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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 1
Kontakte und Standorte
Studienkontakt
- Name: Gilead Clinical Study Information Center
- Telefonnummer: 1-833-445-3230 (GILEAD-0)
- E-Mail: GileadClinicalTrials@gilead.com
Studienorte
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California
-
Los Angeles, California, Vereinigte Staaten, 90027
- Rekrutierung
- Kaiser Permanente Los Angeles Medical Center
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District of Columbia
-
Washington D.C., District of Columbia, Vereinigte Staaten, 20007
- Rekrutierung
- Georgetown University Medical Center
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-
Florida
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West Palm Beach, Florida, Vereinigte Staaten, 33407
- Rekrutierung
- Triple O Research Institute, P.A.
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Nevada
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Las Vegas, Nevada, Vereinigte Staaten, 89113
- Rekrutierung
- PPD Development, LP
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New Jersey
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Newark, New Jersey, Vereinigte Staaten, 07102
- Noch keine Rekrutierung
- St. Michaels Medical Center
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New York
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The Bronx, New York, Vereinigte Staaten, 10461
- Rekrutierung
- Jacobi Medical Center
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Ohio
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Columbus, Ohio, Vereinigte Staaten, 43210
- Rekrutierung
- The Ohio State University Medical Center Infectious Diseases Clinic
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
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Administered SC or IV
|
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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.
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Administered SC or IV
|
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Experimental: Group B SAD: GS-0415
Participants will receive single escalating doses of GS-0415 via SC or IV on Day 1.
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Administered SC or IV
|
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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.
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Administered SC or IV
|
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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.
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Administered SC or IV
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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.
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Administered SC or IV
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)
Zeitfenster: 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
Zeitfenster: First dose date up to 99 days
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First dose date up to 99 days
|
|
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Serum Pharmacokinetic (PK) Parameter (After Single Ascending Dose (SAD)): AUCinf of GS-0145
Zeitfenster: 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
Zeitfenster: Up to 43 days
|
Cmax is defined as the maximum observed concentration of drug.
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Up to 43 days
|
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Serum PK Parameters Multiple Ascending Dose (MAD): Dose 1 and Dose 5: AUCtau of GS-0145
Zeitfenster: Up to 99 days
|
AUCtau is defined as the area under the concentration versus time curve over the dosing interval.
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Up to 99 days
|
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Serum PK Parameters MAD: Dose 1 and Dose 5: Cmax of GS-0145
Zeitfenster: Up to 99 days
|
Up to 99 days
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Percentages of participants With of Treatment-Emergent Anti-GS-0415 Antibodies
Zeitfenster: 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)
Zeitfenster: Up to 99 days
|
Up to 99 days
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Gilead Study Director, Gilead Sciences
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- GS-US-531-7345
Plan für individuelle Teilnehmerdaten (IPD)
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