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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_543 | Other Identifier | Merck Registration Number | |
| CTRI/2009/091/000145 | Registry Identifier | CTRI |
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Primary efficacy analysis at Week 48 did not demonstrate non-inferiority of raltegravir 800 mg once daily versus raltegravir 400 mg twice daily
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A study to evaluate the safety, tolerability and efficacy of once daily Raltegravir compared to twice daily raltegravir when each is given in combination with TRUVADA™ in treatment-naïve human immunodeficiency virus (HIV)-infected patients.
Following the 96-week double-blind study period (MK0518-071)(NCT00745823), subjects may enroll in an extension study (MK0518-071-10)(NCT00745823). From weeks 96 to 120, subjects' treatment assignments will remain as in the base study.
From week 120 to 240, all subjects will receive open-label raltegravir (800 mg, once daily) in combination with TRUVADA™.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raltegravir 400 mg b.i.d. | Active Comparator |
| |
| Raltegravir 800 mg q.d. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: Raltegravir 400 mg b.i.d. | Drug | Raltegravir 400 mg tablet by mouth (PO) twice daily (b.i.d.) + two raltegravir placebo tablets + one tablet of TRUVADA™ once daily (q.d.) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL at 48 Weeks | Week 48 | |
| Number of Participants With One or More Adverse Events at 48 Weeks | Week 48 | |
| Number of Participants Who Discontinued Due to an Adverse Event at 48 Weeks | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With HIV Ribonucleic Acid (RNA) <400 Copies/mL at 48 Weeks | 48 weeks | |
| Mean Change From Baseline to Week 48 in CD4 Cell Count | Baseline and Week 48 | |
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Inclusion Criteria:
Extension Study:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21933752 | Derived | Eron JJ Jr, Rockstroh JK, Reynes J, Andrade-Villanueva J, Ramalho-Madruga JV, Bekker LG, Young B, Katlama C, Gatell-Artigas JM, Arribas JR, Nelson M, Campbell H, Zhao J, Rodgers AJ, Rizk ML, Wenning L, Miller MD, Hazuda D, DiNubile MJ, Leavitt R, Isaacs R, Robertson MN, Sklar P, Nguyen BY; QDMRK Investigators. Raltegravir once daily or twice daily in previously untreated patients with HIV-1: a randomised, active-controlled, phase 3 non-inferiority trial. Lancet Infect Dis. 2011 Dec;11(12):907-15. doi: 10.1016/S1473-3099(11)70196-7. Epub 2011 Sep 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Raltegravir 800 mg q.d. | Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks |
| FG001 | Raltegravir 400 mg b.i.d. | Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Raltegravir 800 mg q.d. | Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks |
| BG001 | Raltegravir 400 mg b.i.d. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 HIV Ribonucleic Acid (RNA) <50 Copies/mL at 48 Weeks | Data were analyzed for all participants treated with study drug. Participants who did not complete the study were treated as treatment failures. | Posted | Number | Participants | Week 48 |
|
Overall Study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Raltegravir 800 mg q.d. | Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
The study was terminated before the 96-week efficacy analysis. Adverse event data were collected for the entire treatment period up to a maximum of Week 108, which defines the Overall Study period.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1- 800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Experimental: Raltegravir 800 mg q.d. | Drug | Raltegravir 800 mg tablet PO q.d. + two raltegravir placebo tablets + one tablet TRUVADA™ q.d. |
|
|
| TRUVADA™ | Drug | One tablet TRUVADA™ q.d. (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) |
|
| Number of Participants With HIV RNA <50 Copies/mL at 96 Weeks |
As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed. |
| Week 96 |
| Number of Participants With HIV RNA <400 Copies/mL at 96 Weeks | As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed. | Week 96 |
| Mean Change From Baseline to Week 96 in CD4 Cell Count | As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed. | Baseline and Week 96 |
| Number of Participants With One or More Adverse Events at 96 Weeks | As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed. | Week 96 |
| Number of Participants Who Discontinued Due to an Adverse Event at 96 Weeks | As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed. | Week 96 |
| Lost to Follow-up |
|
| Physician Decision |
|
| Pregnancy |
|
| Withdrawal by Subject |
|
| Study Terminated by Sponsor |
|
Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Number of Participants With HIV Ribonucleic Acid (RNA) <400 Copies/mL at 48 Weeks | Data were analyzed for all participants treated with study drug. Participants who did not complete the study were treated as treatment failures. | Posted | Number | Participants | 48 weeks |
|
|
|
|
| Primary | Number of Participants With One or More Adverse Events at 48 Weeks | Data were analyzed for all randomized participants who received at least one dose of study drug. | Posted | Number | Participants | Week 48 |
|
|
|
|
| Primary | Number of Participants Who Discontinued Due to an Adverse Event at 48 Weeks | Data were analyzed for all randomized participants who received at least one dose of study drug. | Posted | Number | Participants | Week 48 |
|
|
|
|
| Secondary | Mean Change From Baseline to Week 48 in CD4 Cell Count | Data were analyzed for all participants treated with study drug. Baseline values were carried forward for participants who discontinued treatment due to lack of efficacy. | Posted | Mean | 95% Confidence Interval | cells/mm^3 | Baseline and Week 48 |
|
|
|
|
| Secondary | Number of Participants With HIV RNA <50 Copies/mL at 96 Weeks | As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed. | The Week 96 data analysis was not performed. | Posted | Week 96 |
|
|
| Secondary | Number of Participants With HIV RNA <400 Copies/mL at 96 Weeks | As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed. | The Week 96 data analysis was not performed. | Posted | Week 96 |
|
|
| Secondary | Mean Change From Baseline to Week 96 in CD4 Cell Count | As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed. | The Week 96 data analysis was not performed. | Posted | Baseline and Week 96 |
|
|
| Secondary | Number of Participants With One or More Adverse Events at 96 Weeks | As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed. | Posted | Week 96 |
|
|
| Secondary | Number of Participants Who Discontinued Due to an Adverse Event at 96 Weeks | As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed. | Posted | Week 96 |
|
|
| 29 |
| 382 |
| 287 |
| 382 |
| EG001 | Raltegravir 400 mg b.i.d. | Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks | 46 | 388 | 282 | 388 |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Retroperitoneal lymphadenopathy | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Immune reconstitution syndrome | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abscess intestinal | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Abscess jaw | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Anogenital warts | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea infectious | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Eye infection syphilitic | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Histoplasmosis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Meningitis aseptic | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Meningitis cryptococcal | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Meningitis viral | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Mycobacterium avium complex infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Orchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Perirectal abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pneumonia pneumococcal | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Post procedural pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Shigella infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Multiple drug overdose | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Muscle injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Penis injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Anal cancer stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Burkitt's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Kaposi's sarcoma AIDS related | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Retroperitoneal neoplasm metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abnormal behaviour | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Epididymitis | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypoaesthesia facial | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
Twenty-four months after completion of this study or after publication of the multicenter results, an investigator may publish the results for their study site independently. The sponsor must have the opportunity to review all proposed publications or presentations regarding the study 60 days before submission.
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D000068698 |
| Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |