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

NCT07719491

Not Yet RecruitingPhase 1

Sponsor: Gilead Sciences

Conditions: HIV -1 Infection

Interventions: GS-0415, GS-0415 Placebo

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria:

* 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 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

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:

  1. Positive HBV surface antigen, regardless of HBV core antibody status, at the Screening visit
  2. 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
* 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.