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Management of Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Antiretroviral (ARV) Combination Therapy Including Raltegravir (MK-0518-138) (RACING)

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ClinicalTrials.gov Identifier: NCT01048671
Recruitment Status : Completed
First Posted : January 14, 2010
Results First Posted : February 14, 2014
Last Update Posted : October 30, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition HIV Infections
Interventions Drug: Raltegravir
Drug: ARV (non-raltegravir)
Enrollment 482
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title ARV naïve at Baseline Suppressed at Baseline Virological Failure at Baseline
Hide Arm/Group Description 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 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 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.
Period Title: Overall Study
Started 66 264 152
Completed 66 263 151
Not Completed 0 1 1
Reason Not Completed
Protocol Violation             0             1             1
Arm/Group Title ARV naïve at Baseline Suppressed at Baseline Virological Failure at Baseline Total
Hide Arm/Group Description 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 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 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 of all reporting groups
Overall Number of Baseline Participants 66 263 151 480
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 263 participants 151 participants 480 participants
42.9  (12.0) 47.3  (10.1) 46.5  (10.4) 46.4  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 263 participants 151 participants 480 participants
Female
17
  25.8%
91
  34.6%
65
  43.0%
173
  36.0%
Male
49
  74.2%
172
  65.4%
86
  57.0%
307
  64.0%
Time Since Human Immunodeficiency Virus (HIV) Infection Diagnosis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 263 participants 151 participants 480 participants
2.8  (4.7) 13.0  (7.0) 11.6  (7.5) 11.1  (7.7)
1.Primary Outcome
Title Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir
Hide Description 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.
Time Frame Up to 25 months after start of raltegravir treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two participants were excluded for protocol violation (inclusion criterion not met) and data were missing for 3 additional participants.
Arm/Group Title Antiretroviral Combination Therapy Including Raltegravir
Hide Arm/Group Description:
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 Number of Participants Analyzed 477
Measure Type: Number
Unit of Measure: Percentage of participants
FTC/TDF + raltegravir 44.4
3TC/ABC + raltegravir 14.0
Other 2 NRTIs + raltegravir 1.3
Mulitple (>=3 ) ARV therapies + raltegravir 15.7
Protease inhibitor + raltegravir 8.8
Other strategies (each <5%) 15.7
2.Primary Outcome
Title Percentage of Participants Responding to Treatment: All Treated Participants
Hide Description Response to treatment was defined as a viral load <50 RNA copies/mL
Time Frame 24 months after start of raltegravir treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ARV naïve at Baseline Suppressed at Baseline Virological Failure at Baseline All Participants
Hide Arm/Group Description:
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 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 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.
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 Number of Participants Analyzed 52 230 125 407
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
94.2
(87.9 to 100.6)
94.3
(91.4 to 97.3)
71.2
(63.3 to 79.1)
87.2
(84.0 to 90.5)
3.Primary Outcome
Title Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24
Hide Description Response to treatment was defined as a viral load <50 RNA copies/mL
Time Frame 24 months after start of raltegravir treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ARV naïve at Baseline Suppressed at Baseline Virological Failure at Baseline All Participants
Hide Arm/Group Description:
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 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 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.
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 Number of Participants Analyzed 39 194 94 327
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
94.9
(87.9 to 101.8)
95.4
(92.4 to 98.3)
77.7
(69.2 to 86.1)
90.2
(87.0 to 93.4)
4.Primary Outcome
Title Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants
Hide Description [Not Specified]
Time Frame Baseline and 24 months after start of raltegravir treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ARV naïve at Baseline Suppressed at Baseline Virological Failure at Baseline All Participants
Hide Arm/Group Description:
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 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 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.
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 Number of Participants Analyzed 55 229 123 407
Mean (95% Confidence Interval)
Unit of Measure: cells/mm^3
260.58
(208.75 to 312.41)
47.97
(19.57 to 76.36)
149.98
(113.71 to 186.26)
107.53
(85.80 to 129.29)
5.Primary Outcome
Title Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24
Hide Description [Not Specified]
Time Frame Baseline and 24 months after start of raltegravir treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ARV naïve at Baseline Suppressed at Baseline Virological Failure at Baseline All Participants
Hide Arm/Group Description:
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 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 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.
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 Number of Participants Analyzed 39 194 91 324
Mean (95% Confidence Interval)
Unit of Measure: cells/mm^3
285.05
(219.96 to 350.15)
49.21
(16.38 to 82.03)
150.87
(110.88 to 190.86)
106.15
(80.87 to 131.43)
6.Secondary Outcome
Title Number of Participants With at Least One Adverse Event
Hide Description 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.
Time Frame Up to 25 months after start of raltegravir treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled and not excluded for a protocol violation were included in the analysis.
