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Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas (Yosemite)

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ClinicalTrials.gov Identifier: NCT01732913
Recruitment Status : Terminated
First Posted : November 26, 2012
Results First Posted : May 11, 2017
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Indolent Non-Hodgkin's Lymphomas
Interventions Drug: Placebo
Drug: Rituximab
Drug: Idelalisib
Enrollment 295
Recruitment Details Participants were enrolled at study sites in the North America, Europe, and Asia Pacific. The first participant was screened on 16 January 2013. The last study visit occurred on 18 May 2016.
Pre-assignment Details 385 participants were screened.
Arm/Group Title Idelalisib + Rituximab Placebo + Rituximab
Hide Arm/Group Description Idelalisib (Zydelig®) 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
Period Title: Overall Study
Started 198 97
Completed [1] 42 28
Not Completed 156 69
Reason Not Completed
Study Terminated by Sponsor             105             55
Withdrawal by Subject             27             4
Physician Decision             14             7
Other             7             1
Initiation of Other Anti-Cancer Therapy             3             2
[1]
Completed = reached primary efficacy endpoint of progressive disease or death
Arm/Group Title Idelalisib + Rituximab Placebo + Rituximab Total
Hide Arm/Group Description Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions Total of all reporting groups
Overall Number of Baseline Participants 198 97 295
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT) Analysis Set: all participants who were randomized regardless of whether they received any study treatment
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 198 participants 97 participants 295 participants
64  (11.4) 67  (11.4) 65  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 198 participants 97 participants 295 participants
Female
99
  50.0%
48
  49.5%
147
  49.8%
Male
99
  50.0%
49
  50.5%
148
  50.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 198 participants 97 participants 295 participants
Asian
35
  17.7%
17
  17.5%
52
  17.6%
Black or African American
5
   2.5%
4
   4.1%
9
   3.1%
White
123
  62.1%
54
  55.7%
177
  60.0%
Other
3
   1.5%
3
   3.1%
6
   2.0%
Not Permitted
32
  16.2%
19
  19.6%
51
  17.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 198 participants 97 participants 295 participants
Hispanic or Latino
12
   6.1%
3
   3.1%
15
   5.1%
Not Hispanic or Latino
150
  75.8%
75
  77.3%
225
  76.3%
Unknown or Not Reported
36
  18.2%
19
  19.6%
55
  18.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 198 participants 97 participants 295 participants
Russian Federation
7
   3.5%
2
   2.1%
9
   3.1%
Singapore
5
   2.5%
4
   4.1%
9
   3.1%
Romania
1
   0.5%
0
   0.0%
1
   0.3%
Hungary
24
  12.1%
6
   6.2%
30
  10.2%
United States
65
  32.8%
34
  35.1%
99
  33.6%
Japan
23
  11.6%
9
   9.3%
32
  10.8%
United Kingdom
3
   1.5%
1
   1.0%
4
   1.4%
Portugal
3
   1.5%
1
   1.0%
4
   1.4%
Spain
6
   3.0%
0
   0.0%
6
   2.0%
Czech Republic
2
   1.0%
0
   0.0%
2
   0.7%
Sweden
6
   3.0%
2
   2.1%
8
   2.7%
Taiwan
1
   0.5%
1
   1.0%
2
   0.7%
Poland
5
   2.5%
7
   7.2%
12
   4.1%
Korea, Republic of
4
   2.0%
2
   2.1%
6
   2.0%
Italy
7
   3.5%
4
   4.1%
11
   3.7%
Israel
3
   1.5%
0
   0.0%
3
   1.0%
Australia
7
   3.5%
6
   6.2%
13
   4.4%
France
25
  12.6%
17
  17.5%
42
  14.2%
Germany
1
   0.5%
1
   1.0%
2
   0.7%
1.Primary Outcome
Title Progression Free Survival
Hide Description Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphoma (iNHL) disease progression or death from any cause. PFS was to be assessed by an independent review committee (IRC).
Time Frame [Not Specified]
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Arm/Group Title Idelalisib + Rituximab Placebo + Rituximab
Hide Arm/Group Description:
Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Overall Response Rate
Hide Description Overall Response Rate (ORR) is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response or minor response for participants with Waldenstrom's). ORR was to be assessed by an IRC.
Time Frame [Not Specified]
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Arm/Group Title Idelalisib + Rituximab Placebo + Rituximab
Hide Arm/Group Description:
Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Lymph Node Response Rate
Hide Description Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC.
Time Frame [Not Specified]
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Arm/Group Title Idelalisib + Rituximab Placebo + Rituximab
Hide Arm/Group Description:
Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Complete Response Rate
Hide Description Complete response rate is defined as the proportion of participants who achieve a complete response. Complete response rate was to be assessed by an IRC.
Time Frame [Not Specified]
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Arm/Group Title Idelalisib + Rituximab Placebo + Rituximab
Hide Arm/Group Description:
Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the interval from randomization to death from any cause.
Time Frame [Not Specified]
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the early termination of the study, efficacy data were not mature for all participants, and therefore the prespecified analyses were not conducted.
Arm/Group Title Idelalisib + Rituximab Placebo + Rituximab
Hide Arm/Group Description:
Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 27 months plus 30 days
Adverse Event Reporting Description Safety Analysis Set
 
Arm/Group Title Idelalisib + Rituximab Placebo + Rituximab
Hide Arm/Group Description Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
All-Cause Mortality
Idelalisib + Rituximab Placebo + Rituximab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Idelalisib + Rituximab Placebo + Rituximab
Affected / at Risk (%) Affected / at Risk (%)
Total   103/198 (52.02%)   11/95 (11.58%) 
Blood and lymphatic system disorders     
Anaemia  1  1/198 (0.51%)  0/95 (0.00%) 
Febrile neutropenia  1  7/198 (3.54%)  0/95 (0.00%) 
Leukopenia  1  1/198 (0.51%)  0/95 (0.00%) 
Neutropenia  1  3/198 (1.52%)  0/95 (0.00%) 
Thrombocytopenia  1  1/198 (0.51%)  1/95 (1.05%) 
Cardiac disorders     
Acute coronary syndrome  1  1/198 (0.51%)  0/95 (0.00%) 
Atrial fibrillation  1  1/198 (0.51%)  0/95 (0.00%) 
Bradycardia  1  0/198 (0.00%)  1/95 (1.05%) 
Cardiac arrest  1  1/198 (0.51%)  0/95 (0.00%) 
Cardiac failure congestive  1  1/198 (0.51%)  2/95 (2.11%) 
Pericarditis  1  1/198 (0.51%)  0/95 (0.00%) 
Tachycardia  1  1/198 (0.51%)  0/95 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/198 (0.51%)  0/95 (0.00%) 
Colitis  1  8/198 (4.04%)  0/95 (0.00%) 
Colitis ulcerative  1  1/198 (0.51%)  0/95 (0.00%) 
Constipation  1  1/198 (0.51%)  0/95 (0.00%) 
Diarrhoea  1  18/198 (9.09%)  0/95 (0.00%) 
Enteritis  1  1/198 (0.51%)  0/95 (0.00%) 
Enterocolitis  1  1/198 (0.51%)  0/95 (0.00%) 
Incarcerated inguinal hernia  1  1/198 (0.51%)  0/95 (0.00%) 
Intestinal obstruction  1  0/198 (0.00%)  1/95 (1.05%) 
Nausea  1  1/198 (0.51%)  0/95 (0.00%) 
Pancreatitis  1  1/198 (0.51%)  0/95 (0.00%) 
Salivary gland disorder  1  0/198 (0.00%)  1/95 (1.05%) 
Salivary gland enlargement  1  0/198 (0.00%)  1/95 (1.05%) 
Stomatitis  1  1/198 (0.51%)  0/95 (0.00%) 
Vomiting  1  3/198 (1.52%)  0/95 (0.00%) 
General disorders     
Asthenia  1  2/198 (1.01%)  0/95 (0.00%) 
Death  1  1/198 (0.51%)  0/95 (0.00%) 
Fatigue  1  1/198 (0.51%)  1/95 (1.05%) 
Gait disturbance  1  1/198 (0.51%)  0/95 (0.00%) 
Oedema  1  1/198 (0.51%)  0/95 (0.00%) 
Pyrexia  1  9/198 (4.55%)  1/95 (1.05%) 
Hepatobiliary disorders     
Cholecystitis acute  1  1/198 (0.51%)  0/95 (0.00%) 
Drug-induced liver injury  1  3/198 (1.52%)  0/95 (0.00%) 
Hepatic failure  1  1/198 (0.51%)  0/95 (0.00%) 
Hepatic function abnormal  1  2/198 (1.01%)  0/95 (0.00%) 
Jaundice  1  2/198 (1.01%)  0/95 (0.00%) 
Immune system disorders     
Hypersensitivity  1  1/198 (0.51%)  0/95 (0.00%) 
Infections and infestations     
Bronchitis  1  1/198 (0.51%)  0/95 (0.00%) 
Cellulitis  1  1/198 (0.51%)  0/95 (0.00%) 
Clostridium difficile colitis  1  1/198 (0.51%)  0/95 (0.00%) 
Cytomegalovirus infection  1  2/198 (1.01%)  0/95 (0.00%) 
Eczema herpeticum  1  1/198 (0.51%)  0/95 (0.00%) 
