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
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Gilead Clinical Study Information Center
- Número de telefone: 1-833-445-3230 (GILEAD-0)
- E-mail: GileadClinicalTrials@gilead.com
Locais de estudo
-
-
California
-
Los Angeles, California, Estados Unidos, 90027
- Recrutamento
- Kaiser Permanente Los Angeles Medical Center
-
-
District of Columbia
-
Washington D.C., District of Columbia, Estados Unidos, 20007
- Recrutamento
- Georgetown University Medical Center
-
-
Florida
-
Miami Lakes, Florida, Estados Unidos, 33016
- Recrutamento
- Floridian Clinical Research, LLC
-
West Palm Beach, Florida, Estados Unidos, 33407
- Recrutamento
- Triple O Research Institute, P.A.
-
-
Georgia
-
Atlanta, Georgia, Estados Unidos, 30308
- Recrutamento
- Emory University Hospital Midtown Infectious Disease Clinic
-
Columbus, Georgia, Estados Unidos, 31904
- Recrutamento
- Centricity Research CPU - Georgia
-
-
Indiana
-
Indianapolis, Indiana, Estados Unidos, 46202
- Recrutamento
- Indiana CTSI Clinical Research Center
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02115
- Recrutamento
- Brigham and Women's Hospital
-
Boston, Massachusetts, Estados Unidos, 02118
- Recrutamento
- Boston Medical Center
-
-
Nevada
-
Las Vegas, Nevada, Estados Unidos, 89113
- Recrutamento
- PPD Development, LP
-
-
New Jersey
-
Newark, New Jersey, Estados Unidos, 07102
- Ainda não está recrutando
- St. Michaels Medical Center
-
-
New York
-
The Bronx, New York, Estados Unidos, 10461
- Recrutamento
- Jacobi Medical Center
-
-
North Carolina
-
Durham, North Carolina, Estados Unidos, 27710
- Recrutamento
- Duke Early Phase Clinical Research Unit
-
Winston-Salem, North Carolina, Estados Unidos, 27157
- Recrutamento
- Wake Forest University Health Sciences
-
-
Ohio
-
Cincinnati, Ohio, Estados Unidos, 45267
- Recrutamento
- University of Cincinnati College of Medicine
-
Columbus, Ohio, Estados Unidos, 43210
- Recrutamento
- The Ohio State University Medical Center Infectious Diseases Clinic
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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:
- 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
-
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Group A Single Ascending Dose (SAD): GS-0415
Participants will receive single escalating doses of GS-0415 via subcutaneous (SC) or intravenously (IV) on Day 1. |
Administered SC or IV |
|
Experimental: Group A SAD: Placebo
Participants will receive placebo to match the single escalating doses of GS-0415 via SC or IV on Day 1. |
Administered SC or IV |
|
Experimental: Group B SAD: GS-0415
Participants will receive single escalating doses of GS-0415 via SC or IV on Day 1. |
Administered SC or IV |
|
Experimental: Group B SAD: Placebo
Participants will receive placebo to match the single escalating doses of GS-0415 via SC or IV on Day 1. |
Administered SC or IV |
|
Experimental: 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. |
Administered SC or IV |
|
Experimental: 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. |
Administered SC or IV |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)
Prazo: First dose date up to 99 days
|
First dose date up to 99 days
|
|
|
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Prazo: First dose date up to 99 days
|
First dose date up to 99 days
|
|
|
Serum PK Parameters MAD: Dose 1 and Dose 5: Cmax of GS-0145
Prazo: Up to 99 days
|
Up to 99 days
|
|
|
Serum Pharmacokinetic (PK) Parameter (After Single Ascending Dose (SAD)): AUCinf of GS-0145
Prazo: Up to 43 days
|
AUCinf is defined as the area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/λz). |
Up to 43 days
|
|
Serum PK Parameters (SAD): Cmax of GS-0145
Prazo: Up to 43 days
|
Cmax is defined as the maximum observed concentration of drug. |
Up to 43 days
|
|
Serum PK Parameters Multiple Ascending Dose (MAD): Dose 1 and Dose 5: AUCtau of GS-0145
Prazo: Up to 99 days
|
AUCtau is defined as the area under the concentration versus time curve over the dosing interval. |
Up to 99 days
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Percentages of participants With of Treatment-Emergent Anti-GS-0415 Antibodies
Prazo: Up to 99 days
|
Up to 99 days
|
|
Percentages of participants With Virological Rebound (Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥ 50 copies/mL)
Prazo: Up to 99 days
|
Up to 99 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Gilead Study Director, Gilead Sciences
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- GS-US-531-7345
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .