GS-0415 safety and PK in people with HIV on ART

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 study examines single and multiple escalating doses of GS-0415 given by subcutaneous and intravenous routes in adults with HIV-1 who have virologic suppression on ART. Primary goals are to assess safety and tolerability and to characterize the pharmacokinetics of GS-0415. Participants will be monitored for adverse events, lab changes, and drug exposure over time. The study will help determine appropriate dose ranges for future trials. Locations include Kaiser Permanente LA, Georgetown University, and Floridian Clinical Research in multiple sites.

Why it matters

Who can join: the full rules

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 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

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 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.

Where it's running

• Kaiser Permanente Los Angeles Medical Center
  Los Angeles, California, United States Recruiting
• Georgetown University Medical Center
  Washington D.C., District of Columbia, United States Recruiting
• Floridian Clinical Research, LLC
  Miami Lakes, Florida, United States Recruiting
• Triple O Research Institute, P.A.
  West Palm Beach, Florida, United States Recruiting
• Emory University Hospital Midtown Infectious Disease Clinic
  Atlanta, Georgia, United States Recruiting
• Centricity Research CPU - Georgia
  Columbus, Georgia, United States Recruiting

Study contacts

• Study coordinator: Gilead Clinical Study Information Center
• Email: GileadClinicalTrials@gilead.com
• Phone: 1-833-445-3230 (GILEAD-0)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.