Trial Outcomes & Findings for A Study of Raltegravir in a Diverse Cohort of HIV-Infected Patients (0518-055) (NCT NCT00764946)
NCT ID: NCT00764946
Last Updated: 2017-03-21
Results Overview
Numbers of participants with HIV RNA copies \<50 copies/mL were summarized by race for each time point.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
209 participants
Primary outcome timeframe
Week 48
Results posted on
2017-03-21
Participant Flow
Participant milestones
| Measure |
Participants Failing Current Therapy
Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg twice daily (b.i.d.) plus other antiretroviral agents at the discretion of the investigator.
|
Participants Intolerant to Current Therapy
Participants with previous HIV treatment experience who could not tolerate the treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
Participants Treatment Naive
Participants with no previous HIV treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
|---|---|---|---|
|
Overall Study
STARTED
|
98
|
89
|
22
|
|
Overall Study
TREATED
|
97
|
88
|
21
|
|
Overall Study
COMPLETED
|
85
|
72
|
18
|
|
Overall Study
NOT COMPLETED
|
13
|
17
|
4
|
Reasons for withdrawal
| Measure |
Participants Failing Current Therapy
Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg twice daily (b.i.d.) plus other antiretroviral agents at the discretion of the investigator.
|
Participants Intolerant to Current Therapy
Participants with previous HIV treatment experience who could not tolerate the treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
Participants Treatment Naive
Participants with no previous HIV treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
0
|
|
Overall Study
Physician Decision
|
2
|
4
|
0
|
|
Overall Study
Adverse Event
|
3
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
6
|
2
|
|
Overall Study
Never Treated
|
1
|
1
|
1
|
Baseline Characteristics
A Study of Raltegravir in a Diverse Cohort of HIV-Infected Patients (0518-055)
Baseline characteristics by cohort
| Measure |
Participants Failing Current Therapy
n=97 Participants
Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
Participants Intolerant to Current Therapy
n=88 Participants
Participants with previous HIV treatment experience who could not tolerate the treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
Participants Treatment Naive
n=21 Participants
Participants with no previous HIV treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.0 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
46.9 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
38.5 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
44.7 years
STANDARD_DEVIATION 9.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
|
Race
Black
|
70 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
153 Participants
n=4 Participants
|
|
Race
Non-Black
|
27 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had at least one postbaseline evaluation. The Treatment-Related Discontinuation = Failure approach was used as the primary method for handling missing HIV RNA values.
Numbers of participants with HIV RNA copies \<50 copies/mL were summarized by race for each time point.
Outcome measures
| Measure |
Treatment Experienced - Failing Current Therapy
n=94 Participants
Participants with previous HIV treatment who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
Treatment Experienced - Treatment Intolerant
n=80 Participants
Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
Treatment Naive
n=21 Participants
Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
|---|---|---|---|
|
Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
Black (n = 69, 62, 14)
|
44 Participants
|
43 Participants
|
11 Participants
|
|
Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
Non-Black (n = 25, 18, 7)
|
16 Participants
|
18 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Week 48Numbers of participants with one or more adverse events were summarized by race.
Outcome measures
| Measure |
Treatment Experienced - Failing Current Therapy
n=97 Participants
Participants with previous HIV treatment who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
Treatment Experienced - Treatment Intolerant
n=88 Participants
Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
Treatment Naive
n=21 Participants
Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
|---|---|---|---|
|
Number of Participants With One or More Adverse Events
Black (n = 70, 69, 14)
|
55 Participants
|
40 Participants
|
12 Participants
|
|
Number of Participants With One or More Adverse Events
Non-Black (n = 27, 19, 7)
|
23 Participants
|
13 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Week 48Numbers of participants who discontinued due to an adverse event were summarized by race.
Outcome measures
| Measure |
Treatment Experienced - Failing Current Therapy
n=97 Participants
Participants with previous HIV treatment who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
Treatment Experienced - Treatment Intolerant
n=88 Participants
Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
Treatment Naive
n=21 Participants
Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
|---|---|---|---|
|
Number of Participants Who Discontinued Due to an Adverse Event
Non-black (n = 27, 19, 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Discontinued Due to an Adverse Event
Black (n = 70, 69, 14)
|
1 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 48Population: Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had at least one postbaseline evaluation. The Treatment-Related Discontinuation = Failure approach was used as the primary method for handling missing HIV RNA values.
Numbers of participants with HIV RNA copies \<400 copies/mL were summarized by race for each time point.
Outcome measures
| Measure |
Treatment Experienced - Failing Current Therapy
n=94 Participants
Participants with previous HIV treatment who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
Treatment Experienced - Treatment Intolerant
n=81 Participants
Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
Treatment Naive
n=21 Participants
Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
|---|---|---|---|
|
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48
Black (n = 69, 62, 14)
|
51 Participants
|
50 Participants
|
12 Participants
|
|
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48
Non-Black (n = 25, 18, 7)
|
17 Participants
|
18 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had baseline and at least one postbaseline evaluation. Baseline values were carried forward for participants who discontinued before Week 48 due to lack of efficacy.
