Study of GS-0415 and How It Works in People With HIV

Prior treatment

• Females who are pregnant or breastfeeding or who may wish to become pregnant during the study or within 42 days after last study drug administration

Other illness

• Documented history of pre-ART CD4 nadir \< 100 cells/μL. Unknown pre-ART CD4 nadir is acceptable
• Known to have initiated ART within 6 months of HIV infection. Unknown time between infection and ART initiation is acceptable
• Have chronic hepatitis B virus (HBV) as determined by either:
  • Positive HBV surface antigen, regardless of HBV core antibody status, at the Screening visit
  • Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the Screening visit
• Have active hepatitis C virus (HCV) infection:
  • 1.) Positive anti-HCV antibody and negative HCV polymerase chain reaction (PCR) results are acceptable

Lab values

• Have a history of any of the following:
  • 2.) Significant serious skin disease, such as but not limited to rash, food allergy, eczema, psoriasis, or urticaria as assessed by the investigator
  • 3.) Significant drug sensitivity or drug allergy ('but not limited to anaphylaxis or drug-induced liver injury) as assessed by the investigator
  • 4.) Known hypersensitivity to the study drugs, their metabolites, or to formulation excipients
  • 5.) Previous or current history of bleeding disorder, platelet disorder including unexplained acute or chronic thrombocytopenia
  • 6.) Autoimmune diseases including Type 1 diabetes mellitus
  • 7.) Serious or active medical or psychiatric illness that would interfere with participant treatment, assessment, or compliance with the protocol.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

• Age ≥ 18 years and age ≤ 65 years at screening
• On stable antiretroviral (ARV) treatment for ≥ 12 consecutive months prior to screening, throughout the duration of study treatment and follow-up
• The following ARV agents are not allowed as part of the current ART regimen: entry inhibitors (maraviroc, enfuvirtide, ibalizumab, or fostemsavir)
• Plasma HIV-1 RNA \< 50 copies/mL for ≥ 12 months before and at screening with at least 2 documented HIV-1 RNA \<50 copies/mL within the last 12 months.
• Clusters of differentiation 4 (CD4) count ≥ 350 cells/μL
• Weight ≥ 50 kg and ≤ 110 kg at screening and Day 1
• Body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 35 kg/m2 at screening and Day 1