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Trial record 5 of 82 for:    Elvitegravir OR Elvitegravir[TREATMENT] AND HIV [CONDITION]

Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir

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ClinicalTrials.gov Identifier: NCT00708162
Recruitment Status : Completed
First Posted : July 2, 2008
Results First Posted : November 6, 2014
Last Update Posted : May 30, 2016
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 HIV Infection
Interventions Drug: Elvitegravir
Drug: Raltegravir
Drug: EVG placebo
Drug: RAL placebo
Drug: Background regimen
Enrollment 724
Recruitment Details Participants were enrolled in a total of 161 study sites in Australia, Europe, and North America. The first participant was screened on 19 June 2008. The last study visit occurred on 22 April 2015.
Pre-assignment Details 1335 participants were screened.
Arm/Group Title Elvitegravir Raltegravir
Hide Arm/Group Description Elvitegravir (EVG) 85 or 150 mg tablet once daily plus raltegravir (RAL) placebo plus background regimen (1 fully-active ritonavir (RTV)-boosted protease inhibitor (PI) plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase. RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
Period Title: Randomized Phase
Started 361 363
Randomized and Treated 354 358
Completed 205 209
Not Completed 156 154
Reason Not Completed
Randomized but Not Treated             7             5
Participant Noncompliance             40             32
Lost to Follow-up             34             34
Withdrew Consent             31             22
Lack of Efficacy             14             19
Protocol Violation             10             11
Adverse Event             8             12
Investigator’s Discretion             7             10
Death             2             9
Pregnancy             3             0
Period Title: Open-Label Phase
Started 196 [1] 151 [2]
Completed 152 121
Not Completed 44 30
Reason Not Completed
Lost to Follow-up             10             8
Withdrew Consent             12             6
Participant Noncompliance             7             7
Lack of Efficacy             7             4
Investigator's Discretion             3             2
Death             3             1
Adverse Event             1             2
Other             1             0
[1]
9 participants completing the Randomized Phase did not continue to the Open-Label Phase.
[2]
58 participants completing the Randomized Phase did not continue to the Open-Label Phase.
Arm/Group Title Elvitegravir Raltegravir Total
Hide Arm/Group Description EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase. RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase. Total of all reporting groups
Overall Number of Baseline Participants 354 358 712
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 354 participants 358 participants 712 participants
44  (9.0) 45  (9.1) 45  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 354 participants 358 participants 712 participants
Female
60
  16.9%
67
  18.7%
127
  17.8%
Male
294
  83.1%
291
  81.3%
585
  82.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 354 participants 358 participants 712 participants
Hispanic or Latino
81
  22.9%
74
  20.7%
155
  21.8%
Not Hispanic or Latino
272
  76.8%
283
  79.1%
555
  77.9%
Unknown or Not Reported
1
   0.3%
1
   0.3%
2
   0.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 354 participants 358 participants 712 participants
White 210 227 437
Black or African American 128 119 247
Asian 9 5 14
American Indian or Alaska Native 3 3 6
Native Hawaiian or Other Pacific Islander 1 0 1
Other 3 4 7
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 354 participants 358 participants 712 participants
United States 230 223 453
Portugal 10 11 21
Spain 14 20 34
United Kingdom 6 5 11
Italy 7 10 17
France 16 9 25
Mexico 26 25 51
Canada 16 18 34
Puerto Rico 8 14 22
Belgium 5 6 11
Australia 17 12 29
Germany 6 8 14
Netherlands 0 2 2
[1]
Measure Description: All randomized participants were analyzed for Region of Enrollment (elvitegravir arm: n = 361; raltegravir arm: n = 363)
HIV-1 RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 354 participants 358 participants 712 participants
4.26  (0.969) 4.27  (0.943) 4.26  (0.955)
HIV-1 RNA category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 354 participants 358 participants 712 participants
≤ 100,000 copies/mL 263 267 530
> 100,000 copies/mL 91 91 182
Cluster of differentiation (CD4) Cell Count  
Mean (Standard Deviation)
Unit of measure:  Cells/mm^3
Number Analyzed 354 participants 358 participants 712 participants
257.9  (204.31) 265.3  (207.04) 261.6  (205.57)
HIV Disease Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 354 participants 358 participants 712 participants
Asymptomatic 172 175 347
Symptomatic HIV Infections 52 54 106
AIDS 126 125 251
Unknown 4 4 8
Type of PI in Background Regimen (Excluding Ritonavir)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 354 participants 358 participants 712 participants
atazanavir 64 53 117
darunavir 202 206 408
fosamprenavir 14 20 34
lopinavir 68 72 140
tipranavir 6 7 13
[1]
Measure Description: One participant in the Raltegravir group switched from darunavir to fosamprenavir at Day 5, and is counted only in the number receiving darunavir at baseline.