Mean changes from baseline in plasma HIV RNA were summarized by race at each time point.
Outcome measures
| Measure |
Treatment Experienced - Failing Current Therapy
n=77 Participants
Participants with previous HIV treatment who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
Treatment Experienced - Treatment Intolerant
n=22 Participants
Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
Treatment Naive
n=19 Participants
Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
|---|---|---|---|
|
Mean Change From Baseline to Week 48 in HIV RNA
Black (n = 55, 16, 13)
|
-1.62 log10 copies/mL
Interval -1.93 to -1.31
|
-1.16 log10 copies/mL
Interval -1.88 to -0.45
|
-2.49 log10 copies/mL
Interval -3.17 to -1.81
|
|
Mean Change From Baseline to Week 48 in HIV RNA
Non-Black ( n= 22, 6, 6)
|
-1.52 log10 copies/mL
Interval -2.05 to -0.99
|
-2.21 log10 copies/mL
Interval -2.87 to -1.56
|
-1.66 log10 copies/mL
Interval -3.14 to -0.18
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had baseline and at least one postbaseline evaluation. Baseline values were carried forward for participants who discontinued before Week 48 due to lack of efficacy.
Mean changes from baseline in CD4 cell counts were summarized by race at each time point.
Outcome measures
| Measure |
Treatment Experienced - Failing Current Therapy
n=89 Participants
Participants with previous HIV treatment who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
Treatment Experienced - Treatment Intolerant
n=76 Participants
Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
Treatment Naive
n=19 Participants
Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
|---|---|---|---|
|
Mean Change From Baseline to Week 48 in CD4 Cell Count
Black (n = 66, 61, 12)
|
141.0 cells/mm^3
Interval 109.6 to 172.5
|
62.3 cells/mm^3
Interval 27.0 to 97.7
|
208.8 cells/mm^3
Interval 108.6 to 309.1
|
|
Mean Change From Baseline to Week 48 in CD4 Cell Count
Non-Black (n = 23, 15, 7)
|
113.1 cells/mm^3
Interval 62.2 to 164.1
|
69.2 cells/mm^3
Interval 16.7 to 121.7
|
164.4 cells/mm^3
Interval 12.8 to 316.1
|
SECONDARY outcome
Timeframe: Week 48Population: Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had at least one postbaseline evaluation.
For participants with confirmed HIV RNA levels \<50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value \>50 copies/mL or loss to follow-up; participants who never achieved HIV RNA \<50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event free).
Outcome measures
| Measure |
Treatment Experienced - Failing Current Therapy
n=97 Participants
Participants with previous HIV treatment who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
Treatment Experienced - Treatment Intolerant
n=88 Participants
Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
Treatment Naive
n=21 Participants
Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
|---|---|---|---|
|
Number of Participants Without Loss of Virologic Response
Black (n = 70, 69, 14)
|
48 participants
|
49 participants
|
11 participants
|
|
Number of Participants Without Loss of Virologic Response
Non-Black (n = 27, 19, 7)
|
16 participants
|
17 participants
|
5 participants
|
Adverse Events
Treatment Experienced - Failing Current Therapy
Serious events: 15 serious events
Other events: 49 other events
Deaths: 0 deaths
Treatment Experienced - Intolerant To Current Therapy
Serious events: 5 serious events
Other events: 26 other events
Deaths: 0 deaths
Treatment Naive
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Experienced - Failing Current Therapy
n=97 participants at risk
Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
Treatment Experienced - Intolerant To Current Therapy
n=88 participants at risk
Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
Treatment Naive
n=21 participants at risk
Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
1/97 • Number of events 1
|
0.00%
0/88
|
0.00%
0/21
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
1.0%
1/97 • Number of events 1
|
0.00%
0/88
|
0.00%
0/21
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/97
|
1.1%
1/88 • Number of events 1
|
0.00%
0/21
|
|
Ear and labyrinth disorders
Sensorineural hearing loss
|
1.0%
1/97 • Number of events 1
|
0.00%
0/88
|
0.00%
0/21
|
|
Gastrointestinal disorders
Acute gastritis
|
1.0%
1/97 • Number of events 1
|
0.00%
0/88
|
0.00%
0/21
|
|
Gastrointestinal disorders
Chronic diarrhoea
|
1.0%
1/97 • Number of events 1
|
0.00%
0/88
|
0.00%
0/21
|
|
Gastrointestinal disorders
Nausea
|
1.0%
1/97 • Number of events 1
|
0.00%
0/88
|
0.00%
0/21
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/97 • Number of events 1
|
0.00%
0/88
|
0.00%
0/21
|
|
Infections and infestations
Acute pharyngitis
|
1.0%
1/97 • Number of events 1
|
0.00%
0/88
|
0.00%
0/21
|
|
Infections and infestations
Community acquired pneumonia
|
0.00%
0/97
|
1.1%
1/88 • Number of events 1
|
0.00%
0/21
|
|
Infections and infestations
Cytomegalovirus colitis
|
1.0%
1/97 • Number of events 1
|
0.00%
0/88
|
0.00%
0/21
|
|
Infections and infestations
Facial abscess
|
1.0%
1/97 • Number of events 1
|
0.00%
0/88
|
0.00%
0/21
|
|
Infections and infestations
Gastroenteritis viral
|
1.0%
1/97 • Number of events 1
|
0.00%
0/88
|
0.00%
0/21
|
|
Infections and infestations
Meningitis cryptococcal
|
1.0%
1/97 • Number of events 1
|
0.00%
0/88
|
4.8%
1/21 • Number of events 1
|
|
Infections and infestations
Pneumocystis pneumonia
|
1.0%
1/97 • Number of events 1
|
0.00%
0/88
|
0.00%
0/21
|
|
Infections and infestations
Pneumonia
|
1.0%
1/97 • Number of events 1
|
0.00%
0/88
|
0.00%
0/21
|
|
Infections and infestations
Respiratory tract infection
|
1.0%
1/97 • Number of events 1
|
0.00%
0/88
|
0.00%
0/21
|
|
Infections and infestations
Septic shock
|
1.0%
1/97 • Number of events 1
|
0.00%
0/88
|
0.00%
0/21
|
|
Infections and infestations
Urinary tract infection
|
1.0%
1/97 • Number of events 1
|
1.1%
1/88 • Number of events 1
|
0.00%
0/21
|
|
Injury, poisoning and procedural complications
Stress fracture
|
1.0%
1/97 • Number of events 1
|
0.00%
0/88
|
0.00%
0/21
|
|
Investigations
Alanine aminotransferase increased
|
1.0%
1/97 • Number of events 1
|
0.00%
0/88
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/97
|
1.1%
1/88 • Number of events 1
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/97
|
1.1%
1/88 • Number of events 1
|
0.00%
0/21
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm malignant
|
1.0%
1/97 • Number of events 1
|
0.00%
0/88
|
0.00%
0/21
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/97
|
1.1%
1/88 • Number of events 1
|
0.00%
0/21
|
|
Psychiatric disorders
Acute psychosis
|
1.0%
1/97 • Number of events 2
|
0.00%
0/88
|
0.00%
0/21
|
|
Psychiatric disorders
Depression worsened
|
1.0%
1/97 • Number of events 1
|
0.00%
0/88
|
0.00%
0/21
|
|
Psychiatric disorders
Mental status changes
|
1.0%
1/97 • Number of events 1
|
0.00%
0/88
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Exacerbation of asthma
|
0.00%
0/97
|
1.1%
1/88 • Number of events 3
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.0%
1/97 • Number of events 1
|
0.00%
0/88
|
0.00%
0/21
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/97
|
0.00%
0/88
|
4.8%
1/21 • Number of events 1
|
Other adverse events
| Measure |
Treatment Experienced - Failing Current Therapy
n=97 participants at risk
Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
Treatment Experienced - Intolerant To Current Therapy
n=88 participants at risk
Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
Treatment Naive
n=21 participants at risk
Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
11.3%
11/97 • Number of events 11
|
5.7%
5/88 • Number of events 6
|
9.5%
2/21 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
15.5%
15/97 • Number of events 18
|
8.0%
7/88 • Number of events 7
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
11.3%
11/97 • Number of events 13
|
3.4%
3/88 • Number of events 3
|
0.00%
0/21
|
|
General disorders
Fatigue
|
2.1%
2/97 • Number of events 2
|
0.00%
0/88
|
9.5%
2/21 • Number of events 2
|
|
Infections and infestations
Bronchitis
|
5.2%
5/97 • Number of events 6
|
2.3%
2/88 • Number of events 2
|
0.00%
0/21
|
|
Infections and infestations
Common cold
|
5.2%
5/97 • Number of events 6
|
1.1%
1/88 • Number of events 1
|
0.00%
0/21
|
|
Infections and infestations
Oral candidiasis
|
8.2%
8/97 • Number of events 10
|
0.00%
0/88
|
4.8%
1/21 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
12.4%
12/97 • Number of events 13
|
10.2%
9/88 • Number of events 10
|
9.5%
2/21 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
2.1%
2/97 • Number of events 2
|
5.7%
5/88 • Number of events 5
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
Headache
|
8.2%
8/97 • Number of events 8
|
1.1%
1/88 • Number of events 1
|
0.00%
0/21
|
|
Psychiatric disorders
Anxiety
|
1.0%
1/97 • Number of events 1
|
0.00%
0/88
|
9.5%
2/21 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.2%
5/97 • Number of events 6
|
2.3%
2/88 • Number of events 2
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.0%
1/97 • Number of events 1
|
6.8%
6/88 • Number of events 6
|
4.8%
1/21 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.0%
1/97 • Number of events 1
|
1.1%
1/88 • Number of events 1
|
9.5%
2/21 • Number of events 2
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharpe & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Twenty-four months after completion of this study or after publication of the multicenter results, an investigator may publish the results for their study site independently. The sponsor must have the opportunity to review all proposed publications or presentations regarding the study 60 days before submission.
- Publication restrictions are in place
Restriction type: OTHER