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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05729568
Registration number
NCT05729568
Ethics application status
Date submitted
6/02/2023
Date registered
15/02/2023
Date last updated
15/07/2025
Titles & IDs
Public title
A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
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Scientific title
A Phase 2 Randomized, Open-label Study to Evaluate the Safety and Efficacy of Broadly Neutralizing Antibodies (bNAbs) GS-5423 and GS-2872 in Combination With the Capsid Inhibitor Lenacapavir as Long-Acting Treatment Dosed Every 6 Months in Virologically Suppressed Adults With HIV-1 Infection
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Secondary ID [1]
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GS-US-536-5939
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV Infection
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Infection
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Sexually transmitted infections
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Teropavimab
Treatment: Drugs - Zinlirvimab
Treatment: Drugs - Lenacapavir Tablet
Treatment: Drugs - Lenacapavir Injection
Treatment: Drugs - Antiretroviral Therapy
Experimental: Randomized Phase Treatment Group 1: LEN + TAB + ZAB - Participants will receive loading dose of lenacapavir (LEN) 600 mg tablets, orally, on Day 1 and Day 2. They will receive 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) up to Week 52 in the Randomized Phase.
Experimental: Randomized Phase Treatment Group 3: SBR - Participants in Stay on Baseline Regimen (SBR) group will continue their baseline oral antiretroviral therapy (ART) up to Week 52. ART 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.
Experimental: Extension Phase: Treatment Group 1: LEN + TAB + ZAB - At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL will be given the option to participate in the study extension phase. In the study extension phase, participants will continue to receive their randomized study drugs every 26 weeks.
Experimental: Extension Phase Treatment Group 3: SBR - 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 will be 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.
Treatment: Drugs: Teropavimab
Administered intravenously
Treatment: Drugs: Zinlirvimab
Administered intravenously
Treatment: Drugs: Lenacapavir Tablet
Administered orally
Treatment: Drugs: Lenacapavir Injection
Administered subcutaneously
Treatment: Drugs: Antiretroviral Therapy
Antiretroviral therapy, administered orally may include regimens such as: bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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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.
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Timepoint [1]
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Week 26
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Secondary outcome [1]
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Percentage of Participants With HIV-1 RNA = 50 Copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm
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Assessment method [1]
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Timepoint [1]
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Week 52
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Secondary outcome [2]
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 26 as Determined by the US FDA-defined Snapshot Algorithm
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Assessment method [2]
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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.
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Timepoint [2]
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Week 26
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Secondary outcome [3]
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm
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Assessment method [3]
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Timepoint [3]
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Week 52
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Secondary outcome [4]
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Change From Baseline in Clusters of Differentiation 4 (CD4) + T-cell Counts at Week 26
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Assessment method [4]
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Timepoint [4]
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Baseline, Week 26
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Secondary outcome [5]
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Change From Baseline in CD4+ T-cell Counts at Week 52
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Assessment method [5]
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Timepoint [5]
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Baseline, Week 52
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Secondary outcome [6]
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Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
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Assessment method [6]
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Timepoint [6]
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Up to approximately 6 years
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Secondary outcome [7]
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Trough Concentration at Week 26 for TAB and ZAB
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Assessment method [7]
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Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.
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Timepoint [7]
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Week 26
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Secondary outcome [8]
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Trough Concentration at Week 26 for LEN
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Assessment method [8]
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Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.
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Timepoint [8]
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Week 26
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Secondary outcome [9]
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Trough Concentration at Week 52 for TAB and ZAB
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Assessment method [9]
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Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.
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Timepoint [9]
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Week 52
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Secondary outcome [10]
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Trough Concentration at Week 52 for LEN
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Assessment method [10]
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Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.
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Timepoint [10]
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Week 52
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Secondary outcome [11]
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Pharmacokinetic (PK) Parameter: AUC0-tau for TAB and ZAB
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Assessment method [11]
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AUC0-tau is defined as the partial area under the concentration versus time curve from time "0" to time "t".
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Timepoint [11]
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Up to approximately 6 years
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Secondary outcome [12]
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PK Parameter: t1/2 for TAB and ZAB
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Assessment method [12]
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t1/2 is defined as the terminal elimination half-life.
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Timepoint [12]
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Up to approximately 6 years
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Secondary outcome [13]
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PK Parameter: Cmax for TAB and ZAB
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Assessment method [13]
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Cmax is defined as the maximum observed concentration of drug.
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Timepoint [13]
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Up to approximately 6 years
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Secondary outcome [14]
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PK Parameter: Cmax for LEN
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Assessment method [14]
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Cmax is defined as the maximum observed concentration of drug.
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Timepoint [14]
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Up to approximately 6 years
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Secondary outcome [15]
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PK Parameter: Tmax for TAB, ZAB, and LEN
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Assessment method [15]
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Tmax is defined as the time (observed time point) of Cmax.
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Timepoint [15]
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Up to approximately 6 years
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Secondary outcome [16]
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Percentage of Participants With Treatment-emergent Anti-TAB and Anti-ZAB Antibodies
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Assessment method [16]
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Anti-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.
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Timepoint [16]
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Up to approximately 6 years
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Eligibility
Key inclusion criteria
Key
* On stable oral antiretroviral therapy (ART) consisting of no more than 2 drug classes (with the exception of pharmacologic boosters cobicistat or ritonavir) for = 1 year prior to screening visit 2. A change in ART regimen = 28 days prior to screening visit 2 for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed.
* No clinically significant documented historical resistance to the current ART regimen with the exception of isolated nucleoside reverse transcriptase inhibitor mutations including M184V or = 2 thymidine analog mutations (TAMs: M41L, D67N, K70R, L210W, T215Y, and/or K219Q).
* Plasma human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) < 50 copies/mL at screening visit 2.
* Documented plasma HIV-1 RNA < 50 copies/mL for = 12 months preceding screening visit 2 (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is = 50 copies/mL). Virologic elevations of = 50 copies/mL (transient detectable viremia or "blips") prior to screening are acceptable.
* Proviral phenotypic sensitivity to both teropavimab and zinlirvimab at screening or from protocol GS-US-536-5816 within 24 months prior to screening.
* Screening clusters of differentiation 4 (CD4)+ T-cell count = 200 cells/µL at screening visit 2.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Comorbid condition requiring ongoing immunosuppression.
* Evidence of hepatitis C virus (HCV) infection (prior infection cleared spontaneously or with treatment is acceptable)
* Evidence of current hepatitis B virus (HBV) infection regardless of HBV surface antigen status, at the screening visit 2.
* History of opportunistic infection or illness indicative of Stage 3 HIV disease.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/05/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2029
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Actual
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Sample size
Target
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Accrual to date
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Final
83
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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East Sydney Doctors - Darlinghurst
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Recruitment hospital [2]
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Holdsworth House Medical Practice - Sydney
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Recruitment hospital [3]
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Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2010 NSW - Sydney
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment outside Australia
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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Colorado
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United States of America
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State/province [3]
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Connecticut
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United States of America
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State/province [4]
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District of Columbia
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United States of America
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Florida
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Country [6]
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United States of America
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Georgia
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Missouri
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New Mexico
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New York
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North Carolina
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United States of America
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State/province [11]
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South Carolina
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United States of America
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State/province [12]
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Tennessee
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Country [13]
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United States of America
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State/province [13]
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Texas
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Country [14]
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United States of America
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State/province [14]
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Virginia
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Country [15]
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Canada
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State/province [15]
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Toronto
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Country [16]
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Puerto Rico
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State/province [16]
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San Juan
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The goal of this study is to test the effectiveness, safety, and tolerability of the combination of broadly neutralizing antibodies (bNAbs) (teropavimab (TAB; GS-5423) and zinlirvimab (ZAB; GS-2872)) with lenacapavir (LEN) in virologically suppressed adults with HIV-1 infection. The purpose of this study is to evaluate the efficacy of switching to a regimen of LEN, TAB and ZAB, versus continuing on baseline oral antiretroviral therapy (ART) as determined by the proportion of participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) = 50 copies/mL at Week 26.
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Trial website
https://clinicaltrials.gov/study/NCT05729568
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Trial related presentations / publications
Mponponsuo K, McMahon JH, Gorgos L, Morales-Ramirez J, Workowski K, Brunetta J, Ogbuagu O, Collins SE, VanderVeen LA, Huang H, Baeten JM, Eron JJ. Efficacy and Safety of Lenacapavir, Teropavimab, and Zinlirvimab: Phase II Week 26 Primary Outcome [Oral 07]. Conference on Retroviruses and Opportunistic Infections (CROI); 2025 9-12 March, San Francisco, CA.
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Public notes
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Contacts
Principal investigator
Name
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Gilead Study Director
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Address
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Gilead Sciences
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/68/NCT05729568/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/68/NCT05729568/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT05729568
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