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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01048671
First received: January 12, 2010
Last updated: June 23, 2014
Last verified: June 2014
Results First Received: December 23, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: HIV Infections
Interventions: Drug: Raltegravir
Drug: ARV (non-raltegravir)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    ARV naïve at Baseline     Suppressed at Baseline     Virological Failure at Baseline  
STARTED     66     264     152  
COMPLETED     66     263     151  
NOT COMPLETED     0     1     1  
Protocol Violation                 0                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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 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 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 Total of all reporting groups

Baseline Measures
    ARV naïve at Baseline     Suppressed at Baseline     Virological Failure at Baseline     Total  
Number of Participants  
[units: participants]
  66     263     151     480  
Age  
[units: Years]
Mean ± Standard Deviation
  42.9  ± 12.0     47.3  ± 10.1     46.5  ± 10.4     46.4  ± 10.6  
Gender  
[units: Participants]
       
Female     17     91     65     173  
Male     49     172     86     307  
Time Since Human Immunodeficiency Virus (HIV) Infection Diagnosis  
[units: Years]
Mean ± Standard Deviation
  2.8  ± 4.7     13.0  ± 7.0     11.6  ± 7.5     11.1  ± 7.7  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir   [ Time Frame: Up to 25 months after start of raltegravir treatment ]

2.  Primary:   Percentage of Participants Responding to Treatment: All Treated Participants   [ Time Frame: 24 months after start of raltegravir treatment ]

3.  Primary:   Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24   [ Time Frame: 24 months after start of raltegravir treatment ]

4.  Primary:   Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants   [ Time Frame: Baseline and 24 months after start of raltegravir treatment ]

5.  Primary:   Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24   [ Time Frame: Baseline and 24 months after start of raltegravir treatment ]

6.  Secondary:   Number of Participants With at Least One Adverse Event   [ Time Frame: Up to 25 months after start of raltegravir treatment ]


  Serious Adverse Events
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Time Frame No text entered.
Additional Description Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).

Reporting Groups
  Description
Antiretroviral Combination Therapy Including Raltegravir 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.

