Phase 2
Completed N=14
A Study to Evaluate the Antiviral Effect, Safety and Tolerability of GSK3810109A in Viremic Human Immunodeficiency Virus (HIV)-1 Infected Adults
Source: ClinicalTrials.gov NCT04871113 ↗Enrolled (actual)
14
Serious AEs
8.1%
Results posted
Nov 2023
Primary outcomePrimary: Maximum Decline From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Levels - Monotherapy Phase — 12258.5; 30833.0; 25466.0; 25689.5 Copies per milliliter (copies/mL)
Summary
This study is to evaluate antiviral activity, efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK3810109A in HIV-1 infected treatment naive adults. Participants will receive a single dose of GSK3810109A administered either intravenously (IV) or subcutaneously (SC). The study includes a screening phase, a randomized monotherapy phase and a standard of care follow-up phase.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Decline From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Levels - Monotherapy Phase |
12258.5; 30833.0; 25466.0; 25689.5; 23146.0; -12014.5 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) - Monotherapy Phase |
7; 4; 9; 8; 11 | — |
| PRIMARY Number of Participants With Worst-case Maximum Grade 2-4 Increase in Post-baseline Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Compared to the Baseline Values - Monotherapy Phase |
8; 6; 15; 12; 15; 0 | — |
| PRIMARY Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Findings - Monotherapy Phase |
0; 0; 0; 0; 0; 3 | — |
| PRIMARY Number of Participants With Grade 2-4 Injection Site Reactions (ISR) - Monotherapy Phase |
0; 0; 0; 0; 0 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time Zero to the Day 14 (AUC [0-14]) of GSK3810109A - Monotherapy Phase |
5346.3194; 690.8944; 1181.1688; 212.6213; 493.0579 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of GSK3810109A - Monotherapy Phase |
1131.5000; 131.1500; 243.0625; 42.7688; 45.0938 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of GSK3810109A - Monotherapy Phase |
0.0385; 0.1233; 0.0340; 0.0278; 5.9177 | — |
| SECONDARY Plasma Concentration at Day 14 (C14) of GSK3810109A - Monotherapy Phase |
221.45; 27.49; 55.30; 7.98; 29.52 | — |
| SECONDARY Change From Baseline in Log10 Plasma HIV-1 RNA Relative to Cmax - Monotherapy Phase |
4.139; 4.493; 4.465; 4.582; 0.091; -0.357 | — |
| SECONDARY Absolute Values of Cluster of Differentiation 4 Plus (CD4+) and CD8+ T Cell Counts - Monotherapy Phase |
360.5; 412.8; 427.3; 467.3; 476.7; 392.3 | — |
| SECONDARY Absolute Values of CD4+ and CD8+ T Cell Counts - SOC Phase |
500.5; 601.0; 580.9; 671.3; 723.9; 685.9 | — |
| SECONDARY Change From Baseline in CD4+ and CD8+ T Cell Counts - Monotherapy Phase |
360.5; 412.8; 427.3; 467.3; 476.7; 31.8 | — |
| SECONDARY Change From Baseline in CD4+ and CD8+ T Cell Counts - SOC Phase |
360.5; 412.8; 427.3; 467.3; 476.7; 140.0 | — |
| SECONDARY Number of Participants With Positive Anti-drug Antibodies (ADAs) Against GSK3810109A - Monotherapy Phase |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Number of Participants With Positive ADAs Against GSK3810109A - SOC Phase |
0; 0; 1; 2; 0 | — |
| SECONDARY Titers of Positive ADAs Against GSK3810109A - Monotherapy Phase |
40; 60; 80 | — |
| SECONDARY Titers of Positive ADAs Against GSK3810109A - SOC Phase |
40; 160 | — |
Eligibility Criteria
Inclusion Criteria
- Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
- Participants must have HIV-1 infection within 45 days of the Screening Visit: Plasma HIV-1 RNA greater than or equal to (>=) 5000 copies/mL (c/mL).
- Confirmed screening CD4+ T-cell count >= 350 cells per cubic millimeter (cells/mm3).
- Antiretroviral naïve: No Antiretroviral therapy (ARTs) (in combination or monotherapy) received after the diagnosis of HIV-1 infection.
- Body weight >= 50 kg to less than or equal to ( = 3 times the upper limit of normal (ULN).
- Creatinine clearance of <50 mL/minute/1.73 meter^2) via Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method.
- The participant has a tattoo or other dermatological condition overlying potential injection sites which may interfere with interpretation of injection site reactions or administration of GSK3810109A.
Data sourced from ClinicalTrials.gov (NCT04871113). 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.