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Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL) (PROGRESS)

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00711009
First received: July 3, 2008
Last updated: February 13, 2012
Last verified: February 2012
History of Changes
Results First Received: November 16, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Human Immunodeficiency Virus Infection
Interventions: Drug: lopinavir/ritonavir (LPV/r)
Drug: emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)
Drug: raltegravir (RAL)

  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
3 additional participants were randomized but did not receive study drug and therefore were not included in the analyses.

Reporting Groups
  Description
LPV/r + FTC/TDF lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
LPV/r + RAL lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily

Participant Flow:   Overall Study
    LPV/r + FTC/TDF     LPV/r + RAL  
STARTED     105     101  
COMPLETED     90     82  
NOT COMPLETED     15     19  
Adverse Event/HIV-Related Event                 4                 5  
Withdrawal by Subject                 4                 2  
Lost to Follow-up                 3                 9  
Participant Noncompliant                 0                 1  
Virologic Failure                 2                 1  
Pregnancy                 1                 0  
Site closing                 0                 1  
Dose adjustment                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
LPV/r + FTC/TDF lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
LPV/r + RAL lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Total Total of all reporting groups

Baseline Measures
    LPV/r + FTC/TDF     LPV/r + RAL     Total  
Number of Participants  
[units: participants]
 		  105     101     206  
Age  
[units: years]
Mean ± Standard Deviation 		  39.4  ± 11.24     39.8  ± 9.94     39.6  ± 10.60  
Gender  
[units: participants]
 		     
Female     19     13     32  
Male     86     88     174  
Race/Ethnicity, Customized  
[units: participants]
 		     
American Indian or Alaska Native     0     0     0  
Asian     1     3     4  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     22     22     44  
White     81     74     155  
More than one race     0     1     1  
Unknown or Not Reported     0     0     0  
Other     1     1     2  
Region of Enrollment  
[units: participants]
 		     
North America     61     59     120  
Europe     44     42     86  
Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Level  
[units: log10 copies/milliliter]
Mean ± Standard Deviation 		  4.3  ± 0.76     4.2  ± 0.83     4.2  ± 0.79  
CD4+ T-Cell Counts  
[units: cells/microliter]
Mean ± Standard Deviation 		  297.6  ± 166.66     289.3  ± 149.03     293.5  ± 157.93  



  Outcome Measures
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1.  Primary:   Percentage of Participants Responding (Plasma HIV-1 Ribonucleic Acid [RNA] Levels Less Than 40 Copies/Milliliter [mL]) at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm   [ Time Frame: Baseline to Week 48 ]
  Show Outcome Measure 1

2.  Primary:   Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events   [ Time Frame: Week 96 ]
  Show Outcome Measure 2

3.  Primary:   Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 4

5.  Secondary:   Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 5

6.  Secondary:   Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 6

7.  Secondary:   Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 7

8.  Secondary:   Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 8

9.  Secondary:   Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 9

10.  Secondary:   Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 10

11.  Secondary:   Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)   [ Time Frame: Week 96 ]
  Show Outcome Measure 11

12.  Secondary:   Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication   [ Time Frame: Week 96 ]
  Show Outcome Measure 12

13.  Secondary:   Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication   [ Time Frame: Week 96 ]
  Show Outcome Measure 13

14.  Secondary:   Mean Change From Baseline in Hemoglobin (Grams/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 14

15.  Secondary:   Mean Change From Baseline in Hematocrit (Fraction)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 15

16.  Secondary:   Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 16

17.  Secondary:   Mean Change From Baseline in Platelet Count (x 10^9/Liter)   [ Time Frame: Baseline to Week 96 ]
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18.  Secondary:   Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)   [ Time Frame: Baseline to Week 96 ]
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19.  Secondary:   Mean Change From Baseline in Neutrophils (x 10^9/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 19

20.  Secondary:   Mean Change From Baseline in Lymphocytes (x 10^9/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 20

21.  Secondary:   Mean Change From Baseline in Monocytes (x 10^9/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 21

22.  Secondary:   Mean Change From Baseline in Eosinophils (x 10^9/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 22

