Phase 1
Completed N=48
Safety and Biological Activity of Vesatolimod in HIV-1 Infected, Virologically Suppressed Adults
Source: ClinicalTrials.gov NCT02858401 ↗Enrolled (actual)
48
Serious AEs
2.1%
Results posted
Feb 2020
Primary outcomePrimary: Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs). — 0.0; 16.7; 0.0; 0.0 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs). |
0.0; 16.7; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Maximum Change From Baseline in Plasma Log10 HIV-1 RNA at Any Postdose Timepoint |
0.06; 0.01; 0.10; 0.04; 0.00; 0.07 | 0.1498 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 2 |
0.00; 0.00; 0.00; 0.00 | 1.0000 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 3 |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | 0.5557 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 5 |
0.00; 0.00; -0.03; 0.00 | 1.0000 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 8 |
0.00; 0.00; -0.03; 0.00; 0.00; 0.00 | 1.0000 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 11 |
0.00; 0.00; -0.03; 0.00 | 1.0000 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 15 |
0.00; 0.00; -0.03; 0.00; 0.00; 0.00 | 1.0000 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 17 |
0.00; 0.00; 0.01; 0.00 | 1.0000 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 19 |
0.00; 0.00; -0.03; 0.00 | 1.0000 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 22 |
0.00; 0.00; 0.02; 0.00; 0.00; 0.00 | 1.0000 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 25 |
0.00; 0.00; -0.03; 0.00 | 1.0000 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 29 |
0.01; 0.00; 0.02; 0.00; 0.00; 0.00 | 0.1949 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 31 |
0.00; 0.00; -0.03; 0.00; 0.00; 0.00 | 0.5186 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 33 |
0.00; 0.00; -0.03; 0.01 | 0.3613 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 36 |
0.00; 0.00; -0.03; 0.00; 0.00; 0.00 | 0.3456 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 39 |
0.00; 0.00; 0.04; 0.25 | 0.4047 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 43 |
0.00; 0.00; -0.03; 0.00; 0.00; 0.00 | 1.0000 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 45 |
0.00; 0.00; -0.03; 0.00; 0.00; 0.00 | 1.0000 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 47 |
0.00; 0.00; 0.07; 0.00 | 1.0000 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 50 |
0.00; 0.00; -0.03; 0.00; 0.00; 0.00 | 1.0000 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 53 |
0.00; 0.00; 0.01; 0.00 | 1.0000 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 57 |
0.00; 0.00; 0.03; 0.00; 0.00; 0.00 | 0.5383 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 58 |
0.00; 0.00; 0.00; 0.00 | 1.0000 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 59 |
0.00; 0.00; -0.01; 0.00; 0.00; 0.00 | 0.3237 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 61 |
0.00; 0.00; 0.01; 0.03 | 0.4047 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 64 |
0.07; 0.01; 0.07; 0.00; 0.00; 0.02 | 0.5546 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 67 |
0.00; 0.00; 0.04; 0.00 | 1.0000 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 71 |
0.00; 0.00; 0.02; 0.00; 0.00; 0.02 | 1.0000 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 73 |
0.00; 0.00; 0.01; 0.00; 0.00; 0.04 | 0.5186 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 75 |
0.00; 0.00; -0.03; 0.00 | 1.0000 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 78 |
0.00; 0.00; -0.03; 0.00; 0.00; 0.00 | 0.5383 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 81 |
0.00; 0.00; -0.03; 0.00 | 1.0000 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 85 |
0.00; 0.00; 0.00; 0.03 | 0.4047 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 87 |
0.00; 0.00; 0.19 | 0.3074 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 92 |
0.00; 0.00; 0.00; 0.11 | 0.4047 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 99 |
0.00; 0.00; 0.03; 0.07 | 0.1757 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 101 |
0.02; 0.00; 0.00; 0.00; 0.00; 0.05 | 0.8504 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 106 |
0.00; 0.00; 0.00; 0.10 | 0.4047 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 113 |
0.00; 0.00; 0.00; 0.09 | 0.4047 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 115 |
0.00; 0.00; 0.08 | 0.3074 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 120 |
0.04; 0.00; 0.00; 0.01 | 1.0000 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 127 |
0.00; 0.00; 0.00; 0.00 | 1.0000 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 128 |
0.00; 0.00; 0.00; 0.06 | 0.1757 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 129 |
0.00; 0.00; 0.00; 0.03 | 0.4047 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 134 |
0.00; 0.00; 0.00; 0.09 | 0.4047 |
| SECONDARY Change From Baseline in Plasma Log10 HIV-1 RNA at Day 157 |
0.00; 0.00; 0.00; 0.13 | 0.1757 |
| SECONDARY Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at Postdose 1 on Day 1 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 2 on Day 15 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 3 on Day 29 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | 1.0000 |
| SECONDARY Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 4 on Day 43 |
0.0; 0.0; 16.7; 0.0; 0.0; 0.0 | 0.3333 |
| SECONDARY Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 5 on Day 57 |
0.0; 0.0; 16.7; 0.0; 0.0; 0.0 | 1.0000 |
| SECONDARY Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 6 on Day 71 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | 1.0000 |
| SECONDARY Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 7 on Day 85 |
0.0; 0.0; 0.0; 16.7 | 1.0000 |
| SECONDARY Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 8 on Day 99 |
0.0; 0.0; 0.0; 16.7 | 1.0000 |
| SECONDARY Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 9 on Day 113 |
0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 10 on Day 127 |
0.0; 0.0; 0.0; 16.7 | 1.0000 |
Eligibility 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
- 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
Key Exclusion Criteria
- 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02858401). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.