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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studiecontact
- Naam: Gilead Clinical Study Information Center
- Telefoonnummer: 1-833-445-3230 (GILEAD-0)
- E-mail: GileadClinicalTrials@gilead.com
Studie Locaties
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California
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Los Angeles, California, Verenigde Staten, 90027
- Werving
- Kaiser Permanente Los Angeles Medical Center
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District of Columbia
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Washington D.C., District of Columbia, Verenigde Staten, 20007
- Werving
- Georgetown University Medical Center
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Florida
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Miami Lakes, Florida, Verenigde Staten, 33016
- Werving
- Floridian Clinical Research, LLC
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West Palm Beach, Florida, Verenigde Staten, 33407
- Werving
- Triple O Research Institute, P.A.
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30308
- Werving
- Emory University Hospital Midtown Infectious Disease Clinic
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Columbus, Georgia, Verenigde Staten, 31904
- Werving
- Centricity Research CPU - Georgia
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Indiana
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Indianapolis, Indiana, Verenigde Staten, 46202
- Werving
- Indiana CTSI Clinical Research Center
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02115
- Werving
- Brigham and Women's Hospital
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Boston, Massachusetts, Verenigde Staten, 02118
- Werving
- Boston Medical Center
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89113
- Werving
- PPD Development, LP
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New Jersey
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Newark, New Jersey, Verenigde Staten, 07102
- Nog niet aan het werven
- St. Michaels Medical Center
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New York
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The Bronx, New York, Verenigde Staten, 10461
- Werving
- Jacobi Medical Center
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North Carolina
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Durham, North Carolina, Verenigde Staten, 27710
- Werving
- Duke Early Phase Clinical Research Unit
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Winston-Salem, North Carolina, Verenigde Staten, 27157
- Werving
- Wake Forest University Health Sciences
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45267
- Werving
- University of Cincinnati College of Medicine
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Columbus, Ohio, Verenigde Staten, 43210
- Werving
- The Ohio State University Medical Center Infectious Diseases Clinic
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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 |
|
Experimenteel: 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 |
|
Experimenteel: 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 |
|
Experimenteel: 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 |
|
Experimenteel: 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 |
|
Experimenteel: 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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)
Tijdsspanne: First dose date up to 99 days
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First dose date up to 99 days
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Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Tijdsspanne: First dose date up to 99 days
|
First dose date up to 99 days
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Serum PK Parameters MAD: Dose 1 and Dose 5: Cmax of GS-0145
Tijdsspanne: Up to 99 days
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Up to 99 days
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Serum Pharmacokinetic (PK) Parameter (After Single Ascending Dose (SAD)): AUCinf of GS-0145
Tijdsspanne: 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
|
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Serum PK Parameters (SAD): Cmax of GS-0145
Tijdsspanne: Up to 43 days
|
Cmax is defined as the maximum observed concentration of drug. |
Up to 43 days
|
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Serum PK Parameters Multiple Ascending Dose (MAD): Dose 1 and Dose 5: AUCtau of GS-0145
Tijdsspanne: Up to 99 days
|
AUCtau is defined as the area under the concentration versus time curve over the dosing interval. |
Up to 99 days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Percentages of participants With of Treatment-Emergent Anti-GS-0415 Antibodies
Tijdsspanne: Up to 99 days
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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)
Tijdsspanne: Up to 99 days
|
Up to 99 days
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Gilead Study Director, Gilead Sciences
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- GS-US-531-7345
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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