[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648284":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":44,"centralContacts":48,"locations":40,"responsibleParty":54,"collaborators":40,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":40,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":40,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":40,"overallStatus":75,"whyStopped":40,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":40},{"fullName":5,"class":6},"Gilead Sciences","INDUSTRY",[8,14,19,23,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A Single Ascending Dose (SAD): GS-0415","EXPERIMENTAL","Participants will receive single escalating doses of GS-0415 via subcutaneous (SC) or intravenously (IV) on Day 1.",[13],"Drug: GS-0415",{"label":15,"type":10,"description":16,"interventionNames":17},"Group A SAD: Placebo","Participants will receive placebo to match the single escalating doses of GS-0415 via SC or IV on Day 1.",[18],"Drug: GS-0415 Placebo",{"label":20,"type":10,"description":21,"interventionNames":22},"Group B SAD: GS-0415","Participants will receive single escalating doses of GS-0415 via SC or IV on Day 1.",[13],{"label":24,"type":10,"description":16,"interventionNames":25},"Group B SAD: Placebo",[18],{"label":27,"type":10,"description":28,"interventionNames":29},"Group C Multiple Ascending Dose (MAD): GS-0415","Participants will receive escalating doses of GS-0415 via SC or IV at five different timepoints up to Date 57.",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Group C MAD: Placebo","Participants will receive placebo to match escalating doses of GS-0415 via SC or IV at five different timepoints up to Day 57.",[18],[35,41],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","GS-0415","Administered SC or IV",[9,20,27],null,{"type":36,"name":42,"description":38,"armGroupLabels":43,"otherNames":40},"GS-0415 Placebo",[15,24,31],[45],{"name":46,"affiliation":5,"role":47},"Gilead Study Director","STUDY_DIRECTOR",[49],{"name":50,"role":51,"phone":52,"phoneExt":40,"email":53},"Gilead Clinical Study Information Center","CONTACT","1-833-445-3230 (GILEAD-0)","GileadClinicalTrials@gilead.com",{"type":55,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100648284","phase-1-study-of-gs-0415-and-how-it-works-in-people-with-hiv-100648284",false,"NCT07719491","Study of GS-0415 and How It Works in People With HIV","A First-in-Human Phase 1b, Single-Blind, Placebo-controlled Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate Safety and Pharmacokinetics of GS-0415 in People With HIV-1 Who Are Virologically Suppressed on Antiretroviral Treatment","Key Inclusion Criteria:\n\n* Age ≥ 18 years and age ≤ 65 years at screening\n* On stable antiretroviral (ARV) treatment for ≥ 12 consecutive months prior to screening, throughout the duration of study treatment and follow-up\n* The following ARV agents are not allowed as part of the current ART regimen: entry inhibitors (maraviroc, enfuvirtide, ibalizumab, or fostemsavir)\n* Plasma HIV-1 RNA \\\u003C 50 copies\u002FmL at screening with at least 2 documented HIV-1 RNA \\\u003C50 copies\u002FmL within the last 12 months.\n* Clusters of differentiation 4 (CD4) count ≥ 350 cells\u002FμL\n* Weight ≥ 50 kg and ≤ 110 kg at screening and Day 1\n* Body mass index (BMI) ≥ 18.5 kg\u002Fm2 and ≤ 35 kg\u002Fm2 at screening and Day 1\n\nKey Exclusion Criteria:\n\n* Documented history of pre-ART CD4 nadir \\\u003C 100 cells\u002FμL. Unknown pre-ART CD4 nadir is acceptable\n* Known to have initiated ART within 6 months of HIV infection. Unknown time between infection and ART initiation is acceptable\n* 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\n* Have chronic hepatitis B virus (HBV) as determined by either:\n\n  1. Positive HBV surface antigen, regardless of HBV core antibody status, at the Screening visit\n  2. Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the Screening visit\n* Have active hepatitis C virus (HCV) infection:\n\n  1.) Positive anti-HCV antibody and negative HCV polymerase chain reaction (PCR) results are acceptable\n* Have a history of any of the following:\n\n  2.) Significant serious skin disease, such as but not limited to rash, food allergy, eczema, psoriasis, or urticaria\n\n  3.) Significant drug sensitivity or drug allergy ('but not limited to anaphylaxis or drug-induced liver injury)\n\n  4.) Known hypersensitivity to the study drugs, their metabolites, or to formulation excipients\n\n  5.) Previous or current history of bleeding disorder, platelet disorder including unexplained acute or chronic thrombocytopenia\n\n  6.) Autoimmune diseases including Type 1 diabetes mellitus\n\n  7.) Serious or active medical or psychiatric illness that would interfere with participant treatment, assessment, or compliance with the protocol.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years","65 Years",{"count":67,"type":68},112,"ESTIMATED","INTERVENTIONAL",[71],"PHASE1","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.\n\nThe 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.",[74],"HIV -1 Infection","NOT_YET_RECRUITING","2026-07-17",{"date":78,"type":79},"2026-07-22","ACTUAL",{"date":81,"type":68},"2026-07",{"date":83,"type":68},"2029-08",{"name":5,"class":6}]