Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00035932

First received: May 6, 2002

Last updated: November 29, 2010

Last verified: November 2010

History of Changes

Results First Received: October 14, 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: Atazanavir + ritonavir + tenofovir + nucleoside Drug: Atazanavir + saquinavir + tenofovir + nucleoside Drug: Lopinavir/ritonavir + tenofovir + nucleoside

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
571 human immunodeficiency virus (HIV)-infected participants were enrolled; 358 (63%) were randomized to treatment. Of the 213 not randomized, 194 did not meet eligibility criteria; other reasons include duplicate enrollment (4), accrual closed (1), noncompliance (1), serious adverse event (2), patient request (11), missing information (4).

Reporting Groups

	Description
ATV 300 mg / RTV	atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg + tenofovir (TDF) 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
ATV 400 mg / SQV	ATV 400 mg + saquinavir (SQV) 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
LPV / RTV	lopinavir (LPV)/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

Description

ATV 300 mg / RTV

atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg + tenofovir (TDF) 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + saquinavir (SQV) 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

lopinavir (LPV)/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

Participant Flow: Overall Study

	ATV 300 mg / RTV	ATV 400 mg / SQV	LPV / RTV
STARTED	119 ^[1]	110 ^[2]	118 ^[3]
Discontinued Prior to Week 48 Visit	26	29	13
Discontinued Between Weeks 48 and 96	26	27	30
Discontinued on or After Week 96	4	4	6
COMPLETED	63 ^[4]	50 ^[5]	69 ^[6]
NOT COMPLETED	56	60	49
Adverse Event	10	9	9
Death	0	0	1
Disease Progression / Relapse	1	1	0
Lost to Follow-up	4	4	3
Noncompliance	6	7	6
Protocol Violation While on Study	0	1	2
Withdrawal by Subject	1	5	0
Study Termination by Sponsor	1	0	0
Lack of Efficacy	33	33	28

[1]	120 randomized, 119 treated
[2]	115 randomized, 110 treated
[3]	123 randomized, 118 treated
[4]	63 remained on treatment, 0 completed at Week 96
[5]	50 remained on treatment, 0 completed at Week 96
[6]	59 remained on treatment, 10 completed at Week 96

Baseline Characteristics

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Reporting Groups

	Description
ATV 300 mg / RTV	ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
ATV 400 mg / SQV	ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
LPV / RTV	LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Total	Total of all reporting groups

Baseline Measures

	ATV 300 mg / RTV	ATV 400 mg / SQV	LPV / RTV	Total
Number of Participants [units: participants]	120	115	123	358
Age [units: years] Median ( Full Range )	39 ( 24 to 71 )	41 ( 26 to 74 )	39 ( 25 to 72 )	40 ( 24 to 74 )
Gender [units: participants]
Female	24	26	27	77
Male	96	89	96	281
Race/Ethnicity, Customized [units: participants]
White	75	70	71	216
Hispanic/Latino	27	26	27	80
Black	18	16	21	55
Other	0	3	4	7
Region of Enrollment [units: participants]
South America	56	55	54	165
North America	39	38	47	124
Europe	25	22	22	69
Acquired Immunodeficiency Virus (AIDS) [units: participants]
Yes	33	33	36	102
No	87	82	87	256
Intravenous (IV) Drug Use [units: participants]
Yes	8	7	8	23
No	112	108	115	335
Cluster of Differentiation 4 (CD4) cell count [units: cells/mm^3] Median ( Full Range )	317 ( 40 to 1025 )	286 ( 42 to 1543 )	283 ( 14 to 1238 )	297 ( 14 to 1543 )
Human Immunodeficiency Virus Ribonucleic Acid (HIV RNA) [units: log10 c/mL] Median ( Full Range )	4.44 ( 2.60 to 5.88 )	4.42 ( 2.60 to 5.88 )	4.47 ( 2.60 to 5.88 )	4.45 ( 2.60 to 5.88 )

Outcome Measures

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1. Primary:

Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24 [ Time Frame: Baseline, Week 24 ]

Show Outcome Measure 1

2. Primary:

Mean Change From Baseline in HIV RNA at Week 48 [ Time Frame: Baseline, Week 48 ]

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3. Primary:

Mean Change From Baseline in HIV RNA at Week 96 [ Time Frame: Baseline, Week 96 ]

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4. Secondary:

Mean Change From Baseline in HIV RNA at Week 2 [ Time Frame: Baseline, Week 2 ]

Show Outcome Measure 4

5. Secondary:

Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity) [ Time Frame: Baseline, Week 24 ]

Show Outcome Measure 5

6. Secondary:

Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity) [ Time Frame: Baseline, Week 48 ]

Show Outcome Measure 6

7. Secondary:

Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 96 [ Time Frame: Baseline, Week 96 ]

