Status:
COMPLETED
Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
Lead Sponsor:
Gilead Sciences
Conditions:
HIV-1 Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of a combination of the broadly neutralizing antibodies (bNAbs) teropavimab (formerly GS-5423) and zinlirvimab (formerly ...
Eligibility Criteria
Inclusion
- Key
- On first-line antiretroviral therapy (ART) for ≥ 2 years prior to screening. A change in ART regimen ≥ 28 days prior to screening for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed
- No documented historical resistance to the current ART regimen
- Plasma HIV-1 RNA \< 50 copies/mL at screening
- Documented plasma HIV-1 RNA \< 50 copies/mL for ≥ 18 months preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable.
- Proviral phenotypic sensitivity to both teropavimab and zinlirvimab at screening by the PhenoSense mAb Assay (Monogram Biosciences) for inclusion in the Primary Cohort; sensitivity at screening by the PhenoSense mAb Assay (Monogram Biosciences) to 1 mAb, either teropavimab or zinlirvimab, within 18 months prior to enrollment for inclusion in the optional Pilot Cohort
- \-- In both cohorts, teropavimab sensitivity is defined as 90% inhibitory concentration (IC90) ≤ 2 μg/mL; zinlirvimab sensitivity is defined as IC90 ≤ 2 μg/mL;
- Cluster determinant 4+ (CD4+) count nadir ≥ 350 cells/μL
- Screening CD4+ count ≥ 500 cells/μL
- Availability of a fully active alternative ART regimen, in the opinion of the investigator, in the event of discontinuation of the current ART regimen with development of resistance
- Key
Exclusion
- Comorbid condition requiring ongoing immunosuppression
- Evidence of current hepatitis B virus (HBV) infection
- Evidence of current hepatitis C virus (HCV) infection (prior infection cleared spontaneously or with treatment is acceptable)
- History of opportunistic infection or illness indicative of Stage 3 HIV disease
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
April 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04811040
Start Date
April 8 2021
End Date
October 26 2023
Last Update
January 27 2025
Active Locations (23)
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1
Ruane Clinical Research Group Inc.
Los Angeles, California, United States, 90036
2
Mills Clinical Research
Los Angeles, California, United States, 90069
3
One Community Health
Sacramento, California, United States, 95811
4
UCSD AntViral Research Center (AVRC)
San Diego, California, United States, 92103