Trial Outcomes & Findings for Management of Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Antiretroviral (ARV) Combination Therapy Including Raltegravir (MK-0518-138) (NCT NCT01048671)
NCT ID: NCT01048671
Last Updated: 2015-10-30
Results Overview
Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. ARV treatments included any nucleoside reverse transcriptase inhibitors (NRTIs), combination of tenovir/emitricitabine (FTC/TDF), combination of lamivudine/abacavir (3TC/ABC), protease inhibitors, and others.
Recruitment status
COMPLETED
Target enrollment
482 participants
Primary outcome timeframe
Up to 25 months after start of raltegravir treatment
Results posted on
2015-10-30
Participant Flow
Of 482 participants included in the trial, 2 were excluded from analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.
Participant milestones
| Measure |
ARV naïve at Baseline
ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
Suppressed at Baseline
Suppressed participants had previous ARV experience and had a viral load \<50 ribonucleic acid (RNA) copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
Virological Failure at Baseline
Virological failure participants had previous ARV experience and had a viral load \>50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
|---|---|---|---|
|
Overall Study
STARTED
|
66
|
264
|
152
|
|
Overall Study
COMPLETED
|
66
|
263
|
151
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
ARV naïve at Baseline
ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
Suppressed at Baseline
Suppressed participants had previous ARV experience and had a viral load \<50 ribonucleic acid (RNA) copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
Virological Failure at Baseline
Virological failure participants had previous ARV experience and had a viral load \>50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
Baseline Characteristics
Management of Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Antiretroviral (ARV) Combination Therapy Including Raltegravir (MK-0518-138)
Baseline characteristics by cohort
| Measure |
ARV naïve at Baseline
n=66 Participants
ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
Suppressed at Baseline
n=263 Participants
Suppressed participants had previous ARV experience and had a viral load \<50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. One participant in this subgroup was excluded from analysis because of protocol violation (inclusion criterion not met).
|
Virological Failure at Baseline
n=151 Participants
Virological failure participants had previous ARV experience and had a viral load \>50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. One participant in this subgroup was excluded from analysis because of protocol violation (inclusion criterion not met).
|
Total
n=480 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.9 Years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
47.3 Years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
46.5 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
46.4 Years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
173 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
307 Participants
n=4 Participants
|
|
Time Since Human Immunodeficiency Virus (HIV) Infection Diagnosis
|
2.8 Years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
13.0 Years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
11.6 Years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
11.1 Years
STANDARD_DEVIATION 7.7 • n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 25 months after start of raltegravir treatmentPopulation: Two participants were excluded for protocol violation (inclusion criterion not met) and data were missing for 3 additional participants.
Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. ARV treatments included any nucleoside reverse transcriptase inhibitors (NRTIs), combination of tenovir/emitricitabine (FTC/TDF), combination of lamivudine/abacavir (3TC/ABC), protease inhibitors, and others.
Outcome measures
| Measure |
Antiretroviral Combination Therapy Including Raltegravir
n=477 Participants
Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
Suppressed at Baseline
Suppressed participants had previous ARV experience and had a viral load \<50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
Virological Failure at Baseline
Virological failure participants had previous ARV experience and had a viral load \>50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
All Participants
Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
|---|---|---|---|---|
|
Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir
FTC/TDF + raltegravir
|
44.4 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir
3TC/ABC + raltegravir
|
14.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir
Other 2 NRTIs + raltegravir
|
1.3 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir
Mulitple (>=3 ) ARV therapies + raltegravir
|
15.7 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir
Protease inhibitor + raltegravir
|
8.8 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir
Other strategies (each <5%)
|
15.7 Percentage of participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 months after start of raltegravir treatmentPopulation: All participants with a viral load assessment available at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.
Response to treatment was defined as a viral load \<50 RNA copies/mL
Outcome measures
| Measure |
Antiretroviral Combination Therapy Including Raltegravir
n=52 Participants
Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
Suppressed at Baseline
n=230 Participants
Suppressed participants had previous ARV experience and had a viral load \<50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
Virological Failure at Baseline
n=125 Participants
Virological failure participants had previous ARV experience and had a viral load \>50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
All Participants
n=407 Participants
Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
|---|---|---|---|---|
|
Percentage of Participants Responding to Treatment: All Treated Participants
|
94.2 Percentage of participants
Interval 87.9 to 100.6
|
94.3 Percentage of participants
Interval 91.4 to 97.3
|
71.2 Percentage of participants
Interval 63.3 to 79.1
|
87.2 Percentage of participants
Interval 84.0 to 90.5
|
PRIMARY outcome
Timeframe: 24 months after start of raltegravir treatmentPopulation: All participants with a viral load assessment available and receiving raltegravir treatment at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.