Show Outcome Measure 7

8. Secondary:

Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24 [ Time Frame: Week 24 ]

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9. Secondary:

Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24, by PI Sensitivity [ Time Frame: Baseline, Week 24 ]

Show Outcome Measure 9

10. Secondary:

Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48 [ Time Frame: Week 48 ]

Show Outcome Measure 10

11. Secondary:

Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48, by PI Sensitivity [ Time Frame: Baseline, Week 48 ]

Show Outcome Measure 11

12. Secondary:

Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 96 [ Time Frame: Week 96 ]

Show Outcome Measure 12

13. Secondary:

Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 24 [ Time Frame: Week 24 ]

Show Outcome Measure 13

14. Secondary:

Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 48 [ Time Frame: Week 48 ]

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15. Secondary:

Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 96 [ Time Frame: Week 96 ]

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16. Secondary:

Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 24 [ Time Frame: Week 24 ]

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17. Secondary:

Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 48 [ Time Frame: Week 48 ]

Show Outcome Measure 17

18. Secondary:

Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 96 [ Time Frame: Week 96 ]

Show Outcome Measure 18

19. Secondary:

Change From Baseline in CD4 Cell Count at Week 24 [ Time Frame: Baseline, Week 24 ]

Show Outcome Measure 19

20. Secondary:

Change From Baseline in CD4 Cell Count at Week 48 [ Time Frame: Baseline, Week 48 ]

Show Outcome Measure 20

21. Secondary:

Change From Baseline in CD4 Cell Count at Week 96 [ Time Frame: Baseline, Week 96 ]

Show Outcome Measure 21

22. Secondary:

Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 24 [ Time Frame: Baseline, Week 24 ]

Show Outcome Measure 22

23. Secondary:

Show Outcome Measure 23

24. Secondary:

Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 24 [ Time Frame: Baseline, Week 24 ]

Show Outcome Measure 24

25. Secondary:

Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 48 [ Time Frame: Baseline, Week 48 ]

Show Outcome Measure 25

26. Secondary:

Lipid Mean Percent Change From Baseline at Week 24 [ Time Frame: Baseline, Week 24 ]

Show Outcome Measure 26

27. Secondary:

Lipid Mean Percent Change From Baseline at Week 48 [ Time Frame: Week 48 ]

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28. Secondary:

Lipid Mean Percent Change From Baseline at Week 96, Observed Values [ Time Frame: Week 96 ]

Show Outcome Measure 28

29. Secondary:

Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) Through Week 48 [ Time Frame: From Enrollment through Week 48 ]

Show Outcome Measure 29

30. Secondary:

Most Common AEs and AEs of Interest Through Week 48 [ Time Frame: From Enrollment to Week 48 ]

Show Outcome Measure 30

31. Secondary:

Fasting Glucose Mean Change From Baseline at Week 24 [ Time Frame: Baseline, Week 24 ]

Show Outcome Measure 31

32. Secondary:

Fasting Glucose Mean Change From Baseline at Week 48 [ Time Frame: Week 48 ]

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33. Secondary:

Grade 3/4 Laboratory Abnormalities Through Week 48 [ Time Frame: From Enrollment to Week 48 ]

Show Outcome Measure 33

34. Secondary:

Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point [ Time Frame: Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48 ]

Show Outcome Measure 34

35. Secondary:

PR Interval and Change From Baseline by Analysis Time Point [ Time Frame: Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48 ]

Show Outcome Measure 35

36. Secondary:

Adherence to Regimen Though Week 48 Based on MACS the Multicenter AIDS Cohort Study (MACS) Adherence Questionnaire [ Time Frame: Baseline, Week 24, Week 48 ]

Show Outcome Measure 36

37. Secondary:

Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Health Index Score at Baseline, Mid-Study (Week 24), and Final (Week 48) [ Time Frame: Baseline, Week 24, Week 48 ]

Show Outcome Measure 37

38. Secondary:

Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Baseline, Mid-Study (Week 24), and Final (Week 48) [ Time Frame: Baseline, Week 24, Week 48 ]

Show Outcome Measure 38

39. Secondary:

Number of Participants Utilizing Resources for Managing Lipid Elevation [ Time Frame: Baseline, Week 24, Week 48 ]

Show Outcome Measure 39

40. Secondary:

Mean ATV, RTV and SQV Minimum Concentration (Cmin) Values [ Time Frame: collected at the pre-dose time point after receiving atazanavir for at least four weeks ]

Show Outcome Measure 40

41. Secondary:

HIV IC50 at Week 24 [ Time Frame: Week 24 ]

Show Outcome Measure 41

42. Secondary:

Inhibitory Quotient at Week 24 [ Time Frame: Baseline, Week 24 ]

Show Outcome Measure 42

43. Secondary:

Inhibitory Quotient at Week 48 [ Time Frame: Baseline, Week 48 ]

Show Outcome Measure 43

44. Secondary:

HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 24 [ Time Frame: Baseline, Week 24 ]

Show Outcome Measure 44

45. Secondary:

HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 48 [ Time Frame: Baseline, Week 48 ]

Show Outcome Measure 45

Serious Adverse Events

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Other Adverse Events

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Time Frame	The AE data below represents data from start of study in November 2001 through the last locked database of the study, 18 November 2009.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
ATV300/RTV	atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg + tenofovir (TDF) 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
ATV400/SQV	ATV 400 mg + saquinavir (SQV) 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
LPV/RTV	lopinavir (LPV)/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

Other Adverse Events

	ATV300/RTV	ATV400/SQV	LPV/RTV
Total, other (not including serious) adverse events
# participants affected / at risk	101/119	95/110	104/118
Eye disorders
OCULAR ICTERUS ^{† 1}
# participants affected / at risk	13/119 (10.92%)	4/110 (3.64%)	0/118 (0.00%)
Gastrointestinal disorders
NAUSEA ^{† 1}
# participants affected / at risk	23/119 (19.33%)	30/110 (27.27%)	18/118 (15.25%)
VOMITING ^{† 1}
# participants affected / at risk	16/119 (13.45%)	17/110 (15.45%)	12/118 (10.17%)
DIARRHOEA ^{† 1}
# participants affected / at risk	30/119 (25.21%)	34/110 (30.91%)	63/118 (53.39%)
DYSPEPSIA ^{† 1}
# participants affected / at risk	7/119 (5.88%)	10/110 (9.09%)	6/118 (5.08%)
GASTRITIS ^{† 1}
# participants affected / at risk	1/119 (0.84%)	6/110 (5.45%)	1/118 (0.85%)
FLATULENCE ^{† 1}
# participants affected / at risk	6/119 (5.04%)	8/110 (7.27%)	6/118 (5.08%)
ABDOMINAL PAIN ^{† 1}
# participants affected / at risk	7/119 (5.88%)	12/110 (10.91%)	10/118 (8.47%)
ABDOMINAL DISTENSION ^{† 1}
# participants affected / at risk	6/119 (5.04%)	8/110 (7.27%)	8/118 (6.78%)
ABDOMINAL PAIN UPPER ^{† 1}
# participants affected / at risk	5/119 (4.20%)	16/110 (14.55%)	7/118 (5.93%)
General disorders
FATIGUE ^{† 1}
# participants affected / at risk	9/119 (7.56%)	10/110 (9.09%)	10/118 (8.47%)
PYREXIA ^{† 1}
# participants affected / at risk	19/119 (15.97%)	9/110 (8.18%)	10/118 (8.47%)
ASTHENIA ^{† 1}
# participants affected / at risk	7/119 (5.88%)	7/110 (6.36%)	9/118 (7.63%)
OEDEMA PERIPHERAL ^{† 1}
# participants affected / at risk	2/119 (1.68%)	2/110 (1.82%)	6/118 (5.08%)
INFLUENZA LIKE ILLNESS ^{† 1}
# participants affected / at risk	8/119 (6.72%)	4/110 (3.64%)	4/118 (3.39%)
Hepatobiliary disorders
JAUNDICE ^{† 1}
# participants affected / at risk	19/119 (15.97%)	7/110 (6.36%)	0/118 (0.00%)
HYPERBILIRUBINAEMIA ^{† 1}
# participants affected / at risk	23/119 (19.33%)	8/110 (7.27%)	1/118 (0.85%)
Immune system disorders
HYPERSENSITIVITY ^{† 1}
# participants affected / at risk	0/119 (0.00%)	6/110 (5.45%)	2/118 (1.69%)
Infections and infestations
INFLUENZA ^{† 1}
# participants affected / at risk	20/119 (16.81%)	17/110 (15.45%)	14/118 (11.86%)
PNEUMONIA ^{† 1}
# participants affected / at risk	6/119 (5.04%)	5/110 (4.55%)	3/118 (2.54%)
SINUSITIS ^{† 1}
# participants affected / at risk	15/119 (12.61%)	14/110 (12.73%)	19/118 (16.10%)
BRONCHITIS ^{† 1}
# participants affected / at risk	13/119 (10.92%)	12/110 (10.91%)	17/118 (14.41%)
PHARYNGITIS ^{† 1}
# participants affected / at risk	8/119 (6.72%)	7/110 (6.36%)	7/118 (5.93%)
GASTROENTERITIS ^{† 1}
# participants affected / at risk	2/119 (1.68%)	4/110 (3.64%)	7/118 (5.93%)
NASOPHARYNGITIS ^{† 1}
# participants affected / at risk	17/119 (14.29%)	13/110 (11.82%)	19/118 (16.10%)
URINARY TRACT INFECTION ^{† 1}
