Trial Outcomes & Findings for Study of VRC07-523LS, CAP256V2LS, and Vesatolimod, in Early Antiretroviral-treated HIV-1 Clade C-infected Women (NCT NCT05281510)
NCT ID: NCT05281510
Last Updated: 2026-01-16
Results Overview
An AE is any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAE was defined as any AE that began on or after the study drug start date and no later than last exposure date after permanent discontinuation of study drug, or led to premature study drug discontinuation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Up to 61.1 weeks
Results posted on
2026-01-16
Participant Flow
Participants were enrolled at a study site in South Africa.
26 participants were screened.
Participant milestones
| Measure |
VRC07-523LS + CAP256V2LS + Vesatolimod (VES)
In Period 1 (Days 0 to 28), participants received antiretroviral therapy (ART) through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued analytical treatment interruption (ATI) and no study treatment was administered. In Period 4, (Days 337-413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
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Overall Study
STARTED
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20
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Overall Study
COMPLETED
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20
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of VRC07-523LS, CAP256V2LS, and Vesatolimod, in Early Antiretroviral-treated HIV-1 Clade C-infected Women
Baseline characteristics by cohort
| Measure |
VRC07-523LS + CAP256V2LS + Vesatolimod (VES)
n=20 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
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Age, Categorical
<=18 years
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0 Participants
n=9 Participants
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Age, Categorical
Between 18 and 65 years
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20 Participants
n=9 Participants
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Age, Categorical
>=65 years
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0 Participants
n=9 Participants
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Age, Continuous
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27 years
STANDARD_DEVIATION 2.4 • n=9 Participants
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Sex: Female, Male
Female
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20 Participants
n=9 Participants
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Sex: Female, Male
Male
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0 Participants
n=9 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=9 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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20 Participants
n=9 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=9 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=9 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=9 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=9 Participants
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Race (NIH/OMB)
Black or African American
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20 Participants
n=9 Participants
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Race (NIH/OMB)
White
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0 Participants
n=9 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=9 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=9 Participants
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Region of Enrollment
South Africa
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20 Participants
n=9 Participants
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PRIMARY outcome
Timeframe: Up to 61.1 weeksPopulation: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
An AE is any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAE was defined as any AE that began on or after the study drug start date and no later than last exposure date after permanent discontinuation of study drug, or led to premature study drug discontinuation.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=20 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
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Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
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95 percentage of participants
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PRIMARY outcome
Timeframe: Up to 61.1 weeksPopulation: Participants in the Safety Analysis Set were analyzed.
A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the last exposure date after permanent discontinuation of study drug. For maximum postbaseline toxicity grade, the most severe graded abnormality from all tests was counted for each participant. The severity grades were defined by Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, Antiviral Toxicity Grading Scale, Version 01 April 2015. The CTCAE v5 grading scale was used to grade AEs determined to be cytokine release syndrome and infusion-related reactions. The grading for both scales are as follows: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-Threatening, Grade 5 = Death.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=20 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
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Percentage of Participants Experiencing Treatment-emergent Graded Laboratory Abnormalities
Any Grade 1 or Higher
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95 percentage of participants
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Percentage of Participants Experiencing Treatment-emergent Graded Laboratory Abnormalities
Grade 1
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20 percentage of participants
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Percentage of Participants Experiencing Treatment-emergent Graded Laboratory Abnormalities
Grade 2
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40 percentage of participants
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Percentage of Participants Experiencing Treatment-emergent Graded Laboratory Abnormalities
Grade 3
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35 percentage of participants
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Percentage of Participants Experiencing Treatment-emergent Graded Laboratory Abnormalities
Grade 4
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0 percentage of participants
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SECONDARY outcome
Timeframe: Up to 56 weeksPopulation: The Full Analysis Set included all participants who were enrolled into the study and had received at least 1 dose of study drug.
Virologic rebound is defined as at any visit a rebound in HIV-1 RNA to ≥ 50 copies/mL or ≥ 200 copies/mL, which is subsequently confirmed at the following scheduled or unscheduled visit. Time to rebound (in weeks) = (date of rebound or censoring date - ATI start date + 1) / 7.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=20 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
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Time to Viral Rebound (Confirmed ≥ 50 Copies/mL and ≥ 200 Copies/mL) Following ATI
Confirmed ≥ 50 copies/mL
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11.00 weeks
Interval 7.0 to 19.07
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Time to Viral Rebound (Confirmed ≥ 50 Copies/mL and ≥ 200 Copies/mL) Following ATI
Confirmed ≥ 200 copies/mL
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11.00 weeks
Interval 7.0 to 19.14
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SECONDARY outcome
Timeframe: Pre-ART (Screening) and prior to ART reinitiation following ATI (Up to 56 weeks)Population: Participants in Full Analysis Set with available data were analyzed.
