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
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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 ]

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2. Primary:

Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events [ Time Frame: Week 96 ]

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3. Primary:

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

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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 ]

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5. Secondary:

Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit [ Time Frame: Baseline to Week 96 ]

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Measure Type	Secondary
Measure Title	Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit
Measure Description	No text entered.
Time Frame	Baseline to Week 96
Safety Issue	No

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.
Participants who had values at Baseline and the visit were included in the analysis of data at that visit. Number of participants in each visit analysis ranged from 98 and 96 participants in the LPV/r+FTC/TDF and LPV/r+RAL groups, respectively, at Week 8, to 80 and 76 participants in the LPV/r+FTC/TDF and LPV/r+RAL groups, respectively, at Week 96.

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

Measured Values

	LPV/r + FTC/TDF	LPV/r + RAL
Number of Participants Analyzed [units: participants]	105	101
Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit [units: cells/microliter] Mean ± Standard Error
Week 4	97.2 ± 10.94	113.4 ± 10.83
Week 8	107.9 ± 12.07	124.5 ± 12.20
Week 16	158.7 ± 13.94	141.6 ± 14.01
Week 24	154.9 ± 13.76	174.5 ± 13.99
Week 32	180.0 ± 13.42	188.2 ± 13.49
Week 40	204.6 ± 15.22	223.0 ± 15.55
Week 48	245.0 ± 18.02	241.9 ± 17.83
Week 60	243.4 ± 18.05	250.6 ± 18.45
Week 72	277.4 ± 20.10	269.9 ± 20.47
Week 84	309.6 ± 19.83	280.2 ± 21.05
Week 96	296.4 ± 20.38	281.0 ± 20.91

No statistical analysis provided for Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit

6. Secondary:

Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672 [ Time Frame: Baseline to Week 96 ]

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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 ]

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8. Secondary:

Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir [ Time Frame: Baseline to Week 96 ]

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9. Secondary:

Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey [ Time Frame: Baseline to Week 96 ]

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10. Secondary:

Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey [ Time Frame: Baseline to Week 96 ]

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11. Secondary:

Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: Week 96 ]

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12. Secondary:

Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication [ Time Frame: Week 96 ]

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13. Secondary:

Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication [ Time Frame: Week 96 ]

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14. Secondary:

Mean Change From Baseline in Hemoglobin (Grams/Liter) [ Time Frame: Baseline to Week 96 ]

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15. Secondary:

Mean Change From Baseline in Hematocrit (Fraction) [ Time Frame: Baseline to Week 96 ]

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16. Secondary:

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

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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 ]

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20. Secondary:

Mean Change From Baseline in Lymphocytes (x 10^9/Liter) [ Time Frame: Baseline to Week 96 ]

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21. Secondary:

Mean Change From Baseline in Monocytes (x 10^9/Liter) [ Time Frame: Baseline to Week 96 ]

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22. Secondary:

Mean Change From Baseline in Eosinophils (x 10^9/Liter) [ Time Frame: Baseline to Week 96 ]

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23. Secondary:

Mean Change From Baseline in Basophils (x 10^9/Liter) [ Time Frame: Baseline to Week 96 ]

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24. Secondary:

Mean Change From Baseline in Alanine Aminotransferase (Units/Liter) [ Time Frame: Baseline to Week 96 ]

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25. Secondary:

Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter) [ Time Frame: Baseline to Week 96 ]

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26. Secondary:

Mean Change From Baseline in Alkaline Phosphatase (Units/Liter) [ Time Frame: Baseline to Week 96 ]

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27. Secondary:

Mean Change From Baseline in Creatine Phosphokinase (Units/Liter) [ Time Frame: Baseline to Week 96 ]

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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 ]

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30. Secondary:

Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter) [ Time Frame: Baseline to Week 96 ]

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31. Secondary:

Mean Change From Baseline in Uric Acid (Micromoles/Liter) [ Time Frame: Baseline to Week 96 ]

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32. Secondary:

Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter) [ Time Frame: Baseline to Week 96 ]

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33. Secondary:

Mean Change From Baseline in Calcium (Micromoles/Liter) [ Time Frame: Baseline to Week 96 ]

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34. Secondary:

Mean Change From Baseline in Sodium (Micromoles/Liter) [ Time Frame: Baseline to Week 96 ]

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35. Secondary:

Mean Change From Baseline in Potassium (Micromoles/Liter) [ Time Frame: Baseline to Week 96 ]

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36. Secondary:

Mean Change From Baseline in Chloride (Micromoles/Liter) [ Time Frame: Baseline to Week 96 ]

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37. Secondary:

Mean Change From Baseline in Bicarbonate (Micromoles/Liter) [ Time Frame: Baseline to Week 96 ]

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38. Secondary:

Mean Change From Baseline in Albumin (Grams/Liter) [ Time Frame: Baseline to Week 96 ]

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39. Secondary:

Mean Change From Baseline in Total Protein (Grams/Liter) [ Time Frame: Baseline to Week 96 ]

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40. Secondary:

Mean Change From Baseline in Cholesterol (Micromoles/Liter) [ Time Frame: Baseline to Week 96 ]

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41. Secondary:

Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter) [ Time Frame: Baseline to Week 96 ]

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42. Secondary:

Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter) [ Time Frame: Baseline to Week 96 ]

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43. Secondary:

Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio) [ Time Frame: Baseline to Week 96 ]

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44. Secondary:

Mean Change From Baseline in Triglycerides (Micromoles/Liter) [ Time Frame: Baseline to Week 96 ]

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45. Secondary:

Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second) [ Time Frame: Baseline to Week 96 ]

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46. Secondary:

Mean Change From Baseline in Fasting Glucose (Millimoles/Liter) [ Time Frame: Baseline to Week 96 ]

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47. Secondary:

Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter) [ Time Frame: Baseline to Week 96 ]

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48. Secondary:

Mean Change From Baseline in Lipase (Units/Liter) [ Time Frame: Baseline to Week 96 ]

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49. Secondary:

Mean Change From Baseline in Magnesium (Millimoles/Liter) [ Time Frame: Baseline to Week 96 ]

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50. Secondary:

Mean Change From Baseline in Adiponectin (Micrograms/Milliliter) [ Time Frame: Baseline to Week 96 ]

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51. Secondary:

Mean Change From Baseline in Interleukin-6 (Nanograms/Liter) [ Time Frame: Baseline to Week 96 ]

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52. Secondary:

Mean Change From Baseline in Lactate (Millimoles/Liter) [ Time Frame: Baseline to Week 96 ]

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53. Secondary:

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

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54. Secondary:

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

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55. Secondary:

Mean Change From Baseline in Leptin (Nanograms/Milliliter) [ Time Frame: Baseline to Week 96 ]

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56. Secondary:

Mean Change From Baseline in Insulin (Picomoles/Liter) [ Time Frame: Baseline to Week 96 ]

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57. Secondary:

Mean Change From Baseline in Urine Specific Gravity [ Time Frame: Baseline to Week 96 ]

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58. Secondary:

Mean Change From Baseline in Urine pH [ Time Frame: Baseline to Week 96 ]

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59. Secondary:

Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg) [ Time Frame: Baseline to Week 96 ]

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60. Secondary:

Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg) [ Time Frame: Baseline to Week 96 ]

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61. Secondary:

Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute) [ Time Frame: Baseline to Week 96 ]

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62. Secondary:

Mean Change From Baseline in Weight (kg) [ Time Frame: Baseline to Week 96 ]

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63. Secondary:

Mean Change From Baseline in Temperature (°F) [ Time Frame: Baseline to Week 96 ]

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64. Secondary:

Mean Change From Baseline in Chest Measurement (cm) [ Time Frame: Baseline to Week 96 ]

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65. Secondary:

Mean Change From Baseline in Waist Measurement (cm) [ Time Frame: Baseline to Week 96 ]

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66. Secondary:

Mean Change From Baseline in Mid-Arm Measurement (cm) [ Time Frame: Baseline to Week 96 ]

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67. Secondary:

Mean Change From Baseline in Hips Measurement (cm) [ Time Frame: Baseline to Week 96 ]

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68. Secondary:

Mean Change From Baseline in Mid-Thigh Measurement (cm) [ Time Frame: Baseline to Week 96 ]

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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 ]

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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 ]

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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 ]

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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 ]

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73. Secondary:

Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams) [ Time Frame: Baseline to Week 96 ]

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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 ]

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75. Secondary:

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

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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 ]

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77. Secondary:

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

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.

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:

Reynes J, Trinh R, Pulido F, Soto-Malave R, Gathe J, Qaqish R, Tian M, Fredrick L, Podsadecki T, Norton M, Nilius A. Lopinavir/ritonavir combined with raltegravir or tenofovir/emtricitabine in antiretroviral-naive subjects: 96-week results of the PROGRESS study. AIDS Res Hum Retroviruses. 2013 Feb;29(2):256-65. doi: 10.1089/AID.2011.0275. Epub 2012 Aug 3.

Reynes J, Lawal A, Pulido F, Soto-Malave R, Gathe J, Tian M, Fredrick LM, Podsadecki TJ, Nilius AM. Examination of noninferiority, safety, and tolerability of lopinavir/ritonavir and raltegravir compared with lopinavir/ritonavir and tenofovir/ emtricitabine in antiretroviral-naïve subjects: the progress study, 48-week results. HIV Clin Trials. 2011 Sep-Oct;12(5):255-67.

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)

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