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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
192
Elvitegravir (EVG) tablet administered orally once daily with food
Ritonavir (RTV; /r) 100 mg capsule administered orally once daily with food
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).
Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event
Time frame: Up to Week 408 plus 30 days
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
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
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
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
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
White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
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Unnamed facility
Pheonix, Arizona, United States
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Beverly Hills, California, United States
Unnamed facility
Costa Mesa, California, United States
Unnamed facility
Fountain Valley, California, United States
Unnamed facility
Long Beach, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Newport Beach, California, United States
Unnamed facility
Palo Alto, California, United States
Unnamed facility
San Diego, California, United States
...and 38 more locations
Time frame: 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
Time frame: 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
Time frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
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
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
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
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
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
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
Incidence of Mortality
The percentage of participants who died was summarized.
Time frame: Up to Week 408 plus 30 days