23.  Secondary:   Mean Change From Baseline in Basophils (x 10^9/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 23

24.  Secondary:   Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 24

25.  Secondary:   Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 25

26.  Secondary:   Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 26

27.  Secondary:   Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 27

28.  Secondary:   Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]
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29.  Secondary:   Mean Change From Baseline in Creatinine (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 29

30.  Secondary:   Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 30

31.  Secondary:   Mean Change From Baseline in Uric Acid (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 31

32.  Secondary:   Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 32

33.  Secondary:   Mean Change From Baseline in Calcium (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 33

34.  Secondary:   Mean Change From Baseline in Sodium (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 34

35.  Secondary:   Mean Change From Baseline in Potassium (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 35

36.  Secondary:   Mean Change From Baseline in Chloride (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 36

37.  Secondary:   Mean Change From Baseline in Bicarbonate (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 37

38.  Secondary:   Mean Change From Baseline in Albumin (Grams/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 38

39.  Secondary:   Mean Change From Baseline in Total Protein (Grams/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 39

40.  Secondary:   Mean Change From Baseline in Cholesterol (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 40

41.  Secondary:   Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 41

42.  Secondary:   Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 42

43.  Secondary:   Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 43

44.  Secondary:   Mean Change From Baseline in Triglycerides (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 44

45.  Secondary:   Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 45

46.  Secondary:   Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 46

47.  Secondary:   Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 47

48.  Secondary:   Mean Change From Baseline in Lipase (Units/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 48

49.  Secondary:   Mean Change From Baseline in Magnesium (Millimoles/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 49

50.  Secondary:   Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 50

51.  Secondary:   Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 51

52.  Secondary:   Mean Change From Baseline in Lactate (Millimoles/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 52

53.  Secondary:   Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 53

54.  Secondary:   Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 54

55.  Secondary:   Mean Change From Baseline in Leptin (Nanograms/Milliliter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 55

56.  Secondary:   Mean Change From Baseline in Insulin (Picomoles/Liter)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 56

57.  Secondary:   Mean Change From Baseline in Urine Specific Gravity   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 57

58.  Secondary:   Mean Change From Baseline in Urine pH   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 58

59.  Secondary:   Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 59

60.  Secondary:   Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 60

61.  Secondary:   Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 61

62.  Secondary:   Mean Change From Baseline in Weight (kg)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 62

63.  Secondary:   Mean Change From Baseline in Temperature (°F)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 63

64.  Secondary:   Mean Change From Baseline in Chest Measurement (cm)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 64

65.  Secondary:   Mean Change From Baseline in Waist Measurement (cm)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 65

66.  Secondary:   Mean Change From Baseline in Mid-Arm Measurement (cm)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 66

67.  Secondary:   Mean Change From Baseline in Hips Measurement (cm)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 67

68.  Secondary:   Mean Change From Baseline in Mid-Thigh Measurement (cm)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 68

69.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 69

70.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 70

71.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 71

72.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 72

73.  Secondary:   Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 73

74.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 74

75.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 75

76.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 76

77.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 77

78.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 78

79.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 79

80.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 80

81.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 81

82.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 82


  Serious Adverse Events
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  Other Adverse Events
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Time Frame Week 96
Additional Description Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
LPV/r + FTC/TDF lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
LPV/r + RAL lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily

Other Adverse Events
    LPV/r + FTC/TDF     LPV/r + RAL  
Total, other (not including serious) adverse events      
# participants affected / at risk     96/105     94/101  
Ear and labyrinth disorders      
Vertigo 1    
# participants affected / at risk     3/105 (2.86%)     6/101 (5.94%)  
Gastrointestinal disorders      
Abdominal pain 1    
# participants affected / at risk     10/105 (9.52%)     4/101 (3.96%)  
Diarrhoea 1    
# participants affected / at risk     64/105 (60.95%)     62/101 (61.39%)  
Dyspepsia 1    
# participants affected / at risk     4/105 (3.81%)     6/101 (5.94%)  
Flatulence 1    
# participants affected / at risk     9/105 (8.57%)     11/101 (10.89%)  
Nausea 1    
# participants affected / at risk     20/105 (19.05%)     13/101 (12.87%)  
Vomiting 1    
# participants affected / at risk     13/105 (12.38%)     8/101 (7.92%)  
General disorders      
Asthenia 1    
# participants affected / at risk     8/105 (7.62%)     8/101 (7.92%)  
Fatigue 1    
# participants affected / at risk     7/105 (6.67%)     4/101 (3.96%)  
Pyrexia 1    
# participants affected / at risk     9/105 (8.57%)     6/101 (5.94%)  
Infections and infestations      
Anogenital warts 1    
# participants affected / at risk     7/105 (6.67%)     4/101 (3.96%)  
Bronchitis 1    
# participants affected / at risk     11/105 (10.48%)     6/101 (5.94%)  
Folliculitis 1    
# participants affected / at risk     1/105 (0.95%)     7/101 (6.93%)  
Gastroenteritis 1    
# participants affected / at risk     6/105 (5.71%)     5/101 (4.95%)  
Influenza 1    
# participants affected / at risk     4/105 (3.81%)     8/101 (7.92%)  
Nasopharyngitis 1    
# participants affected / at risk     15/105 (14.29%)     11/101 (10.89%)  
Pharyngitis 1    
# participants affected / at risk     4/105 (3.81%)     6/101 (5.94%)  
Sinusitis 1    
# participants affected / at risk     8/105 (7.62%)     6/101 (5.94%)  
Syphilis 1    
# participants affected / at risk     5/105 (4.76%)     6/101 (5.94%)  
Upper respiratory tract infection 1    
# participants affected / at risk     10/105 (9.52%)     14/101 (13.86%)  
Urinary tract infection 1    
# participants affected / at risk     8/105 (7.62%)     3/101 (2.97%)  
Metabolism and nutrition disorders      
Hypercholesterolaemia 1    
# participants affected / at risk     10/105 (9.52%)     15/101 (14.85%)  
Hypertriglyceridaemia 1    
# participants affected / at risk     6/105 (5.71%)     16/101 (15.84%)  
Musculoskeletal and connective tissue disorders      
Arthralgia 1    
# participants affected / at risk     8/105 (7.62%)     8/101 (7.92%)  
Back pain 1    
# participants affected / at risk     9/105 (8.57%)     6/101 (5.94%)  
Nervous system disorders      
Dizziness 1    
# participants affected / at risk     7/105 (6.67%)     4/101 (3.96%)  
Headache 1    
# participants affected / at risk     18/105 (17.14%)     13/101 (12.87%)  
Psychiatric disorders      
Depression 1    
# participants affected / at risk     11/105 (10.48%)     10/101 (9.90%)  
Insomnia 1    
# participants affected / at risk     10/105 (9.52%)     9/101 (8.91%)  
Respiratory, thoracic and mediastinal disorders      
Cough 1    
# participants affected / at risk     10/105 (9.52%)     10/101 (9.90%)  
Oropharyngeal pain 1    
# participants affected / at risk     10/105 (9.52%)     6/101 (5.94%)  
Rhinorrhoea 1    
# participants affected / at risk     6/105 (5.71%)     4/101 (3.96%)  
Sinus congestion 1    
# participants affected / at risk     6/105 (5.71%)     4/101 (3.96%)  
Skin and subcutaneous tissue disorders      
Rash 1    
# participants affected / at risk     4/105 (3.81%)     7/101 (6.93%)  
Vascular disorders      
Hypertension 1    
# participants affected / at risk     6/105 (5.71%)     6/101 (5.94%)  
1 Term from vocabulary, MedDRA 12.1



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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: Abbott
phone: 800-633-9110


No publications provided by Abbott

Publications automatically indexed to this study:


Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00711009     History of Changes
Other Study ID Numbers: M10-336, 2008-000881-22
Study First Received: July 3, 2008
Results First Received: November 16, 2010
Last Updated: February 13, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Italy: The Italian Medicines Agency
Poland: The Central Register of Clinical Trials
Spain: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)