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.
연구 개요
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Gilead Clinical Study Information Center
- 전화번호: 1-833-445-3230 (GILEAD-0)
- 이메일: GileadClinicalTrials@gilead.com
연구 장소
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California
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Los Angeles, California, 미국, 90027
- 모병
- Kaiser Permanente Los Angeles Medical Center
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District of Columbia
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Washington D.C., District of Columbia, 미국, 20007
- 모병
- Georgetown University Medical Center
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Florida
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West Palm Beach, Florida, 미국, 33407
- 모병
- Triple O Research Institute, P.A.
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Nevada
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Las Vegas, Nevada, 미국, 89113
- 모병
- PPD Development, LP
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New Jersey
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Newark, New Jersey, 미국, 07102
- 아직 모집하지 않음
- St. Michaels Medical Center
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New York
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The Bronx, New York, 미국, 10461
- 모병
- Jacobi Medical Center
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Ohio
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Columbus, Ohio, 미국, 43210
- 모병
- The Ohio State University Medical Center Infectious Diseases Clinic
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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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실험적: 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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실험적: 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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실험적: 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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실험적: 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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실험적: 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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)
기간: 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
기간: 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
기간: Up to 43 days
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AUCinf is defined as the area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/λz).
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Up to 43 days
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Serum PK Parameters (SAD): Cmax of GS-0145
기간: Up to 43 days
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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
기간: Up to 99 days
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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
기간: Up to 99 days
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Up to 99 days
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Percentages of participants With of Treatment-Emergent Anti-GS-0415 Antibodies
기간: 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)
기간: Up to 99 days
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Up to 99 days
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Gilead Study Director, Gilead Sciences
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- GS-US-531-7345
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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