The goals of this clinical study are to learn more about the study drug GS-0415, safety, tolerability, and pharmacokinetics (PK) of single ascending doses (SAD) and multiple ascending doses (MAD) of subcutaneous (SC) and intravenous (IV) GS-0415 in people with HIV-1 (PWH) on antiretroviral treatment.
The primary objectives of this study are to evaluate the safety and tolerability of escalating, single and multiple subcutaneous (SC) and intravenous (IV) doses of GS-0415, administered in PWH who are virologically suppressed on antiretroviral therapy (ART) and to evaluate the pharmacokinetics (PK) of GS-0415.
Key Inclusion Criteria:
Key Exclusion Criteria:
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
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
Have chronic hepatitis B virus (HBV) as determined by either:
Have active hepatitis C virus (HCV) infection:
1.) Positive anti-HCV antibody and negative HCV polymerase chain reaction (PCR) results are acceptable
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
3.) Significant drug sensitivity or drug allergy ('but not limited to anaphylaxis or drug-induced liver injury)
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.
GileadClinicalTrials@gilead.com
Participants will receive single escalating doses of GS-0415 via subcutaneous (SC) or intravenously (IV) on Day 1.
Participants will receive placebo to match the single escalating doses of GS-0415 via SC or IV on Day 1.
Participants will receive single escalating doses of GS-0415 via SC or IV on Day 1.
Participants will receive placebo to match the single escalating doses of GS-0415 via SC or IV on Day 1.
Participants will receive escalating doses of GS-0415 via SC or IV at five different timepoints up to Date 57.
Participants will receive placebo to match escalating doses of GS-0415 via SC or IV at five different timepoints up to Day 57.
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