# participants affected / at risk	10/119 (8.40%)	9/110 (8.18%)	9/118 (7.63%)
UPPER RESPIRATORY TRACT INFECTION ^{† 1}
# participants affected / at risk	7/119 (5.88%)	5/110 (4.55%)	14/118 (11.86%)
Investigations
LIPASE INCREASED ^{† 1}
# participants affected / at risk	8/119 (6.72%)	2/110 (1.82%)	8/118 (6.78%)
WEIGHT DECREASED ^{† 1}
# participants affected / at risk	10/119 (8.40%)	9/110 (8.18%)	13/118 (11.02%)
BLOOD BILIRUBIN INCREASED ^{† 1}
# participants affected / at risk	11/119 (9.24%)	4/110 (3.64%)	1/118 (0.85%)
BLOOD TRIGLYCERIDES INCREASED ^{† 1}
# participants affected / at risk	7/119 (5.88%)	2/110 (1.82%)	9/118 (7.63%)
ASPARTATE AMINOTRANSFERASE INCREASED ^{† 1}
# participants affected / at risk	2/119 (1.68%)	2/110 (1.82%)	6/118 (5.08%)
Metabolism and nutrition disorders
DECREASED APPETITE ^{† 1}
# participants affected / at risk	7/119 (5.88%)	12/110 (10.91%)	12/118 (10.17%)
HYPERTRIGLYCERIDAEMIA ^{† 1}
# participants affected / at risk	8/119 (6.72%)	6/110 (5.45%)	8/118 (6.78%)
Musculoskeletal and connective tissue disorders
MYALGIA ^{† 1}
# participants affected / at risk	12/119 (10.08%)	6/110 (5.45%)	9/118 (7.63%)
BACK PAIN ^{† 1}
# participants affected / at risk	15/119 (12.61%)	13/110 (11.82%)	13/118 (11.02%)
ARTHRALGIA ^{† 1}
# participants affected / at risk	10/119 (8.40%)	10/110 (9.09%)	7/118 (5.93%)
PAIN IN EXTREMITY ^{† 1}
# participants affected / at risk	5/119 (4.20%)	7/110 (6.36%)	4/118 (3.39%)
Nervous system disorders
HEADACHE ^{† 1}
# participants affected / at risk	23/119 (19.33%)	28/110 (25.45%)	22/118 (18.64%)
DIZZINESS ^{† 1}
# participants affected / at risk	7/119 (5.88%)	9/110 (8.18%)	7/118 (5.93%)
PARAESTHESIA ^{† 1}
# participants affected / at risk	5/119 (4.20%)	5/110 (4.55%)	10/118 (8.47%)
HYPOAESTHESIA ^{† 1}
# participants affected / at risk	2/119 (1.68%)	2/110 (1.82%)	8/118 (6.78%)
NEUROPATHY PERIPHERAL ^{† 1}
# participants affected / at risk	5/119 (4.20%)	4/110 (3.64%)	7/118 (5.93%)
Psychiatric disorders
ANXIETY ^{† 1}
# participants affected / at risk	8/119 (6.72%)	9/110 (8.18%)	4/118 (3.39%)
INSOMNIA ^{† 1}
# participants affected / at risk	12/119 (10.08%)	6/110 (5.45%)	10/118 (8.47%)
DEPRESSION ^{† 1}
# participants affected / at risk	12/119 (10.08%)	11/110 (10.00%)	14/118 (11.86%)
Respiratory, thoracic and mediastinal disorders
COUGH ^{† 1}
# participants affected / at risk	14/119 (11.76%)	9/110 (8.18%)	17/118 (14.41%)
OROPHARYNGEAL PAIN ^{† 1}
# participants affected / at risk	9/119 (7.56%)	5/110 (4.55%)	11/118 (9.32%)
Skin and subcutaneous tissue disorders
RASH ^{† 1}
# participants affected / at risk	7/119 (5.88%)	10/110 (9.09%)	12/118 (10.17%)
PRURITUS ^{† 1}
# participants affected / at risk	4/119 (3.36%)	7/110 (6.36%)	6/118 (5.08%)
LIPOATROPHY ^{† 1}
# participants affected / at risk	2/119 (1.68%)	6/110 (5.45%)	5/118 (4.24%)
LIPODYSTROPHY ACQUIRED ^{† 1}
# participants affected / at risk	9/119 (7.56%)	10/110 (9.09%)	11/118 (9.32%)

†	Events were collected by systematic assessment
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:

	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: Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

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: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com

No publications provided

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00035932 History of Changes
Obsolete Identifiers:	NCT00028054
Other Study ID Numbers:	AI424-045
Study First Received:	May 6, 2002
Results First Received:	October 14, 2010
Last Updated:	November 29, 2010
Health Authority:	United States: Food and Drug Administration

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