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| ID | Type | Description | Link |
|---|---|---|---|
| AI438-011 | Other Identifier | Bristol-Myers Squibb |
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The purpose of this study is to assess the safety, efficacy, tolerability and pharmacokinetics of four doses of BMS-663068 with Raltegravir (RAL) + Tenofovir Disoproxil Fumarate (TDF). At least 1 dose of BMS-663068 can be identified which is safe, well tolerated, and efficacious when combined with RAL + TDF for treatment-experienced HIV-1 infected subjects. PHENOSENSE® is a registered trademark of Monogram Biosciences.
Masking: Double-blind for BMS-6630368 treatment groups until the Week 24 Primary Endpoint analysis, then open label. The reference groups is all open-label.
Arms: 5 (4 BMS-663068 treatment groups and 1 reference group)
Intervention Model: Parallel (with unblinding after the Week 24 primary endpoint analysis)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: BMS-663068 (400mg) + Raltegravir + Tenofovir | Experimental | Treatment Group 1 |
|
| Arm B: BMS-663068 (800 mg) + Raltegravir + Tenofovir | Experimental | Treatment Group 2 |
|
| Arm C: BMS-663068 (600 mg) + Raltegravir + Tenofovir | Experimental | Treatment Group 3 |
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| Arm D: BMS-663068 (1200 mg) + Raltegravir + Tenofovir | Experimental | Treatment Group 4 |
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| Arm E: Atazanavir + Ritonavir + Raltegravir + Tenofovir | Active Comparator | Treatment Group 1 (reference arm) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-663068 400 mg | Drug | Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) < 50 Copies Per Milliliter (c/mL) at Week 24 | Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 24 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage confidence intervals (CI). Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest. Intent-To-Treat-Exposed (ITT-E) Population includes all randomized participants who received at least one dose of study treatment. | Week 24 |
| Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24 | Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety population included all participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week 24 included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 24 visit snapshot window. | Up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Monotherapy Baseline in log10 HIV RNA of the Monotherapy Period | Change from monotherapy Baseline in log10 HIV RNA to assess the antiviral activity of temsavir following administration of selected doses of FTR administered orally to HIV-1-infected participants for 7 days. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as value at indicated time point minus Baseline value. ITT-E Monotherapy Population comprised of participants that were randomized and participated in the monotherapy sub-study and received at least one dose of FTR Monotherapy. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | San Francisco | California | 94102 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27922453 | Derived | Thompson M, Lalezari JP, Kaplan R, Pinedo Y, Pena OAS, Cahn P, Stock DA, Joshi SR, Hanna GJ, Lataillade M; AI438011 study team. Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in antiretroviral-experienced subjects: week 48 analysis of AI438011, a Phase IIb, randomized controlled trial. Antivir Ther. 2017;22(3):215-223. doi: 10.3851/IMP3112. Epub 2016 Dec 6. | |
| 26902761 |
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A total of 581 participants were screened, 254 were enrolled of which 2 participants withdrew consent and 1 was randomized in error. A total 251 participants were randomized and treated of which 32 were in Monotherapy sub-study (only FTR) and continued to Primary study.
Participants with Human Immunodeficiency Virus (HIV-1) were randomized in ratio of 1:1:1:1:1 to 5 treatment arms of the study. Four groups with distinct dose of Fostemsavir (FTR, also referred BMS-663068) with Raltegravir (RAL) Tenofovir Disoproxil Fumarate (TDF). There was a reference group with ritonavir (r) boosted atazanavir (ATV), RAL and TDF.
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| ID | Title | Description |
|---|---|---|
| FG000 | FTR 400 mg BID/RAL/TDF | Participants were randomized and administered 400 milligrams (mg) FTR twice daily (BID) (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label). |
| FG001 | FTR 800 mg BID/RAL/TDF |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| BMS-663068 800 mg | Drug | Tablets, Oral, 800 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose |
|
| BMS-663068 600 mg | Drug | Tablets, Oral, 600 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose |
|
| BMS-663068 1200 mg | Drug | Tablets, Oral, 1200 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose |
|
| Raltegravir 400 mg | Drug | Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose |
|
| Tenofovir 300 mg | Drug | Tablets, Oral, 300 mg, Once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose |
|
| Ritonavir 100 mg | Drug | Tablets, Oral, 100 mg, Once daily, 96 weeks |
|
| Atazanavir 300 mg | Drug | Capsules, Oral, 300 mg, Once daily, 96 weeks |
|
| Baseline and up to Day 8 of the monotherapy period |
| Maximum Decrease From Monotherapy Baseline in log10 Plasma HIV-1 RNA | Maximum decrease from monotherapy Baseline in log10 plasma HIV-1 RNA during monotherapy to assess the antiviral activity of temsavir following administration of selected doses of FTR administered orally to HIV-1-infected participants for 7 days. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as value at indicated time point minus Baseline value. The data for monotherapy nadir has been presented where nadir represents the maximum decrease from Baseline. | Baseline and up to Day 8 of the monotherapy period |
| Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Day 8 of the Monotherapy Period | Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Baseline of combination therapy was assessed to evaluate the antiviral activity of four doses of FTR. Baseline of combination therapy was the Day 1 of the combination therapy. Virologic success or failure was determined using the non-missing viral load value at Baseline of combination therapy. The assessment closest to the window target Study Day was used for the analysis. Only those participants with data available at the specified time points were analyzed. | Up to Day 8 of the monotherapy period |
| Number of Participants With SAE and Discontinuation Due to AEs During Monotherapy Period | Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. | Up to Day 8 of the monotherapy period |
| Change From Monotherapy Baseline in Cluster of Differentiation (CD)4+ and CD8+ T-cell Counts During Monotherapy | Blood was collected and CD4+ and CD8+ cell count assessment was done by flow cytometery and was carried out at Baseline (Day 1) to evaluate the immunological activity of multiple doses of FTR. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and the values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed. | Baseline and Day 8 |
| Change From Monotherapy Baseline in CD4+ and CD8+ T-cell Proportion During Monotherapy | Blood was collected and CD4+ and CD8+ proportion assessment was done by flow cytometery and was carried out at Baseline (Day 1) to evaluate the immunological activity of multiple doses of FTR. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and the values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed. | Baseline and Day 8 |
| Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Primary Study | Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage CI. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest. | Weeks 48 and 96 |
| Number of Participants With SAE and Discontinuation Due to AEs During Primary Study | Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety Population comprised of participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week X (where X = 48 or 96) included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 48 and 96 visit snapshot window. | Weeks 48 and 96 |
| Change From Baseline in CD4+ T-cell Count | Blood was collected and CD4+ cell count assessment by flow cytometery was carried out at Baseline (Day 1), Weeks 24, 48 and 96 to evaluate the immunological activity of multiple doses of BMS-663068/GSK3684934. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | Baseline and Weeks 24, 48 and 96 |
| Number of Participants With Newly-emergent Genotypic Substitutions at Week 24 | Participants who administered antiretroviral (ARV) with virologic failure (VF) were assessed. Genotypic substitution included assessment of Reverse Transcriptase (RT) substitution, Protease Inhibitor (PI) substitution and Integrase RAL substitution as per International Acquired Immune Deficiency Syndrome (AIDS) Society-USA (IAS-USA) list. ITT-E Resistance Tested through Week 24 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 24 Snapshot analysis window. The criteria for resistance tested was participant who had virologic failure or met the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL. | Up to Week 24 |
