Baricitinib for Reduction of HIV - CNS
NCT05452564, Phase 2, Recruiting, William Tyor
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Baricitinib for Reduction of HIV - CNS | ClinicalTrials.gov |
| NCT number | NCT05452564 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 95 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | William Tyor | ClinicalTrials.gov |
| Conditions | Human Immunodeficiency Virus | ClinicalTrials.gov |
| Interventions | Baricitinib 2 MG Oral Tablet, Placebo | ClinicalTrials.gov |
| First posted | 2022-07-11 | ClinicalTrials.gov |
| Last updated | 2026-03-23 | ClinicalTrials.gov |
Registered outcomes 28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Changes in CSF integrated proviral DNA | Baseline and study week 10 | The study team will obtain up to 40 milliliters (ml) of CSF from individuals who weigh at least 60 kilograms, otherwise, they will draw up to 30 ml of CSF. CSF integrated proviral DNA (IPDA and Alu-PCR) will be assessed: Integrated proviral DNA will be performed using existing methods in the clinical research group, which employ the Alu-PCR real-time platform, with a limit of 3 copies. Integrated proviral DNA assay (IPDA) to measure the replication-competent reservoir will be used with digital droplet PCR methodology. | ClinicalTrials.gov |
| Secondary | Changes in CSF HIV RNA by single copy assay | Baseline and study week 10 | This method is based on a proprietary protocol which is used in conjunction with a commercial HIV-1 RNA easyQ reagent kit (bioMerieux Inc, Lyon, France). Briefly, a specimen of up to 2 ml of human plasma or CSF is added to lysis buffer containing guanidine thiocyanate. HIV-1 RNA is extracted in combination with the easyMAG platform (bioMerieux, Inc). Eluates containing HIV-1 RNA are aliquoted into 0.5 mL reaction tubes and amplified using 3 enzymes: T7 RNA polymerase, avian myeloblastosis virus reverse transcriptase, and RNase H. Molecular beacons targeting the pol/gag region of HIV-1 RNA are used for amplification and detection by isothermal reactions at 41oC. HIV-1 RNA level is quantified in conjunction with the NucliSENS easyQ HIV-1 v2.0 Director software and a proprietary algorithm developed by bioMONTR Labs. The dynamic range of this HIV-1 assay is 1-5,000,000 copies/mL of 0.73 - 1600 HIV-1 copies /μl. The HIV-1 copy number is normalized per one million of WBCs. | ClinicalTrials.gov |
| Secondary | Changes in HIV tat protein in CSF | Baseline and study week 10 | The study team will obtain up to 40 milliliters (ml) of CSF from individuals who weigh at least 60 kilograms, otherwise we will draw up to 30 ml of CSF. HIV Tat in the CSF will be quantified according to published methods for ELISA to measure HIV Tat in human CSF. | ClinicalTrials.gov |
| Secondary | Changes in CSF HIV cell-associated RNA by Double-R assay. | Baseline and study week 10 | The study team will obtain up to 40 milliliters (ml) of CSF from individuals who weigh at least 60 kilograms, otherwise, they will draw up to 30 ml of CSF. Briefly, after the isolation of Peripheral blood mononuclear cells (PBMC) and cells from CSF, samples will be resuspended in phosphate-buffered saline and stored for shipment in O-ring tubes. RNA will then be extracted using the Maxwell rapid sample concentrator (RSC) automated extraction platform. White Blood Cells (WBC) will be counted after red blood cell lysis using TC20 Automated Cell Counter, and these counts will be used to normalize the HIV-1 RNA results as copy numbers/106 cells. HIV-1 copy number per patient sample, in duplicate, is determined from a standard curve generated with HIV-1 plasmid controls, with a range of 0.73 - 1600 HIV-1 copies /μl. The HIV-1 copy number is normalized per one million of WBCs. | ClinicalTrials.gov |
| Secondary | Changes in CSF HIV cell associated CSF HIV DNA by Double-R assay. | Baseline and study week 10 | The study team will obtain up to 40 milliliters (ml) of CSF from individuals who weigh at least 60 kilograms, otherwise they will draw up to 30 ml of CSF. Briefly, after the isolation of Peripheral blood mononuclear cells (PBMC) and cells from CSF, samples will be resuspended in phosphate-buffered saline and stored for shipment in O-ring tubes. DNA will then be extracted using the Maxwell rapid sample concentrator (RSC) automated extraction platform. WBCs will be counted after red blood cell lysis using TC20 Automated Cell Counter, and these counts will be used to normalize the HIV-1 DNA results as copy numbers/106 cells. HIV-1 copy number per patient sample, in duplicate, is determined from a standard curve generated with HIV-1 plasmid controls, with a range of 0.73 - 1600 HIV-1 copies /μl. The HIV-1 copy number is normalized per one million of WBCs. | ClinicalTrials.gov |
| Secondary | Changes in CSF cell associated DNA | Baseline and study week 10 | The study team will obtain up to 40 milliliters (ml) of CSF from individuals who weigh at least 60 kilograms, otherwise we will draw up to 30 ml of CSF. Cell associated DNA will be performed according to standard existing protocols using real-time PCR with a limit of detection of five copies. | ClinicalTrials.gov |
| Secondary | Changes in Blood HIV cell associated RNA by Double-R assay | Baseline and study week 10 | Changes in the blood between baseline and week ten after study medication. Briefly, after isolation of Peripheral blood mononuclear cells (PBMC) and cells from patient's blood sample, samples will be resuspended in phosphate buffered saline and stored for shipment in O-ring tubes. RNA will then be extracted using the Maxwell rapid sample concentrator (RSC) automated extraction platform. WBCs will be counted after red blood cell lysis using TC20 Automated Cell Counter, and these counts will be used to normalize the HIV-1 RNA results as copy numbers/106 cells. HIV-1 copy number per patient sample, in duplicate, is determined from a standard curve generated with HIV-1 plasmid controls, with a range of 0.73 - 1600 HIV-1 copies /μl. The HIV-1 copy number is normalized per one million of WBCs. | ClinicalTrials.gov |
| Secondary | Changes in Blood HIV cell associated DNA by Double-R assay | Baseline and study week 10 | Changes in the blood between baseline and week ten after study medication. Briefly, after isolation of Peripheral blood mononuclear cells (PBMC) and cells from the patient's blood sample, samples will be resuspended in phosphate buffered saline and stored for shipment in O-ring tubes. DNA will then be extracted using the Maxwell rapid sample concentrator (RSC) automated extraction platform. WBCs will be counted after red blood cell lysis using TC20 Automated Cell Counter, and these counts will be used to normalize the HIV-1 DNA results as copy numbers/106 cells. HIV-1 copy number per patient sample, in duplicate, is determined from a standard curve generated with HIV-1 plasmid controls, with a range of 0.73 - 1600 HIV-1 copies /μl. The HIV-1 copy number is normalized per one million of WBCs. | ClinicalTrials.gov |
| Secondary | Changes in Blood cell associated DNA | Baseline and study week 10 | Change in the blood between baseline and week ten after study medication. Cell associated DNA will be performed according to standard existing protocols using real-time PCR with a limit of detection of five copies. | ClinicalTrials.gov |
| Secondary | Change in HIV DNA levels by Integrated proviral DNA assay | Baseline and study week 10 | Change in the blood between baseline and week ten after study medication. The study team will obtain up to 40 milliliters (ml) of CSF from individuals who weigh at least 60 kilograms, otherwise we will draw up to 30 ml of CSF. Blood integrated proviral DNA (IPDA and Alu-PCR) will be assessed: Integrated proviral DNA will be performed using existing methods in our group, which employ the Alu-PCR real-time platform, with a limit of 3 copies. Integrated proviral DNA assay (IPDA) to measure the replication competent reservoir will be used with digital droplet PCR methodology | ClinicalTrials.gov |
| Secondary | Changes in Blood HIV RNA by single copy assay | Baseline and study week 10 | This method is based on a proprietary protocol which is used in conjunction with a commercial HIV-1 RNA easyQ reagent kit (bioMerieux Inc, Lyon, France). Briefly, a specimen of up to 2 ml of human plasma or CSF is added to lysis buffer containing guanidine thiocyanate. HIV-1 RNA is extracted in combination with the easyMAG platform (bioMerieux, Inc). Eluates containing HIV-1 RNA are aliquoted into 0.5 mL reaction tubes and amplified using 3 enzymes: T7 RNA polymerase, avian myeloblastosis virus reverse transcriptase, and RNase H. Molecular beacons targeting the pol/gag region of HIV-1 RNA are used for amplification and detection by isothermal reactions at 41oC. HIV-1 RNA level is quantified in conjunction with the NucliSENS easyQ HIV-1 v2.0 Director software and a proprietary algorithm developed by bioMONTR Labs. The dynamic range of this HIV-1 assay is 1-5,000,000 copies/mLof 0.73 | ClinicalTrials.gov |
| Secondary | Changes in Blood indirect viral markers: anti-HIV antibody levels | Baseline and study week 10 | Change in HIV and inflammation levels in the blood between baseline and week ten after study medication. Blood HIV antibodies by LIPS assay (gp120, integrase, protease, and p24) will be assayed. The LIPS assay uses recombinant chimeric fusion proteins with luciferase producing light and specific antigens for quantitative detection of antibodies. | ClinicalTrials.gov |
| Secondary | Changes in Blood indirect viral markers: HIV specific T cells | Baseline and study week 10 | Change in HIV and inflammation levels in the blood between baseline and week ten after study medication Fresh Human peripheral blood mononuclear cells (PBMC) will be cultured in the presence or absence of overlapping peptides which induces broad, non-specific T-cell activation. In addition to cytokine production (focusing on TNFα, IFNγ, and IL-6 measured with Quanterix technology). Researchers will measure cell surface markers by flow cytometry. | ClinicalTrials.gov |
| Secondary | Changes in Blood CXCL10 | Baseline and study week 10 | Change in levels in the blood between baseline and week ten after study medication. The study team will measure CXCL10 from participants blood samples, in the setting of HIV using single molecule array technology by Quanterix. | ClinicalTrials.gov |
| Secondary | Changes in Blood Neopterin | Baseline and study week 10 | Change in levels in the blood between baseline and week ten after study medication. The study team will measure neopterin in the setting of HIV using the enzyme linked immunosorbent assays produced by Uman diagnostics, R\&D Systems (ultra-sensitive), and Themo Fisher. | ClinicalTrials.gov |
| Secondary | Changes in Blood IL-7 | Baseline and study week 10 | Change in levels in the blood between baseline and week ten after study medication. This will be measured using mesoscale discovery platform. | ClinicalTrials.gov |
| Secondary | Changes in Blood IL-15 | Baseline and study week 10 | Change in levels in the blood between baseline and week ten after study medication. This will be measured using mesoscale discovery platform. | ClinicalTrials.gov |
| Secondary | Changes in Stroop Test (Color Naming and Color-Word) | Baseline and study week 10 | In psychology, the Stroop effect is the delay in reaction time between congruent and incongruent stimuli. The effect has been used to create a psychological test (the Stroop test) that is widely used in clinical practice and investigation. A basic task that demonstrates this effect occurs when there is a mismatch between the name of a color (e.g., "blue", "green", or "red") and the color it is printed on (i.e., the word "red" printed in blue ink instead of red ink). When asked to name the color of the word it takes longer and is more prone to errors when the color of the ink does not match the name of the color. Word, color, and color-word T-Scores of 40 or less are considered "low." Word, color, and color-word T-Scores above 40 or are considered "normal." In order for one score to be considered "higher" or "lower" than another, a 10 point or greater T score difference is required. | ClinicalTrials.gov |
| Secondary | Changes in Hopkins Verbal Learning Test II (Learning and Recall) | Baseline and study week 10 | This will be performed in a quiet exam room. Participants will have the opportunity to take breaks as needed and snacks will be provided. The Hopkins Verbal Learning Test-Revised (HVLT-R) is used to assess acquisition and delayed recall. The HVLT-R is a list learning test, which consists of 12 nouns within three semantic groups. The acquisition variable consists of three acquisition trials in which the administrator reads the words aloud and then asks the child to repeat as many as he/she can remember in any order. A delayed recall trial is introduced after 20-25 min, in which the child is asked to simply retrieve as many of the words listed in the acquisition trial as he/she can remember. The children are not informed about the delayed recall trial beforehand. Lower raw scores indicate difficulties with the task. | ClinicalTrials.gov |
| Secondary | Changes in Brief Visuospatial Test (Learning and Recall) | Baseline and study week 10 | The Brief Visuospatial Memory Test (BVMT) is a commonly used assessment tool to measure visuospatial learning and memory abilities. In three Learning Trials, the respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Last, a Recognition Trial, in which the respondent is asked to identify which of 12 figures were included among the original geometric figures, is administered. An optional Copy Trial may be administered to screen for severe visuoconstructive deficits and to help in scoring recall responses. 12 scores may be derived from BVMT-R performance. Recall performance is recorded for each of the immediate recall trials (Trial 1, Trail 2, and Trial 3) and for the delayed recall trial (Delayed Recall). The recall scores are combined to form three additional summary measures of learning and memory. | 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 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 41652359 | DERIVED | PubMed |
Grants 1
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 |
|---|---|---|---|---|---|---|
| R01MH128158 | Phase II study to evaluate the efficacy and safety of baricitinib for reduction of HIV in the central nervous system | GAVEGNANO, CHRISTINA; MARCONI, VINCENT CHARLES; TYOR, WILLIAM R | EMORY UNIVERSITY | NATIONAL INSTITUTE OF MENTAL HEALTH | 2022 to 2025 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 9
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 |
|---|---|---|
| Card Sorting Test (Berg) | Secondary outcome | ConductCognition |
| Category Fluency | Secondary outcome | ConductCognition |
| Letter-Number Sequencing Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Task Switching Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
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)