV) regimen as demonstrated by the proportion of participants achieving human immunodeficiency virus ribonucleic acid (HIV-1 RNA) > 0.5 log10 decreases from baseline after up to 14 days of therapy in HIV-1 positive, ARV treatment experienced adult participants with nucleos(t)ide resistant virus.
This is a two-part study. Part 1 consists of three cohorts: 2 Sentinel Cohorts and 1 Randomized Cohort. Eligible participants from Part 1 will proceed to Part 2 followed by an optional open-label extension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Sentinel Cohort 1: GS-9131 60 mg | Experimental | Treatment experienced participants will receive GS-9131 60 mg in addition to their current failing ARV regimen for a period of 10 days. |
|
| Part 1 Sentinel Cohort 2: GS-9131 180 mg | Experimental | Treatment experienced participants will receive GS-9131 180 mg in addition to their current failing ARV regimen for a period of 14 days. |
|
| Part 1: Randomized Cohort | Experimental | Participants will be randomized in 1:1:1:1 so as to receive GS-9131 in 3 active dose levels up to a maximum of 180 mg or Placebo to match GS-9131 in addition to their current failing ARV regimen for a period of 14 days in Part 1. |
|
| Part 2 Sentinel Cohort 1: GS-9131 + BIC + DRV + RTV | Experimental | Participants who complete dosing in Sentinel Cohort 1 of Part 1 and show a reduction in plasma HIV RNA > 0.5 log10 from their pre-GS-9131 baseline value at Day 11 and discontinue their current failing regimen will receive an optimized regimen consisting of GS-9131 60 mg + bictegravir (BIC) 30 mg + darunavir (DRV) 800 mg + ritonavir (RTV) 100 mg for a period of 24 weeks. After Week 24, participants will be given the option to participate in an open label extension and receive GS-9131 60 mg + BIC 75 mg + tenofovir alafenamide (TAF) 25 mg, for an additional 24 weeks or until Gilead Sciences elects to discontinue the study drug in that country, whichever occurs first. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-9131 | Drug | Tablet(s) administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 Randomized Cohort: Percentage of Participants With Plasma HIV-1 RNA Decreases From Baseline Exceeding 0.5 log10 at Day 15 | The criteria for analyzing percentage of participants with plasma HIV-1 RNA > 0.5 log10 decrease from baseline in randomized cohort was at least 50% of the participants should achieve HIV-1 RNA > 0.5 log10 decrease from baseline in the Part 1 sentinel cohort 2. | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 Sentinel Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Day 11 | Baseline, Day 11 | |
| Part 1 Sentinel Cohort 2: Change From Baseline in Plasma log10 HIV-1 RNA at Day 15 | Baseline, Day 15 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Joint Clinical Research Centre | Kampala | 10005 | Uganda | |||
| Joint Research Ethics Committee for the University of Zimbabwe College of Health Sciences and Parirenyatwa Group of Hospitals |
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88 participants were screened. The study was conducted in 2 parts. The Part 1 consisted of 3 cohorts- 2 Sentinel Cohorts and 1 Randomized Cohort and Part 2 consisted of 2 Sentinel Cohorts only. The Randomized Cohort in Part 1 was not initiated. The study was terminated because a majority of Sentinel Cohort 2 (Part 1) participants did not meet primary endpoint of human immunodeficiency virus ribonucleic acid (HIV-1 RNA) > 0.5 log10 decrease from baseline in through up to 14 days of therapy.
Participants were enrolled at study sites in Uganda and Zimbawe. The first participant was screened on 03 April 2018. The last study visit occurred on 09 December 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 Sentinel Cohort 1: GS-9131 60 mg | Participants received GS-9131 60 mg tablets orally once daily in addition to their current failing antiretroviral (ARV) regimen for a period of 10 days. |
| FG001 | Part 1 Sentinel Cohort 2: GS-9131 180 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1: GS-9131 Functional Monotherapy |
|
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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 | Nov 1, 2018 | Nov 9, 2020 |
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|
| Part 2 Sentinel Cohort 2: GS-9131 + BIC + TAF | Experimental | Participants who complete dosing in Sentinel Cohort 2 of Part 1 and show a reduction in plasma HIV RNA > 0.5 log10 from their pre-GS-9131 baseline value at Day 15 and discontinue their current failing regimen will receive an optimized regimen consisting of GS-9131 180 mg + BIC 75 mg + TAF 25 mg, for a period of 24 weeks. After Week 24, participants will be given the option to participate in an open label extension and receive GS-9131 180 mg + BIC 75 mg + TAF 25 mg, for an additional 24 weeks or until Gilead Sciences elects to discontinue the study drug in that country, whichever occurs first. |
|
| BIC | Drug | Tablet(s) administered orally once daily |
|
| TAF | Drug | Tablet(s) administered orally once daily |
|
|
| ARV regimen | Drug | ARV regimen may consist of the ARV agents containing nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitor (NNRTI) |
|
| DRV | Drug | Tablet(s) administered orally once daily |
|
|
| RTV | Drug | Tablet(s) administered orally once daily |
|
|
| Part 1 Randomized Cohort: Change From Baseline in Plasma log10 HIV-1 RNA at Day 15 | Baseline, Day 15 |
| Part 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis at Week 24 | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Week 24 |
| Part 2: Change From Baseline in Plasma log10 HIV-1 RNA at Week 24 | Baseline, Week 24 |
| Part 2: Change From Baseline in CD4+ Cell Count at Week 24 | Baseline, Week 24 |
| Part 2: Number of Participants With Treatment Emergent Nucleos(t)Ide Reverse Transcriptase Inhibitor (NRTI) Mutations at the Time of Virologic Failure | Treatment emergent virological failure was defined as an event with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of the study drug. Virologic failure was defined as virologic rebound or as suboptimal virologic response in relation to pre-GS-9131 baseline plasma HIV-1 RNA levels. Virological rebound was defined as if participant at any visit after achieving HIV-1 RNA < 50 copies/mL, a rebound in HIV-1 RNA ≥ 50 copies/mL, or a >1 log10 increase in HIV-1 RNA from the nadir which was subsequently confirmed at the following scheduled or unscheduled visit. Suboptimal virologic response was defined as plasma HIV-1 RNA ≥ 200 copies/mL and reduction in HIV-1 RNA ≤ 1 log10 from pre-GS-9131 baseline at the Week 8 visit with confirmation at the next scheduled or unscheduled visit. | From first dose up to Week 24 |
| Part 2: Number of Participants With Treatment Emergent Protease Inhibitor (PI) Mutations at the Time of Virologic Failure | Treatment emergent virological failure was defined as an event with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of the study drug. Virologic failure was defined as virologic rebound or as suboptimal virologic response in relation to pre-GS-9131 baseline plasma HIV-1 RNA levels. Virological rebound was defined as if participant at any visit after achieving HIV-1 RNA < 50 copies/mL, a rebound in HIV-1 RNA ≥ 50 copies/mL, or a >1 log10 increase in HIV-1 RNA from the nadir which was subsequently confirmed at the following scheduled or unscheduled visit. Suboptimal virologic response was defined as plasma HIV-1 RNA ≥ 200 copies/mL and reduction in HIV-1 RNA ≤ 1 log10 from pre-GS-9131 baseline at the Week 8 visit with confirmation at the next scheduled or unscheduled visit. | From first dose up to Week 24 |
| Part 2: Number of Participants With Treatment Emergent Integrase Strand Transfer Inhibitor (INSTI) Mutations at the Time of Virologic Failure | Treatment emergent virological failure was defined as an event with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of the study drug. Virologic failure was defined as virologic rebound or as suboptimal virologic response in relation to pre-GS-9131 baseline plasma HIV-1 RNA levels. Virological rebound was defined as if participant at any visit after achieving HIV-1 RNA < 50 copies/mL, a rebound in HIV-1 RNA ≥ 50 copies/mL, or a >1 log10 increase in HIV-1 RNA from the nadir which was subsequently confirmed at the following scheduled or unscheduled visit. Suboptimal virologic response was defined as plasma HIV-1 RNA ≥ 200 copies/mL and reduction in HIV-1 RNA ≤ 1 log10 from pre-GS-9131 baseline at the Week 8 visit with confirmation at the next scheduled or unscheduled visit. | From first dose up to Week 24 |
| Harare |
| Zimbabwe |
Participants received GS-9131 180 mg tablets orally once daily in addition to their current failing ARV regimen for a period of 14 days. |
| FG002 | Part 2 Sentinel Cohort 1: GS-9131 + BIC + DRV + RTV | Participants who completed dosing in Sentinel Cohort 1 and showed a reduction in plasma HIV RNA > 0.5 log10 from their pre-GS-9131 baseline value at Day 11 and discontinued their current failing regimen received an optimized regimen consisting of GS-9131 60 mg tablets + bictegravir (BIC) 30 mg tablets + darunavir (DRV) 800 mg tablets + ritonavir (RTV) 100 mg tablets, orally once daily for a period of 24 weeks. After Week 24, participants had the option to participate in an open label extension and receive GS-9131 60 mg tablets + BIC 75 mg tablets + tenofovir alafenamide (TAF) 25 mg tablets, orally once daily for an additional 24 weeks or until Gilead Sciences elects to discontinue the study drug in that country, whichever occurred first. |
| FG003 | Part 2 Sentinel Cohort 2: GS-9131 + BIC + TAF | Participants who completed dosing in Sentinel Cohort 2 and showed a reduction in plasma HIV RNA > 0.5 log10 from their pre-GS-9131 baseline value at Day 15 and discontinued their current failing regimen received an optimized regimen consisting of GS-9131 180 mg tablets + BIC 75 mg tablets + TAF 25 mg tablets, orally once daily for a period of 24 weeks. After Week 24, participants had the option to participate in an open label extension and receive GS-9131 180 mg tablets + BIC 75 mg tablets + TAF 25 mg tablets, orally once daily for an additional 24 weeks or until Gilead Sciences elects to discontinue the study drug in that country, whichever occurred first. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Part 2: Combination Therapy |
|
|
The Safety Analysis Set included all participants who took at least 1 dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sentinel Cohort 1: GS-9131 60 mg | Participants in Sentinel Cohort 1 received GS-9131 60 mg tablets orally once daily in addition to their current failing ARV regimen for a period of 10 days in Part 1. |
| BG001 | Sentinel Cohort 2: GS-9131 180 mg | Participants in Sentinel Cohort 2 received GS-9131 180 mg tablets orally once daily in addition to their current failing ARV regimen for a period of 14 days in Part 1. |
| BG002 | 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 (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| HIV-1 RNA | Mean | Standard Deviation | log10 copies/mL |
| |||||||||||||||
| HIV-1 RNA Category | Count of Participants | Participants | No |
| |||||||||||||||
| CD4 Cell Count | Mean | Standard Deviation | cells/µL |
|
| 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 1 Randomized Cohort: Percentage of Participants With Plasma HIV-1 RNA Decreases From Baseline Exceeding 0.5 log10 at Day 15 | The criteria for analyzing percentage of participants with plasma HIV-1 RNA > 0.5 log10 decrease from baseline in randomized cohort was at least 50% of the participants should achieve HIV-1 RNA > 0.5 log10 decrease from baseline in the Part 1 sentinel cohort 2. | Data was not analyzed as ≥ 50% participants did not achieve HIV-1 RNA > 0.5 log10 decrease from baseline in Part 1 sentinel cohort 2. | Posted | Day 15 |
|
| |||||||||||||||||||
| Secondary | Part 1 Sentinel Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Day 11 | The Safety Analysis Set included all participants who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | log10 copies/mL | Baseline, Day 11 |
|
| |||||||||||||||||
| Secondary | Part 1 Sentinel Cohort 2: Change From Baseline in Plasma log10 HIV-1 RNA at Day 15 | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 copies/mL | Baseline, Day 15 |
|
| |||||||||||||||||
| Secondary | Part 1 Randomized Cohort: Change From Baseline in Plasma log10 HIV-1 RNA at Day 15 | Data was not reported as the Randomized Cohort in Part 1 was not initiated as the study was terminated early because a majority of Sentinel Cohort 2 participants did not meet primary endpoint of HIV-1 RNA > 0.5 log10 decrease from baseline in through up to 14 days of therapy. | Posted | Baseline, Day 15 |
|
| ||||||||||||||||||||
| Secondary | Part 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis at Week 24 | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Data were collected for only 1 participant, and due to participant confidentiality data is not being reported. | Posted | Week 24 |
| ||||||||||||||||||||
| Secondary | Part 2: Change From Baseline in Plasma log10 HIV-1 RNA at Week 24 | Data were collected for only 1 participant, and due to participant confidentiality data is not being reported. | Posted | Baseline, Week 24 |
| |||||||||||||||||||||
| Secondary | Part 2: Change From Baseline in CD4+ Cell Count at Week 24 | Data were collected for only 1 participant, and due to participant confidentiality data is not being reported. | Posted | Baseline, Week 24 |
| |||||||||||||||||||||
| Secondary | Part 2: Number of Participants With Treatment Emergent Nucleos(t)Ide Reverse Transcriptase Inhibitor (NRTI) Mutations at the Time of Virologic Failure | Treatment emergent virological failure was defined as an event with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of the study drug. Virologic failure was defined as virologic rebound or as suboptimal virologic response in relation to pre-GS-9131 baseline plasma HIV-1 RNA levels. Virological rebound was defined as if participant at any visit after achieving HIV-1 RNA < 50 copies/mL, a rebound in HIV-1 RNA ≥ 50 copies/mL, or a >1 log10 increase in HIV-1 RNA from the nadir which was subsequently confirmed at the following scheduled or unscheduled visit. Suboptimal virologic response was defined as plasma HIV-1 RNA ≥ 200 copies/mL and reduction in HIV-1 RNA ≤ 1 log10 from pre-GS-9131 baseline at the Week 8 visit with confirmation at the next scheduled or unscheduled visit. | Due to early study termination, data were not collected as none of the participants qualified for resistance testing after Week 8. | Posted | No | From first dose up to Week 24 |
| |||||||||||||||||||
| Secondary | Part 2: Number of Participants With Treatment Emergent Protease Inhibitor (PI) Mutations at the Time of Virologic Failure | Treatment emergent virological failure was defined as an event with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of the study drug. Virologic failure was defined as virologic rebound or as suboptimal virologic response in relation to pre-GS-9131 baseline plasma HIV-1 RNA levels. Virological rebound was defined as if participant at any visit after achieving HIV-1 RNA < 50 copies/mL, a rebound in HIV-1 RNA ≥ 50 copies/mL, or a >1 log10 increase in HIV-1 RNA from the nadir which was subsequently confirmed at the following scheduled or unscheduled visit. Suboptimal virologic response was defined as plasma HIV-1 RNA ≥ 200 copies/mL and reduction in HIV-1 RNA ≤ 1 log10 from pre-GS-9131 baseline at the Week 8 visit with confirmation at the next scheduled or unscheduled visit. | Due to early study termination, data were not collected as none of the participants qualified for resistance testing after Week 8. | Posted | No | From first dose up to Week 24 |
| |||||||||||||||||||
| Secondary | Part 2: Number of Participants With Treatment Emergent Integrase Strand Transfer Inhibitor (INSTI) Mutations at the Time of Virologic Failure | Treatment emergent virological failure was defined as an event with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of the study drug. Virologic failure was defined as virologic rebound or as suboptimal virologic response in relation to pre-GS-9131 baseline plasma HIV-1 RNA levels. Virological rebound was defined as if participant at any visit after achieving HIV-1 RNA < 50 copies/mL, a rebound in HIV-1 RNA ≥ 50 copies/mL, or a >1 log10 increase in HIV-1 RNA from the nadir which was subsequently confirmed at the following scheduled or unscheduled visit. Suboptimal virologic response was defined as plasma HIV-1 RNA ≥ 200 copies/mL and reduction in HIV-1 RNA ≤ 1 log10 from pre-GS-9131 baseline at the Week 8 visit with confirmation at the next scheduled or unscheduled visit. | Due to early study termination, data were not collected as none of the participants qualified for resistance testing after Week 8. | Posted | From first dose up to Week 24 |
|
From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
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 1 Setinel Cohort 1: GS-9131 60 mg | Participants in Sentinel Cohort 1 received GS-9131 60 mg tablets orally once daily in addition to their current failing ARV regimen for a period of 10 days in Part 1. | 0 | 11 | 0 | 11 | 5 | 11 |
| EG001 | Part 1 Sentinel Cohort 2: GS-9131 180 mg | Participants in Sentinel Cohort 2 received GS-9131 180 mg tablets orally once daily in addition to their current failing ARV regimen for a period of 14 days in Part 1. | 0 | 10 | 0 | 10 | 10 | 10 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Neutrophilia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pica | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
The study was terminated because a majority of Sentinel Cohort 2 participants did not meet primary endpoint of HIV-1 RNA > 0.5 log10 decrease from baseline through up to 14 days of therapy.
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years
| 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 | Mar 3, 2020 | Nov 9, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| C519972 | GS-9131 |
| C100119 | imidazole mustard |
| C442442 | tenofovir alafenamide |
| D000069454 | Darunavir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |
Not provided
Not provided
| Pregnancy |
|
| 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 |
|
| Zimbabwe |
|
| ≥ 50 copies/mL |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
|
|
| OG001 | Part 2: GS-9131 + BIC + TAF | Participants who completed dosing in Sentinel Cohort 2 and showed a reduction in plasma HIV RNA > 0.5 log10 from their pre-GS-9131 baseline value at Day 15 and discontinued their current failing regimen received an optimized regimen consisting of GS-9131 180 mg tablets + BIC 75 mg tablets + TAF 25 mg tablets, orally once daily for a period of 24 weeks. After Week 24, participants will be given the option to participate in an open label extension and receive GS-9131 180 mg tablets + BIC 75 mg tablets + TAF 25 mg tablets, orally once daily for an additional 24 weeks or until Gilead Sciences elects to discontinue the study drug in that country, whichever occurred first. |
|
| OG001 | Part 2: GS-9131 + BIC + TAF | Participants who completed dosing in Sentinel Cohort 2 and showed a reduction in plasma HIV RNA > 0.5 log10 from their pre-GS-9131 baseline value at Day 15 and discontinued their current failing regimen received an optimized regimen consisting of GS-9131 180 mg tablets + BIC 75 mg tablets + TAF 25 mg tablets, orally once daily for a period of 24 weeks. After Week 24, participants will be given the option to participate in an open label extension and receive GS-9131 180 mg tablets + BIC 75 mg tablets + TAF 25 mg tablets, orally once daily for an additional 24 weeks or until Gilead Sciences elects to discontinue the study drug in that country, whichever occurred first. |
|
| OG001 | Part 2: GS-9131 + BIC + TAF | Participants who completed dosing in Sentinel Cohort 2 and showed a reduction in plasma HIV RNA > 0.5 log10 from their pre-GS-9131 baseline value at Day 15 and discontinued their current failing regimen received an optimized regimen consisting of GS-9131 180 mg tablets + BIC 75 mg tablets + TAF 25 mg tablets, orally once daily for a period of 24 weeks. After Week 24, participants will be given the option to participate in an open label extension and receive GS-9131 180 mg tablets + BIC 75 mg tablets + TAF 25 mg tablets, orally once daily for an additional 24 weeks or until Gilead Sciences elects to discontinue the study drug in that country, whichever occurred first. |
|