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This is an observational, non-comparative, multicenter, open-label study. Participants will be treated with Raltegravir according to standard clinical practice, and monitored over a total period of 96 weeks. In an extension to the study (Amendment 1), a new cohort of aging participants (≥ 50 years) will be recruited and monitored over a total period of 48 weeks. Participants who stop taking Raltegravir before the end of the 96-week period or 48-week period, respectively, will be followed up for 3 months after discontinuing the drug. The primary objective is to determine the proportion of participants with a human immunodeficiency virus (HIV)-1 viral load < 50 copies/mL after 48 weeks of treatment with Raltegravir.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overall Participants | HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany. |
| |
| Aging Participants | HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany. Includes newly enrolled participants ≥ 50 years of age (Amendment Cohort), plus participants from the Initial Cohort who were ≥ 50 years of age at time of recruitment and who completed 48 weeks of treatment (Prolonged Cohort). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltegravir | Drug | Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 48 or 144 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment | The percentage of participants with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined. | Baseline and 48 weeks |
| Percentage of Aging Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment | The percentage of aging participants (>=50 years old at initiation of raltegravir treatment) with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined. | Baseline and 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 96 Weeks of Raltegravir Treatment | The percentage of participants with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 96 weeks of raltegravir treatment was determined. | Baseline and 96 weeks |
| HIV-1 Viral Load After 96 Weeks of Raltegravir Treatment |
Not provided
Inclusion Criteria
The prospective participant must meet, at least, all of the criteria below to be eligible for study participation. The participant:
Exclusion criteria
If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation. The participant:
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Adults with confirmed HIV-1 infection
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20543702 | Background | Friis-Moller N, Thiebaut R, Reiss P, Weber R, Monforte AD, De Wit S, El-Sadr W, Fontas E, Worm S, Kirk O, Phillips A, Sabin CA, Lundgren JD, Law MG; DAD study group. Predicting the risk of cardiovascular disease in HIV-infected patients: the data collection on adverse effects of anti-HIV drugs study. Eur J Cardiovasc Prev Rehabil. 2010 Oct;17(5):491-501. doi: 10.1097/HJR.0b013e328336a150. | |
| 18212285 |
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The Initial Cohort included participants >=18 years old to receive treatment for 96 weeks. With the amendment, participants in the initial cohort >=50 years old could continue for an additional 48-weeks observation (Prolonged Cohort), and participants >=50 years old were newly enrolled to receive treatment for 48 weeks (Amendment Cohort).
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Participants | HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Raltegravir | Drug | Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 96, 144, or 48 weeks |
|
|
The HIV-1 viral load (log10 copies/mL of HIV-1 RNA) was determined at Baseline and after 96 weeks of raltegravir treatment. |
| Baseline and 96 weeks |
| Change From Baseline in CD4+ T-cell Counts After 96 Weeks of Raltegravir Treatment | Mean CD4+ T-cell counts were determined at baseline and after 96 weeks of raltegravir treatment. A positive change from baseline indicates an increase in CD4+ T-cell count. | Baseline and 96 weeks |
| HIV-1 Viral Load in Aging Participants After 48 Weeks of Raltegravir Treatment | The HIV-1 viral load (log10 copies/mL of HIV-1 RNA) was determined in aging participants (>=50 years old at initiation of raltegravir treatment) at Baseline and after 48 weeks of raltegravir treatment. | Baseline and 48 weeks |
| Change From Baseline in CD4+ T-cell Counts in Aging Participants After 48 Weeks of Raltegravir Treatment | Mean CD4+ T-cell counts were determined in aging participants (>=50 years old at initiation of raltegravir treatment) at baseline and after 48 weeks of raltegravir treatment was determined. A positive change from baseline indicates an increase in CD4+ T-cell count. | Baseline and 48 weeks |
| Change From Baseline in Mean Framingham Risk Score for the 10-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment | Mean Framingham Risk for 10-year cardiovascular risk was determined in aging participants (>=50 years old at initiation of raltegravir treatment). Points were allotted for each of following 8 risk factors : sex, age, systolic blood pressure, treatment for hypertension, smoking, diabetes, total cholesterol, and high-density lipoprotein. The sum of the points for each participant was assigned a percent 10-year cardiovascular risk on a lookup table, and could range from 0% to 100%. The mean Framingham Risk for 10-year cardiovascular risk was then calculated for the analysis population. The change from baseline was calculated as Baseline minus Week 48; a positive change indicates reduced risk. This Outcome Measure was added with Amendment 1 and applies only to aging participants. | Baseline and 48 weeks |