Change in plasma viral load set-point between pre-ART value and prior to ART reinitiation following ATI was summarized. The pre-ART set point value is the HIV-RNA load count prior to start of initial ARV treatment recorded in the clinical database.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=11 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
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Change in Plasma Viral Load Set-point Following ATI
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-1.42 log10 copies/mL
Interval -1.85 to -0.77
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SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: Participants in Full Analysis Set were analyzed.
Baseline value was the last available value collected on or prior to first dose of study drug.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=20 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
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Change From Baseline of Viral Load at the End of ATI
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2.96 log10 copies/mL
Interval 1.58 to 4.07
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SECONDARY outcome
Timeframe: Up to 56 weeksPopulation: Participants in full analysis set were analyzed.
Time to ART resumption (in weeks) = (date of restart ART after ATI period start or censoring date - ATI start date + 1) / 7.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=20 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
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Time to ART Resumption Following ATI
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24.21 weeks
Interval 12.64 to 47.14
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SECONDARY outcome
Timeframe: Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdosePopulation: The VES PK Analysis Set included all participants who were enrolled and had received at least 1 dose of VES and for whom PK concentrations of analyte VES were available.
Cmax is defined as maximum observed concentration of drug.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=20 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
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Pharmacokinetic (PK) Parameter of VES: Cmax
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6350 pg/mL
Standard Deviation 4220
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SECONDARY outcome
Timeframe: Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdosePopulation: Participants in VES PK Analysis Set were analyzed.
Tmax is defined as time (observed time point) of Cmax.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=20 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
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PK Parameter of VES: Tmax
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2.00 hours (h)
Interval 0.833 to 8.0
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SECONDARY outcome
Timeframe: Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdosePopulation: Participants in VES PK Analysis Set were analyzed.
Clast is defined as last observed quantifiable concentration of the drug.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=20 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
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PK Parameter of VES: Clast
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279 pg/mL
Standard Deviation 177
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SECONDARY outcome
Timeframe: Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdosePopulation: Participants in VES PK Analysis Set were anlayzed.
Tlast is defined as time (observed time point) of Clast.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=20 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
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PK Parameter of VES: Tlast
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48.0 h
Interval 47.1 to 49.7
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SECONDARY outcome
Timeframe: Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdosePopulation: Participants in VES analysis set were analyzed.
AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/λz).
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=20 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
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PK Parameter of VES: AUCinf
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62700 h*pg/mL
Standard Deviation 37700
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SECONDARY outcome
Timeframe: Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdosePopulation: Participants in VES analysis set were analyzed.
AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=20 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
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PK Parameter of VES: AUClast
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55500 h*pg/mL
Standard Deviation 34200
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SECONDARY outcome
Timeframe: Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdosePopulation: Participants in VES PK Analysis Set were analyzed.
AUCexp is defined as AUC extrapolated between AUClast and AUCinf.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=20 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
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PK Parameter of VES: AUCexp
|
12.4 percent
Standard Deviation 6.68
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SECONDARY outcome
Timeframe: Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdosePopulation: Participants in VES PK Analysis Set were analyzed.
t1/2 is defined as estimate of the terminal elimination half-life of the drug, calculated by dividing the natural log of 2 by the terminal elimination rate constant (λz).
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=20 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
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PK Parameter of VES: t1/2
|
15.9 h
Interval 10.4 to 27.0
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SECONDARY outcome
Timeframe: Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdosePopulation: Participants in VES PK Analysis Set were analyzed.
CL/F is defined as apparent clearance following extravascular administration.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=20 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
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|---|---|
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PK Parameter of VES: CL/F
|
144 Liters (L)/h
Standard Deviation 112
|
SECONDARY outcome
Timeframe: Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdosePopulation: Participants with VES PK Analysis Set were analyzed.
Vz/F is defined as apparent volume of distribution during the terminal phase following extravascular administration.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=20 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
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|---|---|
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PK Parameter of VES: Vz/F
|
3810 L
Standard Deviation 3650
|
SECONDARY outcome
Timeframe: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413Population: The VRC07-523LS PK Analysis Set included all participants who were enrolled and had received at least 1 dose of VRC07-523LS and for whom PK concentrations of analyte VRC07-523LS were available. Participants in VRC07-523LS PK Analysis Set with available data were analyzed.
