Phase 1
Completed N=25
Study to Evaluate the Safety and Efficacy of Vesatolimod in Antiretroviral Treated Human Immunodeficiency Virus (HIV-1) Infected Controllers
Source: ClinicalTrials.gov NCT03060447 ↗Enrolled (actual)
25
Serious AEs
4.0%
Results posted
Apr 2021
Primary outcomePrimary: Percentage of Participants Experiencing Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Emergent Adverse Events (TEAEs) — 0; 0; 0; 33.3 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Emergent Adverse Events (TEAEs) |
0; 0; 0; 33.3; 0; 0 | — |
| SECONDARY Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 |
-0.01; 0.00; 0.05; 0.00; 0.09; 0.00 | 0.55 |
| SECONDARY Time to Virologic Rebound |
4.3; 4.0; 5.1; 4.1 | 0.035 sig |
| SECONDARY Peak HIV-1 Viral Load During Period 2 |
4.21; 3.97 | 0.67 |
| SECONDARY Change in Plasma Viral Load Set-Point Following ATI |
-0.37; -0.28 | 0.78 |
| SECONDARY Change From Baseline in Levels of Serum Cytokines |
0.02; 0.05; 0.41; -0.01; 0.14; 0.04 | 0.34 |
| SECONDARY Fold Change in Messenger Ribonucleic Acid (mRNA) of Interferon-Stimulated Genes (ISGs) in Whole Blood |
19.53; 1.06; 3.35; 1.24; 19.09; 8.41 | 0.002 sig |
| SECONDARY Change From Baseline in Immune Cell Activation |
2.7; 2.3; 0.4; -0.3; 0.9; 0.4 | 0.7469 |
| SECONDARY Pharmacokinetic (PK) Parameter: Cmax of Vesatolimod |
7149.6 | — |
| SECONDARY PK Parameter: AUClast of Vesatolimod |
49323.5 | — |
| SECONDARY PK Parameter: AUCinf of Vesatolimod |
60040.3 | — |
| SECONDARY PK Parameter: %AUCexp of Vesatolimod |
22.4 | — |
| SECONDARY PK Parameter: Tmax of Vesatolimod |
2.00 | — |
Eligibility Criteria
Key Inclusion Criteria
- Plasma HIV-1 ribonucleic acid (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 consecutive 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
- Cluster of Differentiation 4 (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.
Data sourced from ClinicalTrials.gov (NCT03060447). 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.