BMS-Reyataz Study in Treatment in Naive Subjects to Compare the Efficacy and Safety Between Boosted Reyataz and Kaletra When in Combination With Fixed Dose Truvada

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00272779
First received: January 5, 2006
Last updated: April 7, 2011
Last verified: April 2011
Results First Received: December 3, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: ATV
Drug: RTV
Drug: Tenofovi-Emtricitabine (TDF/FTC) tablet
Drug: LPV

  Participant Flow


  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
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Total Total of all reporting groups

Baseline Measures
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD     Total  
Number of Participants  
[units: participants]
  440     443     883  
Age  
[units: years]
Mean ± Standard Deviation
  36  ± 9.1     37  ± 10.0     36  ± 9.6  
Gender  
[units: participants]
     
Female     138     139     277  
Male     302     304     606  
Race/Ethnicity, Customized  
[units: participants]
     
Asian     42     41     83  
Black or African American     83     80     163  
White     207     221     428  
Hispanic/Latino     7     6     13  
Mestizo     71     68     139  
Mixed race     30     27     57  



  Outcome Measures
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1.  Primary:   Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]

2.  Primary:   Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given every day (QD) and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given twice daily (BID) and TDF given QD. ]

3.  Primary:   Area Under the Concentration-time Curve, in One Dosing Interval [AUC(TAU)] of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

4.  Primary:   Minimum Plasma Concentration (Cmin) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

5.  Primary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

6.  Primary:   Terminal Elimination Half-life (T-half) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

7.  Primary:   Protein Binding Adjusted Effective Concentration (EC-90) of ATV and LPV When Dosed With RTV at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

8.  Primary:   Inhibitory Quotient (IQ) of ATV and LPV When Dosed With RTV at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

9.  Primary:   Cmax of RTV at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

10.  Primary:   AUC (0-24) of RTV at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

11.  Primary:   Cmin of RTV at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

12.  Primary:   Cmax of Tenofovir at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

13.  Primary:   Cmin of Tenofovir at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

14.  Primary:   AUC (TAU) of Tenofovir at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

15.  Primary:   Mean Change From Baseline in Trunk-to-Limb Fat Ratio as Measured by Dual Energy X-ray Absorptiometry (DEXA) at Week 96   [ Time Frame: Baseline (Day 1) and Week 96. ]

16.  Primary:   Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis   [ Time Frame: Baseline visit ]

17.  Primary:   Mean Change From Baseline in Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

18.  Primary:   Mean Change From Baseline in Fasting Triglycerides Associated With RETN_097   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

19.  Primary:   Mean Change From Baseline in Fasting Triglycerides Associated With RETN_2265   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

20.  Primary:   Mean Change From Baseline in Fasting Triglycerides Associated With RETN_598   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

21.  Primary:   Mean Change From Baseline in Fasting Triglycerides Associated With APOE_C130R   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

22.  Primary:   Mean Change From Baseline in Fasting Triglycerides Associated With RETN_734   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

23.  Primary:   Mean Change From Baseline in Fasting Plasminogen Activator Inhibitor (PAI)-1 Associated With APOE_R176C   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

24.  Primary:   Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Associated With IL6_5309   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

25.  Primary:   Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

26.  Primary:   Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

27.  Primary:   Mean Change From Baseline in Visceral Adipose Tissue (VAT) Associated With BRUNOL_1842   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

28.  Primary:   Mean Change From Baseline in VAT Associated With RETN_730   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

29.  Primary:   Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

30.  Secondary:   Number of Participants With HIV RNA < 400 c/mL at Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]

31.  Secondary:   Number of Participants With Confirmed Plasma HIV RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time to Loss of Virologic Response [TLOVR] Algorithm)   [ Time Frame: Baseline (Day 1) and Week 48 ]

32.  Secondary:   Reduction of log10 HIV RNA Levels From Baseline to Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]

33.  Secondary:   Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48   [ Time Frame: Baseline (Day 1) and Week 48. ]

34.  Secondary:   Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]

35.  Secondary:   Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced AEs Leading to Discontinuation Through Week 48   [ Time Frame: From baseline (Day 1) to Week 48. ]

36.  Secondary:   Number of Participants With Laboratory Abnormalities in Hematology Through Week 48: Hemoglobin, Hematocrit, Platelet Count, International Normalized Ratio (INR), Neutrophils, Prothrombin Time (PT) and White Blood Cells (WBC)   [ Time Frame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48. ]

37.  Secondary:   Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48   [ Time Frame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48. ]

38.  Secondary:   Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48   [ Time Frame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48. ]

39.  Secondary:   Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48   [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, and 48. ]

40.  Secondary:   Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48   [ Time Frame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48. ]

41.  Secondary:   Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 48   [ Time Frame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48. ]

42.  Secondary:   Number of Participants With Laboratory Abnormalities in Fasting Lipids Through Week 48   [ Time Frame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48. ]

43.  Secondary:   Number of Participants With Laboratory Abnormalities in Fasting Glucose Through Week 48   [ Time Frame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48. ]

44.  Secondary:   Mean Change in Weight From Baseline at Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]

45.  Secondary:   Mean Change in Body Mass Index (BMI) in Participants at Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]

46.  Secondary:   Mean Change in Fasting Lipid at Week 48   [ Time Frame: Baseline (Day 1) and Week 48. ]

47.  Secondary:   Mean Change in Fasting Glucose at Week 48   [ Time Frame: Baseline (Day 1) and Week 48. ]

48.  Secondary:   Mean Change in Fasting Insulin at Week 48   [ Time Frame: Baseline (Day 1) and Week 48. ]

49.  Secondary:   Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24   [ Time Frame: Baseline (Day 1) and Week 24. ]

50.  Secondary:   Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]

51.  Secondary:   Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL)   [ Time Frame: IBS-QoL is administered at baseline (Day 1) and Week 4. ]

52.  Secondary:   Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL)   [ Time Frame: IBS-QoL is administered at baseline (Day 1) and Week 12. ]

53.  Secondary:   Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 24 Using the Irritable Bowel Syndrome Quality of Life (IBS-QoL)   [ Time Frame: Baseline (Day 1) and Week 24 ]

54.  Secondary:   Number of Participants Who Adhered to Regimen as Measured by Multicenter AIDS Cohort Study Adherence Questionnaire (MACS) at Week 48   [ Time Frame: Week 48 ]

55.  Secondary:   Number of Participants With HIV RNA < 50 c/mL) at Week 96   [ Time Frame: Baseline (Day 1) and Week 96 ]

56.  Secondary:   Number of Participants With HIV RNA < 400 c/mL) at Week 96   [ Time Frame: Baseline (Day 1) and Week 96 ]

57.  Secondary:   Reduction of log10 HIV RNA Levels From Baseline at Week 96   [ Time Frame: Baseline (Day 1) and Week 96 ]

58.  Secondary:   Mean Change From Baseline in CD4 Cell Count at Week 96   [ Time Frame: Baseline (Day 1) and Week 96 ]

59.  Secondary:   Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96   [ Time Frame: From Day 1 through Week 96 ]

60.  Secondary:   Mean Changes in Fasting Lipids at Week 96   [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ]

61.  Secondary:   Mean Changes in Fasting Glucose at Week 96   [ Time Frame: Baseline (Day 1) and Week 96 ]

62.  Secondary:   Mean Changes in Fasting Insulin at Week 96   [ Time Frame: Baseline (Day 1) and Week 96. ]

63.  Secondary:   Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96   [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ]

64.  Secondary:   Number of Participants With Laboratory Abnormalities in Serum Enzyme Levels Through Week 96   [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ]

65.  Secondary:   Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96   [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ]

66.  Secondary:   Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96   [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ]

67.  Secondary:   Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96   [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ]

68.  Secondary:   Number of Participants With Laboratory Abnormalities in Fasting Lipids Level Through Week 96   [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ]

69.  Secondary:   Number of Participants With Laboratory Abnormalities in Fasting Glucose Levels Through Week 96   [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ]

70.  Secondary:   Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 96   [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ]

71.  Secondary:   Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96   [ Time Frame: Baseline (Day 1) and Week 96. ]

72.  Secondary:   Mean Change From Baseline in Trunk-to-limb Fat Ratio Measured by DEXA at Week 48   [ Time Frame: DEXA scans were taken at Baseline (Day 1) and at Weeks 48. ]

73.  Secondary:   Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48   [ Time Frame: DEXA scans were performed at baseline (within 30 days of starting study treatment), and at Weeks 48. ]

74.  Secondary:   Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 96   [ Time Frame: Baseline (Day 1) and Week 96. ]

75.  Secondary:   Median Changes From Baseline at Week 96 in VAT-to-TAT, VAT-to-SAT and, Trunk-to-limb Fat Ratio Measured by Computed Tomography (CT)/DEXA   [ Time Frame: Baseline (Day 1) and Week 96. ]

76.  Secondary:   Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48   [ Time Frame: DEXA scans were taken at Baseline (Day 1) and Week 48. ]

77.  Secondary:   Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96   [ Time Frame: Baseline (Day 1) and Week 96 ]

78.  Secondary:   Mean Change From Baseline in Body Weight at Week 96   [ Time Frame: Baseline (Day 1) and Week 96 ]

79.  Secondary:   Mean Change From Baseline in Body Weight at Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]

80.  Secondary:   Mean Change From Baseline in BMI at Week 96   [ Time Frame: Baseline (Day 1) and Week 96 ]

81.  Secondary:   Mean Change From Baseline in Waist Circumference at Week 96   [ Time Frame: Baseline (Day 1) and Week 96. ]

82.  Secondary:   Mean Change From Baseline in Waist Circumference at Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]

83.  Secondary:   Mean Change From Baseline in Waist-to-hip-ratio at Week 96   [ Time Frame: Baseline (Day 1) and Week 96 ]

84.  Secondary:   Mean Change From Baseline in BMI at Week 48   [ Time Frame: Baseline (Day 1) and Week 48. ]

85.  Secondary:   Mean Change From Baseline in Waist-to-hip-ratio at Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]

86.  Secondary:   Percentage of Participants With Lipoatrophy at Week 96   [ Time Frame: Baseline (Day 1) and Week 96 ]

87.  Secondary:   Mean Changes From Baseline in Body Weight at Week 96   [ Time Frame: Physical examination was performed at Baseline (Day 1) and Weeks 48 and 96. ]

88.  Secondary:   Mean Change From Baseline in BMI at Week 96   [ Time Frame: Baseline (Day 1) and Week 96 ]


  Serious Adverse Events


  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
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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:
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.


Results Point of Contact:  
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: ClinicalTrials@bms.com


Publications:
Publications automatically indexed to this study:

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00272779     History of Changes
Other Study ID Numbers: AI424-138
Study First Received: January 5, 2006
Results First Received: December 3, 2010
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration