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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Gilead Clinical Study Information Center
- Numéro de téléphone: 1-833-445-3230 (GILEAD-0)
- E-mail: GileadClinicalTrials@gilead.com
Lieux d'étude
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California
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Los Angeles, California, États-Unis, 90027
- Recrutement
- Kaiser Permanente Los Angeles Medical Center
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District of Columbia
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Washington D.C., District of Columbia, États-Unis, 20007
- Recrutement
- Georgetown University Medical Center
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Florida
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Miami Lakes, Florida, États-Unis, 33016
- Recrutement
- Floridian Clinical Research, LLC
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West Palm Beach, Florida, États-Unis, 33407
- Recrutement
- Triple O Research Institute, P.A.
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Georgia
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Atlanta, Georgia, États-Unis, 30308
- Recrutement
- Emory University Hospital Midtown Infectious Disease Clinic
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Columbus, Georgia, États-Unis, 31904
- Recrutement
- Centricity Research CPU - Georgia
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Indiana
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Indianapolis, Indiana, États-Unis, 46202
- Recrutement
- Indiana CTSI Clinical Research Center
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Massachusetts
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Boston, Massachusetts, États-Unis, 02115
- Recrutement
- Brigham and Women's Hospital
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Boston, Massachusetts, États-Unis, 02118
- Recrutement
- Boston Medical Center
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Nevada
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Las Vegas, Nevada, États-Unis, 89113
- Recrutement
- PPD Development, LP
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New Jersey
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Newark, New Jersey, États-Unis, 07102
- Pas encore de recrutement
- St. Michaels Medical Center
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New York
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The Bronx, New York, États-Unis, 10461
- Recrutement
- Jacobi Medical Center
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North Carolina
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Durham, North Carolina, États-Unis, 27710
- Recrutement
- Duke Early Phase Clinical Research Unit
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Winston-Salem, North Carolina, États-Unis, 27157
- Recrutement
- Wake Forest University Health Sciences
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Ohio
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Cincinnati, Ohio, États-Unis, 45267
- Recrutement
- University of Cincinnati College of Medicine
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Columbus, Ohio, États-Unis, 43210
- Recrutement
- The Ohio State University Medical Center Infectious Diseases Clinic
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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:
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Documented history of pre-ART CD4 nadir < 100 cells/μL. Unknown pre-ART CD4 nadir is acceptable
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Known to have initiated ART within 6 months of HIV infection. Unknown time between infection and ART initiation is acceptable
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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
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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
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Have active hepatitis C virus (HCV) infection:
1.) Positive anti-HCV antibody and negative HCV polymerase chain reaction (PCR) results are acceptable
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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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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 |
|
Expérimental: 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 |
|
Expérimental: 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 |
|
Expérimental: 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 |
|
Expérimental: 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 |
|
Expérimental: 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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)
Délai: First dose date up to 99 days
|
First dose date up to 99 days
|
|
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Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Délai: First dose date up to 99 days
|
First dose date up to 99 days
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|
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Serum PK Parameters MAD: Dose 1 and Dose 5: Cmax of GS-0145
Délai: Up to 99 days
|
Up to 99 days
|
|
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Serum Pharmacokinetic (PK) Parameter (After Single Ascending Dose (SAD)): AUCinf of GS-0145
Délai: 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
Délai: 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
Délai: Up to 99 days
|
AUCtau is defined as the area under the concentration versus time curve over the dosing interval. |
Up to 99 days
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Percentages of participants With of Treatment-Emergent Anti-GS-0415 Antibodies
Délai: Up to 99 days
|
Up to 99 days
|
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Percentages of participants With Virological Rebound (Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥ 50 copies/mL)
Délai: Up to 99 days
|
Up to 99 days
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Gilead Study Director, Gilead Sciences
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- GS-US-531-7345
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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