LM11A-31 Safety and Tolerability in Aging People Living With HIV and Neurocognitive Impairment
NCT07934186, Phase 1, Phase 2, Not yet recruiting, University of North Carolina, Chapel Hill
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | LM11A-31 Safety and Tolerability in Aging People Living With HIV and Neurocognitive Impairment | ClinicalTrials.gov |
| NCT number | NCT07934186 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1, Phase 2 | ClinicalTrials.gov |
| Enrollment | 68 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of North Carolina, Chapel Hill | ClinicalTrials.gov |
| Conditions | The Study Will Focus on People Living With HIV Ages 50-75 With Cognitive Decline | ClinicalTrials.gov |
| Interventions | LM11A-31, Placebo | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Adverse effects (AE) | From enrollment until the end of treatments at 48 weeks | Any clinical signs/symptoms, laboratory toxicities and clinical events that are possibly or definitely related to study treatment. The incidence and severity of adverse effects will be summarized from Baseline to 24 weeks and 24 weeks to 48 weeks. | ClinicalTrials.gov |
| Primary | Cluster of Differentiation (CD4)+ T cells | From enrollment until the end of treatments at 48 weeks | Participants that show a CD4+ T cell decline \>33% from Baseline to Week 24 and week 24 to week 48 | ClinicalTrials.gov |
| Primary | HIV-1 ribonucleic acid (RNA) | From enrollment until the end of treatments at 48 weeks | Participants during each 24 week period with confirmed HIV-1 RNA level \>40 copies/mL in the absence of an interruption in antiretroviral therapy | ClinicalTrials.gov |
| Primary | Neurocognitive performance | From enrollment until the end of treatments at 48 weeks | Change in neurocognitive performance from Baseline to Week 24 and week 24 to week 48 based on the neurocognitive test battery for HIV-associated neurocognitive impairment. The neurocognitive test battery contains 7 cognitive domains scored on a sliding scale. An aggregate z-score for all 7 domains will be calculated. Negative z-scores reflect poorer cognitive performance. | ClinicalTrials.gov |
| Primary | Number of Participants with Depressive symptoms or suicidal ideation | From enrollment until the end of treatments at 48 weeks | Depressive symptoms or new suicidal ideation during baseline to 24 weeks and 24 to 48 weeks based on psychiatric assessments, self-report, diary review or during interviews with the study coordinator. | ClinicalTrials.gov |
| Secondary | Change in Expression of the Biomarker Neurofilament light chain (NFL) | From enrollment until the end of treatments at weeks 24 and 48 | Neurofilament light chain (NFL) is a marker of neuronal damage. Increased expression, measured from baseline to 24 weeks and 24 to 48 weeks, indicates degeneration of neurons in the brain. | ClinicalTrials.gov |
| Secondary | Change in expression of the biomarker Neurogranin | From enrollment until the end of treatments at 48 weeks | Neurogranin is a protein released from damaged dendritic spines in the brain. Increased expression, measured from baseline to 24 weeks and 24 to 48 weeks, indicates degeneration of neuronal connections in the brain. | ClinicalTrials.gov |
| Secondary | Change in expression of the biomarker Synaptosomal Protein-25 (SNAP-25) | From enrollment until the end of treatments at 48 weeks | Synaptosomal Protein-25 (SNAP-25) is released from damaged brain synapses. Increased expression, measured from baseline to 24 weeks and 24 to 48 weeks, indicates loss of neuronal connections in the brain. | ClinicalTrials.gov |
| Secondary | Change in Expression of the Biomarker phosphoThreonine 181 Tau (pThr181 Tau) | From enrollment until the end of treatments at 48 weeks | PhosphoThreonine 181 Tau (pThr181 Tau) is a protein in neurons that is mistakenly phosphorylated when neurons are stressed. Increased expression, measured from baseline to 24 weeks and 24 to 48 weeks, indicates a loss of normal function of neurons in the brain. | ClinicalTrials.gov |
| Secondary | 48-plex cytokine array | From enrollment until the end of treatments at 48 weeks | Cytokines are protein released to regulate immune functions. Measurement of changes in a broad range of cytokines from baseline to 24 weeks and 24 to 48 weeks provides information on the pattern of changes in the immune system that may predict disease processes. | ClinicalTrials.gov |
| Secondary | Change in expression of the biomarker C-X-C Motif Chemokine Ligand 10 (CXCL10) | From enrollment until the end of treatments at 48 weeks | C-X-C Motif Chemokine Ligand 10 (CXCL10) is a protein released in response to HIV-associated inflammation. An increase from baseline to 24 weeks and 24 to 48 weeks signals an increase in inflammatory activity that could damage the brain. | ClinicalTrials.gov |
| Secondary | Change in expression of the biomarkerChitinase-3-like protein 1 (YKL-40) | From enrollment until the end of treatments at 48 weeks | Chitinase-3-like protein 1, also known as YKL-40, is a protein released from brain astrocytes in response to inflammation. An increase from baseline to 24 weeks and 24 to 48 weeks signals an increase in inflammatory activity that could damage the brain. | ClinicalTrials.gov |
| Secondary | Change in expression of the biomarker Amyloid beta 1-42 (Aβ1-42) | From enrollment until the end of treatments at 48 weeks | Amyloid beta 1-42 (Aβ1-42) is a protein generated by abnormal protein processing under conditions of stress in the brain. Often associated with Alzheimer's disease it can also accumulate in people with HIV. An increase from baseline to 24 weeks and 24 to 48 weeks indicates degenerative processes associated with cognitive decline. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)