Fungaemia  1  1/198 (0.51%)  0/95 (0.00%) 
Gastroenteritis  1  1/198 (0.51%)  0/95 (0.00%) 
Herpes zoster meningomyelitis  1  1/198 (0.51%)  0/95 (0.00%) 
Infection  1  1/198 (0.51%)  1/95 (1.05%) 
Infective exacerbation of chronic obstructive airways disease  1  1/198 (0.51%)  0/95 (0.00%) 
Lower respiratory tract infection  1  0/198 (0.00%)  1/95 (1.05%) 
Metapneumovirus infection  1  0/198 (0.00%)  1/95 (1.05%) 
Neutropenic sepsis  1  1/198 (0.51%)  0/95 (0.00%) 
Otitis externa  1  1/198 (0.51%)  0/95 (0.00%) 
Pneumocystis jirovecii pneumonia  1  1/198 (0.51%)  0/95 (0.00%) 
Pneumonia  1  19/198 (9.60%)  0/95 (0.00%) 
Sepsis  1  5/198 (2.53%)  0/95 (0.00%) 
Septic shock  1  1/198 (0.51%)  0/95 (0.00%) 
Skin bacterial infection  1  1/198 (0.51%)  0/95 (0.00%) 
Staphylococcal bacteraemia  1  1/198 (0.51%)  0/95 (0.00%) 
Upper respiratory tract infection  1  2/198 (1.01%)  0/95 (0.00%) 
Urinary tract infection  1  4/198 (2.02%)  0/95 (0.00%) 
Injury, poisoning and procedural complications     
Clavicle fracture  1  1/198 (0.51%)  0/95 (0.00%) 
Fall  1  1/198 (0.51%)  0/95 (0.00%) 
Infusion related reaction  1  1/198 (0.51%)  2/95 (2.11%) 
Laceration  1  1/198 (0.51%)  0/95 (0.00%) 
Rib fracture  1  1/198 (0.51%)  0/95 (0.00%) 
Spinal compression fracture  1  1/198 (0.51%)  0/95 (0.00%) 
Subdural haematoma  1  1/198 (0.51%)  0/95 (0.00%) 
Subdural haemorrhage  1  1/198 (0.51%)  0/95 (0.00%) 
Upper limb fracture  1  0/198 (0.00%)  1/95 (1.05%) 
Investigations     
Alanine aminotransferase increased  1  11/198 (5.56%)  0/95 (0.00%) 
Aspartate aminotransferase increased  1  10/198 (5.05%)  0/95 (0.00%) 
Blood alkaline phosphatase increased  1  0/198 (0.00%)  1/95 (1.05%) 
Blood creatinine increased  1  1/198 (0.51%)  0/95 (0.00%) 
Blood lactate dehydrogenase increased  1  1/198 (0.51%)  0/95 (0.00%) 
Transaminases increased  1  1/198 (0.51%)  0/95 (0.00%) 
Metabolism and nutrition disorders     
Cachexia  1  1/198 (0.51%)  0/95 (0.00%) 
Dehydration  1  4/198 (2.02%)  0/95 (0.00%) 
Hypercalcaemia  1  1/198 (0.51%)  0/95 (0.00%) 
Hyperglycaemia  1  1/198 (0.51%)  0/95 (0.00%) 
Hypoglycaemia  1  1/198 (0.51%)  0/95 (0.00%) 
Hypokalaemia  1  2/198 (1.01%)  0/95 (0.00%) 
Hyponatraemia  1  2/198 (1.01%)  0/95 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/198 (0.51%)  0/95 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer recurrent  1  0/198 (0.00%)  1/95 (1.05%) 
Glioblastoma  1  1/198 (0.51%)  0/95 (0.00%) 
Nervous system disorders     
Cerebrovascular accident  1  2/198 (1.01%)  0/95 (0.00%) 
Dizziness  1  2/198 (1.01%)  0/95 (0.00%) 
Syncope  1  3/198 (1.52%)  0/95 (0.00%) 
Transient ischaemic attack  1  3/198 (1.52%)  0/95 (0.00%) 
Psychiatric disorders     
Anxiety  1  1/198 (0.51%)  0/95 (0.00%) 
Major depression  1  1/198 (0.51%)  0/95 (0.00%) 
Mental status changes  1  2/198 (1.01%)  0/95 (0.00%) 
Suicidal ideation  1  1/198 (0.51%)  0/95 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  5/198 (2.53%)  0/95 (0.00%) 
Nephrolithiasis  1  1/198 (0.51%)  0/95 (0.00%) 
Urinary retention  1  1/198 (0.51%)  0/95 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Bronchitis chronic  1  1/198 (0.51%)  0/95 (0.00%) 
Chronic obstructive pulmonary disease  1  2/198 (1.01%)  0/95 (0.00%) 
Cough  1  1/198 (0.51%)  0/95 (0.00%) 
Dyspnoea  1  3/198 (1.52%)  0/95 (0.00%) 
Dyspnoea exertional  1  1/198 (0.51%)  0/95 (0.00%) 
Hypoxia  1  2/198 (1.01%)  0/95 (0.00%) 