Response to treatment was defined as a viral load \<50 RNA copies/mL
Outcome measures
| Measure |
Antiretroviral Combination Therapy Including Raltegravir
n=39 Participants
Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
Suppressed at Baseline
n=194 Participants
Suppressed participants had previous ARV experience and had a viral load \<50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
Virological Failure at Baseline
n=94 Participants
Virological failure participants had previous ARV experience and had a viral load \>50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
All Participants
n=327 Participants
Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
|---|---|---|---|---|
|
Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24
|
94.9 Percentage of participants
Interval 87.9 to 101.8
|
95.4 Percentage of participants
Interval 92.4 to 98.3
|
77.7 Percentage of participants
Interval 69.2 to 86.1
|
90.2 Percentage of participants
Interval 87.0 to 93.4
|
PRIMARY outcome
Timeframe: Baseline and 24 months after start of raltegravir treatmentPopulation: All participants with a CD4 cell count available at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.
Outcome measures
| Measure |
Antiretroviral Combination Therapy Including Raltegravir
n=55 Participants
Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
Suppressed at Baseline
n=229 Participants
Suppressed participants had previous ARV experience and had a viral load \<50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
Virological Failure at Baseline
n=123 Participants
Virological failure participants had previous ARV experience and had a viral load \>50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
All Participants
n=407 Participants
Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants
|
260.58 cells/mm^3
Interval 208.75 to 312.41
|
47.97 cells/mm^3
Interval 19.57 to 76.36
|
149.98 cells/mm^3
Interval 113.71 to 186.26
|
107.53 cells/mm^3
Interval 85.8 to 129.29
|
PRIMARY outcome
Timeframe: Baseline and 24 months after start of raltegravir treatmentPopulation: All participants with a CD4 cell count available and receiving raltegravir treatment at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.
Outcome measures
| Measure |
Antiretroviral Combination Therapy Including Raltegravir
n=39 Participants
Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
Suppressed at Baseline
n=194 Participants
Suppressed participants had previous ARV experience and had a viral load \<50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
Virological Failure at Baseline
n=91 Participants
Virological failure participants had previous ARV experience and had a viral load \>50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
All Participants
n=324 Participants
Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
|---|---|---|---|---|
|
Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24
|
285.05 cells/mm^3
Interval 219.96 to 350.15
|
49.21 cells/mm^3
Interval 16.38 to 82.03
|
150.87 cells/mm^3
Interval 110.88 to 190.86
|
106.15 cells/mm^3
Interval 80.87 to 131.43
|
SECONDARY outcome
Timeframe: Up to 25 months after start of raltegravir treatmentPopulation: Participants enrolled and not excluded for a protocol violation were included in the analysis.
An adverse event was defined as any untoward, undesired, or unplanned clinical event in the form of physical signs, symptoms, disease, laboratory or physiological observations in a participant administered the sponsor's product whether or not related to the use of the product.
Outcome measures
| Measure |
Antiretroviral Combination Therapy Including Raltegravir
n=480 Participants
Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
Suppressed at Baseline
Suppressed participants had previous ARV experience and had a viral load \<50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
Virological Failure at Baseline
Virological failure participants had previous ARV experience and had a viral load \>50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
All Participants
Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
|---|---|---|---|---|
|
Number of Participants With at Least One Adverse Event
|
287 Participants
|
—
|
—
|
—
|
Adverse Events
Antiretroviral Combination Therapy Including Raltegravir
Serious events: 66 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Antiretroviral Combination Therapy Including Raltegravir
n=480 participants at risk
Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Blood and lymphatic system disorders
FEBRILE BONE MARROW APLASIA
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Cardiac disorders
CARDIAC DISORDER
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Cardiac disorders
CORONARY ARTERY STENOSIS
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Ear and labyrinth disorders
DEAFNESS
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Gastrointestinal disorders
ASCITES
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Gastrointestinal disorders
DIARRHOEA HAEMORRHAGIC
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Gastrointestinal disorders
INGUINAL HERNIA STRANGULATED
|
0.21%
1/480 • Number of events 2
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Gastrointestinal disorders
NAUSEA
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Gastrointestinal disorders
VOMITING
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
General disorders
ASTHENIA
|
0.42%
2/480 • Number of events 2
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
General disorders
CHEST PAIN
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
General disorders
DEATH
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.42%
2/480 • Number of events 2
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
General disorders
OEDEMA PERIPHERAL
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
General disorders
PAIN
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
General disorders
SWELLING
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Hepatobiliary disorders
CHOLESTASIS
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Hepatobiliary disorders
HEPATIC CIRRHOSIS
|
0.21%
1/480 • Number of events 2
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Immune system disorders
CRYOGLOBULINAEMIA
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Immune system disorders
IMMUNE RECONSTITUTION SYNDROME
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Infections and infestations