| Change From Baseline in Mean D:A:D Risk Score for the 5-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment | Mean Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Risk Score for 5-year cardiovascular risk was determined in aging participants (>=50 years old at initiation of raltegravir treatment) at Baseline and after 48 weeks of raltegravir treatment. The score included the following 8 risk factors: sex, age, systolic blood pressure, family cardiovascular disease history, current smoking, previous cigarette smoker, diabetes, total cholesterol, high-density lipoprotein, currently on indinavir, currently on lopinavir, currently on abacavir, duration and current use of indinavir and duration and current use of lopinavir. The D:A:D Risk Score is interpreted as low: <1%; moderate: 1-5%; high: 5-10%; and very high: >10%. The change from baseline was calculated as Week 48 minus Baseline; a positive change indicates increased risk. This Outcome Measure was added with Amendment 1 and applies only to aging participants. | Baseline and 48 weeks |
| Percentage of Aging Participants With Concomitant Diseases at Baseline | The percentage of aging participants with Baseline comorbidities was reported. This Outcome Measure was added with Amendment 1 and applies only to aging participants. | Baseline |
| Percentage of Aging Participants Taking Concomitant Medications at Baseline | The percentage of aging participants taking concomitant medication in addition to their other antiretroviral therapy was reported. This Outcome Measure was added with Amendment 1 and applies only to aging participants. | Baseline |
| Background |
| D'Agostino RB Sr, Vasan RS, Pencina MJ, Wolf PA, Cobain M, Massaro JM, Kannel WB. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. 2008 Feb 12;117(6):743-53. doi: 10.1161/CIRCULATIONAHA.107.699579. Epub 2008 Jan 22. |
| 1985385 | Background | Anderson KM, Odell PM, Wilson PW, Kannel WB. Cardiovascular disease risk profiles. Am Heart J. 1991 Jan;121(1 Pt 2):293-8. doi: 10.1016/0002-8703(91)90861-b. |
| 1984895 | Background | Anderson KM, Wilson PW, Odell PM, Kannel WB. An updated coronary risk profile. A statement for health professionals. Circulation. 1991 Jan;83(1):356-62. doi: 10.1161/01.cir.83.1.356. No abstract available. |
| 28385065 | Derived | Naumann U, Moll A, Schleehauf D, Lutz T, Schmidt W, Jaeger H, Funke B, Witte V. Similar efficacy and tolerability of raltegravir-based antiretroviral therapy in HIV-infected patients, irrespective of age group, burden of comorbidities and concomitant medication: Real-life analysis of the German 'WIP' cohort. Int J STD AIDS. 2017 Aug;28(9):893-901. doi: 10.1177/0956462416679550. Epub 2016 Nov 14. |
| Amendment Cohort: Prolonged Participants |
|
| Amendment Cohort: Newly Enrolled |
|
| Discontinued Treatment Before 48 Weeks |
|
| Initial Cohort |
|
| COMPLETED |
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| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment | The percentage of participants with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined. | The analysis set included all participants who received at least one dose of raltegravir during the observation period. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline and 48 weeks |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Percentage of Aging Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment | The percentage of aging participants (>=50 years old at initiation of raltegravir treatment) with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined. | The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline and 48 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 96 Weeks of Raltegravir Treatment | The percentage of participants with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 96 weeks of raltegravir treatment was determined. | The analysis set included participants in the Initial Cohort who received at least one dose of raltegravir during the observation period. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline and 96 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | HIV-1 Viral Load After 96 Weeks of Raltegravir Treatment | The HIV-1 viral load (log10 copies/mL of HIV-1 RNA) was determined at Baseline and after 96 weeks of raltegravir treatment. | The analysis set included participants in the Initial Cohort who received at least one dose of raltegravir during the observation period. | Posted | Mean | Standard Deviation | Log10 Copies/mL | Baseline and 96 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD4+ T-cell Counts After 96 Weeks of Raltegravir Treatment | Mean CD4+ T-cell counts were determined at baseline and after 96 weeks of raltegravir treatment. A positive change from baseline indicates an increase in CD4+ T-cell count. | The analysis set included participants in the Initial Cohort who received at least one dose of raltegravir during the observation period. | Posted | Mean | Standard Deviation | CD4+ T-cells/µL | Baseline and 96 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | HIV-1 Viral Load in Aging Participants After 48 Weeks of Raltegravir Treatment | The HIV-1 viral load (log10 copies/mL of HIV-1 RNA) was determined in aging participants (>=50 years old at initiation of raltegravir treatment) at Baseline and after 48 weeks of raltegravir treatment. | The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period. | Posted | Mean | Standard Deviation | Log10 Copies/mL | Baseline and 48 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD4+ T-cell Counts in Aging Participants After 48 Weeks of Raltegravir Treatment | Mean CD4+ T-cell counts were determined in aging participants (>=50 years old at initiation of raltegravir treatment) at baseline and after 48 weeks of raltegravir treatment was determined. A positive change from baseline indicates an increase in CD4+ T-cell count. | The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period. | Posted | Mean | Standard Deviation | CD4+ T-cells/µL | Baseline and 48 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Framingham Risk Score for the 10-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment | Mean Framingham Risk for 10-year cardiovascular risk was determined in aging participants (>=50 years old at initiation of raltegravir treatment). Points were allotted for each of following 8 risk factors : sex, age, systolic blood pressure, treatment for hypertension, smoking, diabetes, total cholesterol, and high-density lipoprotein. The sum of the points for each participant was assigned a percent 10-year cardiovascular risk on a lookup table, and could range from 0% to 100%. The mean Framingham Risk for 10-year cardiovascular risk was then calculated for the analysis population. The change from baseline was calculated as Baseline minus Week 48; a positive change indicates reduced risk. This Outcome Measure was added with Amendment 1 and applies only to aging participants. | The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period and had evaluable results. | Posted | Mean | Standard Deviation | Percentage risk | Baseline and 48 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean D:A:D Risk Score for the 5-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment | Mean Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Risk Score for 5-year cardiovascular risk was determined in aging participants (>=50 years old at initiation of raltegravir treatment) at Baseline and after 48 weeks of raltegravir treatment. The score included the following 8 risk factors: sex, age, systolic blood pressure, family cardiovascular disease history, current smoking, previous cigarette smoker, diabetes, total cholesterol, high-density lipoprotein, currently on indinavir, currently on lopinavir, currently on abacavir, duration and current use of indinavir and duration and current use of lopinavir. The D:A:D Risk Score is interpreted as low: <1%; moderate: 1-5%; high: 5-10%; and very high: >10%. The change from baseline was calculated as Week 48 minus Baseline; a positive change indicates increased risk. This Outcome Measure was added with Amendment 1 and applies only to aging participants. | The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period and had evaluable results. | Posted | Mean | Standard Deviation | Percentage risk | Baseline and 48 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Aging Participants With Concomitant Diseases at Baseline | The percentage of aging participants with Baseline comorbidities was reported. This Outcome Measure was added with Amendment 1 and applies only to aging participants. | The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period. | Posted | Number | Percentage of participants | Baseline |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Aging Participants Taking Concomitant Medications at Baseline | The percentage of aging participants taking concomitant medication in addition to their other antiretroviral therapy was reported. This Outcome Measure was added with Amendment 1 and applies only to aging participants. | The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period. | Posted | Number | Percentage of participants | Baseline |
|
|
Overall Participants: up to 48 weeks; Initial Cohort Participants: up to 96 weeks; Aging Participants: up to 48 weeks.
Overall Participants and Aging Participants: MedDRA version 17.1; Initial Cohort Participants: MedDRA version 14.1.
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 | Overall Participants | HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany. | 34 | 451 | 0 | 451 | ||
| EG001 | Initial Cohort Participants | HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany. | 25 | 272 | 0 | 272 | ||
| EG002 | Aging Participants | HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany. | 17 | 227 | 0 | 227 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia megaloblastic | Blood and lymphatic system disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Spirochaetal infection | Infections and infestations | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Electrocardiogram Q wave abnormal | Investigations | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Kaposi's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Salivary gland cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Respiratory tract haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Cholecystectomy | Surgical and medical procedures | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Syphilis | Infections and infestations | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Vascular disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 14.1 and 17.1 | Systematic Assessment |
|
Not provided
The results of this study will be published by the sponsor according to the current guidelines for publication. The Contract Research Organization will assist the sponsor with initial publication. Further details will be laid down in the financial agreement between the sponsor and the Contract Research Organization.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & 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 |
| 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 |
|---|---|
| D000068898 | Raltegravir Potassium |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
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|
|
|
|