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 |
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.
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
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Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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