Serious Adverse Events
    Antiretroviral Combination Therapy Including Raltegravir  
Total, serious adverse events    
# participants affected / at risk     66/480 (13.75%)  
Blood and lymphatic system disorders    
ANAEMIA † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
FEBRILE BONE MARROW APLASIA † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
NEUTROPENIA † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
Cardiac disorders    
ANGINA PECTORIS † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
CARDIAC DISORDER † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
CARDIAC FAILURE † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
CARDIO-RESPIRATORY ARREST † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
CARDIOGENIC SHOCK † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
CORONARY ARTERY STENOSIS † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
PERICARDIAL EFFUSION † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
Ear and labyrinth disorders    
DEAFNESS † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
Gastrointestinal disorders    
ASCITES † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
DIARRHOEA † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
DIARRHOEA HAEMORRHAGIC † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
GASTROINTESTINAL HAEMORRHAGE † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
INGUINAL HERNIA † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
INGUINAL HERNIA STRANGULATED † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     2  
NAUSEA † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
PANCREATITIS ACUTE † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
VOMITING † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
General disorders    
ASTHENIA † 1  
# participants affected / at risk     2/480 (0.42%)  
# events     2  
CHEST PAIN † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
DEATH † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
GENERAL PHYSICAL HEALTH DETERIORATION † 1  
# participants affected / at risk     2/480 (0.42%)  
# events     2  
INFLUENZA LIKE ILLNESS † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
MULTI-ORGAN FAILURE † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
OEDEMA PERIPHERAL † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
PAIN † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
SWELLING † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
Hepatobiliary disorders    
CHOLESTASIS † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
HEPATIC CIRRHOSIS † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     2  
Immune system disorders    
CRYOGLOBULINAEMIA † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
IMMUNE RECONSTITUTION SYNDROME † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
Infections and infestations    
ABSCESS NECK † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
BRONCHOPNEUMONIA † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
CANDIDA SEPSIS † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
CEREBRAL TOXOPLASMOSIS † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
CLOSTRIDIUM DIFFICILE COLITIS † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
CYTOMEGALOVIRUS CHORIORETINITIS † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
HISTOPLASMOSIS † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     2  
HISTOPLASMOSIS DISSEMINATED † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
LUNG INFECTION † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
MENINGITIS VIRAL † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
MYCOBACTERIAL INFECTION † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
PNEUMOCYSTIS JIROVECI PNEUMONIA † 1  
# participants affected / at risk     2/480 (0.42%)  
# events     2  
POST PROCEDURAL INFECTION † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
PULMONARY SEPSIS † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
PYELONEPHRITIS † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
SEPSIS † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
SEPTIC SHOCK † 1  
# participants affected / at risk     2/480 (0.42%)  
# events     2  
STAPHYLOCOCCAL INFECTION † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
TOOTH INFECTION † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
Injury, poisoning and procedural complications    
ACCIDENT † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
ALCOHOL POISONING † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
DEVICE FAILURE † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
FOOT FRACTURE † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
HEAD INJURY † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
POST-TRAUMATIC PAIN † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
Investigations    
BLOOD CREATINE PHOSPHOKINASE INCREASED † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
SCAN † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
TRANSAMINASES INCREASED † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
WEIGHT DECREASED † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
Metabolism and nutrition disorders    
CACHEXIA † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
MALNUTRITION † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     2  
MITOCHONDRIAL CYTOPATHY † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
Musculoskeletal and connective tissue disorders    
ARTHRALGIA † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
FISTULA † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
INTERVERTEBRAL DISC PROTRUSION † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
MYALGIA † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
OSTEOPENIA † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
OSTEOPOROSIS † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
CARCINOMA IN SITU † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
CERVIX CARCINOMA † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
ENDOMETRIAL CANCER † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
LYMPHOMA † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     2  
NON-HODGKIN'S LYMPHOMA † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
OROPHARYNGEAL CANCER STAGE UNSPECIFIED † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
Nervous system disorders    
CEREBROVASCULAR ACCIDENT † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     2  
HEADACHE † 1  
# participants affected / at risk     3/480 (0.63%)  
# events     4  
HEMIPARESIS † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
ISCHAEMIC STROKE † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
Psychiatric disorders    
ANXIETY † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
DEPRESSION † 1  
# participants affected / at risk     5/480 (1.04%)  
# events     5  
LIBIDO DECREASED † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
NEGATIVE THOUGHTS † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
PARANOIA † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
SCHIZOPHRENIA † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
SUICIDE ATTEMPT † 1  
# participants affected / at risk     4/480 (0.83%)  
# events     4  
Renal and urinary disorders    
RENAL FAILURE † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
Reproductive system and breast disorders    
GYNAECOMASTIA † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
PELVIC PAIN † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
Respiratory, thoracic and mediastinal disorders    
ACUTE RESPIRATORY DISTRESS SYNDROME † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
ACUTE RESPIRATORY FAILURE † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
CHRONIC OBSTRUCTIVE PULMONARY DISEASE † 1  
# participants affected / at risk     2/480 (0.42%)  
# events     2  
COUGH † 1  
# participants affected / at risk     2/480 (0.42%)  
# events     2  
DYSPNOEA † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
HYPERCAPNIA † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
LUNG DISORDER † 1  
# participants affected / at risk     2/480 (0.42%)  
# events     2  
PLEURAL EFFUSION † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
PNEUMOTHORAX † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
RESPIRATORY FAILURE † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
Skin and subcutaneous tissue disorders    
ANGIOEDEMA † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
ECCHYMOSIS † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
LIPODYSTROPHY ACQUIRED † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
PRURITUS † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
RASH † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
Surgical and medical procedures    
BENIGN TUMOUR EXCISION † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
DENTAL OPERATION † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
HERNIA REPAIR † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
INGUINAL HERNIA REPAIR † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
LEG AMPUTATION † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     2  
PHLEBOTOMY † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
PULMONARY VALVE REPLACEMENT † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
TOOTH EXTRACTION † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
Vascular disorders    
HYPERTENSION † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
PERIPHERAL ISCHAEMIA † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
PHLEBITIS † 1  
# participants affected / at risk     1/480 (0.21%)  
# events     1  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 12.1




  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01048671     History of Changes
Other Study ID Numbers: 0518-138, MK0518-138
Study First Received: January 12, 2010
Results First Received: December 23, 2013
Last Updated: June 23, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)