Type of NRTI in Background Regimen  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 354 participants 358 participants 712 participants
tenofovir disoproxil fumarate 163 171 334
emtricitabine/tenofovir disoproxil fumarate 91 66 157
lamivudine 13 13 26
abacavir 6 15 21
abacavir/lamivudine 4 8 12
lamivudine/zidovudine 6 5 11
zidovudine 3 6 9
didanosine 1 7 8
emtricitabine 2 3 5
no NRTI in background regimen 65 64 129
Enfuvirtide (T-20) in background regimen  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 354 participants 358 participants 712 participants
No 352 357 709
Yes 2 1 3
Etravirine in background regimen  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 354 participants 358 participants 712 participants
No 309 303 612
Yes 45 55 100
Maraviroc in background regimen  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 354 participants 358 participants 712 participants
No 330 340 670
Yes 24 18 42
Phenotypic Sensitivity Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 354 participants 358 participants 712 participants
1.0 5 4 9
1.5 23 28 51
2.0 309 313 622
2.5 2 1 3
3.0 14 10 24
3.5 0 1 1
No baseline PSS score 1 1 2
[1]
Measure Description: Phenotypic sensitivity score (PSS) was calculated by summing up drug susceptibility values (1=sensitive; 0.5=partially sensitive; 0=resistance or reduced susceptibility) on all drugs in the baseline background regimen. For subjects naive to enfuvirtide (or maraviroc), a score of 1 was assigned for enfuvirtide (or maraviroc). Higher scores correspond to increased sensitivity.
Chronic Hepatitis B (HBV) Infection Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 354 participants 358 participants 712 participants
Indeterminant 1 0 1
Negative 333 342 675
Positive 17 13 30
No baseline HBV measurement 3 3 6
Chronic Hepatitis C (HCV) Infection Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 354 participants 358 participants 712 participants
Indeterminant 2 2 4
Negative 305 298 603
Positive 44 55 99
No baseline HCV measurement 3 3 6
1.Primary Outcome
Title Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48
Hide Description The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA-defined Time to Loss of Virologic Response (TLOVR) algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Elvitegravir Raltegravir
Hide Arm/Group Description:
EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
Overall Number of Participants Analyzed 351 351
Measure Type: Number
Unit of Measure: percentage of participants
59.0 57.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Elvitegravir, Raltegravir
Comments The planned sample size of 700 HIV-1 infected participants, (350 in each group) was estimated to provide at least 85% power to establish noninferiority in the percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL through Week 48. For sample size and power computation, it was assumed that both elvitegravir and raltegravir arms have a response rate of 0.74, that a noninferiority margin was 0.10, and that the significance level of the test was 1-sided 0.025 level.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Null hypothesis: the EVG group was at least 10% worse than the RAL group with respect to percentage of participants achieving and maintaining HIV-1 RNA < 50 copies/mL through Week 48; alternative hypothesis: the EVG group was less than 10% worse than the RAL group.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
-6.0 to 8.2
Estimation Comments The difference in percentages and its 95% confidence interval (CI) were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using Mantel-Haenszel (MH) proportions and normal approximation.
