Trial Outcomes & Findings for Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients (NCT NCT01332227)
NCT ID: NCT01332227
Last Updated: 2015-02-19
Results Overview
HIV-1 RNA level was measured with the Abbott m2000rt® polymerase chain reaction assay. Response rates were assessed using an intent-to-treat algorithm, with numerator representing patients meeting the response criteria, and denominator representing all randomized patients. Randomized patients not meeting the criteria for treatment failure (eg, discontinuation of study therapy or virologic rebound at or before Week 24) were considered responders. Virologic rebound was defined as 2 consecutive on-treatment HIV-1 RNA levels ≥40 c/mL or the last on-treatment HIV-1 RNA level ≥40 c/mL followed by discontinuation. Patients who experienced treatment failure or had missing Week 24 HIV-1 RNA levels were considered failures. RNA=ribonucleic acid; HIV=human immunodeficiency virus.
COMPLETED
PHASE4
132 participants
From Day 1 to Week 24
2015-02-19
Participant Flow
Of 132 patients enrolled, 109 were randomized to receive treatment, and 23 patients were not randomized for the following reasons: 10 did not meet study criteria; 5 withdrew consent; 3 were lost to follow-up, and 5 withdrew for other reasons.
Participant milestones
| Measure |
Atazanavir/Ritonavir + Raltegravir
Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
|
Atazanavir/Ritonavir + Tenofovir/Emtricitabine
Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
37
|
|
Overall Study
COMPLETED
|
56
|
32
|
|
Overall Study
NOT COMPLETED
|
16
|
5
|
Reasons for withdrawal
| Measure |
Atazanavir/Ritonavir + Raltegravir
Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
|
Atazanavir/Ritonavir + Tenofovir/Emtricitabine
Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
3
|
1
|
|
Overall Study
Poor compliance/noncompliance
|
1
|
1
|
|
Overall Study
Patient moved from area
|
1
|
0
|
|
Overall Study
Patient began prohibited medication
|
0
|
1
|
Baseline Characteristics
Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients
Baseline characteristics by cohort
| Measure |
Atazanavir/Ritonavir + Raltegravir
n=72 Participants
Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
|
Atazanavir/Ritonavir + Tenofovir/Emtricitabine
n=37 Participants
Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.0 Years
n=5 Participants
|
44.0 Years
n=7 Participants
|
44.0 Years
n=5 Participants
|
|
Age, Customized
< 65 years
|
69 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Age, Customized
65-85 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
38 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
54 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Mean CD4 count
|
587.7 Cells/mm^3
STANDARD_DEVIATION 252.09 • n=5 Participants
|
630.9 Cells/mm^3
STANDARD_DEVIATION 270.02 • n=7 Participants
|
601.5 Cells/mm^3
STANDARD_DEVIATION 257.48 • n=5 Participants
|
|
Median CD4 count
|
588.5 Cells/mm^3
n=5 Participants
|
639.5 Cells/mm^3
n=7 Participants
|
593.0 Cells/mm^3
n=5 Participants
|
|
Cardiovascular disease risk factors
Hypertension
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Cardiovascular disease risk factors
Diabetes mellitus
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Cardiovascular disease risk factors
Current smoker
|
27 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Cardiovascular disease risk factors
Previous smoker
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Cardiovascular disease risk factors
Family history of premature coronary heart disease
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Week 24Population: All patients who received study drug and who had an HIV-1 RNA measurement at the analysis week.
HIV-1 RNA level was measured with the Abbott m2000rt® polymerase chain reaction assay. Response rates were assessed using an intent-to-treat algorithm, with numerator representing patients meeting the response criteria, and denominator representing all randomized patients. Randomized patients not meeting the criteria for treatment failure (eg, discontinuation of study therapy or virologic rebound at or before Week 24) were considered responders. Virologic rebound was defined as 2 consecutive on-treatment HIV-1 RNA levels ≥40 c/mL or the last on-treatment HIV-1 RNA level ≥40 c/mL followed by discontinuation. Patients who experienced treatment failure or had missing Week 24 HIV-1 RNA levels were considered failures. RNA=ribonucleic acid; HIV=human immunodeficiency virus.