ABSCESS NECK
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Infections and infestations
CANDIDA SEPSIS
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Infections and infestations
CEREBRAL TOXOPLASMOSIS
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Infections and infestations
CYTOMEGALOVIRUS CHORIORETINITIS
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Infections and infestations
HISTOPLASMOSIS
|
0.21%
1/480 • Number of events 2
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Infections and infestations
HISTOPLASMOSIS DISSEMINATED
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Infections and infestations
LUNG INFECTION
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Infections and infestations
MENINGITIS VIRAL
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Infections and infestations
MYCOBACTERIAL INFECTION
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Infections and infestations
PNEUMOCYSTIS JIROVECI PNEUMONIA
|
0.42%
2/480 • Number of events 2
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Infections and infestations
POST PROCEDURAL INFECTION
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Infections and infestations
PULMONARY SEPSIS
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Infections and infestations
PYELONEPHRITIS
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Infections and infestations
SEPSIS
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Infections and infestations
SEPTIC SHOCK
|
0.42%
2/480 • Number of events 2
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Infections and infestations
TOOTH INFECTION
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Injury, poisoning and procedural complications
ACCIDENT
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Injury, poisoning and procedural complications
ALCOHOL POISONING
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Injury, poisoning and procedural complications
DEVICE FAILURE
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Injury, poisoning and procedural complications
POST-TRAUMATIC PAIN
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Investigations
SCAN
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Investigations
TRANSAMINASES INCREASED
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Investigations
WEIGHT DECREASED
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Metabolism and nutrition disorders
CACHEXIA
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Metabolism and nutrition disorders
MALNUTRITION
|
0.21%
1/480 • Number of events 2
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Metabolism and nutrition disorders
MITOCHONDRIAL CYTOPATHY
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Musculoskeletal and connective tissue disorders
FISTULA
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Musculoskeletal and connective tissue disorders
OSTEOPENIA
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CARCINOMA IN SITU
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CERVIX CARCINOMA
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ENDOMETRIAL CANCER
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOMA
|
0.21%
1/480 • Number of events 2
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-HODGKIN'S LYMPHOMA
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OROPHARYNGEAL CANCER STAGE UNSPECIFIED
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.21%
1/480 • Number of events 2
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Nervous system disorders
HEADACHE
|
0.62%
3/480 • Number of events 4
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Nervous system disorders
HEMIPARESIS
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Psychiatric disorders
ANXIETY
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Psychiatric disorders
DEPRESSION
|
1.0%
5/480 • Number of events 5
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Psychiatric disorders
LIBIDO DECREASED
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Psychiatric disorders
NEGATIVE THOUGHTS
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Psychiatric disorders
PARANOIA
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Psychiatric disorders
SCHIZOPHRENIA
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.83%
4/480 • Number of events 4
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Reproductive system and breast disorders
GYNAECOMASTIA
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.42%
2/480 • Number of events 2
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.42%
2/480 • Number of events 2
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Respiratory, thoracic and mediastinal disorders
HYPERCAPNIA
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
0.42%
2/480 • Number of events 2
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Skin and subcutaneous tissue disorders
ANGIOEDEMA
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Skin and subcutaneous tissue disorders
LIPODYSTROPHY ACQUIRED
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Surgical and medical procedures
BENIGN TUMOUR EXCISION
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Surgical and medical procedures
DENTAL OPERATION
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Surgical and medical procedures
HERNIA REPAIR
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Surgical and medical procedures
INGUINAL HERNIA REPAIR
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Surgical and medical procedures
LEG AMPUTATION
|
0.21%
1/480 • Number of events 2
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Surgical and medical procedures
PHLEBOTOMY
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Surgical and medical procedures
PULMONARY VALVE REPLACEMENT
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Surgical and medical procedures
TOOTH EXTRACTION
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Vascular disorders
HYPERTENSION
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
|
Vascular disorders
PHLEBITIS
|
0.21%
1/480 • Number of events 1
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
Other adverse events
| Measure |
Antiretroviral Combination Therapy Including Raltegravir
n=480 participants at risk
Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
|
|---|---|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
5.6%
27/480 • Number of events 27
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place