Cmax is defined as maximum observed concentration of drug.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=19 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
PK Parameter of VRC07-523LS: Cmax
|
481 µg/mL
Standard Deviation 83.5
|
SECONDARY outcome
Timeframe: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413Population: Participants in VRC07-523LS PK Analysis Set with available data were analyzed.
Tmax is defined as time (observed time point) of Cmax.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=19 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
PK Parameter of VRC07-523LS: Tmax
|
0.550 h
Interval 0.467 to 4.83
|
SECONDARY outcome
Timeframe: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413Population: Participants in VRC07-523LS PK Analysis Set with available data were analyzed.
Clast is defined as last observed quantifiable concentration of the drug.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=19 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
PK Parameter of VRC07-523LS: Clast
|
3.51 µg/mL
Standard Deviation 2.98
|
SECONDARY outcome
Timeframe: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413Population: Participants in VRC07-523LS PK Analysis Set with available data were analyzed.
Tlast is defined as time (observed time point) of Clast.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=19 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
PK Parameter of VRC07-523LS: Tlast
|
238 day
Interval 147.0 to 336.0
|
SECONDARY outcome
Timeframe: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413Population: Participants in VRC07-523LS PK Analysis Set with available data were analyzed.
AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/λz).
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=19 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
PK Parameter of VRC07-523LS: AUCinf
|
7540 day*µg/mL
Standard Deviation 1360
|
SECONDARY outcome
Timeframe: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413Population: Participants in VRC07-523LS PK Analysis Set with available data were analyzed.
AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=19 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
PK Parameter of VRC07-523LS: AUClast
|
7320 day*µg/mL
Standard Deviation 1340
|
SECONDARY outcome
Timeframe: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413Population: Participants in VRC07-523LS PK Analysis Set with available data were analyzed.
AUCexp is defined as AUC extrapolated between AUClast and AUCinf.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=19 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
PK Parameter of VRC07-523LS: AUCexp
|
2.94 percent
Standard Deviation 2.71
|
SECONDARY outcome
Timeframe: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413Population: Participants in VRC07-523LS PK Analysis Set with available data were analyzed.
t1/2 is defined as estimate of the terminal elimination half-life of the drug, calculated by dividing the natural log of 2 by the terminal elimination rate constant (λz).
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=19 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
PK Parameter of VRC07-523LS: t1/2
|
41.9 day
Interval 25.7 to 60.5
|
SECONDARY outcome
Timeframe: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413Population: Participants in VRC07-523LS PK Analysis Set with available data were analyzed.
CL is defined as clearance following intravenous administration.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=19 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
PK Parameter of VRC07-523LS: Clearance (CL)
|
0.198 L/day
Standard Deviation 0.0513
|
SECONDARY outcome
Timeframe: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413Population: Participants in VRC07-523LS PK Analysis Set with available data were analyzed.
Vss is defined as the volume of distribution at steady-state following intravenous administration.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=19 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
PK Parameter of VRC07-523LS: Vss
|
11.5 L
Standard Error 2.54
|
SECONDARY outcome
Timeframe: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413Population: Participants in VRC07-523LS PK Analysis Set with available data were analyzed.
Vz is defined as volume of distribution of the drug during the terminal phase after intravenous administration.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=19 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
PK Parameter of VRC07-523LS: Vz
|
12.0 L
Standard Deviation 3.96
|
SECONDARY outcome
Timeframe: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413Population: The CAP256V2LS PK Analysis Set included all participants who were enrolled and had received at least 1 dose of CAP256V2LS and for whom PK concentrations of analyte CAP256V2LS were available. Participants in CAP256V2LS PK Analysis Set with available data were analyzed.
Cmax is defined as maximum observed concentration of drug.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=19 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
PK Parameter of CAP256V2LS: Cmax
|
644 µg/mL
Standard Deviation 309
|
SECONDARY outcome
Timeframe: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413Population: Participants in CAP256V2LS PK Analysis Set with available data were analyzed.
Tmax is defined as time (observed time point) of Cmax.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=19 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
PK Parameter of CAP256V2LS: Tmax
|
1.50 h
Interval 0.5 to 4.5
|
SECONDARY outcome
Timeframe: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413Population: Participants in CAP256V2LS PK Analysis Set with available data were analyzed.
Clast is defined as last observed quantifiable concentration of the drug.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=19 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
PK Parameter of CAP256V2LS: Clast
|
1.52 µg/mL
Standard Deviation 0.493
|
SECONDARY outcome
Timeframe: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413Population: Participants in CAP256V2LS PK Analysis Set with available data were analyzed.