| Number of Participants With Newly-emergent Genotypic Substitutions at Week 48 | Participants who administered ARV with VF were assessed. Genotypic substitution included assessment of RT substitution, PI substitution and Integrase RAL substitution as per IAS-USA list. ITT-E Resistance Tested through Week 48 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 48 Snapshot analysis window. The criteria for resistance tested was participant who had virologic failure or the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL. | Up to Week 48 |
| Number of Participants With Newly-emergent Genotypic Substitutions at Week 96 | Participants who administered ARV with VF were assessed. Genotypic substitution included assessment of RT substitution, PI substitution and Integrase RAL substitution as per IAS-USA list. ITT-E Resistance Tested through Week 96 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 96 Snapshot analysis window. The criteria for resistance tested was participants with virologic failure or the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL. | Up to Week 96 |
| Maximum Change From Baseline in Inhibitory Concentration at 50% (IC50) Fold Change Among Participants With VF at Week 24 | Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL . The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed. | Baseline and up to Week 24 |
| Change From Baseline in IC50 Fold Change Among Participants With VF at Week 48 | Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL. The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed. | Baseline and up to Week 48 |
| Change From Baseline in IC50 Fold Change Among Participants With VF at Week 96 | Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL. The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed. | Baseline and up to Week 96 |
| San Francisco |
| California |
| 94115 |
| United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20009 | United States |
| GSK Investigational Site | Coral Gables | Florida | 33134 | United States |
| GSK Investigational Site | Orlando | Florida | 32803 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30312 | United States |
| GSK Investigational Site | New York | New York | 10008 | United States |
| GSK Investigational Site | Durham | North Carolina | 27710 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45267-0405 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| GSK Investigational Site | Austin | Texas | 78705 | United States |
| GSK Investigational Site | Dallas | Texas | 75246 | United States |
| GSK Investigational Site | Longview | Texas | 75605 | United States |
| GSK Investigational Site | Ciudad de Buenos Aires | Buenos Aires | C1202ABB | Argentina |
| GSK Investigational Site | Rosario | Santa Fe Province | 2000 | Argentina |
| GSK Investigational Site | Buenos Aires | C1141ACG | Argentina |
| GSK Investigational Site | Buenos Aires | C1426EGR | Argentina |
| GSK Investigational Site | Córdoba | X5000JJS | Argentina |
| GSK Investigational Site | Rosario | S2000CXP | Argentina |
| GSK Investigational Site | Bogotá | Colombia |
| GSK Investigational Site | Bonn | North Rhine-Westphalia | 53127 | Germany |
| GSK Investigational Site | Berlin | 12157 | Germany |
| GSK Investigational Site | Hamburg | 20099 | Germany |
| GSK Investigational Site | München | 80336 | Germany |
| GSK Investigational Site | Guadalajara | Jalisco | 44280 | Mexico |
| GSK Investigational Site | Zapopan | Jalisco | 45170 | Mexico |
| GSK Investigational Site | San Luis Potosí City | San Luis Potosí | 78240 | Mexico |
| GSK Investigational Site | Aguascalientes | 20230 | Mexico |
| GSK Investigational Site | DF | 14000 | Mexico |
| GSK Investigational Site | Distrito Federal | 03720 | Mexico |
| GSK Investigational Site | Mexico City | 3100 | Mexico |
| GSK Investigational Site | Iquitos | Loreto | Iqui 01 | Peru |
| GSK Investigational Site | Lima | 13 | Peru |
| GSK Investigational Site | Lima | 1 | Peru |
| GSK Investigational Site | Lima | 32 | Peru |
| GSK Investigational Site | Lima | 4 | Peru |
| GSK Investigational Site | Lima | Lima 11 | Peru |
| GSK Investigational Site | Lima | Lima 31 | Peru |
| GSK Investigational Site | Bucharest | 021105 | Romania |
| GSK Investigational Site | Constanța | 900709 | Romania |
| GSK Investigational Site | Craiova | Romania |
| GSK Investigational Site | Iași | 700116 | Romania |
| GSK Investigational Site | Saint Petersburg | 190103 | Russia |
| GSK Investigational Site | Saint Petersburg | 191167 | Russia |
| GSK Investigational Site | Saint Petersburg | 196645 | Russia |
| GSK Investigational Site | Smolensk | 214006 | Russia |
| GSK Investigational Site | Dundee | KwaZulu-Natal | 3000 | South Africa |
| GSK Investigational Site | Durban | 4001 | South Africa |
| GSK Investigational Site | Johannesburg | 2010 | South Africa |
| GSK Investigational Site | Observatory, Cape Town | 7925 | South Africa |
| GSK Investigational Site | Badalona | 08916 | Spain |
| GSK Investigational Site | Barcelona | 08036 | Spain |
| GSK Investigational Site | Córdoba | 14004 | Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| Derived |
| Landry I, Zhu L, Abu Tarif M, Hruska M, Sadler BM, Pitsiu M, Joshi S, Hanna GJ, Lataillade M, Boulton DW, Bertz RJ. Model-Based Phase 3 Dose Selection for HIV-1 Attachment Inhibitor Prodrug BMS-663068 in HIV-1-Infected Patients: Population Pharmacokinetics/Pharmacodynamics of the Active Moiety, BMS-626529. Antimicrob Agents Chemother. 2016 Apr 22;60(5):2782-9. doi: 10.1128/AAC.02503-15. Print 2016 May. |
| 26423650 | Derived | Lalezari JP, Latiff GH, Brinson C, Echevarria J, Trevino-Perez S, Bogner JR, Thompson M, Fourie J, Sussmann Pena OA, Mendo Urbina FC, Martins M, Diaconescu IG, Stock DA, Joshi SR, Hanna GJ, Lataillade M; AI438011 study team. Safety and efficacy of the HIV-1 attachment inhibitor prodrug BMS-663068 in treatment-experienced individuals: 24 week results of AI438011, a phase 2b, randomised controlled trial. Lancet HIV. 2015 Oct;2(10):e427-37. doi: 10.1016/S2352-3018(15)00177-0. Epub 2015 Sep 1. |
| 24128669 | Derived | Zhou N, Nowicka-Sans B, McAuliffe B, Ray N, Eggers B, Fang H, Fan L, Healy M, Langley DR, Hwang C, Lataillade M, Hanna GJ, Krystal M. Genotypic correlates of susceptibility to HIV-1 attachment inhibitor BMS-626529, the active agent of the prodrug BMS-663068. J Antimicrob Chemother. 2014 Mar;69(3):573-81. doi: 10.1093/jac/dkt412. Epub 2013 Oct 14. |
Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
| FG002 | FTR 600 mg QD/RAL/TDF | Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
| FG003 | FTR 1200 mg QD/RAL/TDF | Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
| FG004 | ATV/r/RAL/TDF | Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | FTR 400 mg BID/RAL/TDF | Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label). |
| BG001 | FTR 800 mg BID/RAL/TDF | Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
| BG002 | FTR 600 mg QD/RAL/TDF | Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
| BG003 | FTR 1200 mg QD/RAL/TDF | Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
| BG004 | ATV/r/RAL/TDF | Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD. |
| BG005 | 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | 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 | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) < 50 Copies Per Milliliter (c/mL) at Week 24 | Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 24 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage confidence intervals (CI). Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest. Intent-To-Treat-Exposed (ITT-E) Population includes all randomized participants who received at least one dose of study treatment. | ITT-E Population | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 24 |
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| Primary | Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24 | Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety population included all participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week 24 included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 24 visit snapshot window. | Safety Population | Posted | Count of Participants | Participants | Up to Week 24 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Monotherapy Baseline in log10 HIV RNA of the Monotherapy Period | Change from monotherapy Baseline in log10 HIV RNA to assess the antiviral activity of temsavir following administration of selected doses of FTR administered orally to HIV-1-infected participants for 7 days. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as value at indicated time point minus Baseline value. ITT-E Monotherapy Population comprised of participants that were randomized and participated in the monotherapy sub-study and received at least one dose of FTR Monotherapy. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | ITT-E Monotherapy Population | Posted | Mean | Standard Deviation | log10 c/mL | Baseline and up to Day 8 of the monotherapy period |
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| Secondary | Maximum Decrease From Monotherapy Baseline in log10 Plasma HIV-1 RNA | Maximum decrease from monotherapy Baseline in log10 plasma HIV-1 RNA during monotherapy to assess the antiviral activity of temsavir following administration of selected doses of FTR administered orally to HIV-1-infected participants for 7 days. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as value at indicated time point minus Baseline value. The data for monotherapy nadir has been presented where nadir represents the maximum decrease from Baseline. | ITT-E Monotherapy Population | Posted | Mean | Standard Deviation | log10 c/mL | Baseline and up to Day 8 of the monotherapy period |
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| Secondary | Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Day 8 of the Monotherapy Period | Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Baseline of combination therapy was assessed to evaluate the antiviral activity of four doses of FTR. Baseline of combination therapy was the Day 1 of the combination therapy. Virologic success or failure was determined using the non-missing viral load value at Baseline of combination therapy. The assessment closest to the window target Study Day was used for the analysis. Only those participants with data available at the specified time points were analyzed. | ITT-E Monotherapy Population | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to Day 8 of the monotherapy period |
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| Secondary | Number of Participants With SAE and Discontinuation Due to AEs During Monotherapy Period | Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. | ITT-E Monotherapy Population | Posted | Count of Participants | Participants | Up to Day 8 of the monotherapy period |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Monotherapy Baseline in Cluster of Differentiation (CD)4+ and CD8+ T-cell Counts During Monotherapy | Blood was collected and CD4+ and CD8+ cell count assessment was done by flow cytometery and was carried out at Baseline (Day 1) to evaluate the immunological activity of multiple doses of FTR. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and the values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed. | ITT-E Monotherapy Population | Posted | Mean | Standard Deviation | cells per cubic millimeter | Baseline and Day 8 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Monotherapy Baseline in CD4+ and CD8+ T-cell Proportion During Monotherapy | Blood was collected and CD4+ and CD8+ proportion assessment was done by flow cytometery and was carried out at Baseline (Day 1) to evaluate the immunological activity of multiple doses of FTR. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and the values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed. | ITT-E Monotherapy Population | Posted | Mean | Standard Deviation | cells per cubic millimeter | Baseline and Day 8 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Primary Study | Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage CI. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest. | ITT-E Population | Posted | Number | 95% Confidence Interval | Percentage of Participants | Weeks 48 and 96 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With SAE and Discontinuation Due to AEs During Primary Study | Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety Population comprised of participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week X (where X = 48 or 96) included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 48 and 96 visit snapshot window. | Safety Population | Posted | Count of Participants | Participants | Weeks 48 and 96 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD4+ T-cell Count | Blood was collected and CD4+ cell count assessment by flow cytometery was carried out at Baseline (Day 1), Weeks 24, 48 and 96 to evaluate the immunological activity of multiple doses of BMS-663068/GSK3684934. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | ITT-E Population | Posted | Mean | Standard Deviation | Cells per cubic millimeter | Baseline and Weeks 24, 48 and 96 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Newly-emergent Genotypic Substitutions at Week 24 | Participants who administered antiretroviral (ARV) with virologic failure (VF) were assessed. Genotypic substitution included assessment of Reverse Transcriptase (RT) substitution, Protease Inhibitor (PI) substitution and Integrase RAL substitution as per International Acquired Immune Deficiency Syndrome (AIDS) Society-USA (IAS-USA) list. ITT-E Resistance Tested through Week 24 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 24 Snapshot analysis window. The criteria for resistance tested was participant who had virologic failure or met the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL. | ITT-E Resistance Tested through Week 24 Population | Posted | Count of Participants | Participants | Up to Week 24 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Newly-emergent Genotypic Substitutions at Week 48 | Participants who administered ARV with VF were assessed. Genotypic substitution included assessment of RT substitution, PI substitution and Integrase RAL substitution as per IAS-USA list. ITT-E Resistance Tested through Week 48 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 48 Snapshot analysis window. The criteria for resistance tested was participant who had virologic failure or the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL. | ITT-E Resistance Tested through Week 48 Population | Posted | Count of Participants | Participants | Up to Week 48 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Newly-emergent Genotypic Substitutions at Week 96 | Participants who administered ARV with VF were assessed. Genotypic substitution included assessment of RT substitution, PI substitution and Integrase RAL substitution as per IAS-USA list. ITT-E Resistance Tested through Week 96 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 96 Snapshot analysis window. The criteria for resistance tested was participants with virologic failure or the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL. | ITT-E Resistance Tested through Week 96 Population | Posted | Count of Participants | Participants | Up to Week 96 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Change From Baseline in Inhibitory Concentration at 50% (IC50) Fold Change Among Participants With VF at Week 24 | Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL . The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed. | ITT-E Resistance Tested through Week 24 Population | Posted | Mean | Standard Deviation | IC50 Fold Change | Baseline and up to Week 24 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in IC50 Fold Change Among Participants With VF at Week 48 | Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL. The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed. | ITT-E Resistance Tested through Week 48 Population | Posted | Mean | Standard Deviation | IC50 Fold Change | Baseline and up to Week 48 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in IC50 Fold Change Among Participants With VF at Week 96 | Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL. The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed. | ITT-E Resistance Tested through Week 96 Population | Posted | Mean | Standard Deviation | IC50 Fold Change | Baseline and up to Week 96 |
|
Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days
The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
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 | FTR/RAL/TDF Total | All participants who were randomized to receive either of FTR 400mg BID, 800 mg BID, 600mg QD or 1200 mg QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). | 3 | 200 | 35 | 200 | 163 | 200 |
| EG001 | ATV/r/RAL/TDF | Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD. | 0 | 51 | 8 | 51 | 46 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone tuberculosis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Cellulitis staphylococcal | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Disseminated tuberculosis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Meningoencephalitis herpetic | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Acute stress disorder | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Adenocarcinoma of salivary gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Ovarian neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hysterectomy | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Ocular icterus | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| ID | Term |
|---|---|
| D007239 | Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C576364 | fostemsavir |
| D000068898 | Raltegravir Potassium |
| D000068698 | Tenofovir |
| D019438 | Ritonavir |
| D000069446 | Atazanavir Sulfate |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D011725 | Pyridines |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
|
| American Indian Or Alaska Native |
|
| Asian |
|
| White |
|
| Other/Mixed |
|
| OG002 |
| FTR 600 mg QD/RAL/TDF |
Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
| OG003 | FTR 1200 mg QD/RAL/TDF | Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
| OG004 | ATV/r/RAL/TDF | Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD. |
|
|
Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
| OG003 | FTR 1200 mg QD/RAL/TDF | Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
|
|
| OG003 | FTR 1200 mg QD/RAL/TDF | Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
|
|
| OG003 | FTR 1200 mg QD/RAL/TDF | Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
|
|
| OG003 | FTR 1200 mg QD/RAL/TDF | Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
|
|
| OG003 | FTR 1200 mg QD/RAL/TDF | Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
|
|
| OG003 | FTR 1200 mg QD/RAL/TDF | Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
|
|
| OG003 | FTR 1200 mg QD/RAL/TDF | Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
| OG004 | ATV/r/RAL/TDF | Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD. |
|
|
| OG002 |
| FTR 600 mg QD/RAL/TDF |
Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
| OG003 | FTR 1200 mg QD/RAL/TDF | Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
| OG004 | ATV/r/RAL/TDF | Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD. |
|
|
| OG003 | FTR 1200 mg QD/RAL/TDF | Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
| OG004 | ATV/r/RAL/TDF | Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD. |
|
|
| OG002 | FTR 600 mg QD/RAL/TDF | Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
| OG003 | FTR 1200 mg QD/RAL/TDF | Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
| OG004 | ATV/r/RAL/TDF | Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD. |
|
|
| OG002 | FTR 600 mg QD/RAL/TDF | Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
| OG003 | FTR 1200 mg QD/RAL/TDF | Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
| OG004 | ATV/r/RAL/TDF | Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD. |
|
|
| OG002 | FTR 600 mg QD/RAL/TDF | Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
| OG003 | FTR 1200 mg QD/RAL/TDF | Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
| OG004 | ATV/r/RAL/TDF | Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD. |
|
|
Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).
| OG002 | FTR 600 mg QD/RAL/TDF | Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
| OG003 | FTR 1200 mg QD/RAL/TDF | Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
|
|
| OG002 | FTR 600 mg QD/RAL/TDF | Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
| OG003 | FTR 1200 mg QD/RAL/TDF | Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
|
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| OG002 | FTR 600 mg QD/RAL/TDF | Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
| OG003 | FTR 1200 mg QD/RAL/TDF | Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). |
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