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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 1
Kontakter och platser
Studiekontakt
- Namn: Gilead Clinical Study Information Center
- Telefonnummer: 1-833-445-3230 (GILEAD-0)
- E-post: GileadClinicalTrials@gilead.com
Studieorter
-
-
California
-
Los Angeles, California, Förenta staterna, 90027
- Rekrytering
- Kaiser Permanente Los Angeles Medical Center
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-
District of Columbia
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Washington D.C., District of Columbia, Förenta staterna, 20007
- Rekrytering
- Georgetown University Medical Center
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-
Florida
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Miami Lakes, Florida, Förenta staterna, 33016
- Rekrytering
- Floridian Clinical Research, LLC
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West Palm Beach, Florida, Förenta staterna, 33407
- Rekrytering
- Triple O Research Institute, P.A.
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-
Georgia
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Atlanta, Georgia, Förenta staterna, 30308
- Rekrytering
- Emory University Hospital Midtown Infectious Disease Clinic
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Columbus, Georgia, Förenta staterna, 31904
- Rekrytering
- Centricity Research CPU - Georgia
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-
Indiana
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Indianapolis, Indiana, Förenta staterna, 46202
- Rekrytering
- Indiana CTSI Clinical Research Center
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02115
- Rekrytering
- Brigham and Women's Hospital
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Boston, Massachusetts, Förenta staterna, 02118
- Rekrytering
- Boston Medical Center
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89113
- Rekrytering
- PPD Development, LP
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New Jersey
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Newark, New Jersey, Förenta staterna, 07102
- Har inte rekryterat ännu
- St. Michaels Medical Center
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New York
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The Bronx, New York, Förenta staterna, 10461
- Rekrytering
- Jacobi Medical Center
-
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North Carolina
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Durham, North Carolina, Förenta staterna, 27710
- Rekrytering
- Duke Early Phase Clinical Research Unit
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Winston-Salem, North Carolina, Förenta staterna, 27157
- Rekrytering
- Wake Forest University Health Sciences
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45267
- Rekrytering
- University of Cincinnati College of Medicine
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Columbus, Ohio, Förenta staterna, 43210
- Rekrytering
- The Ohio State University Medical Center Infectious Diseases Clinic
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
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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
-
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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 |
|
Experimentell: 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 |
|
Experimentell: 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 |
|
Experimentell: 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 |
|
Experimentell: 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 |
|
Experimentell: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)
Tidsram: First dose date up to 99 days
|
First dose date up to 99 days
|
|
|
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Tidsram: 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
Tidsram: Up to 99 days
|
Up to 99 days
|
|
|
Serum Pharmacokinetic (PK) Parameter (After Single Ascending Dose (SAD)): AUCinf of GS-0145
Tidsram: 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
Tidsram: 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
Tidsram: Up to 99 days
|
AUCtau is defined as the area under the concentration versus time curve over the dosing interval. |
Up to 99 days
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Percentages of participants With of Treatment-Emergent Anti-GS-0415 Antibodies
Tidsram: 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)
Tidsram: Up to 99 days
|
Up to 99 days
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Gilead Study Director, Gilead Sciences
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- GS-US-531-7345
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