Evaluate the Safety and Efficacy of Vesatolimod in Antiretroviral Treated HIV-1 Infected Controllers



Status:Active, not recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/14/2019
Start Date:May 9, 2017
End Date:July 2020

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A Phase 1b, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of GS-9620 in Antiretroviral Treated HIV-1 Infected Controllers

The primary objective of this study is to evaluate the safety and tolerability of a 10-dose
regimen of vesatolimod in HIV-1 infected controllers on antiretroviral treatment (ART) and
during analytical treatment interruption (ATI) following vesatolimod dosing.


Key Inclusion Criteria:

- Plasma HIV-1 RNA levels <50 copies/mL at screening

- Chronic HIV-1 infection (for ≥ 6 months) prior to ART initiation

- Pre-ART Plasma HIV-1 RNA set point between 50 and ≤ 5,000 copies/mL measured within
two years prior to ART initiation

- On ART for ≥ 6 months prior to screening

- Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 6 months preceding the screening
visit (or undetectable HIV-1 RNA level according to the local assay being used if the
limit of detection is ≥ 50 copies/mL). Unconfirmed virologic elevations of ≥ 50
copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable.

- No documented history of resistance to any components of the current ART regimen

- Availability of a fully active alternative ART regimen, in the opinion of the
Investigator, in the event of discontinuation of the current ART regimen with
development of resistance.

- Hemoglobin ≥ 11.5 g/dL (males) or ≥ 11 g/dL (females)

- White Blood Cells ≥ 2,500 cells/μL

- Platelets ≥ 125,000/mL

- Absolute Neutrophil Counts ≥ 1000 cells/μL

- CD4+ count ≥ 500 cells/μL

- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or bilirubin ≤ 2 ×
upper limit of normal (ULN)

- Estimated glomerular filtration rate ≥ 60 mL/min

- No autoimmune disease requiring on-going immunosuppression

- No evidence of current hepatitis B virus (HBV) infection

- No evidence of current hepatitis C virus (HCV) infection (positive anti-HCV antibody
and negative HCV polymerase chain reaction (PCR) results are acceptable)

- No documented history of pre-ART CD4 nadir < 200 cells/μL (unknown pre-ART CD4 nadir
is acceptable)

- No history of opportunistic illness indicative of stage 3 HIV

- No acute febrile illness within 35 days prior to Pre-Baseline/ Day -13

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
6
sites
Los Angeles, California 90069
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900 East 30th Street
Austin, Texas 78705
512-480-9660
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Austin, TX
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Fort Pierce, Florida 34982
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Fort Pierce, FL
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1701 North Mills Avenue
Orlando, Florida 32803
(407)647-3960
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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Orlando, FL
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1001 Potrero Avenue
San Francisco, California 94110
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San Francisco, CA
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Seattle, Washington 98104
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Seattle, WA
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