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Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection

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ClinicalTrials.gov Identifier: NCT00445146
Recruitment Status : Completed
First Posted : March 8, 2007
Results First Posted : April 25, 2016
Last Update Posted : April 25, 2016
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: EVG
Drug: RTV
Drug: ARV regimen
Enrollment 192

Recruitment Details Participants were enrolled at study sites in the United States and Puerto Rico. The first participant was screened on 26 February 2007. The last study visit occurred on 24 March 2015.
Pre-assignment Details Participants must have been enrolled in other Gilead-sponsored studies of elvitegravir (EVG) + ritonavir (RTV) to be eligible to receive continued access to EVG+RTV in this study.
Arm/Group Title EVG+RTV
Hide Arm/Group Description

Elvitegravir (EVG) 85 or 150 mg tablet boosted with ritonavir (RTV; r/) 100 mg capsule once daily with food in combination with an investigator-selected antiretroviral (ARV) regimen for the duration of the study.

Some participants may have received EVG 300 mg during the course of protocol amendment 2.

Period Title: Overall Study
Started 192
Completed 73
Not Completed 119
Reason Not Completed
Withdrew Consent             29
Lack of Efficacy             28
Investigator’s Discretion             22
Adverse Event             13
Lost to Follow-up             13
Death             9
Protocol Violation             4
Pregnancy             1
Arm/Group Title EVG+RTV
Hide Arm/Group Description EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study. Some participants may have received EVG 300 mg during the course of protocol amendment 2.
Overall Number of Baseline Participants 192
Hide Baseline Analysis Population Description
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 192 participants
45  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 192 participants
Female
19
   9.9%
Male
173
  90.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 192 participants
Hispanic or Latino
39
  20.3%
Not Hispanic or Latino
153
  79.7%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 192 participants
White 139
Black or African American 48
Native Hawaiian or Other Pacific Islander 1
Other 4
1.Primary Outcome
Title Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event
Hide Description [Not Specified]
Time Frame Up to Week 408 plus 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
Arm/Group Title EVG+RTV
Hide Arm/Group Description:

EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.

Some participants may have received EVG 300 mg during the course of protocol amendment 2.

Overall Number of Participants Analyzed 192
Measure Type: Number
Unit of Measure: percentage of participants
14.6
2.Secondary Outcome
Title Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Hide Description Adverse events (AEs) occurring during treatment and for 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.
Time Frame Up to Week 408 plus 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title EVG+RTV
Hide Arm/Group Description:

EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.

Some participants may have received EVG 300 mg during the course of protocol amendment 2.

Overall Number of Participants Analyzed 192
Measure Type: Number
Unit of Measure: percentage of participants
Any AE 93.8
Grade 3 or 4 AE 45.3
Grade 3 or 4 Drug-related AE 3.1
Serious AE 44.8
3.Secondary Outcome
Title Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality
Hide Description Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.
Time Frame Up to Week 408 plus 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with at least 1 postbaseline measurement were analyzed.
Arm/Group Title EVG+RTV
Hide Arm/Group Description:

EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.

Some participants may have received EVG 300 mg during the course of protocol amendment 2.

Overall Number of Participants Analyzed 191
Measure Type: Number
Unit of Measure: percentage of participants
Grade 1 18.3
Grade 2 31.9
Grade 3 35.1
Grade 4 14.1
4.Secondary Outcome
Title Percentage of Participants Experiencing Any Marked Treatment-Emergent Laboratory Abnormality
Hide Description A 'marked abnormality’ was defined as a shift from grade 0 (or missing) at baseline to at least grade 3 postbaseline; or grade 1 at baseline to grade 4 postbaseline.
Time Frame Up to Week 408 plus 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with at least 1 postbaseline measurement were analyzed.
Arm/Group Title EVG+RTV
Hide Arm/Group Description:

EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.

Some participants may have received EVG 300 mg during the course of protocol amendment 2.

Overall Number of Participants Analyzed 191
Measure Type: Number
Unit of Measure: percentage of participants
40.3
5.Secondary Outcome
Title Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Hide Description [Not Specified]
Time Frame Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title EVG+RTV
Hide Arm/Group Description:

EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.

Some participants may have received EVG 300 mg during the course of protocol amendment 2.

Overall Number of Participants Analyzed 192
Mean (Standard Deviation)
Unit of Measure: g/dL
Baseline (n = 190) 14.2  (1.86)
Change at Week 24 (n = 165) 0.1  (1.01)
Change at Week 48 (n = 151) 0.3  (1.12)
Change at Week 96 (n = 139) 0.2  (1.44)
Change at Week 144 (n = 118) 0.2  (1.40)
Change at Week 192 (n = 106) 0.3  (1.36)
Change at Week 240 (n = 91) 0.2  (1.54)
Change at Week 288 (n = 84) 0.3  (1.79)
Change at Week 336 (n = 78) 0.3  (1.49)
Change at Week 384 (n = 70) 0.4  (1.55)
6.Secondary Outcome
Title Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Hide Description [Not Specified]
Time Frame Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title EVG+RTV
Hide Arm/Group Description:

EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.

Some participants may have received EVG 300 mg during the course of protocol amendment 2.

Overall Number of Participants Analyzed 192
Mean (Standard Deviation)
Unit of Measure: 10^6 cells/μL
Baseline (n = 190) 4.6  (0.65)
Change at Week 24 (n = 165) 0.0  (0.37)
Change at Week 48 (n = 151) 0.0  (0.35)
Change at Week 96 (n = 139) 0.0  (0.45)
Change at Week 144 (n = 118) 0.0  (0.50)
Change at Week 192 (n = 106) 0.0  (0.48)
Change at Week 240 (n = 91) 0.0  (0.55)
Change at Week 288 (n = 84) 0.0  (0.55)
Change at Week 336 (n = 78) 0.0  (0.44)
Change at Week 384 (n = 70) 0.0  (0.45)
7.Secondary Outcome
Title White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Hide Description [Not Specified]
Time Frame Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title EVG+RTV
Hide Arm/Group Description:

EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.

Some participants may have received EVG 300 mg during the course of protocol amendment 2.

Overall Number of Participants Analyzed 192
Mean (Standard Deviation)
Unit of Measure: 10^3 cells/μL
Baseline (n = 190) 5.64  (2.074)
Change at Week 24 (n = 165) 0.02  (1.670)
Change at Week 48 (n = 151) 0.12  (1.899)
Change at Week 96 (n = 139) -0.17  (1.761)
Change at Week 144 (n = 118) -0.25  (1.948)
Change at Week 192 (n = 106) -0.19  (2.072)
Change at Week 240 (n = 91) -0.09  (2.082)
Change at Week 288 (n = 84) -0.21  (2.091)
Change at Week 336 (n = 78) -0.35  (1.961)
Change at Week 384 (n = 70) -0.28  (1.759)
8.Secondary Outcome
Title Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Hide Description [Not Specified]
Time Frame Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title EVG+RTV
Hide Arm/Group Description:

EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.

Some participants may have received EVG 300 mg during the course of protocol amendment 2.

Overall Number of Participants Analyzed 192
Mean (Standard Deviation)
Unit of Measure: 10^3 cells/µL
Baseline (n = 187) 226  (75.0)
Change at Week 24 (n = 154) 2  (47.3)
Change at Week 48 (n = 148) 5  (49.5)
Change at Week 96 (n = 134) 13  (59.4)
Change at Week 144 (n = 114) 3  (48.7)
Change at Week 192 (n = 103) -2  (53.8)
Change at Week 240 (n = 88) 6  (45.7)
Change at Week 288 (n = 80) 6  (60.9)
Change at Week 336 (n = 76) -6  (61.0)
Change at Week 384 (n = 70) -15  (56.8)
9.Secondary Outcome
Title Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Hide Description [Not Specified]
Time Frame Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title EVG+RTV
Hide Arm/Group Description:

EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.

Some participants may have received EVG 300 mg during the course of protocol amendment 2.

Overall Number of Participants Analyzed 192
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline (n = 192) 101  (43.3)
Change at Week 24 (n = 170) -6  (26.8)
Change at Week 48 (n = 156) -9  (31.0)
Change at Week 96 (n = 143) -9  (28.9)
Change at Week 144 (n = 122) -13  (27.8)
Change at Week 192 (n = 110) -18  (27.7)
Change at Week 240 (n = 95) -17  (29.2)
Change at Week 288 (n = 86) -20  (29.3)
Change at Week 336 (n = 80) -19  (31.3)
Change at Week 384 (n = 72) -20  (33.5)
10.Secondary Outcome
Title Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Hide Description [Not Specified]
Time Frame Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title EVG+RTV
Hide Arm/Group Description:

EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.

Some participants may have received EVG 300 mg during the course of protocol amendment 2.

Overall Number of Participants Analyzed 192
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline (n = 191) 28  (16.6)
Change at Week 24 (n = 169) 2  (16.3)
Change at Week 48 (n = 154) 1  (17.5)
Change at Week 96 (n = 141) 2  (19.4)
Change at Week 144 (n = 120) 2  (18.6)
Change at Week 192 (n = 109) 1  (16.2)
Change at Week 240 (n = 94) 0  (18.0)
Change at Week 288 (n = 85) 3  (17.0)
Change at Week 336 (n = 79) 3  (22.9)
Change at Week 384 (n = 71) 1  (15.9)
11.Secondary Outcome
Title Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Hide Description [Not Specified]
Time Frame Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title EVG+RTV
Hide Arm/Group Description:

EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.

Some participants may have received EVG 300 mg during the course of protocol amendment 2.

Overall Number of Participants Analyzed 192
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline (n = 185) 29  (14.5)
Change at Week 24 (n = 163) 2  (13.4)
Change at Week 48 (n = 150) 0  (13.5)
Change at Week 96 (n = 137) 2  (16.2)
Change at Week 144 (n = 116) 1  (14.5)
Change at Week 192 (n = 105) -1  (12.4)
Change at Week 240 (n = 91) 0  (16.3)
Change at Week 288 (n = 82) 1  (12.8)
Change at Week 336 (n = 76) 1  (13.2)
Change at Week 384 (n = 68) 1  (12.0)
12.Secondary Outcome
Title HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Hide Description [Not Specified]
Time Frame Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Efficacy Analysis Set (enrolled participants who received at least 1 dose of EVG and had at least 1 postbaseline HIV-1 RNA or CD4 cell count measurement) with available data were analyzed.
Arm/Group Title EVG+RTV
Hide Arm/Group Description:

EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.

Some participants may have received EVG 300 mg during the course of protocol amendment 2.

Overall Number of Participants Analyzed 191
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
Baseline (n = 190) 2.70  (1.337)
Change at Week 24 (n = 174) -0.13  (0.795)
Change at Week 48 (n = 158) -0.20  (0.892)
Change at Week 96 (n = 142) -0.11  (0.963)
Change at Week 144 (n = 123) -0.22  (0.998)
Change at Week 192 (n = 110) -0.21  (1.043)
Change at Week 240 (n = 96) -0.15  (0.955)
Change at Week 288 (n = 86) -0.34  (1.066)
Change at Week 336 (n = 82) -0.70  (1.055)
Change at Week 384 (n = 73) -0.68  (1.029)
13.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Hide Description [Not Specified]
Time Frame Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Efficacy Analysis Set with available data were analyzed. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.
Arm/Group Title EVG+RTV
Hide Arm/Group Description:

EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.

Some participants may have received EVG 300 mg during the course of protocol amendment 2.

Overall Number of Participants Analyzed 191
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (n = 190) 65.3
Week 24 (n = 175) 69.7
Week 48 (n = 159) 78.6
Week 96 (n = 142) 76.8
Week 144 (n = 123) 82.9
Week 192 (n = 110) 84.5
Week 240 (n = 96) 89.6
Week 288 (n = 86) 95.3
Week 336 (n = 82) 95.1
Week 384 (n = 73) 93.2
14.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Hide Description [Not Specified]
Time Frame Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Efficacy Analysis Set with available data were analyzed. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.
Arm/Group Title EVG+RTV
Hide Arm/Group Description:

EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.

Some participants may have received EVG 300 mg during the course of protocol amendment 2.

Overall Number of Participants Analyzed 191
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (n = 190) 44.2
Week 24 (n = 175) 56.0
Week 48 (n = 159) 62.9
Week 96 (n = 142) 65.5
Week 144 (n = 123) 73.2
Week 192 (n = 110) 79.1
Week 240 (n = 96) 78.1
Week 288 (n = 86) 89.5
Week 336 (n = 82) 86.6
Week 384 (n = 73) 90.4
15.Secondary Outcome
Title CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Hide Description [Not Specified]
Time Frame Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Efficacy Analysis Set with available data were analyzed.
Arm/Group Title EVG+RTV
Hide Arm/Group Description:

EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.

Some participants may have received EVG 300 mg during the course of protocol amendment 2.

Overall Number of Participants Analyzed 191
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
Baseline (n = 189) 283  (211.8)
Change at Week 24 (n = 168) 22  (98.9)
Change at Week 48 (n = 152) 38  (119.5)
Change at Week 96 (n = 138) 78  (132.3)
Change at Week 144 (n = 118) 126  (177.0)
Change at Week 192 (n = 106) 149  (167.5)
Change at Week 240 (n = 93) 176  (198.1)
Change at Week 288 (n = 84) 205  (210.8)
Change at Week 336 (n = 80) 225  (206.8)
Change at Week 384 (n = 71) 234  (214.4)
16.Secondary Outcome
Title Incidence of Mortality
Hide Description The percentage of participants who died was summarized.
Time Frame Up to Week 408 plus 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title EVG+RTV
Hide Arm/Group Description:

EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.

Some participants may have received EVG 300 mg during the course of protocol amendment 2.

Overall Number of Participants Analyzed 192
Measure Type: Number
Unit of Measure: percentage of participants
6.8
Time Frame Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Adverse Event Reporting Description Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
 
Arm/Group Title EVG+RTV
Hide Arm/Group Description

EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule administered orally once daily with food in combination with an investigator-selected antiretroviral (ARV) regimen for the duration of the study.

Some participants may have received EVG 300 mg during the course of protocol amendment 2.

All-Cause Mortality
EVG+RTV
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
EVG+RTV
Affected / at Risk (%)
Total   86/192 (44.79%) 
Blood and lymphatic system disorders   
Anaemia  1  2/192 (1.04%) 
Lymphadenitis  1  1/192 (0.52%) 
Neutropenia  1  1/192 (0.52%) 
Cardiac disorders   
Acute myocardial infarction  1  3/192 (1.56%) 
Aortic valve stenosis  1  1/192 (0.52%) 
Arteriosclerosis coronary artery  1  1/192 (0.52%) 
Atrial fibrillation  1  5/192 (2.60%) 
Atrial flutter  1  1/192 (0.52%) 
Cardiac arrest  1  2/192 (1.04%) 
Cardiac failure congestive  1  2/192 (1.04%) 
Cardiomyopathy  1  1/192 (0.52%) 
Congestive cardiomyopathy  1  2/192 (1.04%) 
Coronary artery disease  1  1/192 (0.52%) 
Ischaemic cardiomyopathy  1  1/192 (0.52%) 
Myocardial infarction  1  4/192 (2.08%) 
Ear and labyrinth disorders   
Vertigo  1  1/192 (0.52%) 
Eye disorders   
Necrotising retinitis  1  1/192 (0.52%) 
Gastrointestinal disorders   
Abdominal pain  1  2/192 (1.04%) 
Colitis  1  1/192 (0.52%) 
Diarrhoea  1  1/192 (0.52%) 
Duodenal perforation  1  1/192 (0.52%) 
Faecal incontinence  1  1/192 (0.52%) 
Intestinal obstruction  1  1/192 (0.52%) 
Intestinal prolapse  1  1/192 (0.52%) 
Oesophagitis  1  1/192 (0.52%) 
Pancreatitis acute  1  1/192 (0.52%) 
Rectal haemorrhage  1  1/192 (0.52%) 
Upper gastrointestinal haemorrhage  1  1/192 (0.52%) 
Vomiting  1  1/192 (0.52%) 
General disorders   
Chest pain  1  3/192 (1.56%) 
Perforated ulcer  1  1/192 (0.52%) 
Pyrexia  1  2/192 (1.04%) 
Hepatobiliary disorders   
Cholecystitis  1  1/192 (0.52%) 
Cholelithiasis  1  1/192 (0.52%) 
Hepatic cirrhosis  1  1/192 (0.52%) 
Immune system disorders   
Serum sickness-like reaction  1  1/192 (0.52%) 
Infections and infestations   
Anal abscess  1  1/192 (0.52%) 
Appendicitis  1  2/192 (1.04%) 
Aspergillus infection  1  1/192 (0.52%) 
Bronchitis  1  1/192 (0.52%) 
Cellulitis  1  5/192 (2.60%) 
Cryptosporidiosis infection  1  1/192 (0.52%) 
Diabetic foot infection  1  1/192 (0.52%) 
Gastroenteritis  1  4/192 (2.08%) 
HIV infection  1  1/192 (0.52%) 
HIV wasting syndrome  1  1/192 (0.52%) 
Herpes zoster  1  2/192 (1.04%) 
Herpes zoster disseminated  1  1/192 (0.52%) 
Influenza  1  3/192 (1.56%) 
Listeriosis  1  1/192 (0.52%) 
Localised infection  1  1/192 (0.52%) 
Meningitis aseptic  1  1/192 (0.52%) 
Meningitis cryptococcal  1  1/192 (0.52%) 
Mycobacterium avium complex infection  1  1/192 (0.52%) 
Oesophageal candidiasis  1  2/192 (1.04%) 
Pneumocystis jirovecii pneumonia  1  2/192 (1.04%) 
Pneumonia  1  9/192 (4.69%) 
Pneumonia streptococcal  1  1/192 (0.52%) 
Progressive multifocal leukoencephalopathy  1  1/192 (0.52%) 
Prostatic abscess  1  1/192 (0.52%) 
Pseudomembranous colitis  1  1/192 (0.52%) 
Pyelonephritis  1  2/192 (1.04%) 
Pyelonephritis acute  1  1/192 (0.52%) 
Secondary syphilis  1  1/192 (0.52%) 
Sepsis  1  2/192 (1.04%) 
Sinusitis aspergillus  1  1/192 (0.52%) 
Subcutaneous abscess  1  1/192 (0.52%) 
Urethritis  1  1/192 (0.52%) 
Urinary tract infection  1  1/192 (0.52%) 
Viral infection  1  1/192 (0.52%) 
Viral pericarditis  1  1/192 (0.52%) 
Injury, poisoning and procedural complications   
Fall  1  1/192 (0.52%) 
Femoral neck fracture  1  1/192 (0.52%) 
Hip fracture  1  1/192 (0.52%) 
Joint dislocation  1  1/192 (0.52%) 
Pelvic fracture  1  1/192 (0.52%) 
Subdural haematoma  1  1/192 (0.52%) 
Toxicity to various agents  1  1/192 (0.52%) 
Investigations   
Weight decreased  1  1/192 (0.52%) 
Metabolism and nutrition disorders   
Dehydration  1  4/192 (2.08%) 
Fluid overload  1  1/192 (0.52%) 
Gout  1  1/192 (0.52%) 
Hypoglycaemia  1  1/192 (0.52%) 
Musculoskeletal and connective tissue disorders   
Arthritis  1  1/192 (0.52%) 
Back pain  1  1/192 (0.52%) 
Flank pain  1  1/192 (0.52%) 
Intervertebral disc degeneration  1  1/192 (0.52%) 
Muscle spasms  1  1/192 (0.52%) 
Osteoarthritis  1  2/192 (1.04%) 
Osteonecrosis  1  4/192 (2.08%) 
Pathological fracture  1  1/192 (0.52%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Castleman's disease  1  1/192 (0.52%) 
Colorectal cancer  1  1/192 (0.52%) 
Diffuse large B-cell lymphoma  1  1/192 (0.52%) 
Hodgkin's disease  1  3/192 (1.56%) 
Nervous system disorders   
Ataxia  1  1/192 (0.52%) 
Cerebrovascular accident  1  1/192 (0.52%) 
Cervical radiculopathy  1  1/192 (0.52%) 
Hepatic encephalopathy  1  1/192 (0.52%) 
Parkinson's disease  1  1/192 (0.52%) 
Presyncope  1  1/192 (0.52%) 
Seizure  1  2/192 (1.04%) 
Syncope  1  1/192 (0.52%) 
Transient ischaemic attack  1  1/192 (0.52%) 
Pregnancy, puerperium and perinatal conditions   
Abortion spontaneous  1  1/192 (0.52%) 
Psychiatric disorders   
Confusional state  1  1/192 (0.52%) 
Depression  1  2/192 (1.04%) 
Homicidal ideation  1  1/192 (0.52%) 
Major depression  1  1/192 (0.52%) 
Mental disorder  1  1/192 (0.52%) 
Mental status changes  1  4/192 (2.08%) 
Suicidal ideation  1  1/192 (0.52%) 
Suicide attempt  1  1/192 (0.52%) 
Renal and urinary disorders   
Acute kidney injury  1  5/192 (2.60%) 
Chronic kidney disease  1  1/192 (0.52%) 
Renal failure  1  1/192 (0.52%) 
Renal impairment  1  1/192 (0.52%) 
Respiratory, thoracic and mediastinal disorders   
Asphyxia  1  1/192 (0.52%) 
Chylothorax  1  1/192 (0.52%) 
Dyspnoea  1  2/192 (1.04%) 
Epistaxis  1  1/192 (0.52%) 
Paranasal cyst  1  1/192 (0.52%) 
Pharyngeal ulceration  1  1/192 (0.52%) 
Pulmonary embolism  1  1/192 (0.52%) 
Respiratory distress  1  1/192 (0.52%) 
Skin and subcutaneous tissue disorders   
Skin reaction  1  1/192 (0.52%) 
Vascular disorders   
Aortic stenosis  1  1/192 (0.52%) 
Deep vein thrombosis  1  3/192 (1.56%) 
Hypertension  1  1/192 (0.52%) 
Hypertensive crisis  1  1/192 (0.52%) 
Hypotension  1  2/192 (1.04%) 
Venous stenosis  1  1/192 (0.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
EVG+RTV
Affected / at Risk (%)
Total   172/192 (89.58%) 
Blood and lymphatic system disorders   
Lymphadenopathy  1  17/192 (8.85%) 
Endocrine disorders   
Hypogonadism  1  11/192 (5.73%) 
Gastrointestinal disorders   
Abdominal pain  1  12/192 (6.25%) 
Constipation  1  13/192 (6.77%) 
Diarrhoea  1  49/192 (25.52%) 
Gastrooesophageal reflux disease  1  22/192 (11.46%) 
Nausea  1  32/192 (16.67%) 
Vomiting  1  16/192 (8.33%) 
General disorders   
Fatigue  1  29/192 (15.10%) 
Pyrexia  1  17/192 (8.85%) 
Immune system disorders   
Seasonal allergy  1  10/192 (5.21%) 
Infections and infestations   
Bronchitis  1  40/192 (20.83%) 
Cellulitis  1  16/192 (8.33%) 
Folliculitis  1  12/192 (6.25%) 
Herpes simplex  1  10/192 (5.21%) 
Influenza  1  19/192 (9.90%) 
Nasopharyngitis  1  34/192 (17.71%) 
Onychomycosis  1  11/192 (5.73%) 
Otitis media  1  12/192 (6.25%) 
Pharyngitis  1  15/192 (7.81%) 
Sinusitis  1  50/192 (26.04%) 
Upper respiratory tract infection  1  62/192 (32.29%) 
Urinary tract infection  1  15/192 (7.81%) 
Viral infection  1  11/192 (5.73%) 
Investigations   
Weight decreased  1  14/192 (7.29%) 
Metabolism and nutrition disorders   
Decreased appetite  1  14/192 (7.29%) 
Hyperlipidaemia  1  10/192 (5.21%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  26/192 (13.54%) 
Back pain  1  33/192 (17.19%) 
Muscle spasms  1  13/192 (6.77%) 
Musculoskeletal pain  1  15/192 (7.81%) 
Pain in extremity  1  24/192 (12.50%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Anogenital warts  1  16/192 (8.33%) 
Skin papilloma  1  19/192 (9.90%) 
Nervous system disorders   
Dizziness  1  10/192 (5.21%) 
Headache  1  24/192 (12.50%) 
Neuropathy peripheral  1  13/192 (6.77%) 
Psychiatric disorders   
Anxiety  1  22/192 (11.46%) 
Depression  1  34/192 (17.71%) 
Insomnia  1  25/192 (13.02%) 
Reproductive system and breast disorders   
Benign prostatic hyperplasia  1  10/192 (5.21%) 
Erectile dysfunction  1  14/192 (7.29%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  33/192 (17.19%) 
Dyspnoea  1  11/192 (5.73%) 
Nasal congestion  1  13/192 (6.77%) 
Oropharyngeal pain  1  14/192 (7.29%) 
Rhinitis allergic  1  14/192 (7.29%) 
Sinus congestion  1  11/192 (5.73%) 
Skin and subcutaneous tissue disorders   
Rash  1  15/192 (7.81%) 
Vascular disorders   
Hypertension  1  16/192 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.1)
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
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00445146     History of Changes
Other Study ID Numbers: GS-US-183-0130
First Submitted: February 28, 2007
First Posted: March 8, 2007
Results First Submitted: March 23, 2016
Results First Posted: April 25, 2016
Last Update Posted: April 25, 2016