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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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HIV/Tuberculosis (TB) co-infection have profound effects on the host's immune system. TB is the most common cause of death in patients with HIV worldwide. Rifamycins (such as rifampicin [RIF]) are an important component of TB therapy because of their unique activity. The problem is that most protease inhibitors (PI) and non-nucleoside reverse transcriptase inhibitors (NNRTI) used to treat HIV have significant drug-drug interactions with RIF that can lead to reduced concentrations of these agents with risk of treatment failure or resistance. The non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (EFV) does not present the same significant drug interactions with RIF. EFV-based HIV treatment was tested in patients concomitantly treated with RIF-containing TB therapy, demonstrating that their co-administration can be used safely and effectively. However, the side effect profile of EFV overlaps with the RIF-containing TB regimens and makes the management of treatment toxicities very complex. Integrase inhibitors (INI), such as dolutegravir (DTG), may offer an important alternative to EFV-based therapy in TB coinfected patients. A Phase I drug-drug interaction study was conducted in healthy, HIV-seronegative subjects, and showed that DTG at 50 mg twice daily given together with RIF was well-tolerated and resulted in DTG concentrations similar to those of DTG 50 mg given once daily alone, which is the recommended dose for INI-naive patients. Therefore, ART regimens using DTG 50 mg twice daily may represent a new treatment option for TB-infected patients who require concurrent treatment for HIV infection. This is a Phase III b, randomized, open-label study describing the efficacy and safety of DTG and EFV-containing ART regimens in HIV/TB co-infected patients. This study is designed to assess the antiviral activity of DTG or efavirenz (EFV) ART-containing regimens through 48 weeks. A total of approximately 115 +/-5% subjects will be randomly assigned in a 3:2 ratio to DTG (approximately 69 subjects) and EFV (approximately 46 subjects), respectively. This study will include a Screening Period, a Randomized Phase (Day 1 to 48 weeks plus a 4-week extension), and a DTG Open-label extension (OLE). During the DTG OLE, subjects will be supplied with DTG until it is locally approved and commercially available, the subject no longer derives clinical benefit, or the subject meets a protocol-defined reason for discontinuation, which ever comes first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dolutegravir | Experimental | Twice-daily DTG 50 mg plus dual NRTI during RIF-containing TB treatment (isoniazid, RIF, pyrazinamide and ethambutol standard doses by the NTP under program conditions or acceptable alternative RIF-containing regimens) and for 2 weeks following discontinuation of TB treatment, then once-daily DTG 50 mg with the same NRTI through Week 52 |
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| Efavirenz | Active Comparator | Once-daily EFV 600 mg plus dual NRTI through Week 52 along with TB treatment including isoniazid, RIF, pyrazinamide and ethambutol standard doses by the NTP under program conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTG 50 mg | Drug | DTG is available as 50 mg film-coated tablet. DTG may be administered with or without food |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Plasma Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/Milliliter at Week 48 in DTG Arm Using the Modified United States (US) Food and Drug Administration (FDA) Snapshot Algorithm | Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with plasma HIV-1 RNA <50 copies/milliliter was assessed at Week 48 using the snapshot algorithm in the DTG arm. Response was assessed using a modified FDA Snapshot algorithm in which participants were not penalized for any single protocol allowed background therapy substitution even if occurs after the first trial visit. In this approach participants with HIV-1 RNA >=50 copies/milliliter are considered as non-responders. Participants without HIV-1 RNA data at Week 48 (due to missing data or discontinuation of investigational product [IP] prior to visit window) are also considered as non-responders, as well as participants with anti-retroviral (ART) substitutions were not permitted. Study drug (i.e. DTG or EFV) was not allowed to be substituted. | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 RNA <50 Copies/Milliliter at Week 48 in EFV Arm Using the Modified Snapshot Algorithm | Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with plasma HIV-1 RNA <50 copies/milliliter were assessed at Week 48 using the snapshot algorithm in the EFV arm. Response was assessed using a modified FDA Snapshot algorithm in which participants were not penalized for any single protocol allowed background therapy substitution even if occurs after the first trial visit. In this approach participants with HIV-1 RNA >=50 copies/milliliter are considered as non-responders. Participants without HIV-1 RNA data at Week 48 (due to missing data or discontinuation of IP prior to visit window) are also considered as non-responders, as well as participants with ART substitutions were not permitted. Study drug (i.e. DTG or EFV) was not allowed to be substituted. |
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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 | Ciudad de Buenos Aires | Buenos Aires | C1202ABB | Argentina | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30918967 | Background | Dooley KE, Kaplan R, Mwelase N, Grinsztejn B, Ticona E, Lacerda M, Sued O, Belonosova E, Ait-Khaled M, Angelis K, Brown D, Singh R, Talarico CL, Tenorio AR, Keegan MR, Aboud M; International Study of Patients with HIV on Rifampicin ING study group. Dolutegravir-based Antiretroviral Therapy for Patients Coinfected With Tuberculosis and Human Immunodeficiency Virus: A Multicenter, Noncomparative, Open-label, Randomized Trial. Clin Infect Dis. 2020 Feb 3;70(4):549-556. doi: 10.1093/cid/ciz256. |
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A total of 263 participants were screened of which 150 were screen failures. A total of 113 participants were enrolled in this study.
This study was conducted in 7 countries across 25 centers; Argentina (2), Brazil (4), Mexico (3), Peru (4), Russia (2), South Africa (8) and Thailand (2). Participants were randomized to receive either Dolutegravir (DTG) or Efavirenz (EFV) containing regimens.
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| ID | Title | Description |
|---|---|---|
| FG000 | DTG 50 mg | Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomized Phase (Up to Week 52) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 10, 2018 | Dec 9, 2020 |
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| EFV 600 mg | Drug | EFV is supplied as film-coated capsule-shaped oral tablet containing 600 mg of EFV and must be administered without food |
|
| Week 48 |
| Percentage of Participants With Plasma HIV-1 RNA <50 Copies/Milliliter at Week 24 in Both EFV and DTG Arms Using the Modified Snapshot Algorithm | Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with plasma HIV-1 RNA <50 copies/milliliter were assessed at Week 24 using the snapshot algorithm in the DTG and EFV arm. Response was assessed according to the Modified Snapshot algorithm. In this approach participants with HIV-1 RNA >=50 copies/milliliter were considered non-responders. Participants without HIV-1 RNA data at Week 24 (due to missing data or discontinuation of IP prior to visit window) were also considered as non-responders, as well as participants with ART substitutions were not permitted. Substitution of a background NRTI agent was permissible one time if it was due to reasons of drug toxicity. | Week 24 |
| Percentage of Participants Without Confirmed Virologic Withdrawal and Without Discontinuation Due to Treatment-related Reasons at Week 24 and Week 48 | Percentage of participants not meeting confirmed virologic withdrawal criteria nor discontinued due to treatment related reasons at the time of analysis at Week 24 (through Day 210) and Week 48 (through Day 350) has been presented by treatment group. The time to meeting confirmed virologic withdrawal criteria or discontinuation due to treatment related reasons (i.e., discontinuation due to drug-related adverse event [AE], or due to protocol defined safety stopping criteria, or due to lack of efficacy) were calculated. Participants who met confirmed virologic withdrawal criteria or discontinuation due to treatment related reasons were considered as Failure. Participants who had not met confirmed virologic withdrawal criteria (per protocol) and were ongoing in the study, or who had discontinued for reasons other than those related to treatment, were censored. This would be the Treatment-Related Discontinuation = Failure (TRDF) data. | Week 24 and Week 48 |
| Change From Baseline in Cluster of Differentiation 4 (CD4+) Counts at Week 24 and Week 48 | Blood samples were collected for assessment of lymphocyte subsets (CD4+ lymphocyte count) by flow cytometry at Baseline and Weeks 24, 48. Baseline was defined as the last pre-treatment value observed (typically from Day 1 visit). Change from Baseline was calculated subtracting the value at the specified time point from the Baseline value. | Baseline (Day 1), Week 24 and Week 48 |
| Number of Participants With Serious Adverse Event (SAE) and Common (>=5%) Non-serious AE (Non-SAE) - Randomized Phase | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, all events of possible drug-induced liver injury with hyperbilirubinemia or any other situation according to medical or scientific judgment. Data for number of participants with SAE and common (>=5%) non-SAE over 52 weeks has been summarized. | Up to Week 52 |
| Number of Participants With SAE and Common (>=5%) Non-SAE - OLE Phase | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, all events of possible drug-induced liver injury with hyperbilirubinemia or any other situation according to medical or scientific judgment. Data for number of participants with SAE and common (>=5%) non-SAE from Week 52 to Week 252 has been summarized. | Week 52 to Week 252 |
| Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Blood samples for assessment of clinical chemistry parameters were collected at indicated time points. Clinical chemistry assessments included alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, glucose, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphate, potassium, and sodium. Data for number of participants who experienced maximum post-Baseline emergent chemistry toxicities were summarized. Maximum post-Baseline emergent chemistry toxicities were graded using Division of Acquired Immune Deficiency Syndrome (DAIDS) toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threating). Higher grade indicates more severity. | Up to Week 52 |
| Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Blood samples for assessment of clinical chemistry parameters were collected at indicated time points. Clinical chemistry assessments included ALT, albumin, alkaline phosphatase, AST, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, glucose, LDL cholesterol calculation, lipase, phosphate, potassium, and sodium. Data for number of participants with maximum post-Baseline emergent chemistry toxicities were summarized. Maximum post-Baseline emergent chemistry toxicities were graded using DAIDS toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threating) . Higher grade indicates more severity. | Up to Week 252 |
| Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Blood samples for assessment of hematology parameters were collected at indicated time points. Hematology assessments included hemoglobin, leukocytes, neutrophils and platelets. Data for number of participants who experienced maximum post-Baseline emergent hematology toxicities were summarized. Maximum post-Baseline emergent hematology toxicities were graded using DAIDS toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threating). Higher grade indicates more severity. | Up to Week 52 |
| Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Blood samples for assessment of hematology parameters were collected at indicated time points. Hematology assessments included hemoglobin, leukocytes, neutrophils and platelets. Data for number of participants who experienced maximum post-Baseline emergent hematology toxicities were summarized. Maximum post-Baseline emergent hematology toxicities were graded using DAIDS toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threating). Higher grade indicates more severity. | Up to Week 252 |
| Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 | Samples for lipid measurements were obtained in a fasted state at Baseline, Week 24 and Week 48. The parameters assessed during the lipid profile were total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, triglycerides. Baseline was defined as the last pre-treatment value observed (typically from Day 1 visit). Percent change from Baseline for a parameter was calculated as the observed value minus the Baseline value divided by Baseline value multiplied by 100. Data for fasting lipid parameters has been summarized. | Baseline (Day 1), Week 24 and Week 48 |
| Change From Baseline in the Fasting Lipid Profile for Total Cholesterol/HDL Ratio at Week 24 and Week 48 | Samples for lipid measurements were obtained in a fasted state at Baseline, Week 24 and Week 48. The parameter assessed during the lipid profile was total cholesterol/HDL ratio. Baseline was defined as the last pre-treatment value observed (typically from Day 1 visit). Change from baseline for a parameter was calculated as the observed value minus the Baseline value. | Baseline (Day 1), Week 24 and Week 48 |
| Percentage of Participants Who Permanently Discontinued Study Treatment Due to AEs - Randomized Phase | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Data for percentage of participants who permanently discontinued study treatment due to any AE over 52 weeks has been summarized. | Up to Week 52 |
| Percentage of Participants Who Permanently Discontinued Study Treatment Due to AEs - OLE Phase | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Data for percentage of participants who permanently discontinued study treatment due to any AE from Week 52 to Week 252 has been summarized. | Week 52 to Week 252 |
| Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Participants were monitored for signs and symptoms of TB-assoc. IRIS. Participants with IRIS symptoms in any AE or HIV assoc. conditions were classified by Endpoint Adjudication Committee in following four categories: met criteria for TB-assoc. IRIS, possibly met criteria for TB-assoc. IRIS, suspected TB-assoc. IRIS but not possible to adjudicate and No TB associated IRIS. They were further graded from Grades 1 to 4 using DAIDS. Higher grade indicates more severity. The preliminary requirements to meet TB-assoc. IRIS criteria were diagnosis of TB and initial response to TB treatment (stabilized or improved condition of participant in presence of TB treatment before starting ART). The clinical criteria was onset of IRIS signs and symptoms related to TB should occur within first 3 months of starting, restarting or changing ART regimen for treatment failure. Number of participants who sent to the adjudication committee and analyzed were presented. | Up to Week 12 |
| Number of Participants With Treatment-emergent Genotypic Resistance | Whole venous blood samples were obtained from each participant until Week 52 for potential viral genotypic and phenotypic analyses. Genotypic and phenotypic testing was conducted for participants meeting confirmed virologic withdrawal criteria, i.e., confirmed HIV-1 RNA >=400 copies/milliliter from Week 24 onwards. Genotypic and phenotypic analyses was carried out by Monogram Biosciences using, but not limited to, their Standard Phenosense and GenoSure testing methods for protease (PRO), reverse transcriptase (RT), and integrase assays. Data for number of participants with treatment-emergent genotypic resistance mutations have been presented for the RT region on codons G190G, K101K, K103K, K65K, V106V and Y181Y. | Up to Week 52 |
| Number of Participants With Treatment-emergent Phenotypic Resistance | Phenotypic susceptibility to all licensed antiretroviral drugs, including DTG and EFV were determined using PhenoSense HIV assays from Monogram Inc. Clinical cutoffs or biological cutoffs by PhenoSense were used to define the phenotypic susceptibility of background treatment and were interpreted as fold change > clinical lower cut-off or biologic cut-off as resistance, fold change <=clinical lower cut-off or biologic cut-off as sensitive, and fold change > clinical higher cut-off as resistance, fold change <=clinical higher cut-off and > clinical lower cut-off as partially sensitive, and fold change <=clinical lower cut-off as sensitive. Data has been presented for participants with treatment-emergent phenotypic resistance. | Up to Week 52 |
| Rosario |
| Santa Fe Province |
| S2000PBJ |
| Argentina |
| GSK Investigational Site | Manaus | Amazonas | 69040-000 | Brazil |
| GSK Investigational Site | Salvador | Estado de Bahia | 40110-010 | Brazil |
| GSK Investigational Site | Rio de Janeiro | 21040-360 | Brazil |
| GSK Investigational Site | São Paulo | 04121-000 | Brazil |
| GSK Investigational Site | Guadalajara | Jalisco | 44160 | Mexico |
| GSK Investigational Site | Guadalajara | Jalisco | 44280 | Mexico |
| GSK Investigational Site | Guadalajara | Jalisco | 44340 | Mexico |
| GSK Investigational Site | Cuernavaca | Morelos | 62290 | Mexico |
| GSK Investigational Site | DF | 14000 | Mexico |
| GSK Investigational Site | San Miguel | Lima region | Lima 32 | Peru |
| GSK Investigational Site | Iquitos | Loreto | Iqui 01 | Peru |
| GSK Investigational Site | Lima | Lima 14 | Peru |
| GSK Investigational Site | Lima | Lima 1 | Peru |
| GSK Investigational Site | Oryol | 302040 | Russia |
| GSK Investigational Site | Saint Petersburg | 194214 | Russia |
| GSK Investigational Site | Soweto | Gauteng | 2013 | South Africa |
| GSK Investigational Site | Durban | KwaZulu-Natal | 4001 | South Africa |
| GSK Investigational Site | Bloemfontein | 9301 | South Africa |
| GSK Investigational Site | Cape Town | 7505 | South Africa |
| GSK Investigational Site | Cape Town | 7700 | South Africa |
| GSK Investigational Site | Klerksdorp | 2574 | South Africa |
| GSK Investigational Site | Observatory, Cape Town | 7925 | South Africa |
| GSK Investigational Site | Westdene | 2092 | South Africa |
| GSK Investigational Site | Bangkok | 10330 | Thailand |
| GSK Investigational Site | Bangkok | 10400 | Thailand |
| GSK Investigational Site | Khon Kaen | 40002 | Thailand |
| FG001 | EFV 600 mg | Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV. |
| COMPLETED |
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| NOT COMPLETED |
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| OLE Phase (Week 52 to Week 252) |
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| ID | Title | Description |
|---|---|---|
| BG000 | DTG 50 mg | Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252). |
| BG001 | EFV 600 mg | Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| 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 | ||||||||||||||||||||
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| Primary | Percentage of Participants With Plasma Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/Milliliter at Week 48 in DTG Arm Using the Modified United States (US) Food and Drug Administration (FDA) Snapshot Algorithm | Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with plasma HIV-1 RNA <50 copies/milliliter was assessed at Week 48 using the snapshot algorithm in the DTG arm. Response was assessed using a modified FDA Snapshot algorithm in which participants were not penalized for any single protocol allowed background therapy substitution even if occurs after the first trial visit. In this approach participants with HIV-1 RNA >=50 copies/milliliter are considered as non-responders. Participants without HIV-1 RNA data at Week 48 (due to missing data or discontinuation of investigational product [IP] prior to visit window) are also considered as non-responders, as well as participants with anti-retroviral (ART) substitutions were not permitted. Study drug (i.e. DTG or EFV) was not allowed to be substituted. | Intent-to-treat exposed (ITT-E) Population comprised of all randomly assigned participants who received at least one dose of IP. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 48 |
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| Secondary | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/Milliliter at Week 48 in EFV Arm Using the Modified Snapshot Algorithm | Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with plasma HIV-1 RNA <50 copies/milliliter were assessed at Week 48 using the snapshot algorithm in the EFV arm. Response was assessed using a modified FDA Snapshot algorithm in which participants were not penalized for any single protocol allowed background therapy substitution even if occurs after the first trial visit. In this approach participants with HIV-1 RNA >=50 copies/milliliter are considered as non-responders. Participants without HIV-1 RNA data at Week 48 (due to missing data or discontinuation of IP prior to visit window) are also considered as non-responders, as well as participants with ART substitutions were not permitted. Study drug (i.e. DTG or EFV) was not allowed to be substituted. | ITT-E Population | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 48 |
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| Secondary | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/Milliliter at Week 24 in Both EFV and DTG Arms Using the Modified Snapshot Algorithm | Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with plasma HIV-1 RNA <50 copies/milliliter were assessed at Week 24 using the snapshot algorithm in the DTG and EFV arm. Response was assessed according to the Modified Snapshot algorithm. In this approach participants with HIV-1 RNA >=50 copies/milliliter were considered non-responders. Participants without HIV-1 RNA data at Week 24 (due to missing data or discontinuation of IP prior to visit window) were also considered as non-responders, as well as participants with ART substitutions were not permitted. Substitution of a background NRTI agent was permissible one time if it was due to reasons of drug toxicity. | ITT-E Population | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
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| Secondary | Percentage of Participants Without Confirmed Virologic Withdrawal and Without Discontinuation Due to Treatment-related Reasons at Week 24 and Week 48 | Percentage of participants not meeting confirmed virologic withdrawal criteria nor discontinued due to treatment related reasons at the time of analysis at Week 24 (through Day 210) and Week 48 (through Day 350) has been presented by treatment group. The time to meeting confirmed virologic withdrawal criteria or discontinuation due to treatment related reasons (i.e., discontinuation due to drug-related adverse event [AE], or due to protocol defined safety stopping criteria, or due to lack of efficacy) were calculated. Participants who met confirmed virologic withdrawal criteria or discontinuation due to treatment related reasons were considered as Failure. Participants who had not met confirmed virologic withdrawal criteria (per protocol) and were ongoing in the study, or who had discontinued for reasons other than those related to treatment, were censored. This would be the Treatment-Related Discontinuation = Failure (TRDF) data. | ITT-E Population | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 and Week 48 |
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| Secondary | Change From Baseline in Cluster of Differentiation 4 (CD4+) Counts at Week 24 and Week 48 | Blood samples were collected for assessment of lymphocyte subsets (CD4+ lymphocyte count) by flow cytometry at Baseline and Weeks 24, 48. Baseline was defined as the last pre-treatment value observed (typically from Day 1 visit). Change from Baseline was calculated subtracting the value at the specified time point from the Baseline value. | ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Cells per millimeter^3 | Baseline (Day 1), Week 24 and Week 48 |
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| Secondary | Number of Participants With Serious Adverse Event (SAE) and Common (>=5%) Non-serious AE (Non-SAE) - Randomized Phase | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, all events of possible drug-induced liver injury with hyperbilirubinemia or any other situation according to medical or scientific judgment. Data for number of participants with SAE and common (>=5%) non-SAE over 52 weeks has been summarized. | Safety Population comprised of all participants who received at least one dose of IP. | Posted | Count of Participants | Participants | Up to Week 52 |
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| Secondary | Number of Participants With SAE and Common (>=5%) Non-SAE - OLE Phase | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, all events of possible drug-induced liver injury with hyperbilirubinemia or any other situation according to medical or scientific judgment. Data for number of participants with SAE and common (>=5%) non-SAE from Week 52 to Week 252 has been summarized. | Safety OLE Population comprised of all participants in Safety Population who entered the OLE phase. | Posted | Count of Participants | Participants | Week 52 to Week 252 |
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| Secondary | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Blood samples for assessment of clinical chemistry parameters were collected at indicated time points. Clinical chemistry assessments included alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, glucose, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphate, potassium, and sodium. Data for number of participants who experienced maximum post-Baseline emergent chemistry toxicities were summarized. Maximum post-Baseline emergent chemistry toxicities were graded using Division of Acquired Immune Deficiency Syndrome (DAIDS) toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threating). Higher grade indicates more severity. | Safety Population | Posted | Count of Participants | Participants | Up to Week 52 |
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| Secondary | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Blood samples for assessment of clinical chemistry parameters were collected at indicated time points. Clinical chemistry assessments included ALT, albumin, alkaline phosphatase, AST, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, glucose, LDL cholesterol calculation, lipase, phosphate, potassium, and sodium. Data for number of participants with maximum post-Baseline emergent chemistry toxicities were summarized. Maximum post-Baseline emergent chemistry toxicities were graded using DAIDS toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threating) . Higher grade indicates more severity. | Safety Population | Posted | Count of Participants | Participants | Up to Week 252 |
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| Secondary | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Blood samples for assessment of hematology parameters were collected at indicated time points. Hematology assessments included hemoglobin, leukocytes, neutrophils and platelets. Data for number of participants who experienced maximum post-Baseline emergent hematology toxicities were summarized. Maximum post-Baseline emergent hematology toxicities were graded using DAIDS toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threating). Higher grade indicates more severity. | Safety Population | Posted | Count of Participants | Participants | Up to Week 52 |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Blood samples for assessment of hematology parameters were collected at indicated time points. Hematology assessments included hemoglobin, leukocytes, neutrophils and platelets. Data for number of participants who experienced maximum post-Baseline emergent hematology toxicities were summarized. Maximum post-Baseline emergent hematology toxicities were graded using DAIDS toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threating). Higher grade indicates more severity. | Safety Population | Posted | Count of Participants | Participants | Up to Week 252 |
| ||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 | Samples for lipid measurements were obtained in a fasted state at Baseline, Week 24 and Week 48. The parameters assessed during the lipid profile were total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, triglycerides. Baseline was defined as the last pre-treatment value observed (typically from Day 1 visit). Percent change from Baseline for a parameter was calculated as the observed value minus the Baseline value divided by Baseline value multiplied by 100. Data for fasting lipid parameters has been summarized. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented as n=X in the category titles). Data for this outcome measure has been presented until Week 48 only (Randomized Phase) as per protocol. It was not planned for OLE Phase, hence data was not collected for OLE Phase. | Posted | Mean | Standard Deviation | Percent change | Baseline (Day 1), Week 24 and Week 48 |
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Fasting Lipid Profile for Total Cholesterol/HDL Ratio at Week 24 and Week 48 | Samples for lipid measurements were obtained in a fasted state at Baseline, Week 24 and Week 48. The parameter assessed during the lipid profile was total cholesterol/HDL ratio. Baseline was defined as the last pre-treatment value observed (typically from Day 1 visit). Change from baseline for a parameter was calculated as the observed value minus the Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented as n=X in the category titles). Data for this outcome measure has been presented until Week 48 only (Randomized Phase) as per protocol. It was not planned for OLE Phase, hence data was not collected for OLE Phase. | Posted | Mean | Standard Deviation | Ratio of total cholesterol to HDL | Baseline (Day 1), Week 24 and Week 48 |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Permanently Discontinued Study Treatment Due to AEs - Randomized Phase | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Data for percentage of participants who permanently discontinued study treatment due to any AE over 52 weeks has been summarized. | Safety Population | Posted | Number | Percentage of participants | Up to Week 52 |
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Permanently Discontinued Study Treatment Due to AEs - OLE Phase | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Data for percentage of participants who permanently discontinued study treatment due to any AE from Week 52 to Week 252 has been summarized. | Safety OLE Population | Posted | Number | Percentage of participants | Week 52 to Week 252 |
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| Secondary | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Participants were monitored for signs and symptoms of TB-assoc. IRIS. Participants with IRIS symptoms in any AE or HIV assoc. conditions were classified by Endpoint Adjudication Committee in following four categories: met criteria for TB-assoc. IRIS, possibly met criteria for TB-assoc. IRIS, suspected TB-assoc. IRIS but not possible to adjudicate and No TB associated IRIS. They were further graded from Grades 1 to 4 using DAIDS. Higher grade indicates more severity. The preliminary requirements to meet TB-assoc. IRIS criteria were diagnosis of TB and initial response to TB treatment (stabilized or improved condition of participant in presence of TB treatment before starting ART). The clinical criteria was onset of IRIS signs and symptoms related to TB should occur within first 3 months of starting, restarting or changing ART regimen for treatment failure. Number of participants who sent to the adjudication committee and analyzed were presented. | Safety Population. Only those participants with data available at the specified time points were analyzed. Data for this outcome measure has been presented until Week 12 only (Randomized phase) as per protocol. It was not planned for OLE Phase, hence data was not collected for OLE Phase. | Posted | Count of Participants | Participants | Up to Week 12 |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Genotypic Resistance | Whole venous blood samples were obtained from each participant until Week 52 for potential viral genotypic and phenotypic analyses. Genotypic and phenotypic testing was conducted for participants meeting confirmed virologic withdrawal criteria, i.e., confirmed HIV-1 RNA >=400 copies/milliliter from Week 24 onwards. Genotypic and phenotypic analyses was carried out by Monogram Biosciences using, but not limited to, their Standard Phenosense and GenoSure testing methods for protease (PRO), reverse transcriptase (RT), and integrase assays. Data for number of participants with treatment-emergent genotypic resistance mutations have been presented for the RT region on codons G190G, K101K, K103K, K65K, V106V and Y181Y. | Viral Genotypic Population comprised of all participants in the ITT-E Population with available on-treatment genotypic data at the time confirmed virologic withdrawal was met. | Posted | Count of Participants | Participants | Up to Week 52 |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Phenotypic Resistance | Phenotypic susceptibility to all licensed antiretroviral drugs, including DTG and EFV were determined using PhenoSense HIV assays from Monogram Inc. Clinical cutoffs or biological cutoffs by PhenoSense were used to define the phenotypic susceptibility of background treatment and were interpreted as fold change > clinical lower cut-off or biologic cut-off as resistance, fold change <=clinical lower cut-off or biologic cut-off as sensitive, and fold change > clinical higher cut-off as resistance, fold change <=clinical higher cut-off and > clinical lower cut-off as partially sensitive, and fold change <=clinical lower cut-off as sensitive. Data has been presented for participants with treatment-emergent phenotypic resistance. | Viral Phenotypic Population comprised of all participants in the ITT-E Population with available on-treatment phenotypic resistance data at the time confirmed virologic withdrawal criteria was met. Only participants available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | Count of Participants | Participants | Up to Week 52 |
|
Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase.
Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
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 | DTG 50 mg- Randomized Phase | In randomized phase, participants received DTG 50 mg tablet with or without food twice-daily with 2 NRTIs, TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through 52 weeks. | 0 | 69 | 5 | 69 | 38 | 69 |
| EG001 | EFV 600 mg- Randomized Phase | In randomized phase, participants received EFV 600 mg tablet administered without food plus 2 NRTIs, TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions through 52 weeks. | 0 | 44 | 5 | 44 | 33 | 44 |
| EG002 | DTG 50 mg- OLE Phase | In OLE Phase, participants received DTG 50 mg tablet until DTG became locally approved and commercially available. | 1 | 47 | 5 | 47 | 36 | 47 |
| EG003 | EFV 600 mg- OLE Phase | In OLE Phase, participants received EFV 600 mg tablet. | 0 | 19 | 2 | 19 | 16 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Immune reconstitution inflammatory syndrome associated tuberculosis | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Tuberculosis gastrointestinal | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA22.1 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA22.1 | Systematic Assessment |
| |
| Immune reconstitution inflammatory syndrome | Immune system disorders | MedDRA22.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA22.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA22.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA22.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA22.1 | Systematic Assessment |
| |
| Psoas abscess | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA22.1 | Systematic Assessment |
| |
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA22.1 | Systematic Assessment |
| |
| Hyperemesis gravidarum | Pregnancy, puerperium and perinatal conditions | MedDRA22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA22.1 | Systematic Assessment |
| |
| Hypocalcaemic seizure | Nervous system disorders | MedDRA22.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA22.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA22.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA22.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA22.1 | Systematic Assessment |
| |
| Ruptured ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA22.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA22.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA22.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA22.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA22.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA22.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA22.1 | Systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA22.1 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Tinea faciei | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Tuberculosis gastrointestinal | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Varicella zoster virus infection | Infections and infestations | MedDRA22.1 | Systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA22.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA22.1 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA22.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA22.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA22.1 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA22.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA22.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA22.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA22.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA22.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA22.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA22.1 | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA22.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA22.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA22.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA22.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA22.1 | Systematic Assessment |
| |
| Mass | General disorders | MedDRA22.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA22.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA22.1 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA22.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA22.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA22.1 | Systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA22.1 | Systematic Assessment |
| |
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA22.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA22.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA22.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA22.1 | 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 |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 11, 2020 | Dec 9, 2020 | SAP_003.pdf |
| ID | Term |
|---|---|
| D007239 | Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| D015658 | HIV Infections |
| D060085 | Coinfection |
| ID | Term |
|---|---|
| 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 |
|---|---|
| C562325 | dolutegravir |
| C098320 | efavirenz |
Not provided
Not provided
Not provided
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Reached Protocol defined stopping criteria |
|
| Lost to Follow-up |
|
| Male |
|
| American Indian or Alaska Native |
|
| Asian - South East Asian Heritage |
|
| White - Arabic/North African Heritage |
|
| White - White/Caucasian/European Heritage |
|
| Mixed Race |
|
|
|
| OG001 | EFV 600 mg | Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV. |
|
|
| OG001 | EFV 600 mg | Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV. |
|
|
Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
|
|
| OG001 | EFV 600 mg | Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV. |
|
|
| OG001 | EFV 600 mg | Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV. |
|
|
| OG001 | EFV 600 mg | Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV. |
|
|
| OG001 | EFV 600 mg | Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV. |
|
|
Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV. |
|
|
Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV. |
|
|
| OG001 | EFV 600 mg | Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV. |
|
|
| OG001 | EFV 600 mg | Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV. |
|
|
|
|
|
|
| OG001 | EFV 600 mg | Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV. |
|
|
| OG001 | EFV 600 mg | Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV. |
|
|
| OG001 | EFV 600 mg | Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV. |
|
|