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).