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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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This 96 week, Phase 2b study in 150 HIV-1 infected antiretroviral (ART) naive adult subjects consists of a dose-ranging evaluation of GSK2248761 at blinded doses of 100 mg and 200 mg once daily with a control arm of open-label efavirenz (EFV) 600 mg once daily. The background ART for all 3 arms will be chosen by the Investigators and will be either abacavir/lamivudine [ABC/3TC] or tenofovir/emtricitabine [TDF/FTC] fixed dose combination (FDC) tablets. Antiviral activity, safety, PK, and development of viral resistance will be evaluated.
Study SGN113404 is a phase 2b randomized, partially blinded, multicenter, parallel group, dose-ranging study. The study will be conducted in approximately 150 HIV-1 infected ART naïve subjects. The background NRTIs to be co-administered with GSK2248761 or EFV will be selected by Investigators prior to randomization and will be either abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC) fixed dose combination (FDC) tablets.
Subjects will participate in a Screening period (Day -28 to Day -1). Subjects may be re-screened once. Subjects will be randomized 1:1:1 to receive 100 mg of GSK2248761 once daily (50 subjects), 200 mg of GSK2248761 once daily (50 subjects) or 600 mg of EFV once daily (50 subjects). All three arms will be combined with either 300 mg/200 mg TDF/FTC or 600 mg/300 mg ABC/3TC, as chosen by the Investigator. The Investigators and subjects will be blinded to the dose of GSK2248761 being administered but will know whether they receive EFV or GSK2248761. The randomization will be stratified by HIV-1 viral load (VL) at screening, < 100,000 copies/mL or >/ 100,000 copies/mL as well as the choice of backbone NRTI, TDF/FTC or ABC/3TC.
This study will be enrolled in two stages. The first stage of the study will enroll approximately 30 subjects, at which time enrollment will be paused. An analysis of safety and tolerability will be reviewed by a safety review committee (SRC) once all subjects enrolled in Stage 1 reach Week 4. The SRC review will determine if the safety and tolerability profile of GSK2248761 supports the continuation of the trial and enrollment of an additional 120 subjects. All subjects will continue on study medications during this Week 4 analysis.
Additional analyses will be conducted once all subjects complete Week 4, Week 16, Week 24 and Week 48. A second review of the safety and tolerability of GSK2248761 will be performed by the SRC once all subjects reach Week 4. There will not be a pause in the study during the Week 4 analysis of all subjects.
The Week 16 and Week 24 analyses will be used respectively to select and confirm the optimal dose of GSK2248761 for continuation. This dose will be selected based on a statistical analysis of antiviral activity, safety and tolerability criteria. If, after confirmation of the optimal dose of GSK2248761 by the Week 24 analysis, both doses are considered acceptable based on efficacy, safety and PK data, then both arms will be continued through Week 48.
Beyond Week 48, those subjects who were randomized to the non-selected dose of GSK2248761 and have not met any criteria for discontinuation will be given the option to switch to the selected dose of GSK2248761 or to discontinue permanently from the study. Once they have switched to the selected dose they will be in the Open-Label phase of the study through Week 96. After Week 96, subjects receiving GSK2248761 will be given the option to continue to receive GSK2248761 until it is locally approved and commercially available, as long as they continue to derive clinical benefit without a protocol-defined reason for discontinuation.
Subjects randomized to EFV will have the option to continue to receive EFV through Week 96 unless they meet a protocol-defined reason for discontinuation. All subjects will have the option to continue TDF/FTC or ABC/3TC through Week 96. After Week 96, subjects will be expected to obtain local access to all commercially available ART.
Randomization will be stratified by:
Switch of a background NRTI for toxicity management to an alternative marketed NRTI is allowed once. Switches of a background NRTI for any other reason are not permitted in the study. A switch of GSK2248761 or EFV is not allowed.
Study Endpoints /Assessments: Subjects will have assessments performed which will include baseline demographics, disease characteristics, and safety (laboratory and clinical evaluations). On study safety, efficacy, virologic, immunologic, and PK evaluations will be conducted.
Primary Endpoint: The proportion of subjects with HIV-1 RNA <50copies/mL at Week 16. Dose selection will be based primarily on antiviral activity and tolerability in conjunction with immunologic, safety, virologic resistance and PK measures. Data from the Week 24 analysis will be used to confirm dose selection.
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2248761 100 mg once daily | Experimental | In combination with either abacavir/lamivudine FDC qd or tenofovir/emtricitabine FDC qd |
|
| GSK2248761 200 mg once daily | Experimental | In combination with either abacavir/lamivudine FDC qd or tenofovir/emtricitabine FDC qd |
|
| Efavirenz 600 mg once daily | Active Comparator | In combination with either abacavir/lamivudine FDC qd or tenofovir/emtricitabine FDC qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2248761 100 mg once daily | Drug | 1x100 mg capsule plus matching placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Plasma HIV-1 RNA Below 50 Copies/mL as a Function of Viral Load | This analysis was based on the Missing, Switch or Discontinuation equals Failure (MSDF) algorithm (as codified by the FDA's "snapshot" algorithm) and was adjusted for stratification factors and stage of recruitment. Dose selection was based primarily on antiviral activity and tolerability in conjunction with immunologic, safety, virologic resistance and pharmacokinetic (PK) measures. The efficacy decision criteria was based on an observed difference of >=8% between the two GSK2248761 dosage arms. | Up to Week 16 |
| Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) | Adverse event (AE) is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. | Up to 20 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (Day 1) in Plasma HIV-1 RNA Over Period | For summaries and analyses which use HIV-1 RNA level as a continuous measure, the logarithm to base 10 of the value was used. In cases where a sample was retested, the retest value was used. Baseline was defined as the value recorded on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Data for participants prior to switch and after the switch has been presented. |
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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 | Levallois-Perret | 92300 | France | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1361652 | Background | 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. MMWR Recomm Rep. 1992 Dec 18;41(RR-17):1-19. |
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Enrollment was terminated prematurely due to safety findings. At the time of enrollment termination, 23 participants were enrolled who continued into this study. At least 5 interim analyses were planned up to Week 48, however, the study was terminated prior to any of these analyses being conducted.
This study was conducted from 18 November 2010 to 04 July 2011. A total of 150 human immunodeficiency virus (HIV)-1 infected adult participants naïve to antiretroviral therapy (ART) were planned to be enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK2248761 100 mg Once Daily | Eligible participants were planned to receive oral GSK2248761 100 milligrams (mg) capsule once daily and matching GSK2248761 Placebo capsule once daily up to 48 weeks, however, participants received GSK2248761 100 mg once daily and matching GSK2248761 Placebo capsule once daily up to 8 weeks due to early termination. All participants received antiretroviral therapy (ART) of Tenofovir disoproxil fumarate/ Emtricitabine (TDF/FTC) 300 mg/200 mg or Abacavir/ Lamivudine (ABC/3TC) 600 mg/300 mg along with the study drug. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
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| GSK2248761 200 mg once daily |
| Drug |
2x100 mg capsules |
|
| Efavirenz 600 mg once daily | Drug | 1x600mg tablet |
|
| Baseline (Day 1) up to Week 16 |
| Number of Participants With HIV Associated Conditions | HIV associated condition included recurrence of previous conditions. Centre for disease control (CDC) associated conditions and non-CDC associated conditions were planned to be monitored. | Up to 20 Weeks |
| Number of Participants With HIV Disease Progression | Number of participants acquiring clinical disease progression or death during the treatment period were presented. Clinical disease progression was defined as the progression from Baseline (Day 1) HIV disease status in either of these categories; CDC Category A at baseline to CDC Category B event, CDC Category A at baseline to CDC Category C event, CDC Category B at baseline to CDC Category C event, CDC Category C at baseline to new CDC Category C event, CDC Category A, B or C at baseline to death. If no change occurs, it was termed as no disease progression. | Up to 20 Weeks |
| Number of Participants Discontinuing the Study Drugs Due to AEs | Adverse event (AE) is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Number of participants quitting/ prematurely discontinuing the use of study drug(s) were recorded. | Up to 20 weeks |
| Number of Participants With Changes in Electrocardiogram (ECG) From Baseline (Day 1) Over 16 Weeks | The QTc interval was assessed by two methods Bazzette's method (QTc[b]) and Federica's method (QTc[f]). Baseline value was recorded at Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Change from Baseline values were categorized into <30 milliseconds (msec), >=30 but <60 msec, and >=60 msec. The data has been presented for QTcB and QTcF for participants prior to switching the therapy. | Baseline (Day 1) to 16 weeks |
| Minimum and Maximum Plasma GSK2248761 Concentration at Week 2 | Maximum observed plasma concentration and minimum observed plasma concentration of GSK2248761 was recorded on Week 2. The PK parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Pro 4.1 or higher. Log transformed values have been presented. All calculations of non-compartmental parameters were based on actual sampling times. | At Week 2 |
| Montpellier |
| 34295 |
| France |
| GSK Investigational Site | Nice | 06202 | France |
| GSK Investigational Site | Paris | 75018 | France |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60311 | Germany |
| GSK Investigational Site | Hanover | Lower Saxony | 30625 | Germany |
| GSK Investigational Site | Berlin | 12157 | Germany |
| GSK Investigational Site | Hamburg | 20146 | Germany |
| GSK Investigational Site | Hamburg | 20246 | Germany |
| GSK Investigational Site | Badalona | 08916 | Spain |
| GSK Investigational Site | Barcelona | 08036 | Spain |
| GSK Investigational Site | Marid | 28040 | Spain |
| FG001 | GSK2248761 200 mg Once Daily | Eligible participants were planned to receive oral GSK2248761 200 mg (2x100 mg) capsule once daily up to 48 weeks, however, participants received GSK2248761 200 mg oral capsule once daily up to 8 weeks due early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug. |
| FG002 | EFV 600 mg Once Daily | Eligible participants were planned to receive oral Efavirenz (EFV) 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GSK2248761 100 mg Once Daily | Eligible participants were planned to receive oral GSK2248761 100 mg capsule once daily and matching GSK2248761 Placebo capsule once daily up to 48 weeks, however, participants received GSK2248761 100 once daily and matching GSK2248761 Placebo capsule once daily up to 8 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug. |
| BG001 | GSK2248761 200 mg Once Daily | Eligible participants were planned to receive oral GSK2248761 200 mg (2x100 mg) capsule once daily up to 48 weeks, however, participants received GSK2248761 200 mg oral capsule once daily up to 8 weeks due early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug. |
| BG002 | EFV 600 mg Once Daily | Eligible participants were planned to receive oral EFV 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug. |
| BG003 | 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 |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Number of Participants With Plasma HIV-1 RNA Below 50 Copies/mL as a Function of Viral Load | This analysis was based on the Missing, Switch or Discontinuation equals Failure (MSDF) algorithm (as codified by the FDA's "snapshot" algorithm) and was adjusted for stratification factors and stage of recruitment. Dose selection was based primarily on antiviral activity and tolerability in conjunction with immunologic, safety, virologic resistance and pharmacokinetic (PK) measures. The efficacy decision criteria was based on an observed difference of >=8% between the two GSK2248761 dosage arms. | Intent to treat exposed (ITT-E) population included all randomized participants who received at least one dose of study drug. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm due to early termination. Only those participants available at indicated timepoints were analyzed. | Posted | Count of Participants | Participants | Up to Week 16 |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) | Adverse event (AE) is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. | Safety population included all randomized participants who were exposed to the study drug(s) with the exception of any participant with documented evidence of not having consumed any amount of the study drug. | Posted | Count of Participants | Participants | Up to 20 Weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline (Day 1) in Plasma HIV-1 RNA Over Period | For summaries and analyses which use HIV-1 RNA level as a continuous measure, the logarithm to base 10 of the value was used. In cases where a sample was retested, the retest value was used. Baseline was defined as the value recorded on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Data for participants prior to switch and after the switch has been presented. | ITT-E population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm due to early termination. | Posted | Mean | Standard Deviation | log10 copies per milliliter | Baseline (Day 1) up to Week 16 |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With HIV Associated Conditions | HIV associated condition included recurrence of previous conditions. Centre for disease control (CDC) associated conditions and non-CDC associated conditions were planned to be monitored. | ITT-E population. | Posted | Count of Participants | Participants | Up to 20 Weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With HIV Disease Progression | Number of participants acquiring clinical disease progression or death during the treatment period were presented. Clinical disease progression was defined as the progression from Baseline (Day 1) HIV disease status in either of these categories; CDC Category A at baseline to CDC Category B event, CDC Category A at baseline to CDC Category C event, CDC Category B at baseline to CDC Category C event, CDC Category C at baseline to new CDC Category C event, CDC Category A, B or C at baseline to death. If no change occurs, it was termed as no disease progression. | ITT-E population. | Posted | Count of Participants | Participants | Up to 20 Weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Discontinuing the Study Drugs Due to AEs | Adverse event (AE) is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Number of participants quitting/ prematurely discontinuing the use of study drug(s) were recorded. | Safety population | Posted | Count of Participants | Participants | Up to 20 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Changes in Electrocardiogram (ECG) From Baseline (Day 1) Over 16 Weeks | The QTc interval was assessed by two methods Bazzette's method (QTc[b]) and Federica's method (QTc[f]). Baseline value was recorded at Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Change from Baseline values were categorized into <30 milliseconds (msec), >=30 but <60 msec, and >=60 msec. The data has been presented for QTcB and QTcF for participants prior to switching the therapy. | Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm due to early termination. | Posted | Count of Participants | Participants | Baseline (Day 1) to 16 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Minimum and Maximum Plasma GSK2248761 Concentration at Week 2 | Maximum observed plasma concentration and minimum observed plasma concentration of GSK2248761 was recorded on Week 2. The PK parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Pro 4.1 or higher. Log transformed values have been presented. All calculations of non-compartmental parameters were based on actual sampling times. | The PK Concentration Population included all participants who received GSK2248761, underwent intensive and/or limited PK sampling during the study, and provided evaluable GSK2248761 plasma concentration data. Only the participants available at the time of assessment were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter | At Week 2 |
|
Up to 20 weeks
AE (SAE and nSAE) were collected and have been reported for safety population
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 | GSK2248761 100 mg Once Daily | Eligible participants were planned to receive oral GSK2248761 100 mg capsule once daily and matching GSK2248761 Placebo capsule once daily up to 48 weeks, however, participants received GSK2248761 100 once daily and matching GSK2248761 Placebo capsule once daily up to 8 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug. | 0 | 8 | 1 | 8 | 8 | 8 |
| EG001 | GSK2248761 200 mg Once Daily | Eligible participants were planned to receive oral GSK2248761 200 mg (2x100 mg) capsule once daily up to 48 weeks, however, participants received GSK2248761 200 mg oral capsule once daily up to 8 weeks due early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug. | 0 | 7 | 0 | 7 | 5 | 7 |
| EG002 | EFV 600 mg Once Daily | Eligible participants were planned to receive oral EFV 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug. | 0 | 8 | 1 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clostridium difficile colitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Circadian rhythm sleep disorder | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Anogenital warts | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Anal chlamydia infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Syphilis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Blindness | Eye disorders | MedDRA | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Lactose intolerance | Metabolism and nutrition disorders | MedDRA | 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 | ViiV Healthcare | 866-435-7343 |
| ID | Term |
|---|---|
| D007239 | Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| D012749 | Sexually Transmitted Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D012192 | Retroviridae Infections |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D016180 | Lentivirus Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C534138 | IDX 899 |
| C098320 | efavirenz |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Before switch, Week 8 |
|
|
| Before switch, Week 12 |
|
|
| After switch, Baseline switch |
|
|
| After switch, Week 1 |
|
|
| After switch, Week 2 |
|
|
| After switch, Week 4 |
|
|
| OG001 | GSK2248761 200 mg Once Daily | Eligible participants were planned to receive oral GSK2248761 200 mg (2x100 mg) capsule once daily up to 48 weeks, however, participants received GSK2248761 200 mg oral capsule once daily up to 8 weeks due early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug. |
| OG002 | EFV 600 mg Once Daily | Eligible participants were planned to receive oral EFV 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug. |
|
|
| OG002 | EFV 600 mg Once Daily | Eligible participants were planned to receive oral EFV 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug. |
|
|
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| OG002 | EFV 600 mg Once Daily | Eligible participants were planned to receive oral EFV 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug. |
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| OG002 |
| EFV 600 mg Once Daily |
Eligible participants were planned to receive oral EFV 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug. |
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| OG002 | EFV 600 mg Once Daily | Eligible participants were planned to receive oral EFV 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug. |
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| OG002 | EFV 600 mg Once Daily | Eligible participants were planned to receive oral EFV 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug. |
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