Arm/Group Title Antiretroviral Combination Therapy Including Raltegravir
Hide Arm/Group Description:
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 Number of Participants Analyzed 480
Measure Type: Number
Unit of Measure: Participants
287
Time Frame [Not Specified]
Adverse Event Reporting Description Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
 
Arm/Group Title Antiretroviral Combination Therapy Including Raltegravir
Hide Arm/Group Description 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-Cause Mortality
Antiretroviral Combination Therapy Including Raltegravir
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Antiretroviral Combination Therapy Including Raltegravir
Affected / at Risk (%) # Events
Total   66/480 (13.75%)    
Blood and lymphatic system disorders   
ANAEMIA † 1  1/480 (0.21%)  1
FEBRILE BONE MARROW APLASIA † 1  1/480 (0.21%)  1
NEUTROPENIA † 1  1/480 (0.21%)  1
Cardiac disorders   
ANGINA PECTORIS † 1  1/480 (0.21%)  1
CARDIAC DISORDER † 1  1/480 (0.21%)  1
CARDIAC FAILURE † 1  1/480 (0.21%)  1
CARDIO-RESPIRATORY ARREST † 1  1/480 (0.21%)  1
CARDIOGENIC SHOCK † 1  1/480 (0.21%)  1
CORONARY ARTERY STENOSIS † 1  1/480 (0.21%)  1
PERICARDIAL EFFUSION † 1  1/480 (0.21%)  1
Ear and labyrinth disorders   
DEAFNESS † 1  1/480 (0.21%)  1
Gastrointestinal disorders   
ASCITES † 1  1/480 (0.21%)  1
DIARRHOEA † 1  1/480 (0.21%)  1
DIARRHOEA HAEMORRHAGIC † 1  1/480 (0.21%)  1
GASTROINTESTINAL HAEMORRHAGE † 1  1/480 (0.21%)  1
INGUINAL HERNIA † 1  1/480 (0.21%)  1
INGUINAL HERNIA STRANGULATED † 1  1/480 (0.21%)  2
NAUSEA † 1  1/480 (0.21%)  1
PANCREATITIS ACUTE † 1  1/480 (0.21%)  1
VOMITING † 1  1/480 (0.21%)  1
General disorders   
ASTHENIA † 1  2/480 (0.42%)  2
CHEST PAIN † 1  1/480 (0.21%)  1
DEATH † 1  1/480 (0.21%)  1
GENERAL PHYSICAL HEALTH DETERIORATION † 1  2/480 (0.42%)  2
INFLUENZA LIKE ILLNESS † 1  1/480 (0.21%)  1
MULTI-ORGAN FAILURE † 1  1/480 (0.21%)  1
OEDEMA PERIPHERAL † 1  1/480 (0.21%)  1
PAIN † 1  1/480 (0.21%)  1
SWELLING † 1  1/480 (0.21%)  1
Hepatobiliary disorders   
CHOLESTASIS † 1  1/480 (0.21%)  1
HEPATIC CIRRHOSIS † 1  1/480 (0.21%)  2
Immune system disorders   
CRYOGLOBULINAEMIA † 1  1/480 (0.21%)  1
IMMUNE RECONSTITUTION SYNDROME † 1  1/480 (0.21%)  1
Infections and infestations   
ABSCESS NECK † 1  1/480 (0.21%)  1
BRONCHOPNEUMONIA † 1  1/480 (0.21%)  1
CANDIDA SEPSIS † 1  1/480 (0.21%)  1
CEREBRAL TOXOPLASMOSIS † 1  1/480 (0.21%)  1
CLOSTRIDIUM DIFFICILE COLITIS † 1  1/480 (0.21%)  1
CYTOMEGALOVIRUS CHORIORETINITIS † 1  1/480 (0.21%)  1
HISTOPLASMOSIS † 1  1/480 (0.21%)  2
HISTOPLASMOSIS DISSEMINATED † 1  1/480 (0.21%)  1
LUNG INFECTION † 1  1/480 (0.21%)  1
MENINGITIS VIRAL † 1  1/480 (0.21%)  1
MYCOBACTERIAL INFECTION † 1  1/480 (0.21%)  1
PNEUMOCYSTIS JIROVECI PNEUMONIA † 1  2/480 (0.42%)  2
POST PROCEDURAL INFECTION † 1  1/480 (0.21%)  1
PULMONARY SEPSIS † 1  1/480 (0.21%)  1
PYELONEPHRITIS † 1  1/480 (0.21%)  1
SEPSIS † 1  1/480 (0.21%)  1
SEPTIC SHOCK † 1  2/480 (0.42%)  2
STAPHYLOCOCCAL INFECTION † 1  1/480 (0.21%)  1
TOOTH INFECTION † 1  1/480 (0.21%)  1
Injury, poisoning and procedural complications   
ACCIDENT † 1  1/480 (0.21%)  1
ALCOHOL POISONING † 1  1/480 (0.21%)  1
DEVICE FAILURE † 1  1/480 (0.21%)  1
FOOT FRACTURE † 1  1/480 (0.21%)  1
HEAD INJURY † 1  1/480 (0.21%)  1
POST-TRAUMATIC PAIN † 1  1/480 (0.21%)  1
Investigations   
BLOOD CREATINE PHOSPHOKINASE INCREASED † 1  1/480 (0.21%)  1
SCAN † 1  1/480 (0.21%)  1
TRANSAMINASES INCREASED † 1  1/480 (0.21%)  1
WEIGHT DECREASED † 1  1/480 (0.21%)  1
Metabolism and nutrition disorders   
CACHEXIA † 1  1/480 (0.21%)  1
MALNUTRITION † 1  1/480 (0.21%)  2
MITOCHONDRIAL CYTOPATHY † 1  1/480 (0.21%)  1
Musculoskeletal and connective tissue disorders   
ARTHRALGIA † 1  1/480 (0.21%)  1
FISTULA † 1  1/480 (0.21%)  1
INTERVERTEBRAL DISC PROTRUSION † 1  1/480 (0.21%)  1
MYALGIA † 1  1/480 (0.21%)  1
OSTEOPENIA † 1  1/480 (0.21%)  1
OSTEOPOROSIS † 1  1/480 (0.21%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
CARCINOMA IN SITU † 1  1/480 (0.21%)  1
CERVIX CARCINOMA † 1  1/480 (0.21%)  1
ENDOMETRIAL CANCER † 1  1/480 (0.21%)  1
LYMPHOMA † 1  1/480 (0.21%)  2
NON-HODGKIN'S LYMPHOMA † 1  1/480 (0.21%)  1
OROPHARYNGEAL CANCER STAGE UNSPECIFIED † 1  1/480 (0.21%)  1
Nervous system disorders   
CEREBROVASCULAR ACCIDENT † 1  1/480 (0.21%)  2
HEADACHE † 1  3/480 (0.63%)  4
HEMIPARESIS † 1  1/480 (0.21%)  1
ISCHAEMIC STROKE † 1  1/480 (0.21%)  1
Psychiatric disorders   
ANXIETY † 1  1/480 (0.21%)  1
DEPRESSION † 1  5/480 (1.04%)  5
LIBIDO DECREASED † 1  1/480 (0.21%)  1
NEGATIVE THOUGHTS † 1  1/480 (0.21%)  1
PARANOIA † 1  1/480 (0.21%)  1
SCHIZOPHRENIA † 1  1/480 (0.21%)  1
SUICIDE ATTEMPT † 1  4/480 (0.83%)  4
Renal and urinary disorders   
RENAL FAILURE † 1  1/480 (0.21%)  1
Reproductive system and breast disorders   
GYNAECOMASTIA † 1  1/480 (0.21%)  1
PELVIC PAIN † 1  1/480 (0.21%)  1
Respiratory, thoracic and mediastinal disorders   
ACUTE RESPIRATORY DISTRESS SYNDROME † 1  1/480 (0.21%)  1
ACUTE RESPIRATORY FAILURE † 1  1/480 (0.21%)  1
CHRONIC OBSTRUCTIVE PULMONARY DISEASE † 1  2/480 (0.42%)  2
COUGH † 1  2/480 (0.42%)  2
DYSPNOEA † 1  1/480 (0.21%)  1
HYPERCAPNIA † 1  1/480 (0.21%)  1
LUNG DISORDER † 1  2/480 (0.42%)  2
PLEURAL EFFUSION † 1  1/480 (0.21%)  1
PNEUMOTHORAX † 1  1/480 (0.21%)  1
RESPIRATORY FAILURE † 1  1/480 (0.21%)  1
Skin and subcutaneous tissue disorders   
ANGIOEDEMA † 1  1/480 (0.21%)  1
ECCHYMOSIS † 1  1/480 (0.21%)  1
LIPODYSTROPHY ACQUIRED † 1  1/480 (0.21%)  1
PRURITUS † 1  1/480 (0.21%)  1
RASH † 1  1/480 (0.21%)  1
Surgical and medical procedures   
BENIGN TUMOUR EXCISION † 1  1/480 (0.21%)  1
DENTAL OPERATION † 1  1/480 (0.21%)  1
HERNIA REPAIR † 1  1/480 (0.21%)  1
INGUINAL HERNIA REPAIR † 1  1/480 (0.21%)  1
LEG AMPUTATION † 1  1/480 (0.21%)  2
PHLEBOTOMY † 1  1/480 (0.21%)  1
PULMONARY VALVE REPLACEMENT † 1  1/480 (0.21%)  1
TOOTH EXTRACTION † 1  1/480 (0.21%)  1
Vascular disorders   
HYPERTENSION † 1  1/480 (0.21%)  1
PERIPHERAL ISCHAEMIA † 1  1/480 (0.21%)  1
PHLEBITIS † 1  1/480 (0.21%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Antiretroviral Combination Therapy Including Raltegravir
Affected / at Risk (%) # Events
Total   27/480 (5.63%)    
Metabolism and nutrition disorders   
VITAMIN D DEFICIENCY † 1  27/480 (5.63%)  27
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01048671     History of Changes
Other Study ID Numbers: 0518-138
MK0518-138
First Submitted: January 12, 2010
First Posted: January 14, 2010
Results First Submitted: December 23, 2013
Results First Posted: February 14, 2014
Last Update Posted: October 30, 2015