HIV Infections
Conditions
Keywords
Phase 2, Open-label, Rollover, Integrase Inhibitor, Antiretroviral Agents, Highly Active Antiretroviral Activity, HAART, HIV, HIV-1, AIDS virus, Human Immunodeficiency Virus, Acquired Immune Deficiency Syndrome Virus, treatment experienced
Brief summary
The main objective of this study is to observe the long-term safety of elvitegravir (EVG) boosted with ritonavir (RTV) in combination with other antiretroviral (ARV) agents in participants who have completed a prior EVG+RTV treatment study.
Interventions
DRUGEVG
Elvitegravir (EVG) tablet administered orally once daily with food
DRUGRTV
Ritonavir (RTV; /r) 100 mg capsule administered orally once daily with food
DRUGARV regimen
The components of the ARV regimen will be selected by the investigator without input from the sponsor. The antiretroviral regimen must consist of at least 2 agents, not including the non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz, nevirapine, or delavirdine; the protease inhibitors saquinavir, nelfinavir, or indinavir; or investigational agents (without sponsor approval).
Sponsors
Gilead Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Completion of a prior EVG+RTV treatment study without treatment-limiting toxicity. * Males and females of childbearing potential must agree to utilize effective contraception methods. * Ability to understand and sign a written informed consent form.
Exclusion criteria
* Females who are pregnant or breastfeeding. * Participation in any other clinical trial without prior approval from the Sponsor. * Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study. * Subjects receiving ongoing therapy with contraindicated drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event | Up to Week 408 plus 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality | Up to Week 408 plus 30 days | Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. |
| Percentage of Participants Experiencing Any Marked Treatment-Emergent Laboratory Abnormality | Up to Week 408 plus 30 days | A 'marked abnormality' was defined as a shift from grade 0 (or missing) at baseline to at least grade 3 postbaseline; or grade 1 at baseline to grade 4 postbaseline. |
| Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | — |
| Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | — |
| White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | — |
| Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | — |
| Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | — |
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Up to Week 408 plus 30 days | Adverse events (AEs) occurring during treatment and for 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event. |
| Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | — |
| HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | — |
| Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | — |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | — |
| CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | — |
| Incidence of Mortality | Up to Week 408 plus 30 days | The percentage of participants who died was summarized. |
| Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | — |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in the United States and Puerto Rico. The first participant was screened on 26 February 2007. The last study visit occurred on 24 March 2015.
Pre-assignment details
Participants must have been enrolled in other Gilead-sponsored studies of elvitegravir (EVG) + ritonavir (RTV) to be eligible to receive continued access to EVG+RTV in this study.
Participants by arm
| Arm | Count |
|---|---|
| EVG+RTV EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study. Some participants may have received EVG 300 mg during the course of protocol amendment 2. | 192 |
| Total | 192 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 13 |
| Overall Study | Death | 9 |
| Overall Study | Investigator's Discretion | 22 |
| Overall Study | Lack of Efficacy | 28 |
| Overall Study | Lost to Follow-up | 13 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Protocol Violation | 4 |
| Overall Study | Withdrew Consent | 29 |
Baseline characteristics
| Characteristic | EVG+RTV |
|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 9.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 153 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 48 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 participants |
| Race/Ethnicity, Customized Other | 4 participants |
| Race/Ethnicity, Customized White | 139 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 173 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 172 / 192 |
| serious Total, serious adverse events | 86 / 192 |
Outcome results
Primary
Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event
Time frame: Up to Week 408 plus 30 days
Population: Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EVG+RTV | Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event | 14.6 percentage of participants |
Secondary
Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Time frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EVG+RTV | Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline (n = 191) | 28 U/L | Standard Deviation 16.6 |
| EVG+RTV | Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 24 (n = 169) | 2 U/L | Standard Deviation 16.3 |
| EVG+RTV | Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 48 (n = 154) | 1 U/L | Standard Deviation 17.5 |
| EVG+RTV | Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 144 (n = 120) | 2 U/L | Standard Deviation 18.6 |
| EVG+RTV | Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 192 (n = 109) | 1 U/L | Standard Deviation 16.2 |
| EVG+RTV | Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 240 (n = 94) | 0 U/L | Standard Deviation 18 |
| EVG+RTV | Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 96 (n = 141) | 2 U/L | Standard Deviation 19.4 |
| EVG+RTV | Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 288 (n = 85) | 3 U/L | Standard Deviation 17 |
| EVG+RTV | Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 336 (n = 79) | 3 U/L | Standard Deviation 22.9 |
| EVG+RTV | Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 384 (n = 71) | 1 U/L | Standard Deviation 15.9 |
Secondary
Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Time frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EVG+RTV | Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 384 (n = 72) | -20 U/L | Standard Deviation 33.5 |
| EVG+RTV | Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline (n = 192) | 101 U/L | Standard Deviation 43.3 |
| EVG+RTV | Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 24 (n = 170) | -6 U/L | Standard Deviation 26.8 |
| EVG+RTV | Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 48 (n = 156) | -9 U/L | Standard Deviation 31 |
| EVG+RTV | Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 96 (n = 143) | -9 U/L | Standard Deviation 28.9 |
| EVG+RTV | Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 144 (n = 122) | -13 U/L | Standard Deviation 27.8 |
| EVG+RTV | Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 192 (n = 110) | -18 U/L | Standard Deviation 27.7 |
| EVG+RTV | Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 240 (n = 95) | -17 U/L | Standard Deviation 29.2 |
| EVG+RTV | Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 288 (n = 86) | -20 U/L | Standard Deviation 29.3 |
| EVG+RTV | Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 336 (n = 80) | -19 U/L | Standard Deviation 31.3 |
Secondary
Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Time frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EVG+RTV | Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 24 (n = 163) | 2 U/L | Standard Deviation 13.4 |
| EVG+RTV | Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 48 (n = 150) | 0 U/L | Standard Deviation 13.5 |
| EVG+RTV | Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 96 (n = 137) | 2 U/L | Standard Deviation 16.2 |
| EVG+RTV | Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 144 (n = 116) | 1 U/L | Standard Deviation 14.5 |
| EVG+RTV | Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 192 (n = 105) | -1 U/L | Standard Deviation 12.4 |
| EVG+RTV | Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 240 (n = 91) | 0 U/L | Standard Deviation 16.3 |
| EVG+RTV | Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline (n = 185) | 29 U/L | Standard Deviation 14.5 |
| EVG+RTV | Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 288 (n = 82) | 1 U/L | Standard Deviation 12.8 |
| EVG+RTV | Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 336 (n = 76) | 1 U/L | Standard Deviation 13.2 |
| EVG+RTV | Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 384 (n = 68) | 1 U/L | Standard Deviation 12 |
Secondary
CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Time frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Population: Participants in the Efficacy Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EVG+RTV | CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 144 (n = 118) | 126 cells/mm^3 | Standard Deviation 177 |
| EVG+RTV | CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline (n = 189) | 283 cells/mm^3 | Standard Deviation 211.8 |
| EVG+RTV | CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 24 (n = 168) | 22 cells/mm^3 | Standard Deviation 98.9 |
| EVG+RTV | CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 48 (n = 152) | 38 cells/mm^3 | Standard Deviation 119.5 |
| EVG+RTV | CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 96 (n = 138) | 78 cells/mm^3 | Standard Deviation 132.3 |
| EVG+RTV | CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 192 (n = 106) | 149 cells/mm^3 | Standard Deviation 167.5 |
| EVG+RTV | CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 240 (n = 93) | 176 cells/mm^3 | Standard Deviation 198.1 |
| EVG+RTV | CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 288 (n = 84) | 205 cells/mm^3 | Standard Deviation 210.8 |
| EVG+RTV | CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 336 (n = 80) | 225 cells/mm^3 | Standard Deviation 206.8 |
| EVG+RTV | CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 384 (n = 71) | 234 cells/mm^3 | Standard Deviation 214.4 |
Secondary
Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Time frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EVG+RTV | Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline (n = 190) | 14.2 g/dL | Standard Deviation 1.86 |
| EVG+RTV | Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 24 (n = 165) | 0.1 g/dL | Standard Deviation 1.01 |
| EVG+RTV | Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 48 (n = 151) | 0.3 g/dL | Standard Deviation 1.12 |
| EVG+RTV | Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 96 (n = 139) | 0.2 g/dL | Standard Deviation 1.44 |
| EVG+RTV | Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 144 (n = 118) | 0.2 g/dL | Standard Deviation 1.4 |
| EVG+RTV | Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 192 (n = 106) | 0.3 g/dL | Standard Deviation 1.36 |
| EVG+RTV | Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 240 (n = 91) | 0.2 g/dL | Standard Deviation 1.54 |
| EVG+RTV | Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 288 (n = 84) | 0.3 g/dL | Standard Deviation 1.79 |
| EVG+RTV | Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 336 (n = 78) | 0.3 g/dL | Standard Deviation 1.49 |
| EVG+RTV | Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 384 (n = 70) | 0.4 g/dL | Standard Deviation 1.55 |
Secondary
HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Time frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Population: Participants in the Efficacy Analysis Set (enrolled participants who received at least 1 dose of EVG and had at least 1 postbaseline HIV-1 RNA or CD4 cell count measurement) with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EVG+RTV | HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline (n = 190) | 2.70 log10 copies/mL | Standard Deviation 1.337 |
| EVG+RTV | HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 24 (n = 174) | -0.13 log10 copies/mL | Standard Deviation 0.795 |
| EVG+RTV | HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 48 (n = 158) | -0.20 log10 copies/mL | Standard Deviation 0.892 |
| EVG+RTV | HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 96 (n = 142) | -0.11 log10 copies/mL | Standard Deviation 0.963 |
| EVG+RTV | HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 144 (n = 123) | -0.22 log10 copies/mL | Standard Deviation 0.998 |
| EVG+RTV | HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 192 (n = 110) | -0.21 log10 copies/mL | Standard Deviation 1.043 |
| EVG+RTV | HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 240 (n = 96) | -0.15 log10 copies/mL | Standard Deviation 0.955 |
| EVG+RTV | HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 288 (n = 86) | -0.34 log10 copies/mL | Standard Deviation 1.066 |
| EVG+RTV | HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 336 (n = 82) | -0.70 log10 copies/mL | Standard Deviation 1.055 |
| EVG+RTV | HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 384 (n = 73) | -0.68 log10 copies/mL | Standard Deviation 1.029 |
Secondary
Incidence of Mortality
The percentage of participants who died was summarized.
Time frame: Up to Week 408 plus 30 days
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EVG+RTV | Incidence of Mortality | 6.8 percentage of participants |
Secondary
Percentage of Participants Experiencing Any Marked Treatment-Emergent Laboratory Abnormality
A 'marked abnormality' was defined as a shift from grade 0 (or missing) at baseline to at least grade 3 postbaseline; or grade 1 at baseline to grade 4 postbaseline.
Time frame: Up to Week 408 plus 30 days
Population: Participants in the Safety Analysis Set with at least 1 postbaseline measurement were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EVG+RTV | Percentage of Participants Experiencing Any Marked Treatment-Emergent Laboratory Abnormality | 40.3 percentage of participants |
Secondary
Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.
Time frame: Up to Week 408 plus 30 days
Population: Participants in the Safety Analysis Set with at least 1 postbaseline measurement were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EVG+RTV | Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality | Grade 1 | 18.3 percentage of participants |
| EVG+RTV | Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality | Grade 2 | 31.9 percentage of participants |
| EVG+RTV | Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality | Grade 3 | 35.1 percentage of participants |
| EVG+RTV | Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality | Grade 4 | 14.1 percentage of participants |
Secondary
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Adverse events (AEs) occurring during treatment and for 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.
Time frame: Up to Week 408 plus 30 days
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EVG+RTV | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Any AE | 93.8 percentage of participants |
| EVG+RTV | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Grade 3 or 4 AE | 45.3 percentage of participants |
| EVG+RTV | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Grade 3 or 4 Drug-related AE | 3.1 percentage of participants |
| EVG+RTV | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Serious AE | 44.8 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Time frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Population: Participants in the Efficacy Analysis Set with available data were analyzed. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EVG+RTV | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline (n = 190) | 65.3 percentage of participants |
| EVG+RTV | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Week 24 (n = 175) | 69.7 percentage of participants |
| EVG+RTV | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Week 48 (n = 159) | 78.6 percentage of participants |
| EVG+RTV | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Week 96 (n = 142) | 76.8 percentage of participants |
| EVG+RTV | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Week 144 (n = 123) | 82.9 percentage of participants |
| EVG+RTV | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Week 192 (n = 110) | 84.5 percentage of participants |
| EVG+RTV | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Week 240 (n = 96) | 89.6 percentage of participants |
| EVG+RTV | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Week 288 (n = 86) | 95.3 percentage of participants |
| EVG+RTV | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Week 336 (n = 82) | 95.1 percentage of participants |
| EVG+RTV | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Week 384 (n = 73) | 93.2 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Time frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Population: Participants in the Efficacy Analysis Set with available data were analyzed. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EVG+RTV | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline (n = 190) | 44.2 percentage of participants |
| EVG+RTV | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Week 24 (n = 175) | 56.0 percentage of participants |
| EVG+RTV | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Week 48 (n = 159) | 62.9 percentage of participants |
| EVG+RTV | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Week 96 (n = 142) | 65.5 percentage of participants |
| EVG+RTV | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Week 144 (n = 123) | 73.2 percentage of participants |
| EVG+RTV | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Week 192 (n = 110) | 79.1 percentage of participants |
| EVG+RTV | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Week 240 (n = 96) | 78.1 percentage of participants |
| EVG+RTV | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Week 288 (n = 86) | 89.5 percentage of participants |
| EVG+RTV | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Week 336 (n = 82) | 86.6 percentage of participants |
| EVG+RTV | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Week 384 (n = 73) | 90.4 percentage of participants |
Secondary
Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Time frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EVG+RTV | Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline (n = 187) | 226 10^3 cells/µL | Standard Deviation 75 |
| EVG+RTV | Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 24 (n = 154) | 2 10^3 cells/µL | Standard Deviation 47.3 |
| EVG+RTV | Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 48 (n = 148) | 5 10^3 cells/µL | Standard Deviation 49.5 |
| EVG+RTV | Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 96 (n = 134) | 13 10^3 cells/µL | Standard Deviation 59.4 |
| EVG+RTV | Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 144 (n = 114) | 3 10^3 cells/µL | Standard Deviation 48.7 |
| EVG+RTV | Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 192 (n = 103) | -2 10^3 cells/µL | Standard Deviation 53.8 |
| EVG+RTV | Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 240 (n = 88) | 6 10^3 cells/µL | Standard Deviation 45.7 |
| EVG+RTV | Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 288 (n = 80) | 6 10^3 cells/µL | Standard Deviation 60.9 |
| EVG+RTV | Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 336 (n = 76) | -6 10^3 cells/µL | Standard Deviation 61 |
| EVG+RTV | Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 384 (n = 70) | -15 10^3 cells/µL | Standard Deviation 56.8 |
Secondary
Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Time frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EVG+RTV | Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 24 (n = 165) | 0.0 10^6 cells/μL | Standard Deviation 0.37 |
| EVG+RTV | Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 48 (n = 151) | 0.0 10^6 cells/μL | Standard Deviation 0.35 |
| EVG+RTV | Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 96 (n = 139) | 0.0 10^6 cells/μL | Standard Deviation 0.45 |
| EVG+RTV | Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 144 (n = 118) | 0.0 10^6 cells/μL | Standard Deviation 0.5 |
| EVG+RTV | Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 192 (n = 106) | 0.0 10^6 cells/μL | Standard Deviation 0.48 |
| EVG+RTV | Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline (n = 190) | 4.6 10^6 cells/μL | Standard Deviation 0.65 |
| EVG+RTV | Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 240 (n = 91) | 0.0 10^6 cells/μL | Standard Deviation 0.55 |
| EVG+RTV | Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 288 (n = 84) | 0.0 10^6 cells/μL | Standard Deviation 0.55 |
| EVG+RTV | Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 336 (n = 78) | 0.0 10^6 cells/μL | Standard Deviation 0.44 |
| EVG+RTV | Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 384 (n = 70) | 0.0 10^6 cells/μL | Standard Deviation 0.45 |
Secondary
White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Time frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EVG+RTV | White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline (n = 190) | 5.64 10^3 cells/μL | Standard Deviation 2.074 |
| EVG+RTV | White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 24 (n = 165) | 0.02 10^3 cells/μL | Standard Deviation 1.67 |
| EVG+RTV | White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 48 (n = 151) | 0.12 10^3 cells/μL | Standard Deviation 1.899 |
| EVG+RTV | White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 96 (n = 139) | -0.17 10^3 cells/μL | Standard Deviation 1.761 |
| EVG+RTV | White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 144 (n = 118) | -0.25 10^3 cells/μL | Standard Deviation 1.948 |
| EVG+RTV | White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 192 (n = 106) | -0.19 10^3 cells/μL | Standard Deviation 2.072 |
| EVG+RTV | White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 240 (n = 91) | -0.09 10^3 cells/μL | Standard Deviation 2.082 |
| EVG+RTV | White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 288 (n = 84) | -0.21 10^3 cells/μL | Standard Deviation 2.091 |
| EVG+RTV | White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 336 (n = 78) | -0.35 10^3 cells/μL | Standard Deviation 1.961 |
| EVG+RTV | White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Change at Week 384 (n = 70) | -0.28 10^3 cells/μL | Standard Deviation 1.759 |