Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
* The following agents are allowed as part of the current ARV regimen: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc
* The following agents are NOT allowed as part of the current ARV regimen: HIV protease inhibitors (including low dose ritonavir), cobicistat-containing regimens, elvitegravir, efavirenz, etravirine, and nevirapine
* A change in ARV regimen ≥ 45 days prior to baseline/Day 1 for reasons other than virologic failure (eg, tolerability, simplification, drug-drug interaction profile) is allowed
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)
* Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable. (If the lower limit of detection of the local HIV-1 RNA assay is \< 50 copies/mL, the plasma HIV-1 RNA level cannot exceed 50 copies/mL on two consecutive HIV-1 RNA tests)
* If ART regimen is changed ≥ 60 days prior to Pre-Baseline/Day -13, plasma HIV-1 RNA \<50 copies/mL at Pre-baseline/Day -13 visit is required
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
You may not be if
Hepatitis B surface antigen (HBsAg) positive
* Positive anti-HBs antibody and negative HBsAg results are acceptable
Hepatitis C antibody (HCVAb) positive
* Positive anti-HCV antibody and negative HCV polymerase chain reaction (PCR) results are acceptable
Documented history of pre-ART CD4 nadir \< 200 cells/µL
* Unknown pre-ART CD4 nadir is acceptable
A new AIDS-defining condition diagnosed within 90 days prior to screening
Acute febrile illness within 35 days prior to pre-baseline/Day -13
Clareo Health | Safety and Biological Activity of Vesatolimod in HIV-1 Infected, Virologically Suppressed Adults
