Trial Outcomes & Findings for A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection (NCT NCT05729568)
NCT ID: NCT05729568
Last Updated: 2025-07-15
Results Overview
Percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 26 was analyzed using US FDA-defined snapshot algorithm, which defines a participant's virologic outcome and included participants a) who had last available on-treatment HIV-1 RNA ≥ 50 copies/mL in the Week 26 analysis window; b) who did not have on-treatment HIV-1 RNA data in the Week 26 analysis window and i) discontinued study drug prior to or in the Week 26 analysis window due to lack of efficacy, or ii) discontinued study drug prior to or in the Week 26 analysis window due to adverse event (AE) or death and had last available on-treatment HIV-1 RNA ≥ 50 copies/mL, or iii) discontinued study drug prior to or in the Week 26 analysis window due to reasons other than AE, death, or lack of efficacy and had the last available on-treatment HIV-1 RNA ≥ 50 copies/mL. Clopper-Pearson exact method was used to calculate the 95% confidence interval (CI) for the outcome measure of each treatment. Percentages were rounded off.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
83 participants
Primary outcome timeframe
Week 26
Results posted on
2025-07-15
Participant Flow
241 participants were screened. The study planned to enroll participants in Treatment Groups 1, 2 and 3. However, per review of the programmatic data overall and from study GS-US-536-5816 (NCT04811040), Treatment Group 2 was removed prior to dosing of all groups in the study and did not enroll any participants. Therefore, data is reported only for Treatment Groups 1 and 3.
Participants were enrolled at study sites in the United States, Puerto Rico, Australia, and Canada. Data submitted represent primary analysis performed on data collected by the Primary Analysis Completion Date (02-July-2024). Complete data will be submitted within 1 year of actual study completion date.
Participant milestones
| Measure |
Randomized Phase Treatment Group 1: LEN + TAB + ZAB
Participants received loading dose of Lenacapavir (LEN) 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg subcutaneous (SC) injection along with teropavimab (TAB) 2550 mg intravenous (IV) infusion and zinlirvimab (ZAB) 2550 mg IV infusion on Day 1 and every 6 months (Q6M) or every 26 weeks (Q26W) up to Week 52 in the Randomized Phase.
At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL are given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.
|
Randomized Phase Treatment Group 3: SBR
Participants in Stay on Baseline Regimen (SBR) group continued their baseline oral antiretroviral therapy (ART) up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care.
At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study are given the option to participate in the Extension Phase to switch from ART to LEN, TAB and ZAB, every 26 weeks at the dose specified for Treatment Group 1.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
27
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
56
|
27
|
Reasons for withdrawal
| Measure |
Randomized Phase Treatment Group 1: LEN + TAB + ZAB
Participants received loading dose of Lenacapavir (LEN) 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg subcutaneous (SC) injection along with teropavimab (TAB) 2550 mg intravenous (IV) infusion and zinlirvimab (ZAB) 2550 mg IV infusion on Day 1 and every 6 months (Q6M) or every 26 weeks (Q26W) up to Week 52 in the Randomized Phase.
At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL are given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.
|
Randomized Phase Treatment Group 3: SBR
Participants in Stay on Baseline Regimen (SBR) group continued their baseline oral antiretroviral therapy (ART) up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care.
At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study are given the option to participate in the Extension Phase to switch from ART to LEN, TAB and ZAB, every 26 weeks at the dose specified for Treatment Group 1.
|
|---|---|---|
|
Overall Study
Still on Study
|
52
|
26
|
|
Overall Study
Randomized but Never Treated
|
3
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Investigator's Discretion
|
1
|
0
|
Baseline Characteristics
A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
Baseline characteristics by cohort
| Measure |
Randomized Phase Treatment Group 1: LEN + TAB + ZAB
n=53 Participants
Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and Q6M up to Week 52 in the Randomized Phase.
At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL are given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.
|
Randomized Phase Treatment Group 3: SBR
n=27 Participants
Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care.
At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study are given the option to participate in the Extension Phase to switch from ART to LEN, TAB and ZAB, every 26 weeks at the dose specified for Treatment Group 1.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
53 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
47 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Clusters of Differentiation 4 (CD4)+ T-cell Counts
|
740 cells/µL
STANDARD_DEVIATION 239.3 • n=5 Participants
|
768 cells/µL
STANDARD_DEVIATION 260.0 • n=7 Participants
|
749 cells/µL
STANDARD_DEVIATION 245.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 26Population: Participants in the Full Analysis Set were analyzed. The Full Analysis Set included all randomized participants who have received at least one dose of the complete long acting study drug regimen (ie, SC LEN + TAB, ZAB) or continued with their baseline ART regimen.
Percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 26 was analyzed using US FDA-defined snapshot algorithm, which defines a participant's virologic outcome and included participants a) who had last available on-treatment HIV-1 RNA ≥ 50 copies/mL in the Week 26 analysis window; b) who did not have on-treatment HIV-1 RNA data in the Week 26 analysis window and i) discontinued study drug prior to or in the Week 26 analysis window due to lack of efficacy, or ii) discontinued study drug prior to or in the Week 26 analysis window due to adverse event (AE) or death and had last available on-treatment HIV-1 RNA ≥ 50 copies/mL, or iii) discontinued study drug prior to or in the Week 26 analysis window due to reasons other than AE, death, or lack of efficacy and had the last available on-treatment HIV-1 RNA ≥ 50 copies/mL. Clopper-Pearson exact method was used to calculate the 95% confidence interval (CI) for the outcome measure of each treatment. Percentages were rounded off.
Outcome measures
| Measure |
Randomized Phase Treatment Group 1: LEN + TAB+ ZAB
n=53 Participants
Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and Q6M up to Week 52 in the Randomized Phase.
At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL are given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.
|
Randomized Phase Treatment Group 3: SBR
n=27 Participants
Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care.
At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study are given the option to participate in the Extension Phase to switch from oral ART to LEN, TAB and ZAB, every 26 weeks at the dose specified for Treatment Group 1.
|
|---|---|---|
|
Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥ 50 Copies/mL at Week 26 as Determined by the United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm
|
1.9 percentage of participants
Interval 0.0 to 10.1
|
0.0 percentage of participants
Interval 0.0 to 12.8
|
SECONDARY outcome
Timeframe: Week 52Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 26Population: Participants in the Full Analysis Set were analyzed.
Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 26 was analyzed using the US FDA-defined snapshot algorithm, which defined a participant's virologic outcome and included participants who had the last available on-treatment HIV-1 RNA \< 50 copies/mL in the Week 26 analysis window. The Clopper-Pearson exact method was used to calculate the 95% CI for the outcome measure of each treatment. Percentages were rounded off.
Outcome measures
| Measure |
Randomized Phase Treatment Group 1: LEN + TAB+ ZAB
n=53 Participants
Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and Q6M up to Week 52 in the Randomized Phase.
At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL are given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.
|
Randomized Phase Treatment Group 3: SBR
n=27 Participants
Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care.
At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study are given the option to participate in the Extension Phase to switch from oral ART to LEN, TAB and ZAB, every 26 weeks at the dose specified for Treatment Group 1.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 26 as Determined by the US FDA-defined Snapshot Algorithm
|
96.2 percentage of participants
Interval 87.0 to 99.5
|
96.3 percentage of participants
Interval 81.0 to 99.9
|
SECONDARY outcome
Timeframe: Week 52Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Participant in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Randomized Phase Treatment Group 1: LEN + TAB+ ZAB
n=52 Participants
Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and Q6M up to Week 52 in the Randomized Phase.
At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL are given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.
|
Randomized Phase Treatment Group 3: SBR
n=26 Participants
Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care.
At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study are given the option to participate in the Extension Phase to switch from oral ART to LEN, TAB and ZAB, every 26 weeks at the dose specified for Treatment Group 1.
|
|---|---|---|
|
Change From Baseline in Clusters of Differentiation 4 (CD4) + T-cell Counts at Week 26
|
23 cells/µL
Standard Deviation 143.4
|
74 cells/µL
Standard Deviation 202.6
|
SECONDARY outcome
Timeframe: Baseline, Week 52Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 6 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 26Population: Participants in the TAB PK Analysis Set and ZAB PK Analysis Set with available data were analyzed. TAB PK Analysis Set included all randomized participants who have received at least 1 dose of study drug, and have at least 1 non-missing TAB concentration value reported by the PK laboratory test. ZAB PK Analysis Set included all randomized participants who have received at least 1 dose of study drug, and have at least 1 non-missing ZAB concentration value reported by the PK laboratory test.
Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.
Outcome measures
| Measure |
Randomized Phase Treatment Group 1: LEN + TAB+ ZAB
n=52 Participants
Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and Q6M up to Week 52 in the Randomized Phase.
At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL are given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.
|
Randomized Phase Treatment Group 3: SBR
Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care.
At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study are given the option to participate in the Extension Phase to switch from oral ART to LEN, TAB and ZAB, every 26 weeks at the dose specified for Treatment Group 1.
|
|---|---|---|
|
Trough Concentration at Week 26 for TAB and ZAB
TAB
|
41.8 µg/mL
Standard Deviation 22.7
|
—
|
|
Trough Concentration at Week 26 for TAB and ZAB
ZAB
|
72.0 µg/mL
Standard Deviation 39.2
|
—
|
SECONDARY outcome
Timeframe: Week 26Population: Participants in the LEN PK Analysis Set with available data were analyzed. LEN PK Analysis Set included all randomized participants who have received at least 1 dose of study drug, and have at least 1 nonmissing LEN concentration value reported by the PK laboratory test.
Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.
Outcome measures
| Measure |
Randomized Phase Treatment Group 1: LEN + TAB+ ZAB
n=52 Participants
Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and Q6M up to Week 52 in the Randomized Phase.
At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL are given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.
|
Randomized Phase Treatment Group 3: SBR
Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care.
At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study are given the option to participate in the Extension Phase to switch from oral ART to LEN, TAB and ZAB, every 26 weeks at the dose specified for Treatment Group 1.
|
|---|---|---|
|
Trough Concentration at Week 26 for LEN
|
20.2 ng/mL
Standard Deviation 10.6
|
—
|
SECONDARY outcome
Timeframe: Week 52Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 52Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 6 yearsAUC0-tau is defined as the partial area under the concentration versus time curve from time "0" to time "t".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 6 yearst1/2 is defined as the terminal elimination half-life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 6 yearsCmax is defined as the maximum observed concentration of drug.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 6 yearsCmax is defined as the maximum observed concentration of drug.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 6 yearsTmax is defined as the time (observed time point) of Cmax.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 6 yearsAnti-TAB and anti-ZAB antibodies incidence referred to the percentage of participants who have treatment-emergent anti-TAB and anti-ZAB antibodies among all participants evaluable for anti-drug antibody (ADA) incidence.
Outcome measures
Outcome data not reported
Adverse Events
Randomized Phase Treatment Group 1: LEN + TAB + ZAB
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Randomized Phase Treatment Group 3: SBR
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Randomized Phase Treatment Group 1: LEN + TAB + ZAB
n=53 participants at risk
Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and Q6M up to Week 52 in the Randomized Phase.
At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL are given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.
|
Randomized Phase Treatment Group 3: SBR
n=27 participants at risk
Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care.
At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study are given the option to participate in the Extension Phase to switch from ART to LEN, TAB and ZAB, every 26 weeks at the dose specified for Treatment Group 1.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/53 • All-cause Mortality and Adverse events: Up to Week 26
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
|
3.7%
1/27 • All-cause Mortality and Adverse events: Up to Week 26
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
|
Other adverse events
| Measure |
Randomized Phase Treatment Group 1: LEN + TAB + ZAB
n=53 participants at risk
Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and Q6M up to Week 52 in the Randomized Phase.
At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL are given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.
|
Randomized Phase Treatment Group 3: SBR
n=27 participants at risk
Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care.
At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study are given the option to participate in the Extension Phase to switch from ART to LEN, TAB and ZAB, every 26 weeks at the dose specified for Treatment Group 1.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.7%
3/53 • All-cause Mortality and Adverse events: Up to Week 26
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
|
0.00%
0/27 • All-cause Mortality and Adverse events: Up to Week 26
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
|
|
Gastrointestinal disorders
Diarrhoea
|
9.4%
5/53 • All-cause Mortality and Adverse events: Up to Week 26
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
|
3.7%
1/27 • All-cause Mortality and Adverse events: Up to Week 26
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
|
|
General disorders
Injection site erythema
|
20.8%
11/53 • All-cause Mortality and Adverse events: Up to Week 26
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
|
0.00%
0/27 • All-cause Mortality and Adverse events: Up to Week 26
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
|
|
General disorders
Injection site induration
|
13.2%
7/53 • All-cause Mortality and Adverse events: Up to Week 26
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
|
0.00%
0/27 • All-cause Mortality and Adverse events: Up to Week 26
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
|
|
General disorders
Injection site mass
|
5.7%
3/53 • All-cause Mortality and Adverse events: Up to Week 26
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
|
0.00%
0/27 • All-cause Mortality and Adverse events: Up to Week 26
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
|
|
General disorders
Injection site nodule
|
41.5%
22/53 • All-cause Mortality and Adverse events: Up to Week 26
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
|
0.00%
0/27 • All-cause Mortality and Adverse events: Up to Week 26
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
|
|
General disorders
Injection site pain
|
22.6%
12/53 • All-cause Mortality and Adverse events: Up to Week 26
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
|
0.00%
0/27 • All-cause Mortality and Adverse events: Up to Week 26
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
|
|
Infections and infestations
Covid-19
|
1.9%
1/53 • All-cause Mortality and Adverse events: Up to Week 26
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
|
7.4%
2/27 • All-cause Mortality and Adverse events: Up to Week 26
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
|
|
Infections and infestations
Sinusitis
|
5.7%
3/53 • All-cause Mortality and Adverse events: Up to Week 26
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
|
3.7%
1/27 • All-cause Mortality and Adverse events: Up to Week 26
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
|
|
Infections and infestations
Upper respiratory tract infection
|
7.5%
4/53 • All-cause Mortality and Adverse events: Up to Week 26
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
|
0.00%
0/27 • All-cause Mortality and Adverse events: Up to Week 26
All-cause mortality: The All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
|
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