Raw Ground Truth
Key Inclusion Criteria:Plasma HIV-1 RNA ≥ 500 copies/mL at screening VisitCurrently taking a failing ARV regimen that contains 2 NRTIs and a NNRTINo prior or current ARV regimens containing integrase inhibitor (INSTI) or protease inhibitor (PI)Screening genotype must show at least the protocol defined resistance mutation profileKey Exclusion Criteria:Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trialUse of an investigational drug other than the study drugIndividuals with chronic hepatitis B virus (HBV) infection are not permitted to participateActive tuberculosis infectionNOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Raw Prediction
Amended Eligibility Criteria (version 15):
Key Inclusion Criteria:
- Non-pregnant/non-lactating females, ≥18 years of age at Screening.
- Subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 7.
- Estimated glomerular filtration rate (eGFR) (Cockcroft-Gault equation) ≥70 mL/min.
- Currently taking a failing antiretroviral (ARV) regimen that contains an NRTI.
- HIV-1 RNA ≥500 copies/mL at Screening.
- CD4 > 100 cells/μL at Screening.
- Have a screening genotype showing at least the following resistance mutation profile (a local genotype at the Screening visit is acceptable for enrollment upon review by the Sponsor):
- K65R or
- at least 3 TAMs; TAMs are defined as: M41L, D67N, K70R, L210W, T215F/Y, or K219Q/E/N/R in reverse transcriptase (RT) or
- Q151M
- and at least one primary resistance mutation to an NNRTI
- No prior or current ARV regimens containing integrase inhibitor (INSTI) or protease inhibitor (PI)
- No evidence of chronic hepatitis B or C infection.
- No active opportunistic infections, including tuberculosis.
Key Exclusion Criteria:
- Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1.
- Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial.
- Use of an investigational drug other than the study drug.
- Individuals with chronic hepatitis B virus (HBV) infection are not permitted to participate.
- Active tuberculosis infection.
- Subjects with known hypersensitivity to investigational medicinal products GS-9131, BIC, TAF, DRV, RTV, their metabolites, or formulation excipients.
- Subjects with acute hepatitis in the 30 days prior to randomization.
- Subjects with chronic HCV infection requiring HCV therapy during the course of the study.
- Subjects receiving ongoing therapy with any of the medications listed in Section 5.4, including drugs not to be used with BIC, TAF, DRV and RTV.
- Subjects with known hypersensitivity to polyvalent cations (e.g., Mg, Al, Ca, Fe) or cation-containing antacids or laxatives.
- Subjects with known hypersensitivity to Prezista® (DRV) or Norvir® (RTV).
- Subjects with known hypersensitivity to Tenofovir alafenamide (TAF).
Processed Ground Truth
1. Key Inclusion Criteria:Plasma HIV-1 RNA ≥ 500 copies/mL at screening VisitCurrently taking a failing ARV regimen that contains 2 NRTIs and a NNRTINo prior or current ARV regimens containing integrase inhibitor (INSTI) or protease inhibitor (PI)Screening genotype must show at least the protocol defined resistance mutation profileKey Exclusion Criteria:Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trialUse of an investigational drug other than the study drugIndividuals with chronic hepatitis B virus (HBV) infection are not permitted to participateActive tuberculosis infectionNOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Processed Prediction
1. Amended Eligibility Criteria (version 15):
2. Key Inclusion Criteria:
3. Non-pregnant/non-lactating females, ≥18 years of age at Screening.
4. Subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 7.
5. Estimated glomerular filtration rate (eGFR) (Cockcroft-Gault equation) ≥70 mL/min.
6. Currently taking a failing antiretroviral (ARV) regimen that contains an NRTI.
7. HIV-1 RNA ≥500 copies/mL at Screening.
8. CD4 > 100 cells/μL at Screening.
9. Have a screening genotype showing at least the following resistance mutation profile (a local genotype at the Screening visit is acceptable for enrollment upon review by the Sponsor):
10. K65R or
11. at least 3 TAMs; TAMs are defined as: M41L, D67N, K70R, L210W, T215F/Y, or K219Q/E/N/R in reverse transcriptase (RT) or
12. Q151M
13. and at least one primary resistance mutation to an NNRTI
14. No prior or current ARV regimens containing integrase inhibitor (INSTI) or protease inhibitor (PI)
15. No evidence of chronic hepatitis B or C infection.
16. No active opportunistic infections, including tuberculosis.
17. Key Exclusion Criteria:
18. Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1.
19. Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial.
20. Use of an investigational drug other than the study drug.
21. Individuals with chronic hepatitis B virus (HBV) infection are not permitted to participate.
22. Active tuberculosis infection.
23. Subjects with known hypersensitivity to investigational medicinal products GS-9131, BIC, TAF, DRV, RTV, their metabolites, or formulation excipients.
24. Subjects with acute hepatitis in the 30 days prior to randomization.
25. Subjects with chronic HCV infection requiring HCV therapy during the course of the study.
26. Subjects receiving ongoing therapy with any of the medications listed in Section 5.4, including drugs not to be used with BIC, TAF, DRV and RTV.
27. Subjects with known hypersensitivity to polyvalent cations (e.g., Mg, Al, Ca, Fe) or cation-containing antacids or laxatives.
28. Subjects with known hypersensitivity to Prezista® (DRV) or Norvir® (RTV).
29. Subjects with known hypersensitivity to Tenofovir alafenamide (TAF).