2.Secondary Outcome
Title Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 96
Hide Description The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Elvitegravir Raltegravir
Hide Arm/Group Description:
EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
Overall Number of Participants Analyzed 351 351
Measure Type: Number
Unit of Measure: percentage of participants
47.6 45.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Elvitegravir, Raltegravir
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Null hypothesis: the EVG arm was at least 10% worse than the RAL arm with respect to percentage of participants achieving and maintaining HIV-1 RNA < 50 copies/mL through Week 48; alternative hypothesis: the EVG arm was less than 10% worse than the RAL arm.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 2.6
Confidence Interval (2-Sided) 95%
-4.6 to 9.9
Estimation Comments The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.
3.Secondary Outcome
Title Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 48
Hide Description The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Elvitegravir Raltegravir
Hide Arm/Group Description:
EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
Overall Number of Participants Analyzed 351 351
Measure Type: Number
Unit of Measure: percentage of participants
68.1 67.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Elvitegravir, Raltegravir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
-6.0 to 7.7
Estimation Comments The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.
4.Secondary Outcome
Title Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 96
Hide Description The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 400 copies/mL at Week 96 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Elvitegravir Raltegravir
Hide Arm/Group Description:
EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
Overall Number of Participants Analyzed 351 351
Measure Type: Number
Unit of Measure: percentage of participants
57.0 56.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Elvitegravir, Raltegravir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
-6.4 to 8.2
Estimation Comments The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.
5.Secondary Outcome
Title Virologic Response at Week 48 (HIV-1 RNA < 50 Copies/mL)
Hide Description Virologic response at Week 48 (percentage of participants with HIV-1 RNA < 50 copies/mL) was analyzed using the FDA-defined Snapshot algorithm, which defines a patient's virologic response status using the viral load along with study drug discontinuation status at the predefined time point within an allowed window of time.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Elvitegravir Raltegravir
Hide Arm/Group Description:
EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
Overall Number of Participants Analyzed 351 351
Measure Type: Number
Unit of Measure: percentage of participants
59.8 57.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Elvitegravir, Raltegravir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 2.2
Confidence Interval (2-Sided) 95%
-5.0 to 9.3
Estimation Comments The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.
6.Secondary Outcome
Title Virologic Response at Week 96 (HIV-1 RNA < 50 Copies/mL)
Hide Description Virologic response at Week 96 (percentage of participants with HIV-1 RNA < 50 copies/mL) was analyzed using the FDA-defined Snapshot algorithm, which defines a patient's virologic response status using the viral load along with study drug discontinuation status at the predefined time point within an allowed window of time.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Elvitegravir Raltegravir
Hide Arm/Group Description:
EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
Overall Number of Participants Analyzed 351 351
Measure Type: Number
Unit of Measure: percentage of participants
52.4 53.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Elvitegravir, Raltegravir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-7.9 to 6.8
Estimation Comments The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.
7.Secondary Outcome
Title Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 48
Hide Description The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 50 copies/mL) up to Week 48 was estimated using the Kaplan-Meier method in the time to event analysis.
Time Frame Baseline to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Elvitegravir Raltegravir
Hide Arm/Group Description:
EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
Overall Number of Participants Analyzed 351 351
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
35
(29.8 to 39.8)
35
(29.8 to 39.8)
8.Secondary Outcome
Title Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 96
Hide Description The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 50 copies/mL) up to Week 96 was estimated using the Kaplan-Meier method in the time to event analysis.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Elvitegravir Raltegravir
Hide Arm/Group Description:
EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
Overall Number of Participants Analyzed 351 351
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
45
(39.3 to 49.9)
46
(41.1 to 51.9)
9.Secondary Outcome
Title Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 48
Hide Description The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 400 copies/mL) up to Week 48 was estimated using the Kaplan-Meier method in the time to event analysis.
Time Frame Baseline to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Elvitegravir Raltegravir
Hide Arm/Group Description:
EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
Overall Number of Participants Analyzed 351 351
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24
(19.5 to 28.5)
24
(19.7 to 28.9)
10.Secondary Outcome
Title Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 96
Hide Description The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 400 copies/mL) up to Week 96 was estimated using the Kaplan-Meier method in the time to event analysis.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Elvitegravir Raltegravir
Hide Arm/Group Description:
EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
Overall Number of Participants Analyzed 351 351
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
32
(26.7 to 36.7)
31
(26.1 to 36.1)
11.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the missing = failure method, where participants with missing data were considered as having failed to meet the criteria for evaluation.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Elvitegravir Raltegravir
Hide Arm/Group Description:
EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
Overall Number of Participants Analyzed 351 351
Measure Type: Number
Unit of Measure: percentage of participants
61.0 60.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Elvitegravir, Raltegravir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-6.9 to 7.3
Estimation Comments The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.
