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Safety and Efficacy of E/C/F/TDF Versus RTV-Boosted ATV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment-Naive Women (WAVES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01705574
Recruitment Status : Completed
First Posted : October 12, 2012
Results First Posted : March 10, 2016
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Acquired Immunodeficiency Syndrome
HIV Infections
Interventions Drug: E/C/F/TDF
Drug: ATV
Drug: RTV
Drug: FTC/TDF
Drug: E/C/F/TDF Placebo
Drug: ATV Placebo
Drug: RTV Placebo
Drug: FTC/TDF Placebo
Drug: E/C/F/TAF
Enrollment 583
Recruitment Details Participants were enrolled at study sites in North America, Europe, Dominican Republic, Thailand, and Uganda. The first participant was screened on 24 October 2012. The last study visit occurred on 06 September 2018.
Pre-assignment Details 810 participants were screened.
Arm/Group Title Double-Blind STB to Open-Label STB Double-Blind ATV+RTV+TVD Double-Blind ATV+RTV+TVD to Open-Label GEN Double-Blind ATV+RTV+TVD to Open-Label ATV+RTV+TVD
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Double-Blind (DB) Phase: Stribild® (STB; elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) 150/150/200/300 mg fixed-dose combination (FDC) + atazanavir (ATV) placebo + ritonavir (RTV) placebo + Truvada® (TVD; emtricitabine/tenofovir disoproxil fumarate; FTC/TDF) placebo orally once daily with food for 48 weeks

Open-Label Extension (OLE) Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to receive open-label STB FDC orally once daily with food for 48 weeks.

Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks

Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks

Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label (OL) Genvoya® (GEN; elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide; E/C/F/TAF) 150/150/200/10 mg FDC orally once daily with food for 48 weeks.

Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks

Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and recieve open-label ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC orally once daily with food for 48 weeks.

Period Title: Double-Blind Phase
Started 293 290 0 0
Completed 260 249 0 0
Not Completed 33 41 0 0
Reason Not Completed
Lost to Follow-up             12             16             0             0
Adverse Event             3             10             0             0
Withdrew Consent             8             5             0             0
Non-Compliance with Study Drug             4             5             0             0
Pregnancy             1             1             0             0
Protocol Violation             1             0             0             0
Randomized but Not Treated             4             4             0             0
Period Title: Open-Label Extension Phase
Started [1] 246 0 [2] 159 [3] 53 [4]
Completed 231 0 148 48
Not Completed 15 0 11 5
Reason Not Completed
Lost to Follow-up             6             0             2             2
Withdrew Consent             4             0             4             1
Adverse Event             3             0             0             1
Death             2             0             1             0
Non-Compliance with Study Drug             0             0             1             0
Physician Decision             0             0             2             0
Pregnancy             0             0             1             1
[1]
14 participants did not enter the OLE STB arm.
[2]
Participants either entered the OL GEN arm or OL ATV+RTV+TVD arm.
[3]
159 participants entered from the DB ATV+RTV+TVD arm.
[4]
53 participants entered from the DB ATV+ RTV + TVD arm.
Arm/Group Title Double-Blind STB to Open-Label STB Double-Blind ATV+RTV+TVD to OL GEN or OL ATV+ RTV+TVD Total
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Double-Blind Phase: STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks

Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to receive open-label STB FDC orally once daily with food for 48 weeks.

Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks

Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and either receive open-label GEN 150/150/200/10 mg FDC or open-label ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC orally once daily with food for 48 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 289 286 575
Hide Baseline Analysis Population Description
Safety Analysis Set included participants who were randomized and received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 289 participants 286 participants 575 participants
36  (10.1) 36  (9.7) 36  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 289 participants 286 participants 575 participants
Female 289 286 575
Male 0 0 0
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 289 participants 286 participants 575 participants
Asian 9 17 26
Black 143 133 276
Native Hawaiian or Pacific Islander 0 1 1
White 128 119 247
Other 9 15 24
Not Permitted 0 1 1
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 289 participants 286 participants 575 participants
Hispanic or Latino 20 24 44
Not Hispanic or Latino 269 262 531
Not Permitted 0 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 289 participants 286 participants 575 participants
Russia 101 91 192
United States 59 60 119
United Kingdom 8 12 20
Thailand 9 15 24
Portugal 8 13 21
Belgium 3 5 8
Dominican Republic 6 13 19
Italy 4 1 5
Mexico 3 1 4
Uganda 87 74 161
France 1 1 2
CD4 Cell Count  
Mean (Standard Deviation)
Unit of measure:  cells/µL
Number Analyzed 289 participants 286 participants 575 participants
376  (199.6) 385  (210.2) 381  (204.8)
HIV-1 RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 289 participants 286 participants 575 participants
≤ 100,000 copies/mL 220 214 434
> 100,000 to ≤400,000 copies/mL 44 50 94
> 400,000 copies/mL 25 22 47
1.Primary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 of the Double-Blind Phase as Determined by the US FDA-Defined Snapshot Algorithm
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 of the double-blind phase was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Intent-to-Treat (ITT) Analysis Set (randomized and received at least one dose of study drug) were analyzed.
Arm/Group Title Double-Blind STB Double-Blind ATV+RTV+TVD
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Double-Blind Phase: STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks
Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + TVD (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
Overall Number of Participants Analyzed 289 286
Measure Type: Number
Unit of Measure: percentage of participants
87.2 80.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-Blind STB, Double-Blind ATV+RTV+TVD
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments The null hypothesis was that the STB group was at least 12% worse than the ATV+RTV+TVD group with respect to the percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 (response rate as defined by the snapshot analysis algorithm). The alternative hypothesis was that the STB group was less than 12% worse than the ATV+RTV+TVD group.
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 6.5
Confidence Interval (2-Sided) 95.2%
0.4 to 12.6
Estimation Comments Difference in percentages of virologic success and its 95.2% confidence interval (CI) were calculated based on baseline HIV-1 RNA and race stratum-adjusted Mantel-Haenszel (MH) proportion.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Double-Blind STB, Double-Blind ATV+RTV+TVD
Comments If noninferiority of STB versus ATV+RTV+TVD was established, the same 95.2% CI used in evaluating noninferiority was used to evaluate superiority. The baseline HIV-1 RNA and race stratum-stratified, 2-sided CMH test was also used to assess superiority as a secondary assessment.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value comparing virologic success was from the CMH test stratified by baseline HIV-1 RNA and race strata.
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 6.5
Confidence Interval (2-Sided) 95.2%
0.4 to 12.6
Estimation Comments Difference in percentages of virologic success and its 95.2% CI were calculated based on baseline HIV-1 RNA and race stratum-adjusted MH proportion. If the lower bound of the CI was > 0, superiority of STB over ATV+RTV+TVD was established.
2.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 48 of the Double-Blind Phase
Hide Description [Not Specified]
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with available data were analyzed.
Arm/Group Title Double-Blind STB Double-Blind ATV+RTV+TVD
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Double-Blind Phase: STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks
Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks
Overall Number of Participants Analyzed 263 243
Mean (Standard Deviation)
Unit of Measure: cells/μL
221  (165.1) 212  (176.8)
3.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 for the STB Group as Determined by the US FDA-Defined Snapshot Algorithm
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set who received STB through 96 weeks were analyzed.
Arm/Group Title ALL STB
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Double-Blind Phase: STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks

Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had option to receive open-label STB FDC orally once daily with food for 48 weeks.

Overall Number of Participants Analyzed 278
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
84.5
(79.7 to 88.6)
4.Secondary Outcome
Title Percentage of Participants Receiving STB or ATV+RTV+TVD With HIV-1 RNA < 50 Copies/mL at Week 48 of the Open-Label Extension Phase
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 of the open-label phase was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame Open-Label Extension Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the OLE ITT Analysis Set were analyzed.
Arm/Group Title Open-Label GEN Open-Label ATV+RTV+TVD
Hide Arm/Group Description:
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label GEN 150/150/200/10 mg FDC orally once daily with food for 48 weeks.
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC orally once daily with food for 48 weeks.
Overall Number of Participants Analyzed 159 53
Measure Type: Number
Unit of Measure: Percentage of participants
94.3 86.8
5.Secondary Outcome
Title Change in CD4+ Cell Count at Week 48 of the Open-Label Extension Phase
Hide Description [Not Specified]
Time Frame Baseline; Open-Label Extension Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the OLE ITT Analysis Set with available on-treatment data were analyzed.
Arm/Group Title Open-Label STB Open-Label GEN Open-Label ATV + RTV + TVD
Hide Arm/Group Description:
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to receive open-label STB FDC orally once daily with food for 48 weeks.
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label GEN 150/150/200/10 mg FDC orally once daily with food for 48 weeks.
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC orally once daily with food for 48 weeks.
Overall Number of Participants Analyzed 239 151 49
Mean (Standard Deviation)
Unit of Measure: cells/uL
265  (190.4) 35  (137.5) 49  (204.8)
Time Frame First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
Adverse Event Reporting Description Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
 
Arm/Group Title Double-Blind: STB Double-Blind: ATV+RTV+TVD DB STB to OL STB DB ATV+RTV+TVD to OL GEN DB ATV+RTV+TVD to OL ATV+RTV+TVD
Hide Arm/Group Description Double-Blind Phase: STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to receive open-label STB FDC orally once daily with food for 48 weeks. Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label GEN 150/150/200/10 mg FDC orally once daily with food for 48 weeks. Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and recieve open-label ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC orally once daily with food for 48 weeks.
All-Cause Mortality
Double-Blind: STB Double-Blind: ATV+RTV+TVD DB STB to OL STB DB ATV+RTV+TVD to OL GEN DB ATV+RTV+TVD to OL ATV+RTV+TVD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Double-Blind: STB Double-Blind: ATV+RTV+TVD DB STB to OL STB DB ATV+RTV+TVD to OL GEN DB ATV+RTV+TVD to OL ATV+RTV+TVD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/289 (8.65%)   29/286 (10.14%)   13/246 (5.28%)   12/159 (7.55%)   4/53 (7.55%) 
Blood and lymphatic system disorders           
Anaemia  1  0/289 (0.00%)  1/286 (0.35%)  1/246 (0.41%)  0/159 (0.00%)  0/53 (0.00%) 
Haemorrhagic anaemia  1  0/289 (0.00%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Iron deficiency anaemia  1  0/289 (0.00%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Cardiac disorders           
Acute coronary syndrome  1  0/289 (0.00%)  0/286 (0.00%)  1/246 (0.41%)  0/159 (0.00%)  0/53 (0.00%) 
Angina unstable  1  1/289 (0.35%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Cardiomegaly  1  0/289 (0.00%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Coronary artery occlusion  1  0/289 (0.00%)  0/286 (0.00%)  0/246 (0.00%)  1/159 (0.63%)  0/53 (0.00%) 
Eye disorders           
Chalazion  1  0/289 (0.00%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Gastrointestinal disorders           
Abdominal pain  1  0/289 (0.00%)  1/286 (0.35%)  1/246 (0.41%)  0/159 (0.00%)  1/53 (1.89%) 
Gastritis  1  1/289 (0.35%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Nausea  1  0/289 (0.00%)  0/286 (0.00%)  1/246 (0.41%)  1/159 (0.63%)  0/53 (0.00%) 
Pancreatitis  1  1/289 (0.35%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Vomiting  1  0/289 (0.00%)  0/286 (0.00%)  1/246 (0.41%)  0/159 (0.00%)  0/53 (0.00%) 
General disorders           
Chest pain  1  0/289 (0.00%)  0/286 (0.00%)  1/246 (0.41%)  1/159 (0.63%)  0/53 (0.00%) 
Death  1  0/289 (0.00%)  0/286 (0.00%)  1/246 (0.41%)  0/159 (0.00%)  0/53 (0.00%) 
Malaise  1  1/289 (0.35%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Hepatobiliary disorders           
Cholecystitis  1  1/289 (0.35%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Cholecystitis acute  1  0/289 (0.00%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Cholelithiasis  1  0/289 (0.00%)  0/286 (0.00%)  0/246 (0.00%)  1/159 (0.63%)  0/53 (0.00%) 
Chronic hepatitis  1  1/289 (0.35%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Drug-induced liver injury  1  0/289 (0.00%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Infections and infestations           
Arthritis bacterial  1  1/289 (0.35%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Bone tuberculosis  1  0/289 (0.00%)  0/286 (0.00%)  1/246 (0.41%)  0/159 (0.00%)  0/53 (0.00%) 
Breast abscess  1  0/289 (0.00%)  0/286 (0.00%)  1/246 (0.41%)  0/159 (0.00%)  0/53 (0.00%) 
Catheter site infection  1  1/289 (0.35%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Cellulitis  1  0/289 (0.00%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Furuncle  1  0/289 (0.00%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Gastroenteritis  1  1/289 (0.35%)  0/286 (0.00%)  1/246 (0.41%)  0/159 (0.00%)  0/53 (0.00%) 
Gastroenteritis viral  1  0/289 (0.00%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Malaria  1  1/289 (0.35%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Ophthalmic herpes zoster  1  0/289 (0.00%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Pelvic inflammatory disease  1  1/289 (0.35%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Peritonitis  1  1/289 (0.35%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Pneumonia  1  2/289 (0.69%)  1/286 (0.35%)  1/246 (0.41%)  0/159 (0.00%)  0/53 (0.00%) 
Pulmonary tuberculosis  1  1/289 (0.35%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Subcutaneous abscess  1  1/289 (0.35%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Syphilis  1  0/289 (0.00%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Injury, poisoning and procedural complications           
Fall  1  0/289 (0.00%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Humerus fracture  1  1/289 (0.35%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Investigations           
Electrocardiogram T wave inversion  1  0/289 (0.00%)  0/286 (0.00%)  1/246 (0.41%)  0/159 (0.00%)  0/53 (0.00%) 
Metabolism and nutrition disorders           
Dehydration  1  1/289 (0.35%)  0/286 (0.00%)  1/246 (0.41%)  0/159 (0.00%)  0/53 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  1/289 (0.35%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Arthritis  1  0/289 (0.00%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Back pain  1  1/289 (0.35%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Musculoskeletal chest pain  1  1/289 (0.35%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Musculoskeletal pain  1  0/289 (0.00%)  2/286 (0.70%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Cervix carcinoma  1  1/289 (0.35%)  0/286 (0.00%)  1/246 (0.41%)  0/159 (0.00%)  0/53 (0.00%) 
Fibroadenoma of breast  1  0/289 (0.00%)  0/286 (0.00%)  1/246 (0.41%)  0/159 (0.00%)  0/53 (0.00%) 
Thyroid cancer  1  0/289 (0.00%)  0/286 (0.00%)  1/246 (0.41%)  0/159 (0.00%)  0/53 (0.00%) 
Uterine leiomyoma  1  0/289 (0.00%)  0/286 (0.00%)  0/246 (0.00%)  1/159 (0.63%)  0/53 (0.00%) 
Nervous system disorders           
Dizziness  1  0/289 (0.00%)  0/286 (0.00%)  0/246 (0.00%)  1/159 (0.63%)  0/53 (0.00%) 
Headache  1  1/289 (0.35%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Pregnancy, puerperium and perinatal conditions           
Abortion spontaneous  1  2/289 (0.69%)  2/286 (0.70%)  1/246 (0.41%)  3/159 (1.89%)  2/53 (3.77%) 
Ectopic pregnancy  1  1/289 (0.35%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  1/53 (1.89%) 
Gestational hypertension  1  1/289 (0.35%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Imminent abortion  1  0/289 (0.00%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Ruptured ectopic pregnancy  1  0/289 (0.00%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  1/53 (1.89%) 
Uterine hypertonus  1  0/289 (0.00%)  0/286 (0.00%)  0/246 (0.00%)  1/159 (0.63%)  0/53 (0.00%) 
Psychiatric disorders           
Confusional state  1  0/289 (0.00%)  0/286 (0.00%)  0/246 (0.00%)  1/159 (0.63%)  0/53 (0.00%) 
Conversion disorder  1  0/289 (0.00%)  0/286 (0.00%)  0/246 (0.00%)  1/159 (0.63%)  0/53 (0.00%) 
Depression  1  2/289 (0.69%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Depression suicidal  1  1/289 (0.35%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Major depression  1  1/289 (0.35%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Stress  1  1/289 (0.35%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Substance abuse  1  0/289 (0.00%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Suicidal ideation  1  0/289 (0.00%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Suicide attempt  1  0/289 (0.00%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Renal and urinary disorders           
Acute kidney injury  1  0/289 (0.00%)  2/286 (0.70%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Reproductive system and breast disorders           
Cervical dysplasia  1  1/289 (0.35%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Ovarian cyst  1  0/289 (0.00%)  0/286 (0.00%)  0/246 (0.00%)  1/159 (0.63%)  0/53 (0.00%) 
Uterine haemorrhage  1  0/289 (0.00%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Vaginal haemorrhage  1  1/289 (0.35%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Asthma  1  2/289 (0.69%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Neonatal respiratory distress  1  0/289 (0.00%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Pleurisy  1  0/289 (0.00%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Skin and subcutaneous tissue disorders           
Erythema multiforme  1  0/289 (0.00%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Stevens-Johnson syndrome  1  1/289 (0.35%)  1/286 (0.35%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Vascular disorders           
Hypertension  1  0/289 (0.00%)  0/286 (0.00%)  1/246 (0.41%)  0/159 (0.00%)  0/53 (0.00%) 
Hypotension  1  1/289 (0.35%)  0/286 (0.00%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 21.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Double-Blind: STB Double-Blind: ATV+RTV+TVD DB STB to OL STB DB ATV+RTV+TVD to OL GEN DB ATV+RTV+TVD to OL ATV+RTV+TVD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   176/289 (60.90%)   194/286 (67.83%)   118/246 (47.97%)   68/159 (42.77%)   20/53 (37.74%) 
Blood and lymphatic system disorders           
Anaemia  1  11/289 (3.81%)  14/286 (4.90%)  18/246 (7.32%)  4/159 (2.52%)  0/53 (0.00%) 
Gastrointestinal disorders           
Abdominal pain  1  17/289 (5.88%)  9/286 (3.15%)  1/246 (0.41%)  3/159 (1.89%)  2/53 (3.77%) 
Diarrhoea  1  15/289 (5.19%)  19/286 (6.64%)  6/246 (2.44%)  5/159 (3.14%)  1/53 (1.89%) 
Dyspepsia  1  13/289 (4.50%)  15/286 (5.24%)  4/246 (1.63%)  3/159 (1.89%)  0/53 (0.00%) 
Nausea  1  43/289 (14.88%)  41/286 (14.34%)  6/246 (2.44%)  7/159 (4.40%)  2/53 (3.77%) 
Vomiting  1  28/289 (9.69%)  17/286 (5.94%)  3/246 (1.22%)  4/159 (2.52%)  0/53 (0.00%) 
General disorders           
Fatigue  1  8/289 (2.77%)  15/286 (5.24%)  2/246 (0.81%)  3/159 (1.89%)  2/53 (3.77%) 
Hepatobiliary disorders           
Jaundice  1  1/289 (0.35%)  30/286 (10.49%)  0/246 (0.00%)  0/159 (0.00%)  1/53 (1.89%) 
Ocular icterus  1  1/289 (0.35%)  34/286 (11.89%)  0/246 (0.00%)  0/159 (0.00%)  0/53 (0.00%) 
Infections and infestations           
Influenza  1  20/289 (6.92%)  20/286 (6.99%)  14/246 (5.69%)  12/159 (7.55%)  1/53 (1.89%) 
Malaria  1  34/289 (11.76%)  25/286 (8.74%)  14/246 (5.69%)  8/159 (5.03%)  1/53 (1.89%) 
Nasopharyngitis  1  15/289 (5.19%)  14/286 (4.90%)  8/246 (3.25%)  6/159 (3.77%)  0/53 (0.00%) 
Upper respiratory tract infection  1  50/289 (17.30%)  45/286 (15.73%)  36/246 (14.63%)  23/159 (14.47%)  10/53 (18.87%) 
Urinary tract infection  1  22/289 (7.61%)  23/286 (8.04%)  15/246 (6.10%)  9/159 (5.66%)  0/53 (0.00%) 
Vulvovaginal candidiasis  1  21/289 (7.27%)  20/286 (6.99%)  15/246 (6.10%)  6/159 (3.77%)  4/53 (7.55%) 
Metabolism and nutrition disorders           
Decreased appetite  1  15/289 (5.19%)  14/286 (4.90%)  3/246 (1.22%)  0/159 (0.00%)  1/53 (1.89%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  10/289 (3.46%)  21/286 (7.34%)  9/246 (3.66%)  5/159 (3.14%)  1/53 (1.89%) 
Back pain  1  20/289 (6.92%)  17/286 (5.94%)  13/246 (5.28%)  14/159 (8.81%)  1/53 (1.89%) 
Nervous system disorders           
Dizziness  1  17/289 (5.88%)  10/286 (3.50%)  7/246 (2.85%)  0/159 (0.00%)  1/53 (1.89%) 
Headache  1  49/289 (16.96%)  44/286 (15.38%)  27/246 (10.98%)  20/159 (12.58%)  5/53 (9.43%) 
Neuropathy peripheral  1  21/289 (7.27%)  20/286 (6.99%)  12/246 (4.88%)  10/159 (6.29%)  7/53 (13.21%) 
Respiratory, thoracic and mediastinal disorders           
Cough  1  20/289 (6.92%)  18/286 (6.29%)  12/246 (4.88%)  9/159 (5.66%)  2/53 (3.77%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 21.0
There were no limitations affecting the analysis or results.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Publications of Results:
Hodder S, Squires K, Gathe J, Kityo C, Supparatpinyo K, Moshkovich G, et al. Elvitegravir (EVG)/cobicistat (COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is superior to ritonavir (RTV)-boosted atazanavir (ATV) plus FTC/TDF in treatment-naive women with HIV-1 infection (WAVES study). Presented at Interscience Conference on Antimicrobial Agents and Chemotherapy and International Congress of Chemotherapy and Infection (ICAAC/ICC) 2015; September 17-21; San Diego, CA.
Squires K, Kityo C, Hodder S, Hagins D, Avihingsanon A, Plotnikova Y, et al. Elvitegravir (EVG)/cobicistat (COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is superior to ritonavir (RTV)-boosted atazanavir (ATV) plus FTC/TDF in treatment-naive women with HIV-1 infection (WAVES study). Poster no. MOLBPE08. Presented at 8th International Antiviral Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention, 2015; 19-22 July, Vancouver, BC, Canada.
Hodder S, Kityo C, Koenig E, Mussini C, Post F, Romanova S, et al. Genotypic analysis of the global clinical trial of treatment-naive women. Abstract 16. Presented at 5th International Workshop on HIV & Women, 2015; 21-22 February, Seattle, WA.
Squires K, Hodder S, Kityo C, Clumeck N, Johnson M, Plotnikova Y, et al. Enrollment in the Women's Antiretroviral Efficacy and Safety study (WAVES), a Phase 3 global study assessing antiretroviral regimen in treatment-naive women. Abstract 54. Presented at 5th International Workshop on HIV & Women, 2015; 21-22 February, Seattle, WA.
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01705574    
Other Study ID Numbers: GS-US-236-0128
2012-003708-11 ( EudraCT Number )
First Submitted: October 10, 2012
First Posted: October 12, 2012
Results First Submitted: February 11, 2016
Results First Posted: March 10, 2016
Last Update Posted: September 20, 2019