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About
The primary objectives of this study are to evaluate the safety and tolerability of escalating, multiple doses of vesatolimod (formerly GS-9620) in HIV-1 infected virologically suppressed adults on antiretroviral therapy (ART) and to evaluate the virologic effect of vesatolimod as measured by changes in plasma HIV-1 RNA.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
HIV-1 infection
Aged ≥ 18 years at Pre-baseline/Day -13
On antiretroviral (ARV) treatment for ≥ 12 consecutive months prior to Pre-Baseline/Day -13
Plasma HIV-1 RNA < 50 copies/mL at screening
Documented plasma HIV-1 RNA levels < 50 copies/mL (according to the local assay being used) for ≥ 12 months preceding the screening visit (measured at least twice using a licensed assay with a lower limit of quantitation of at least 40 copies/mL)
No documented history of resistance to any components of the current ARV regimen
Availability of a fully active alternative ARV regimen, in the opinion of the Investigator, in the event of discontinuation of the current ARV regimen with development of resistance
Hgb ≥ 11.5 g/dL (males) or ≥ 11 g/dL (females)
White blood cells (WBC) ≥ 4,000 cells/μL
Platelets ≥ 150,000/mL
Absolute neutrophil count (ANC) ≥ 1500 cells/μL
CD4 count ≥ 400 cells/μL
Albumin ≥ 3.9 g/dL
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 × upper limit of the normal range (ULN)
Estimated glomerular filtration rate ≥ 60 mL/min
No autoimmune disease
Key Exclusion Criteria:
Hepatitis B surface antigen (HBsAg) positive
Hepatitis C antibody (HCVAb) positive
Documented history of pre-ART CD4 nadir < 200 cells/µL
A new AIDS-defining condition diagnosed within 90 days prior to screening
Acute febrile illness within 35 days prior to pre-baseline/Day -13
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
48 participants in 10 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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