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
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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 1057 HIV-infected participants, 174 participants were not randomized to receive study drug, the main reason being that they did not meet the study criteria (133/174; 76%). 441 randomized to ATV received any drug and 437 randomized to LPV received any drug. 438 and 440 participants randomized to ATV and LPV, respectively, received correct drug.

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.

Participant Flow for 2 periods

Period 1:   Baseline Through Week 48
    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  
STARTED     440 [1]   443 [2]
RECEIVED ANY TREATMENT     441 [3]   437 [4]
TREATED AS RANDOMIZED     438     440  
Discontinued Before Week 48     39     58  
Discontinued on or After Week 48     14     14  
STILL ON TREATMENT     385     368  
COMPLETED     0     0  
NOT COMPLETED     440     443  
Adverse event before Week 48                 10                 14  
Death before Week 48                 4                 4  
Lack of efficacy before Week 48                 5                 8  
Lost to follow-up before Week 48                 6                 6  
Viral load rebound before Week 48                 1                 0  
Poor/non compliance before Week 48                 6                 9  
Pregnancy before Week 48                 2                 2  
No longer meets criteria before Week 48                 1                 0  
Withdrew consent before Week 48                 4                 13  
Participant's decision before wk 48                 0                 1  
Chose different site before wk 48                 0                 1  
Adverse event on/after Week 48                 1                 1  
Death on/after Week 48                 1                 1  
Lack of efficacy on/after Week 48                 7                 1  
Poor/non compliance on/after Week                 2                 2  
No longer meets criteria on/after Wk 48                 2                 2  
Pregnancy on/after Week 48                 1                 2  
Withdrew consent on/after Week 48                 0                 2  
Continuing treatment                 385                 368  
Lost to follow-up on/after Week 48                 0                 3  
Never treated                 2                 3  
[1] Number of participants randomized to ATV
[2] Number of participants randomized to LPV
[3] 1 participant randomized to LPV received ATV instead (treatment error)
[4] 3 participants received ATV instead of LPV (treatment error), 3 participants never treated with LPV

Period 2:   Baseline Through Week 96
    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  
STARTED     440 [1]   443 [2]
RECEIVED ANY TREATMENT     441 [3]   437 [4]
COMPLETED     301     307  
NOT COMPLETED     139     136  
Adverse event before Week 96                 13                 22  
Death before Week 96                 6                 5  
Lack of efficacy before Week 96                 16                 10  
Lost to follow up before Week 96                 10                 13  
Participant Imprisoned before Week 96                 1                 0  
Poor/non compliance before Week 96                 12                 16  
Pregnancy before Week 96                 5                 7  
No longer meets criteria before Week 96                 4                 3  
Withdrew consent before Week 96                 5                 18  
Changed address before Week 96                 0                 1  
Lost to follow-up at Week 96                 1                 0  
Poor/non compliance at Week 96]                 2                 0  
Pregnancy at Week 96                 1                 0  
Never treated                 2                 3  
Continuing on treatment                 61                 38  
[1] Number randomized to ATV
[2] Number randomized to LPV
[3] 1 participant randomized to LPV received ATV instead (treatment error)
[4] 3 participants received ATV instead of LPV (treatment error) and 3 participants never treated



  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
  Show All Outcome Measures

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. ]
  Hide Outcome Measure 26

Measure Type Primary
Measure Title Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980
Measure Description The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. SAT and TAT were measured by computed tomography (CT).
Time Frame Baseline (Day 1), Week 48, and 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 with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

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.

Measured Values
    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  
Number of Participants Analyzed  
[units: participants]
  99     100  
Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980  
[units: cm^2]
Mean ± Standard Error
   
SAT-to-TAT Ratio: CCDC122_5980 WT     0.03  ± 0.01     0.03  ± 0.02  
SAT-to-TAT Ratio: CCDC122_5980 MAC     0.11  ± 0.02     0.02  ± 0.02  


Statistical Analysis 1 for Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980
Groups [1] All groups
Method [2] linear mixed effect model
P Value [3] 0.1694
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null Hypothesis: There is no association between the mean change from baseline in SAT-to-TAT Ratio (phenotype) and the CCDC122_5980 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with CCDC122_5980 reported in Outcome Measure 16.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.



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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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