Ground Truth
Key Inclusion Criteria: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.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.
Prediction
**Amended Eligibility Criteria (Version 17)**
Key Inclusion Criteria:
- On stable oral antiretroviral therapy (ART) consisting of no more than 2 drug classes (excluding pharmacologic boosters cobicistat or ritonavir) for ≥ 1 year prior to screening visit.
- Change in ART regimen ≥ 28 days prior to screening visit for reasons other than virologic failure (VF) (e.g., 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 K219Q).
- Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 12 months preceding screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).
- Documented plasma HIV-1 RNA < 50 copies/mL at screening visit 2.
- Proviral phenotypic sensitivity to both teropavimab and zinlirvimab at screening or from protocol GS-US-536-5816 within 24 months prior to screening.
- Screening CD4+ T-cell count ≥ 200 cells/μL at screening visit 2.
- No evidence of hepatitis C virus (HCV) infection (prior infection cleared spontaneously or with treatment is acceptable).
- No evidence of current hepatitis B virus (HBV) infection, regardless of HBV surface antigen status.
- No history of opportunistic infection or illness indicative of Stage 3 HIV disease.
- No evidence of comorbid condition requiring ongoing immunosuppression.
Key Exclusion Criteria:
- 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.
- History of opportunistic infection or illness indicative of Stage 3 HIV disease.
- Other protocol-defined Inclusion/Exclusion criteria may apply.
Notably, the revised criteria incorporate the findings from the study protocol, including the demonstration of enhanced clearance of HIV-1-infected cells by broadly neutralizing antibodies in vivo, as well as the successful maintenance of viral suppression in virologically suppressed participants treated with a combination of GS-5423, GS-2872, and lenacapavir.