Interstitial lung disease  1  1/198 (0.51%)  0/95 (0.00%) 
Lung disorder  1  2/198 (1.01%)  0/95 (0.00%) 
Pneumonitis  1  8/198 (4.04%)  0/95 (0.00%) 
Pulmonary embolism  1  3/198 (1.52%)  0/95 (0.00%) 
Respiratory failure  1  1/198 (0.51%)  0/95 (0.00%) 
Skin and subcutaneous tissue disorders     
Psoriasis  1  2/198 (1.01%)  0/95 (0.00%) 
Rash  1  4/198 (2.02%)  0/95 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Idelalisib + Rituximab Placebo + Rituximab
Affected / at Risk (%) Affected / at Risk (%)
Total   189/198 (95.45%)   83/95 (87.37%) 
Blood and lymphatic system disorders     
Anaemia  1  12/198 (6.06%)  6/95 (6.32%) 
Neutropenia  1  25/198 (12.63%)  5/95 (5.26%) 
Gastrointestinal disorders     
Abdominal pain  1  20/198 (10.10%)  4/95 (4.21%) 
Constipation  1  28/198 (14.14%)  13/95 (13.68%) 
Diarrhoea  1  88/198 (44.44%)  18/95 (18.95%) 
Gastrooesophageal reflux disease  1  10/198 (5.05%)  3/95 (3.16%) 
Nausea  1  50/198 (25.25%)  12/95 (12.63%) 
Vomiting  1  29/198 (14.65%)  7/95 (7.37%) 
General disorders     
Asthenia  1  15/198 (7.58%)  9/95 (9.47%) 
Chills  1  11/198 (5.56%)  4/95 (4.21%) 
Fatigue  1  41/198 (20.71%)  20/95 (21.05%) 
Oedema peripheral  1  14/198 (7.07%)  5/95 (5.26%) 
Pyrexia  1  50/198 (25.25%)  11/95 (11.58%) 
Infections and infestations     
Bronchitis  1  9/198 (4.55%)  6/95 (6.32%) 
Nasopharyngitis  1  10/198 (5.05%)  6/95 (6.32%) 
Upper respiratory tract infection  1  23/198 (11.62%)  8/95 (8.42%) 
Urinary tract infection  1  13/198 (6.57%)  3/95 (3.16%) 
Injury, poisoning and procedural complications     
Infusion related reaction  1  36/198 (18.18%)  20/95 (21.05%) 
Investigations     
Alanine aminotransferase increased  1  65/198 (32.83%)  0/95 (0.00%) 
Aspartate aminotransferase increased  1  56/198 (28.28%)  0/95 (0.00%) 
Gamma-glutamyltransferase increased  1  11/198 (5.56%)  1/95 (1.05%) 
Transaminases increased  1  12/198 (6.06%)  1/95 (1.05%) 
Weight decreased  1  20/198 (10.10%)  1/95 (1.05%) 
Metabolism and nutrition disorders     
Decreased appetite  1  26/198 (13.13%)  2/95 (2.11%) 
Dehydration  1  11/198 (5.56%)  0/95 (0.00%) 
Hypokalaemia  1  21/198 (10.61%)  4/95 (4.21%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  9/198 (4.55%)  6/95 (6.32%) 
Back pain  1  9/198 (4.55%)  6/95 (6.32%) 
Pain in extremity  1  16/198 (8.08%)  3/95 (3.16%) 
Nervous system disorders     
Dizziness  1  12/198 (6.06%)  6/95 (6.32%) 
Headache  1  30/198 (15.15%)  12/95 (12.63%) 
Psychiatric disorders     
Anxiety  1  10/198 (5.05%)  3/95 (3.16%) 
Insomnia  1  21/198 (10.61%)  11/95 (11.58%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  28/198 (14.14%)  14/95 (14.74%) 
Dyspnoea  1  12/198 (6.06%)  2/95 (2.11%) 
Oropharyngeal pain  1  12/198 (6.06%)  3/95 (3.16%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  25/198 (12.63%)  4/95 (4.21%) 
Rash  1  38/198 (19.19%)  12/95 (12.63%) 
Rash maculo-papular  1  16/198 (8.08%)  2/95 (2.11%) 
Vascular disorders     
Hypertension  1  12/198 (6.06%)  2/95 (2.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
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.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01732913     History of Changes
Other Study ID Numbers: GS-US-313-0124
First Submitted: November 14, 2012
First Posted: November 26, 2012
Results First Submitted: March 30, 2017
Results First Posted: May 11, 2017
Last Update Posted: November 16, 2018