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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_555 |
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A study to test the safety and effect of twice daily raltegravir in a diverse cohort of patients currently infected with human immunodeficiency virus (HIV), where at least 50% are African American and at least 25% are female, either having received antiretroviral drugs before or not.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | raltegravir |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: raltegravir | Drug | 400 mg tablets taken twice daily. Total treatment period is 48 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48 | Numbers of participants with HIV RNA copies <50 copies/mL were summarized by race for each time point. | Week 48 |
| Number of Participants With One or More Adverse Events | Numbers of participants with one or more adverse events were summarized by race. | Week 48 |
| Number of Participants Who Discontinued Due to an Adverse Event | Numbers of participants who discontinued due to an adverse event were summarized by race. | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48 | Numbers of participants with HIV RNA copies <400 copies/mL were summarized by race for each time point. | Week 48 |
| Mean Change From Baseline to Week 48 in HIV RNA |
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Inclusion Criteria:
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 |
|---|---|---|---|
| 23351187 | Result | Squires KE, Bekker LG, Eron JJ, Cheng B, Rockstroh JK, Marquez F, Kumar P, Thompson M, Campo RE, Mounzer K, Strohmaier KM, Lu C, Rodgers A, Jackson BE, Wenning LA, Robertson M, Nguyen BY, Sklar P; REALMRK Investigators. Safety, tolerability, and efficacy of raltegravir in a diverse cohort of HIV-infected patients: 48-week results from the REALMRK Study. AIDS Res Hum Retroviruses. 2013 Jun;29(6):859-70. doi: 10.1089/AID.2012.0292. Epub 2013 Feb 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants Failing Current Therapy | Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg twice daily (b.i.d.) plus other antiretroviral agents at the discretion of the investigator. |
| FG001 | Participants Intolerant to Current Therapy | Participants with previous HIV treatment experience who could not tolerate the treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator. |
| FG002 | Participants Treatment Naive | Participants with no previous HIV treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants Failing Current Therapy | Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator. |
| BG001 | Participants Intolerant to Current Therapy |
| Units | Counts |
|---|---|
| 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 | Participants who did not receive treatment are excluded from this measure. |
| 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 Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48 | Numbers of participants with HIV RNA copies <50 copies/mL were summarized by race for each time point. | Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had at least one postbaseline evaluation. The Treatment-Related Discontinuation = Failure approach was used as the primary method for handling missing HIV RNA values. | Posted | Number | Participants | Week 48 |
|
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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 | Treatment Experienced - Failing Current Therapy | Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator. |
| 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 |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharpe & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Mean changes from baseline in plasma HIV RNA were summarized by race at each time point.
| Baseline and Week 48 |
| Mean Change From Baseline to Week 48 in CD4 Cell Count | Mean changes from baseline in CD4 cell counts were summarized by race at each time point. | Baseline and Week 48 |
| Number of Participants Without Loss of Virologic Response | For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event free). | Week 48 |
| Physician Decision |
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| Adverse Event |
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| Withdrawal by Subject |
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| Never Treated |
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Participants with previous HIV treatment experience who could not tolerate the treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator. |
| BG002 | Participants Treatment Naive | Participants with no previous HIV treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Participants who did not receive treatment are excluded from this measure. | Count of Participants | Participants |
|
| Race | Participants who did not receive treatment are excluded from this measure. | Number | Participants |
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| OG001 | Treatment Experienced - Treatment Intolerant | Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator. |
| OG002 | Treatment Naive | Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator. |
|
|
| Secondary | Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48 | Numbers of participants with HIV RNA copies <400 copies/mL were summarized by race for each time point. | Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had at least one postbaseline evaluation. The Treatment-Related Discontinuation = Failure approach was used as the primary method for handling missing HIV RNA values. | Posted | Number | Participants | Week 48 |
|
|
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| Secondary | Mean Change From Baseline to Week 48 in HIV RNA | Mean changes from baseline in plasma HIV RNA were summarized by race at each time point. | Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had baseline and at least one postbaseline evaluation. Baseline values were carried forward for participants who discontinued before Week 48 due to lack of efficacy. | Posted | Mean | 95% Confidence Interval | log10 copies/mL | Baseline and Week 48 |
|
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| Secondary | Mean Change From Baseline to Week 48 in CD4 Cell Count | Mean changes from baseline in CD4 cell counts were summarized by race at each time point. | Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had baseline and at least one postbaseline evaluation. Baseline values were carried forward for participants who discontinued before Week 48 due to lack of efficacy. | Posted | Mean | 95% Confidence Interval | cells/mm^3 | Baseline and Week 48 |
|
|
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| Secondary | Number of Participants Without Loss of Virologic Response | For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event free). | Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had at least one postbaseline evaluation. | Posted | Number | participants | Week 48 |
|
|
|
| Primary | Number of Participants With One or More Adverse Events | Numbers of participants with one or more adverse events were summarized by race. | Posted | Number | Participants | Week 48 |
|
|
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| Primary | Number of Participants Who Discontinued Due to an Adverse Event | Numbers of participants who discontinued due to an adverse event were summarized by race. | Posted | Number | Participants | Week 48 |
|
|
|
| 15 |
| 97 |
| 49 |
| 97 |
| EG001 | Treatment Experienced - Intolerant To Current Therapy | Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator. | 5 | 88 | 26 | 88 |
| EG002 | Treatment Naive | Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator. | 2 | 21 | 10 | 21 |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Sensorineural hearing loss | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
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| Acute gastritis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Chronic diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Acute pharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Community acquired pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Cytomegalovirus colitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Facial abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Meningitis cryptococcal | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Pneumocystis pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Stress fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Bone neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
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| Lumbar radiculopathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Acute psychosis | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Depression worsened | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Exacerbation of asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Common cold | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Low back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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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.
| 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 |
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