12.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the missing = failure method.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Elvitegravir Raltegravir
Hide Arm/Group Description:
EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
Overall Number of Participants Analyzed 351 351
Measure Type: Number
Unit of Measure: percentage of participants
53.6 56.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Elvitegravir, Raltegravir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value -2.9
Confidence Interval (2-Sided) 95%
-10.2 to 4.4
Estimation Comments The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.
13.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48
Hide Description The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the missing = failure method.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Elvitegravir Raltegravir
Hide Arm/Group Description:
EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
Overall Number of Participants Analyzed 351 351
Measure Type: Number
Unit of Measure: percentage of participants
70.1 72.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Elvitegravir, Raltegravir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-8.6 to 4.7
Estimation Comments The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.
14.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96
Hide Description The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 96 was analyzed using the missing = failure method.
Time Frame Week 96
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Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Elvitegravir Raltegravir
Hide Arm/Group Description:
EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
Overall Number of Participants Analyzed 351 351
Measure Type: Number
Unit of Measure: percentage of participants
61.3 63.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Elvitegravir, Raltegravir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-8.8 to 5.5
Estimation Comments The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.
15.Secondary Outcome
Title Change From Baseline in HIV-1 RNA at Week 48
Hide Description The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 48 was analyzed.
Time Frame Baseline to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with evaluable change data at Week 48 were analyzed.
Arm/Group Title Elvitegravir Raltegravir
Hide Arm/Group Description:
EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
Overall Number of Participants Analyzed 280 291
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-2.17  (1.162) -2.18  (1.178)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Elvitegravir, Raltegravir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in log10 copies/mL
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.16 to 0.19
Estimation Comments The difference in least squares means (LSM) and its 95% CI were obtained using an analysis of variance model (ANOVA) adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).
16.Secondary Outcome
Title Change From Baseline in HIV-1 RNA at Week 96
Hide Description The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 96 was analyzed.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with evaluable change data at Week 96 were analyzed.
Arm/Group Title Elvitegravir Raltegravir
Hide Arm/Group Description:
EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
Overall Number of Participants Analyzed 238 238
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-2.26  (1.078) -2.31  (1.068)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Elvitegravir, Raltegravir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in log10 copies/mL
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.12 to 0.22
Estimation Comments The difference in LSM and its 95% CI were obtained using ANOVA adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).
17.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 48
Hide Description The change from baseline in CD4 cell count (cells/mm^3) at Week 48 was analyzed.
Time Frame Baseline to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with evaluable change data at Week 48 were analyzed.
Arm/Group Title Elvitegravir Raltegravir
Hide Arm/Group Description:
EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
Overall Number of Participants Analyzed 267 282
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
138  (141.4) 147  (148.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Elvitegravir, Raltegravir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in cells/mm^3
Estimated Value -9
Confidence Interval (2-Sided) 95%
-33 to 16
Estimation Comments The difference in LSM and its 95% CI were obtained using ANOVA adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).
18.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 96
Hide Description The change from baseline in CD4 cell count (cells/mm^3) at Week 96 was analyzed.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with evaluable change data at Week 96 were analyzed.
Arm/Group Title Elvitegravir Raltegravir
Hide Arm/Group Description:
EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
Overall Number of Participants Analyzed 231 233
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
205  (191.5) 198  (162.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Elvitegravir, Raltegravir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in cells/mm^3
Estimated Value 7
Confidence Interval (2-Sided) 95%
-25 to 39
Estimation Comments The difference in LSM and its 95% CI were obtained using ANOVA adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).
Time Frame Baseline through end of study drug treatment (average exposure: 100 weeks) plus 30 days
Adverse Event Reporting Description Safety Analysis Set: participants who were randomized and received at least one dose of study drug
 
Arm/Group Title Elvitegravir Raltegravir All Elvitegravir
Hide Arm/Group Description

Adverse events in this reporting group are those experienced by participants in the Elvitegravir group during the Randomized Phase

EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.

Adverse events in this reporting group are those experienced by participants in the Raltegravir group during the Randomized Phase

RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.

Adverse events in this reporting group are those experienced by participants in the Elvitegravir group during both the Randomized Phase and Open-Label Phase, and those experienced by participants in the Raltegravir group following switch to EVG in the Open-Label Phase only.
All-Cause Mortality
Elvitegravir Raltegravir All Elvitegravir
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Elvitegravir Raltegravir All Elvitegravir
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   73/354 (20.62%)   86/358 (24.02%)   127/505 (25.15%) 
Blood and lymphatic system disorders       
Coombs positive haemolytic anaemia  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Disseminated intravascular coagulation  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Febrile neutropenia  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Haemolytic anaemia  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Neutropenia  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Thrombocytopenia  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Cardiac disorders       
Acute coronary syndrome  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Acute myocardial infarction  1  2/354 (0.56%)  0/358 (0.00%)  3/505 (0.59%) 
Atrial fibrillation  1  0/354 (0.00%)  1/358 (0.28%)  1/505 (0.20%) 
Cardiac arrest  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Cardiac failure  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Cardiac failure congestive  1  1/354 (0.28%)  0/358 (0.00%)  2/505 (0.40%) 
Cardiac tamponade  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Cardiac ventricular thrombosis  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Cardiogenic shock  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Coronary artery disease  1  0/354 (0.00%)  2/358 (0.56%)  0/505 (0.00%) 
Coronary artery stenosis  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Mitral valve prolapse  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Myocardial infarction  1  0/354 (0.00%)  2/358 (0.56%)  3/505 (0.59%) 
Pericardial effusion  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Pericarditis  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Sinus node dysfunction  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Tachycardia  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Congenital, familial and genetic disorders       
Haemophilia  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Phimosis  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Endocrine disorders       
Basedow's disease  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Cushing's syndrome  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Eye disorders       
Retinal detachment  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Gastrointestinal disorders       
Abdominal hernia  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Abdominal pain  1  1/354 (0.28%)  2/358 (0.56%)  1/505 (0.20%) 
Anal fistula  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Anogenital dysplasia  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Ascites  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Colitis  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Diarrhoea  1  0/354 (0.00%)  2/358 (0.56%)  0/505 (0.00%) 
Dysphagia  1  1/354 (0.28%)  1/358 (0.28%)  1/505 (0.20%) 
Gastritis  1  0/354 (0.00%)  1/358 (0.28%)  1/505 (0.20%) 
Haematemesis  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Haemorrhoids  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Impaired gastric emptying  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Odynophagia  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Pancreatitis  1  1/354 (0.28%)  1/358 (0.28%)  2/505 (0.40%) 
Pancreatitis acute  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Rectal haemorrhage  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Small intestinal obstruction  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Vomiting  1  1/354 (0.28%)  1/358 (0.28%)  1/505 (0.20%) 
General disorders       
Chest pain  1  1/354 (0.28%)  4/358 (1.12%)  4/505 (0.79%) 
Drug withdrawal syndrome  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Non-cardiac chest pain  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Pyrexia  1  0/354 (0.00%)  1/358 (0.28%)  1/505 (0.20%) 
Hepatobiliary disorders       
Cholecystitis  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Chronic hepatic failure  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Drug-induced liver injury  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Hepatitis  1  0/354 (0.00%)  2/358 (0.56%)  0/505 (0.00%) 
Hepatitis cholestatic  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Immune system disorders       
Hypersensitivity  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Immune reconstitution inflammatory syndrome  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Infections and infestations       
Abscess limb  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Acute hepatitis B  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Anal abscess  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Appendicitis  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Arthritis infective  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Biliary sepsis  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Breast abscess  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Bronchitis  1  2/354 (0.56%)  4/358 (1.12%)  3/505 (0.59%) 
Bursitis infective  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Candida infection  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Cellulitis  1  5/354 (1.41%)  5/358 (1.40%)  8/505 (1.58%) 
Enterocolitis bacterial  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Epididymitis  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Extradural abscess  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Folliculitis  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Gastroenteritis  1  1/354 (0.28%)  0/358 (0.00%)  3/505 (0.59%) 
Genital herpes  1  0/354 (0.00%)  1/358 (0.28%)  1/505 (0.20%) 
Hepatitis A  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Herpes simplex  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Herpes zoster  1  0/354 (0.00%)  1/358 (0.28%)  1/505 (0.20%) 
Infectious colitis  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Influenza  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Liver abscess  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Meningitis aseptic  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Muscle abscess  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Neurosyphilis  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Oesophageal candidiasis  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Ophthalmic herpes zoster  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Osteomyelitis  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Parotid abscess  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Periorbital cellulitis  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Perirectal abscess  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Pharyngotonsillitis  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Pneumocystis jirovecii pneumonia  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Pneumonia  1  12/354 (3.39%)  7/358 (1.96%)  15/505 (2.97%) 
Pneumonia bacterial  1  0/354 (0.00%)  1/358 (0.28%)  2/505 (0.40%) 
Postoperative wound infection  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Pyelonephritis  1  1/354 (0.28%)  0/358 (0.00%)  3/505 (0.59%) 
Respiratory tract infection  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Sepsis  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Septic shock  1  1/354 (0.28%)  0/358 (0.00%)  2/505 (0.40%) 
Skin infection  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Spinal cord abscess  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Streptococcal sepsis  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Subcutaneous abscess  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Urinary tract infection  1  2/354 (0.56%)  0/358 (0.00%)  3/505 (0.59%) 
Urosepsis  1  1/354 (0.28%)  1/358 (0.28%)  1/505 (0.20%) 
Viral infection  1  1/354 (0.28%)  0/358 (0.00%)  2/505 (0.40%) 
Injury, poisoning and procedural complications       
Alcohol poisoning  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Ankle fracture  1  1/354 (0.28%)  0/358 (0.00%)  2/505 (0.40%) 
Chemical poisoning  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Contusion  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Craniocerebral injury  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Facial bones fracture  1  1/354 (0.28%)  0/358 (0.00%)  2/505 (0.40%) 
Fall  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Fibula fracture  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Foreign body  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Gastrointestinal stoma complication  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Head injury  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Humerus fracture  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Jaw fracture  1  0/354 (0.00%)  2/358 (0.56%)  0/505 (0.00%) 
Limb traumatic amputation  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Lower limb fracture  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Overdose  1  2/354 (0.56%)  2/358 (0.56%)  3/505 (0.59%) 
Perirenal haematoma  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Radius fracture  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Road traffic accident  1  0/354 (0.00%)  2/358 (0.56%)  0/505 (0.00%) 
Skull fractured base  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Splenic injury  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Subdural haematoma  1  1/354 (0.28%)  0/358 (0.00%)  2/505 (0.40%) 
Thermal burn  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Tibia fracture  1  1/354 (0.28%)  0/358 (0.00%)  2/505 (0.40%) 
Toxicity to various agents  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Ulna fracture  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Wound  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Investigations       
Liver function test abnormal  1  0/354 (0.00%)  2/358 (0.56%)  0/505 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  1  0/354 (0.00%)  0/358 (0.00%)  3/505 (0.59%) 
Diabetic ketoacidosis  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Electrolyte imbalance  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Gout  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Hyperosmolar hyperglycaemic state  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Lactic acidosis  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Type 1 diabetes mellitus  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Fasciitis  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Intervertebral disc protrusion  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Myopathy  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Myositis  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Osteoarthritis  1  1/354 (0.28%)  1/358 (0.28%)  1/505 (0.20%) 
Osteonecrosis  1  0/354 (0.00%)  1/358 (0.28%)  2/505 (0.40%) 
Spondylolisthesis  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Anal cancer recurrent  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Anal cancer stage 0  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Anogenital warts  1  2/354 (0.56%)  1/358 (0.28%)  2/505 (0.40%) 
Basal cell carcinoma  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Bowen's disease  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Diffuse large B-cell lymphoma  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Gallbladder adenocarcinoma  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Hodgkin's disease stage IV  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Kaposi's sarcoma  1  1/354 (0.28%)  1/358 (0.28%)  2/505 (0.40%) 
Lung cancer metastatic  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Lung neoplasm malignant  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Malignant neoplasm of unknown primary site  1  0/354 (0.00%)  1/358 (0.28%)  1/505 (0.20%) 
Metastases to liver  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Non-Hodgkin's lymphoma  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Oral papilloma  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Primary effusion lymphoma  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Queyrat erythroplasia  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Rectal adenocarcinoma  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Renal cancer  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Salivary gland neoplasm  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
T-cell lymphoma  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Uterine leiomyoma  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Nervous system disorders       
Aphasia  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Ataxia  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Carotid artery dissection  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Cerebral haemorrhage  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Cerebral infarction  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Cerebrovascular accident  1  1/354 (0.28%)  2/358 (0.56%)  2/505 (0.40%) 
Dizziness  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Embolic stroke  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Epilepsy  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Headache  1  1/354 (0.28%)  1/358 (0.28%)  1/505 (0.20%) 
Hemiparesis  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Loss of consciousness  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Partial seizures  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Seizure  1  1/354 (0.28%)  2/358 (0.56%)  3/505 (0.59%) 
Subarachnoid haemorrhage  1  1/354 (0.28%)  0/358 (0.00%)  3/505 (0.59%) 
Syncope  1  2/354 (0.56%)  0/358 (0.00%)  7/505 (1.39%) 
Transient ischaemic attack  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Unresponsive to stimuli  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Psychiatric disorders       
Acute psychosis  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Alcohol abuse  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Alcohol withdrawal syndrome  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Anxiety  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Confusional state  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Depression  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Drug dependence  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Hallucination, auditory  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Homicidal ideation  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Major depression  1  0/354 (0.00%)  1/358 (0.28%)  1/505 (0.20%) 
Mental status changes  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Psychotic disorder  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Substance abuse  1  1/354 (0.28%)  1/358 (0.28%)  1/505 (0.20%) 
Suicidal ideation  1  3/354 (0.85%)  4/358 (1.12%)  4/505 (0.79%) 
Suicide attempt  1  1/354 (0.28%)  1/358 (0.28%)  2/505 (0.40%) 
Renal and urinary disorders       
Acute kidney injury  1  2/354 (0.56%)  1/358 (0.28%)  5/505 (0.99%) 
Calculus urinary  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Nephrolithiasis  1  0/354 (0.00%)  2/358 (0.56%)  0/505 (0.00%) 
Obstructive uropathy  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Renal tubular acidosis  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Renal vein thrombosis  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Respiratory, thoracic and mediastinal disorders       
Acute pulmonary oedema  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Asthma  1  2/354 (0.56%)  1/358 (0.28%)  2/505 (0.40%) 
Choking  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Chronic obstructive pulmonary disease  1  1/354 (0.28%)  1/358 (0.28%)  2/505 (0.40%) 
Dyspnoea  1  2/354 (0.56%)  1/358 (0.28%)  5/505 (0.99%) 
Hypoxia  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Lung infiltration  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Pneumothorax  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Pulmonary cavitation  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Pulmonary embolism  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Pulmonary oedema  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Respiratory distress  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Respiratory failure  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Skin and subcutaneous tissue disorders       
Dermatitis allergic  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Skin ulcer  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Vascular disorders       
Aortic stenosis  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Deep vein thrombosis  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Haemodynamic instability  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Haemorrhage  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Hypertensive crisis  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Peripheral arterial occlusive disease  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Peripheral artery thrombosis  1  1/354 (0.28%)  0/358 (0.00%)  1/505 (0.20%) 
Peripheral ischaemia  1  0/354 (0.00%)  1/358 (0.28%)  0/505 (0.00%) 
Shock  1  0/354 (0.00%)  0/358 (0.00%)  1/505 (0.20%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Elvitegravir Raltegravir All Elvitegravir
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   279/354 (78.81%)   250/358 (69.83%)   394/505 (78.02%) 
Gastrointestinal disorders       
Abdominal pain  1  24/354 (6.78%)  18/358 (5.03%)  40/505 (7.92%) 
Diarrhoea  1  120/354 (33.90%)  77/358 (21.51%)  158/505 (31.29%) 
Gastrooesophageal reflux disease  1  14/354 (3.95%)  9/358 (2.51%)  28/505 (5.54%) 
Nausea  1  45/354 (12.71%)  41/358 (11.45%)  61/505 (12.08%) 
Vomiting  1  22/354 (6.21%)  28/358 (7.82%)  30/505 (5.94%) 
General disorders       
Fatigue  1  39/354 (11.02%)  25/358 (6.98%)  55/505 (10.89%) 
Pyrexia  1  18/354 (5.08%)  19/358 (5.31%)  29/505 (5.74%) 
Infections and infestations       
Bronchitis  1  34/354 (9.60%)  34/358 (9.50%)  57/505 (11.29%) 
Folliculitis  1  18/354 (5.08%)  7/358 (1.96%)  25/505 (4.95%) 
Gastroenteritis  1  15/354 (4.24%)  7/358 (1.96%)  28/505 (5.54%) 
Influenza  1  15/354 (4.24%)  10/358 (2.79%)  30/505 (5.94%) 
Nasopharyngitis  1  40/354 (11.30%)  32/358 (8.94%)  56/505 (11.09%) 
Oral herpes  1  15/354 (4.24%)  6/358 (1.68%)  26/505 (5.15%) 
Sinusitis  1  28/354 (7.91%)  28/358 (7.82%)  48/505 (9.50%) 
Upper respiratory tract infection  1  75/354 (21.19%)  59/358 (16.48%)  116/505 (22.97%) 
Urinary tract infection  1  28/354 (7.91%)  35/358 (9.78%)  52/505 (10.30%) 
Metabolism and nutrition disorders       
Hypercholesterolaemia  1  12/354 (3.39%)  20/358 (5.59%)  26/505 (5.15%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  30/354 (8.47%)  28/358 (7.82%)  57/505 (11.29%) 
Back pain  1  42/354 (11.86%)  36/358 (10.06%)  68/505 (13.47%) 
Muscle spasms  1  18/354 (5.08%)  13/358 (3.63%)  28/505 (5.54%) 
Myalgia  1  14/354 (3.95%)  11/358 (3.07%)  26/505 (5.15%) 
Pain in extremity  1  28/354 (7.91%)  25/358 (6.98%)  48/505 (9.50%) 
Nervous system disorders       
Headache  1  49/354 (13.84%)  37/358 (10.34%)  63/505 (12.48%) 
Psychiatric disorders       
Anxiety  1  16/354 (4.52%)  9/358 (2.51%)  33/505 (6.53%) 
Depression  1  33/354 (9.32%)  33/358 (9.22%)  49/505 (9.70%) 
Insomnia  1  26/354 (7.34%)  21/358 (5.87%)  42/505 (8.32%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  41/354 (11.58%)  47/358 (13.13%)  65/505 (12.87%) 
Oropharyngeal pain  1  18/354 (5.08%)  10/358 (2.79%)  24/505 (4.75%) 
Skin and subcutaneous tissue disorders       
Rash  1  28/354 (7.91%)  29/358 (8.10%)  40/505 (7.92%) 
Vascular disorders       
Hypertension  1  14/354 (3.95%)  26/358 (7.26%)  39/505 (7.72%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
10 participants from a single study site were excluded from Intent-to-Treat (ITT) Analysis Set due to critical and multiple protocol violations (elvitegravir arm: n = 3; raltegravir arm: n = 7).
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, Inc.
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00708162     History of Changes
Obsolete Identifiers: NCT00707733
Other Study ID Numbers: GS-US-183-0145
2007-004225-26 ( EudraCT Number )
First Submitted: June 30, 2008
First Posted: July 2, 2008
Results First Submitted: October 23, 2014
Results First Posted: November 6, 2014
Last Update Posted: May 30, 2016