Safety, Tolerability, and Pharmacokinetics of GS-8588 in People With HIV-1 Who are Virologically Suppressed on Antiretroviral Therapy
S
Samir Gupta, MD
Primary Investigator
Enrolling By Invitation
18-100 years
All
Phase
N/A
5 participants needed
2 Locations
Brief description of study
To evaluate the safety and tolerability of escalating, single and multiple intravenous (IV)
doses GS-8588, administered in PWH who are virologically suppressed on ART
To evaluate the PK of GS-8588
doses GS-8588, administered in PWH who are virologically suppressed on ART
To evaluate the PK of GS-8588
Detailed description of study
The current study will evaluate safety, tolerability, and pharmacokinetics (PK) of single
ascending doses (SAD) and multiple ascending doses (MAD) of GS-8588. Given the absence of
HIV-1-infected target cells in healthy volunteers, the study will be carried out in
ART-suppressed PWH. The results of this study will form the basis for further clinical
evaluation of GS-8588 as part of a combination HIV-1 cure treatment strategy
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: HIV
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion Criteria:
- Age ≥ 18 years at screening
- 2) Have the ability to understand and sign a written ICF, which must be obtained prior to
- initiation of study procedures
- 3) On stable ART treatment for at least 6
- Plasma HIV-1 RNA < 50 copies/mL at screening
- No documented history of clinically significant resistance by genotype or phenotype to any
- components of the current ARV regimen, as judged by the investigator and confirmed by the
- medical monitor. Isolated M184V/I mutation is acceptable.
- 6) CD4+ count ≥ 350 cells/μL
- 7) No documented pre-ART CD4+ nadir < 100 cells/μL; unknown pre-ART CD4+ nadir is
- acceptable
- 8) Have a calculated body mass index (BMI) of ≥ 18.5 and ≤ 35.0 kg/m2 at screening
- 9) Have normal hematologic function with an absolute neutrophil count ≥ 1500 cells/mm3,
- platelets ≥ 150,000/mm3; hemoglobin ≥ 10.5 g/dL for females and ≥ 11.5 g/dL for males
Exclusion Criteria:
- Female participants who are pregnant or lactating or who may wish to become pregnant
- during the course of the study or within 90 days after last study drug administration
- 2) Have received any investigational drug within 30 days prior to study dosing
- 3) Have current alcohol or substance abuse judged by the investigator to potentially interfere
- with participants compliance or participants safety
- 4) Have evidence of chronic hepatitis B virus (HBV) infection as determined by positive HBV
- surface antigen and negative HBV surface antibody at the screening visit
- 5) Have evidence of active hepatitis C virus (HCV) infection
- 6) Positive anti-HCV antibody and negative HCV polymerase chain reaction (PCR) results are
- acceptable
Updated on
01 Aug 2024.
Study ID: 13997, INFD-GILEAD-GS-US-425-6143
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