Outcome measures
| Measure |
Atazanavir/Ritonavir + Raltegravir
n=72 Participants
Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
|
Atazanavir/Ritonavir + Tenofovir/Emtricitabine
n=37 Participants
Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24
|
80.6 Percentage of participants
Interval 69.5 to 88.9
|
94.6 Percentage of participants
Interval 81.8 to 99.3
|
SECONDARY outcome
Timeframe: From Day 1 to Week 48Population: All patients who received study drug and who had an HIV-1 RNA measurement at the analysis week.
Percentages of patients with HIV-1 RNA levels \<40 c/mL were summarized at each scheduled visit. Longitudinal plots were created to display proportion versus visit week through Weeks 24 and 48 with error bars representing 95% confidence intervals.
Outcome measures
| Measure |
Atazanavir/Ritonavir + Raltegravir
n=72 Participants
Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
|
Atazanavir/Ritonavir + Tenofovir/Emtricitabine
n=37 Participants
Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48
|
69.4 Percentage of participants
Interval 57.5 to 79.8
|
86.5 Percentage of participants
Interval 71.2 to 95.5
|
SECONDARY outcome
Timeframe: Day 1 to Weeks 28 and 48Population: All patients who received study drug and who had an HIV-1 RNA measurement at the analysis week.
Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates.
Outcome measures
| Measure |
Atazanavir/Ritonavir + Raltegravir
n=72 Participants
Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
|
Atazanavir/Ritonavir + Tenofovir/Emtricitabine
n=37 Participants
Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
|
|---|---|---|
|
Number of Participants With Virologic Rebound at Weeks 24 and 48
Week 24: Virologic rebound
|
7 Participants
|
1 Participants
|
|
Number of Participants With Virologic Rebound at Weeks 24 and 48
Week 48: Virologic rebound
|
9 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Week 24Population: Patients who received study drug, who had an HIV-1 RNA measurement at the analysis week and who experienced virologic rebound.
Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients
Outcome measures
| Measure |
Atazanavir/Ritonavir + Raltegravir
n=7 Participants
Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
|
Atazanavir/Ritonavir + Tenofovir/Emtricitabine
n=1 Participants
Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
|
|---|---|---|
|
Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24
Genotypable (GI)/phenotypable isolates (PI)
|
4 Participants
|
0 Participants
|
|
Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24
Emergent genotypic substitutions in GI pts (n=4,0)
|
4 Participants
|
0 Participants
|
|
Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24
Phenotypic resistance in PI pts (n=4,0)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Week 48Population: Participants with virologic rebound
Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients
Outcome measures
| Measure |
Atazanavir/Ritonavir + Raltegravir
n=9 Participants
Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
|
Atazanavir/Ritonavir + Tenofovir/Emtricitabine
n=1 Participants
Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
|
|---|---|---|
|
Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48
Emergent genotypic substitutions in GI pts (n=5,0)
|
5 Participants
|
0 Participants
|
|
Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48
Genotypable (GI)/phenotypable isolates (PI)
|
5 Participants
|
0 Participants
|
|
Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48
Phenotypic resistance in PI pts (n=5,0)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Week 48Population: All participants who received study drug
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.
Outcome measures
| Measure |
Atazanavir/Ritonavir + Raltegravir
n=72 Participants
Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
|
Atazanavir/Ritonavir + Tenofovir/Emtricitabine
n=37 Participants
Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
|
|---|---|---|
|
Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs
Deaths
|
0 Particpants
|
0 Particpants
|
|
Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs
SAEs
|
4 Particpants
|
1 Particpants
|
|
Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs
Related SAEs
|
1 Particpants
|
0 Particpants
|
|
Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs
Treatment-emergent AEs leading to discontinuation
|
3 Particpants
|
1 Particpants
|
|
Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs
Treatment-emergent AEs
|
51 Particpants
|
28 Particpants
|
SECONDARY outcome
Timeframe: From Baseline to Week 48Population: All participants who received study drug
LD=low-density lipoprotein; HDL=high-density lipoprotein.