Tlast is defined as time (observed time point) of Clast.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=19 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
PK Parameter of CAP256V2LS: Tlast
|
172 day
Interval 126.0 to 321.0
|
SECONDARY outcome
Timeframe: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413Population: Participants in CAP256V2LS PK Analysis Set with available data were analyzed.
AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/λz).
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=19 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
PK Parameter of CAP256V2LS: AUCinf
|
4290 day*µg/mL
Standard Deviation 729
|
SECONDARY outcome
Timeframe: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413Population: Participants in CAP256V2LS PK Analysis Set with available data were analyzed.
AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=19 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
PK Parameter of CAP256V2LS: AUClast
|
4230 day*µg/mL
Standard Deviation 710
|
SECONDARY outcome
Timeframe: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413Population: Participants in CAP256V2LS PK Analysis Set with available data were analyzed.
AUCexp is defined as AUC extrapolated between AUClast and AUCinf.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=19 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
PK Parameter of CAP256V2LS: AUCexp
|
1.58 percent
Standard Deviation 0.452
|
SECONDARY outcome
Timeframe: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413Population: Participants in CAP256V2LS PK Analysis Set with available data were analyzed.
t1/2 is defined as estimate of the terminal elimination half-life of the drug, calculated by dividing the natural log of 2 by the terminal elimination rate constant (λz).
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=19 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
PK Parameter of CAP256V2LS: t1/2
|
31.4 day
Interval 20.2 to 77.8
|
SECONDARY outcome
Timeframe: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413Population: Participants in CAP256V2LS PK Analysis Set with available data were analyzed.
CL is defined as clearance following intravenous administration.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=19 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
PK Parameter of CAP256V2LS: CL
|
0.352 L/day
Standard Deviation 0.116
|
SECONDARY outcome
Timeframe: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413Population: Participants in CAP256V2LS PK Analysis Set with available data were analyzed.
Vz is defined as volume of distribution of the drug during the terminal phase after intravenous administration.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=19 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
PK Parameter of CAP256V2LS: Vz
|
15.3 L
Standard Deviation 3.72
|
SECONDARY outcome
Timeframe: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413Population: Participants in CAP256V2LS PK Analysis Set with available data were analyzed.
Vss is defined as the volume of distribution at steady-state after intravenous administration.
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=19 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
PK Parameter of CAP256V2LS: Vss
|
10.6 L
Standard Deviation 2.21
|
SECONDARY outcome
Timeframe: Prebaseline (Day -13) up to Day 413Population: The VRC07-523LS Immunogenicity Analysis Set included all enrolled participants who received at least 1 dose of VRC07-523LS and have had at least 1 nonmissing value for the immunogenicity evaluation of interest (ie, anti-VRC07-523LS antibody).
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=20 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
Percentage of Participants With Treatment-emergent Positive Anti-VRC07-523LS Antibodies
|
15.0 percentage of participants
|
SECONDARY outcome
Timeframe: Prebaseline (Day -13) up to Day 413Population: The CAP256V2LS Immunogenicity Analysis Set included all enrolled participants who received at least 1 dose of CAP256V2LS and have had at least 1 nonmissing value for the immunogenicity evaluation of interest (ie, anti-CAP256V2LS antibody).
Outcome measures
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=20 Participants
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
Percentage of Participants With Treatment-emergent Positive Anti-CAP256V2LS Antibodies
|
55 percentage of participants
|
Adverse Events
VRC07-523LS + CAP256V2LS + VES
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=20 participants at risk
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
Infections and infestations
Cellulitis
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Overdose
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Intentional self-injury
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
VRC07-523LS + CAP256V2LS + VES
n=20 participants at risk
In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg \& CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was \>=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A).
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.0%
3/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
40.0%
8/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Eye irritation
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gingival swelling
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
5/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
10.0%
2/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Chest discomfort
|
25.0%
5/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Chills
|
15.0%
3/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
20.0%
4/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
15.0%
3/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Malaise
|
10.0%
2/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
10.0%
2/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
35.0%
7/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Swelling
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Cytokine release syndrome
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Abscess
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
10.0%
2/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Groin infection
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Latent syphilis
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Subcutaneous abscess
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
4/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
90.0%
18/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
35.0%
7/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
70.0%
14/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Genital swelling
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.0%
3/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
10.0%
2/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Phlebitis
|
5.0%
1/20 • All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study. Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER