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

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

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

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 ]

2.  Primary:

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

3.  Primary:

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

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 ]

5.  Secondary:

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

6.  Secondary:

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

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 ]

8.  Secondary:

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

9.  Secondary:

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

10.  Secondary:

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

11.  Secondary:

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

12.  Secondary:

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

13.  Secondary:

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

14.  Secondary:

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

15.  Secondary:

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

16.  Secondary:

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

17.  Secondary:

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

18.  Secondary:

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

19.  Secondary:

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

20.  Secondary:

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

21.  Secondary:

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

22.  Secondary:

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

23.  Secondary:

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

24.  Secondary:

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

25.  Secondary:

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

26.  Secondary:

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

27.  Secondary:

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

28.  Secondary:

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

29.  Secondary:

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

30.  Secondary:

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

31.  Secondary:

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

32.  Secondary:

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

33.  Secondary:

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

34.  Secondary:

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

35.  Secondary:

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

36.  Secondary:

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

37.  Secondary:

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

38.  Secondary:

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

39.  Secondary:

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

40.  Secondary:

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

41.  Secondary:

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

42.  Secondary:

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

43.  Secondary:

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

44.  Secondary:

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

45.  Secondary:

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

46.  Secondary:

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

47.  Secondary:

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

48.  Secondary:

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

49.  Secondary:

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

50.  Secondary:

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

51.  Secondary:

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

52.  Secondary:

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

53.  Secondary:

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

54.  Secondary:

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

55.  Secondary:

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

56.  Secondary:

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

57.  Secondary:

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

58.  Secondary:

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

59.  Secondary:

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

60.  Secondary:

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

61.  Secondary:

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

62.  Secondary:

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

63.  Secondary:

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

64.  Secondary:

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

65.  Secondary:

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

66.  Secondary:

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

67.  Secondary:

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

68.  Secondary:

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

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 ]

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 ]

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 ]

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 ]

73.  Secondary:

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

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 ]

75.  Secondary:

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

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 ]

77.  Secondary:

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

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 ]

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 ]

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 ]

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 ]

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 ]