Outcome measures
| Measure |
Atazanavir/Ritonavir + Raltegravir
n=72 Participants
Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
|
Atazanavir/Ritonavir + Tenofovir/Emtricitabine
n=37 Participants
Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
|
|---|---|---|
|
Mean Changes in Fasting Lipid Levels From Baseline to Week 48
Fasting total cholesterol
|
11.7 mg/dL
Standard Error 5.239
|
-10.2 mg/dL
Standard Error 4.769
|
|
Mean Changes in Fasting Lipid Levels From Baseline to Week 48
Fasting LDL cholesterol
|
7.7 mg/dL
Standard Error 3.986
|
-5.4 mg/dL
Standard Error 4.691
|
|
Mean Changes in Fasting Lipid Levels From Baseline to Week 48
Fasting HDL cholesterol
|
2.7 mg/dL
Standard Error 2.055
|
-0.3 mg/dL
Standard Error 1.915
|
|
Mean Changes in Fasting Lipid Levels From Baseline to Week 48
Fasting non-HDL cholesterol
|
9.0 mg/dL
Standard Error 4.983
|
-9.8 mg/dL
Standard Error 4.430
|
|
Mean Changes in Fasting Lipid Levels From Baseline to Week 48
Fasting triglycerides
|
14.7 mg/dL
Standard Error 16.667
|
-17.6 mg/dL
Standard Error 16.994
|
Adverse Events
Atazanavir/Ritonavir + Raltegravir
Atazanavir/Ritonavir + Tenofovir/Emtricitabine
Serious adverse events
| Measure |
Atazanavir/Ritonavir + Raltegravir
n=72 participants at risk
Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
|
Atazanavir/Ritonavir + Tenofovir/Emtricitabine
n=37 participants at risk
Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
|
|---|---|---|
|
Metabolism and nutrition disorders
Cachexia
|
1.4%
1/72
|
0.00%
0/37
|
|
Infections and infestations
Device related infection
|
1.4%
1/72
|
0.00%
0/37
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.4%
1/72
|
0.00%
0/37
|
|
Renal and urinary disorders
Calculus urinary
|
1.4%
1/72
|
0.00%
0/37
|
|
General disorders
Non-cardiac chest pain
|
1.4%
1/72
|
0.00%
0/37
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/72
|
2.7%
1/37
|
|
Infections and infestations
Pneumonia legionella
|
1.4%
1/72
|
0.00%
0/37
|
Other adverse events
| Measure |
Atazanavir/Ritonavir + Raltegravir
n=72 participants at risk
Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
|
Atazanavir/Ritonavir + Tenofovir/Emtricitabine
n=37 participants at risk
Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperlactacidaemia
|
0.00%
0/72
|
5.4%
2/37
|
|
Hepatobiliary disorders
Jaundice
|
5.6%
4/72
|
10.8%
4/37
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/72
|
5.4%
2/37
|
|
Eye disorders
Ocular icterus
|
8.3%
6/72
|
8.1%
3/37
|
|
Infections and infestations
Gonorrhoea
|
1.4%
1/72
|
5.4%
2/37
|
|
Gastrointestinal disorders
Abdominal distension
|
1.4%
1/72
|
5.4%
2/37
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
4/72
|
5.4%
2/37
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/72
|
5.4%
2/37
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
8.3%
6/72
|
10.8%
4/37
|
|
Nervous system disorders
Headache
|
5.6%
4/72
|
5.4%
2/37
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.4%
1/72
|
5.4%
2/37
|
|
Renal and urinary disorders
Proteinuria
|
1.4%
1/72
|
8.1%
3/37
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/72
|
5.4%
2/37
|
|
Infections and infestations
Bronchitis
|
5.6%
4/72
|
2.7%
1/37
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
3/72
|
10.8%
4/37
|
|
Psychiatric disorders
Insomnia
|
5.6%
4/72
|
0.00%
0/37
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER