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This study consists of 2 parts, Part A and Part B. Part A, the Phase 1 drug interaction/early viral kinetic study, will evaluate the effect of selected antiretroviral therapies on the safety, viral kinetics, and pharmacokinetics of sofosbuvir (GS-7977; PSI-7977) and its metabolites in participants with HIV and hepatitis C virus (HCV) coinfection. Part B, the Phase 2 treatment study, will investigate the efficacy and safety of sofosbuvir, pegylated interferon alpha (PEG) and ribavirin (RBV) in participants with HIV/HCV coinfection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: SOF+EFV/FTC/TDF (Cohort 1) | Experimental | Participants with a prestudy regimen of EFV/FTC/TDF will receive SOF+EFV/FTC/TDF FDC for 7 days, followed by EFV/FTC/TDF FDC (or EFV+FTC/TDF) for 7 days, coadministered once daily in the evening under fasting conditions. |
|
| Part A: SOF+EFV+ZDV/3TC (Cohort 2) | Experimental | Participants with a prestudy regimen of EFV+ZDV/3TC will receive SOF+EFV+ZDV/3TC for 7 days followed by EFV+ZDV/3TC for 7 days. Sofosbuvir and EFV will be administered once daily in the evening under fasting conditions; ZDV/3TC will be administered twice daily, in the morning without regard to food and in the evening on an empty stomach. |
|
| Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3) | Experimental | Participants with a prestudy regimen of RTV+ATV+FTC/TDF will receive SOF+RTV+ATV+FTC/TDF for 7 days followed by RTV+ATV+FTC/TDF for 7 days coadministered once daily in the morning with food. |
|
| Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4) | Experimental | Participants with a prestudy regimen of RTV+DRV+FTC/TDF will receive SOF+RTV+DRV+FTC/TDF for 7 days followed by RTV+DRV+FTC/TDF for 7 days coadministered once daily in the morning with food. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF | Drug | Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Plasma Pharmacokinetics of SOF, EFV, Tenofovir (TFV), and FTC: AUCtau at Day 7 | AUCtau: concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). Data for this outcome measure were collected for participants in Part A only. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose |
| Part A: Plasma Pharmacokinetics of SOF, EFV, TFV, and FTC: Cmax at Day 7 | Cmax: maximum observed concentration of drug in plasma. Data for this outcome measure were collected for participants in Part A only. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose |
| Part B: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. Data for this outcome measure were collected for participants in Part B only. | Posttreatment Week 12 |
| Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) | The percentage of participants discontinuing any study drug due to an adverse event was summarized. | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Part B: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR24 was defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Data for this outcome measure were collected for participants in Part B only. | Posttreatment Weeks 4 and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Part B: On-treatment HCV RNA | Data for this outcome measure were collected for participants in Part B only. | Up to 8 weeks |
| Part B: On-treatment HIV RNA | Data for this outcome measure were collected for participants in Part B only. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anuj Gaggar, MD/PhD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacion de Investigacion de Diego | San Juan | 00927 | Puerto Rico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25622055 | Derived | Rodriguez-Torres M, Gaggar A, Shen G, Kirby B, Svarovskaia E, Brainard D, Symonds WT, McHutchison JG, Gonzalez M, Rodriguez-Orengo J. Sofosbuvir for chronic hepatitis C virus infection genotype 1-4 in patients coinfected with HIV. J Acquir Immune Defic Syndr. 2015 Apr 15;68(5):543-9. doi: 10.1097/QAI.0000000000000516. |
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Part A: 52 participants were screened; 38 were enrolled and treated, and comprise the Part A Safety Analysis Set (SAS) and Part A Full Analysis Set (FAS).
Part B: 42 participants were screened; 23 were enrolled and treated (9 from Part A and 14 who joined the study), and comprise the Part B SAS and Part B FAS.
52 participants were enrolled at one study site in Puerto Rico, a commonwealth of the United States (US). The first participant was screened on 27 February 2012. The last participant observation occurred on 10 December 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: SOF+EFV/FTC/TDF (Cohort 1) | Sofosbuvir (SOF; 1 × 400 mg tablet or 2 × 200 mg tablets) + efavirenz (EFV) 600 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part A |
|
Not provided
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| Part A: SOF+RAL+FTC/TDF (Cohort 5) | Experimental | Participants with a prestudy regimen of RAL+FTC/TDF will receive SOF+RAL+FTC/TDF for 7 days followed by RAL+FTC/TDF for 7 days. Sofosbuvir and FTC/TDF will be administered once daily in the morning with food; RAL will be administered twice daily, in the morning with food and in the evening without regard to food. |
|
| Part B: SOF+PEG+RBV | Experimental | Participants will receive SOF+PEG+RBV for 12 weeks. |
|
|
| EFV/FTC/TDF | Drug | Efavirenz (EFV) 600 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination (FDC) tablet administered orally once daily |
|
|
| EFV | Drug | Efavirenz (EFV) 600 mg tablet administered orally once daily |
|
|
| ZDV/3TC | Drug | Zidovudine (ZDV) 300 mg/lamivudine (3TC) 150 mg FDC tablet administered orally twice daily |
|
|
| ATV | Drug | Atazanavir (ATV) 400 mg tablet administered orally once daily |
|
| Ritonavir | Drug | Ritonavir (RTV) 100 mg tablet administered orally once daily |
|
| FTC/TDF | Drug | FTC/TDF (200/300 mg) FDC tablet administered orally once daily |
|
|
| DRV | Drug | Darunavir (DRV) 800 mg (2 × 400 mg tablets) administered orally once daily |
|
| RAL | Drug | Raltegravir (RAL) 400 mg administered administered orally twice daily |
|
| PEG | Drug | Pegylated interferon alfa (PEG) 180 μg administered once weekly by subcutaneous injection |
|
|
| RBV | Drug | Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg) |
|
|
| Part B: Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse | Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) on treatment after having previously had undetectable HCV RNA levels (HCV RNA < LLOQ) while on treatment. Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR. Data for this outcome measure were collected for participants in Part B only. | Posttreatment Weeks 4 and 24 |
| Up to 8 weeks |
| Part A: SOF+EFV+ZDV/3TC (Cohort 2) |
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + zidovudine (ZDV) 300 mg/lamivudine (3TC) 150 mg tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days. |
| FG002 | Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3) | SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + atazanavir (ATV) 400 mg tablet boosted with ritonavir (RTV) 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days. |
| FG003 | Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4) | SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + darunavir (DRV; 800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days. |
| FG004 | Part A: SOF+RAL+FTC/TDF (Cohort 5) | SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + raltegravir (RAL) 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days. |
| FG005 | Part B: SOF+PEG+RBV | SOF 400 mg tablet once daily + pegylated interferon alpha (PEG) 180 μg subcutaneous injection once weekly + weight-based ribavirin (RBV; 1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part B |
|
|
Safety Analysis Set: participants who enrolled and received at least one dose of study drug(s)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A: SOF+EFV/FTC/TDF (Cohort 1) | SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days. |
| BG001 | Part A: SOF+EFV+ZDV/3TC (Cohort 2) | SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days. |
| BG002 | Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3) | SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days. |
| BG003 | Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4) | SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days. |
| BG004 | Part A: SOF+RAL+FTC/TDF (Cohort 5) | SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days. |
| BG005 | Part B: SOF+PEG+RBV | SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks. This reporting group presents data for those participants who joined the study for Part B only. |
| BG006 | 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| HCV Genotype | There are variations of HCV which are all similar enough to be called HCV, but are distinct enough to be referred to as HCV genotypes. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part A: Plasma Pharmacokinetics of SOF, EFV, Tenofovir (TFV), and FTC: AUCtau at Day 7 | AUCtau: concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). Data for this outcome measure were collected for participants in Part A only. | Pharmacokinetics (PK) Analysis Set: participants with evaluable PK profiles who enrolled into Part A of the study and received study drug. Participants in the PK Analysis Set with available data were included. | Mean | Standard Deviation | h*ng/mL | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Part A: Plasma Pharmacokinetics of SOF, EFV, TFV, and FTC: Cmax at Day 7 | Cmax: maximum observed concentration of drug in plasma. Data for this outcome measure were collected for participants in Part A only. | Participants in the PK Analysis Set with available data were included. | Mean | Standard Deviation | ng/mL | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Part B: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. Data for this outcome measure were collected for participants in Part B only. | Part B Full Analysis Set: participants enrolled into Part B of the study and dosed with at least 1 dose of study drug(s) | Number | percentage of participants | Posttreatment Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Part B: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR24 was defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Data for this outcome measure were collected for participants in Part B only. | Part B Full Analysis Set | Number | percentage of participants | Posttreatment Weeks 4 and 24 |
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Part B: Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse | Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) on treatment after having previously had undetectable HCV RNA levels (HCV RNA < LLOQ) while on treatment. Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR. Data for this outcome measure were collected for participants in Part B only. | Part B Full Analysis Set | Number | percentage of participants | Posttreatment Weeks 4 and 24 |
|
| ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Part B: On-treatment HCV RNA | Data for this outcome measure were collected for participants in Part B only. | Part B Full Analysis Set | Mean | Standard Deviation | log10 IU/mL | Up to 8 weeks |
|
| |||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Part B: On-treatment HIV RNA | Data for this outcome measure were collected for participants in Part B only. | Part B Safety Analysis Set: participants enrolled in Part B and received at least one dose of study drug(s). | Mean | Standard Deviation | copies/mL | Up to 8 weeks |
|
| |||||||||||||||||||||||||||||||||||||||
| Primary | Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) | The percentage of participants discontinuing any study drug due to an adverse event was summarized. | Safety Analysis Set: participants who received at least 1 dose of study drug(s) | Number | percentage of participants | Up to 12 weeks |
|
Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A: SOF+EFV/FTC/TDF (Cohort 1) | SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days. | 0 | 12 | 2 | 12 | ||
| EG001 | Part A: SOF+EFV+ZDV/3TC (Cohort 2) | SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days. | 0 | 4 | 0 | 4 | ||
| EG002 | Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3) | SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days. | 0 | 8 | 0 | 8 | ||
| EG003 | Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4) | SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days. | 0 | 7 | 2 | 7 | ||
| EG004 | Part A: SOF+RAL+FTC/TDF (Cohort 5) | SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days. | 0 | 7 | 1 | 7 | ||
| EG005 | Part B: SOF+PEG+RBV | SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks. | 0 | 23 | 16 | 23 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Version 16 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 16 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 16 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 16 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 16 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA Version 16 | Systematic Assessment |
| |
| Body temperature decreased | Investigations | MedDRA Version 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 16 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA Version 16 | Systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MedDRA Version 16 | Systematic Assessment |
| |
| Thinking abnormal | Psychiatric disorders | MedDRA Version 16 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16 | 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 | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences, Inc. | ClinicalTrialDisclosures@gilead.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| D000068257 | Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| C098320 | efavirenz |
| C109078 | lamivudine, zidovudine drug combination |
| D019438 | Ritonavir |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D010078 | Oxazines |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D012263 | Ribonucleosides |
Not provided
Not provided
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Genotype 1B |
|
| Genotype 2B |
|
| Genotype 3A |
|
| Genotype 4 |
|
| Genotype 4A/4C/4D |
|
| Pharmacokinetics of EFV (AUCtau at Day 7) |
|
| Pharmacokinetics of TFV (AUCtau at Day 7) |
|
| Pharmacokinetics of FTC (AUCtau at Day 7) |
|
| OG003 | Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4) | SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days. |
| OG004 | Part A: SOF+RAL+FTC/TDF (Cohort 5) | SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days. |
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Baseline (n = 23) |
| |||||
| Week 1 (n = 20) |
| |||||
| Week 2 (n = 22) |
| |||||
| Week 4 (n = 23) |
| |||||
| Week 6 (n = 23) |
| |||||
| Week 8 (n = 21) |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Baseline (n = 23) |
| |||||
| Week 1 (n = 20) |
| |||||
| Week 2 (n = 22) |
| |||||
| Week 4 (n = 22) |
| |||||
| Week 6 (n = 22) |
| |||||
| Week 8 (n = 21) |
|
| OG003 | Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4) | SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days. |
| OG004 | Part A: SOF+RAL+FTC/TDF (Cohort 5) | SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days. |
| OG005 | Part B: SOF+PEG+RBV | SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks. |
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