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Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIg) in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant

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ClinicalTrials.gov Identifier: NCT00507689
Recruitment Status : Completed
First Posted : July 26, 2007
Results First Posted : September 19, 2013
Last Update Posted : March 14, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Chronic Hepatitis B
Interventions Drug: FTC/TDF
Drug: Hepatitis B Immunoglobulin (HBIg)
Enrollment 40
Recruitment Details Participants were enrolled at 7 sites in the United States. The first participant was screened on 12 September 2007. The last participant observation was on 03 May 2011.
Pre-assignment Details 51 participants were screened; 40 received emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)+HBIg in the pre-randomization period; 37 received FTC/TDF+HBIg or FTC/TDF in the randomized period.
Arm/Group Title FTC/TDF+HBIg FTC/TDF
Hide Arm/Group Description For the Participant Flow, this group includes all participants who received any treatment in the pre-randomization period, and participants who received FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols. For the Participant Flow, this group includes participants who received FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily.
Period Title: Pre-Randomization Period
Started 40 0
Completed 37 0
Not Completed 3 0
Reason Not Completed
Adverse Event             1             0
Physician Decision             1             0
Withdrawal by Subject             1             0
Period Title: Randomized Period
Started 19 [1] 18 [2]
Completed 18 16
Not Completed 1 2
Reason Not Completed
Adverse Event             1             1
Withdrawal by Subject             0             1
[1]
19 of 37 participants who completed the pre-randomization period were randomized to FTC/TDF+HBIg.
[2]
18 of 37 participants who completed the pre-randomization period were randomized to FTC/TDF.
Arm/Group Title FTC/TDF+HBIg FTC/TDF Not Randomized Total
Hide Arm/Group Description For Baseline Characteristics, this group includes participants who received FTC/TDF+HBIg in the pre-randomization period, and were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols. For Baseline Characteristics, this group includes participants who received FTC/TDF+HBIg in the pre-randomization period, and were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols. For Baseline Characteristics, this group includes participants who received FTC/TDF+HBIg in the pre-randomization period only. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols. Total of all reporting groups
Overall Number of Baseline Participants 19 18 3 40
Hide Baseline Analysis Population Description
Three groups are reported for baseline characteristics: the 2 treatment groups in the randomized period, and non-randomized participants who discontinued prior to the randomized period.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 18 participants 3 participants 40 participants
54  (9.7) 59  (9.1) 64  (6.0) 57  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 18 participants 3 participants 40 participants
Female
4
  21.1%
3
  16.7%
1
  33.3%
8
  20.0%
Male
15
  78.9%
15
  83.3%
2
  66.7%
32
  80.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 18 participants 3 participants 40 participants
Hispanic or Latino
1
   5.3%
2
  11.1%
0
   0.0%
3
   7.5%
Not Hispanic or Latino
17
  89.5%
16
  88.9%
3
 100.0%
36
  90.0%
Unknown or Not Reported
1
   5.3%
0
   0.0%
0
   0.0%
1
   2.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 18 participants 3 participants 40 participants
Asian 6 8 1 15
White 7 5 1 13
Black 5 4 1 10
Other 1 1 0 2
Baseline hepatitis B virus (HBV) DNA Below 169 copies/mL  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 18 participants 3 participants 40 participants
< 169 copies/mL 19 18 3 40
≥ 169 copies/mL 0 0 0 0
Baseline alanine aminotransferase (ALT) above the upper limit of the normal range (ULN)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 18 participants 3 participants 40 participants
> ULN 0 2 0 2
≤ ULN 19 16 3 38
[1]
Measure Description: The upper limit of the normal range (ULN) for ALT was 34 U/L for females 18-69 years of age, and 32 U/L for females over age 69; the ULN was 43 U/L for males 18-69 years of age, and 35 U/L for males over age 69.
1.Primary Outcome
Title Percentage of Participants With HBV Recurrence Prior to or at Week 72
Hide Description HBV recurrence was defined as either HBV DNA ≥ 400 at 2 consecutive visits before Week 72, or HBV DNA ≥ 400 at the Week 72 visit.
Time Frame Pretreatment baseline through Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title FTC/TDF+HBIg FTC/TDF
Hide Arm/Group Description:
Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
Overall Number of Participants Analyzed 19 18
Measure Type: Number
Unit of Measure: percentage of participants
0 0
2.Secondary Outcome
Title Percentage of Participants With HBV Recurrence at Week 96
Hide Description HBV recurrence was defined as HBV DNA ≥ 400 at the Week 96 visit.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data at Week 96 were analyzed.
Arm/Group Title FTC/TDF+HBIg FTC/TDF
Hide Arm/Group Description:
Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
Overall Number of Participants Analyzed 17 16
Measure Type: Number
Unit of Measure: percentage of participants
0 0
3.Secondary Outcome
Title Percentage of Subjects With HBV DNA < 169 Copies/mL at Week 72
Hide Description [Not Specified]
Time Frame Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data at Week 72 were analyzed.
Arm/Group Title FTC/TDF+HBIg FTC/TDF
Hide Arm/Group Description:
Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
Overall Number of Participants Analyzed 19 16
Measure Type: Number
Unit of Measure: percentage of participants
100 100
4.Secondary Outcome
Title Percentage of Participants With HBV DNA < 169 Copies/mL at Week 96
Hide Description [Not Specified]
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data at Week 96 were analyzed.
Arm/Group Title FTC/TDF+HBIg FTC/TDF
Hide Arm/Group Description:
Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
Overall Number of Participants Analyzed 17 16
Measure Type: Number
Unit of Measure: percentage of participants
100 100
5.Secondary Outcome
Title Percentage of Participants With Normal ALT at Week 72
Hide Description Range of normal ALT was 6 to 34 U/L for females 18-69 years of age, and 6 to 32 U/L for females over age 69. Range of normal ALT was 6 to 43 U/L for males 18-69 years of age, and 6 to 35 U/L for males over age 69.
Time Frame Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data at Week 72 were analyzed.
Arm/Group Title FTC/TDF+HBIg FTC/TDF
Hide Arm/Group Description:
Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
Overall Number of Participants Analyzed 19 16
Measure Type: Number
Unit of Measure: percentage of participants
89 81
6.Secondary Outcome
Title Percentage of Participants With Normal ALT at Week 96
Hide Description Range of normal ALT was 6 to 34 U/L for females 18-69 years of age, and 6 to 32 U/L for females over age 69. Range of normal ALT was 6 to 43 U/L for males 18-69 years of age, and 6 to 35 U/L for males over age 69.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data at Week 96 were analyzed.
Arm/Group Title FTC/TDF+HBIg FTC/TDF
Hide Arm/Group Description:
Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
Overall Number of Participants Analyzed 17 15
Measure Type: Number
Unit of Measure: percentage of participants
88 80
Time Frame Pretreatment baseline to Week 96
Adverse Event Reporting Description Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.
 
Arm/Group Title FTC/TDF+HBIg, Pre-randomization Period FTC/TDF+HBIg, Randomized Period FTC/TDF, Randomized Period
Hide Arm/Group Description For the reporting of Adverse Events, this group includes participants who received FTC/TDF+HBIg during the pre-randomization period, and were analyzed from pretreatment baseline to Week 24 (pre-randomization period). FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols. For the reporting of Adverse Events, this group includes participants who received FTC/TDF+HBIg during the randomized period, and were analyzed from randomization (at the Week 24 visit) to Week 96 (randomized period). FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols. For the reporting of Adverse Events, this group includes participants who received FTC/TDF during the randomized period, and were analyzed from randomization (at the Week 24 visit) to Week 96 (randomized period). FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
All-Cause Mortality
FTC/TDF+HBIg, Pre-randomization Period FTC/TDF+HBIg, Randomized Period FTC/TDF, Randomized Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
FTC/TDF+HBIg, Pre-randomization Period FTC/TDF+HBIg, Randomized Period FTC/TDF, Randomized Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/40 (5.00%)   6/19 (31.58%)   3/18 (16.67%) 
Gastrointestinal disorders       
Diarrhoea  1  1/40 (2.50%)  0/19 (0.00%)  0/18 (0.00%) 
Immune system disorders       
Liver transplant rejection  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Transplant rejection  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Infections and infestations       
Cytomegalovirus hepatitis  1  1/40 (2.50%)  0/19 (0.00%)  0/18 (0.00%) 
Pneumonia  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Injury, poisoning and procedural complications       
Spinal compression fracture  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Metabolism and nutrition disorders       
Hyperglycaemia  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Hepatic cancer metastatic  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Nervous system disorders       
Aphasia  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Cerebrovascular accident  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Syncope  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Psychiatric disorders       
Psychotic disorder  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Vascular disorders       
Hypertension  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FTC/TDF+HBIg, Pre-randomization Period FTC/TDF+HBIg, Randomized Period FTC/TDF, Randomized Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   22/40 (55.00%)   15/19 (78.95%)   11/18 (61.11%) 
Blood and lymphatic system disorders       
Splenomegaly  1  2/40 (5.00%)  0/19 (0.00%)  0/18 (0.00%) 
Anaemia  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Cardiac disorders       
Angina pectoris  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Cardiomegaly  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Left ventricular dysfunction  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Endocrine disorders       
Adrenal disorder  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Eye disorders       
Macular degeneration  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Vision blurred  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Gastrointestinal disorders       
Diarrhoea  1  3/40 (7.50%)  1/19 (5.26%)  1/18 (5.56%) 
Nausea  1  3/40 (7.50%)  0/19 (0.00%)  0/18 (0.00%) 
Haemorrhoids  1  2/40 (5.00%)  0/19 (0.00%)  0/18 (0.00%) 
Vomiting  1  0/40 (0.00%)  1/19 (5.26%)  2/18 (11.11%) 
Chapped lips  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Gastrooesophageal reflux disease  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Inguinal hernia  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
General disorders       
Oedema peripheral  1  5/40 (12.50%)  1/19 (5.26%)  1/18 (5.56%) 
Fatigue  1  0/40 (0.00%)  3/19 (15.79%)  0/18 (0.00%) 
Pyrexia  1  0/40 (0.00%)  2/19 (10.53%)  1/18 (5.56%) 
Chest pain  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Noncardiac chest pain  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Hepatobiliary disorders       
Hepatic fibrosis  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Immune system disorders       
Seasonal allergies  1  0/40 (0.00%)  2/19 (10.53%)  0/18 (0.00%) 
Transplant rejection  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Infections and infestations       
Helicobacter gastritis  1  0/40 (0.00%)  1/19 (5.26%)  1/18 (5.56%) 
Nasopharyngitis  1  0/40 (0.00%)  2/19 (10.53%)  0/18 (0.00%) 
Bronchiectasis  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Bronchitis  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Oral herpes  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Sinusitis  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Upper respiratory tract infection  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Injury, poisoning and procedural complications       
Skin laceration  1  0/40 (0.00%)  1/19 (5.26%)  1/18 (5.56%) 
Jaw fracture  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Muscle strain  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Procedural pain  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Stress fracture  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Investigations       
Creatine renal clearance decreased  1  3/40 (7.50%)  0/19 (0.00%)  0/18 (0.00%) 
Hepatic enzyme increased  1  0/40 (0.00%)  1/19 (5.26%)  1/18 (5.56%) 
Cardiac murmur  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Electrocardiogram T wave abnormal  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  2/40 (5.00%)  1/19 (5.26%)  1/18 (5.56%) 
Arthralgia  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Pain in extremity  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Lung neoplasm  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Melanocytic naevus  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Nervous system disorders       
Dizziness  1  2/40 (5.00%)  3/19 (15.79%)  1/18 (5.56%) 
Headache  1  2/40 (5.00%)  2/19 (10.53%)  1/18 (5.56%) 
Tremor  1  0/40 (0.00%)  1/19 (5.26%)  1/18 (5.56%) 
Sciatica  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Psychiatric disorders       
Depression  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Renal and urinary disorders       
Dysuria  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Pollakiurua  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders       
Pharyngolarylngeal pain  1  3/40 (7.50%)  0/19 (0.00%)  0/18 (0.00%) 
Sinus congestion  1  0/40 (0.00%)  2/19 (10.53%)  0/18 (0.00%) 
Cough  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Emphysema  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Respiratory disorder  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Skin and subcutaneous tissue disorders       
Acne  1  3/40 (7.50%)  0/19 (0.00%)  0/18 (0.00%) 
Rash  1  2/40 (5.00%)  1/19 (5.26%)  1/18 (5.56%) 
Pruritis  1  0/40 (0.00%)  0/19 (0.00%)  2/18 (11.11%) 
Erythema  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Palmar erythema  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Rash pruritic  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Skin fissures  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Skin lesion  1  0/40 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Vascular disorders       
Hypertension  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Varicose vein  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Vein disorder  1  0/40 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.1)
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
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
EMail: ClinicalTrialDisclosures@gilead.com
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00507689    
Other Study ID Numbers: GS-US-203-0107
First Submitted: July 25, 2007
First Posted: July 26, 2007
Results First Submitted: July 15, 2013
Results First Posted: September 19, 2013
Last Update Posted: March 14, 2014