Trial · NCT03960541
Efprezimod Alfa (CD24Fc, MK-7110) Administration to Decrease Low-Density Lipoprotein (LDL) and Inflammation in Human Immunodeficiency Virus (HIV) Patients (CALIBER) (MK-7110-003)
NCT03960541, Phase 2, Terminated, Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2022-06-08
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Efprezimod Alfa (CD24Fc, MK-7110) Administration to Decrease Low-Density Lipoprotein (LDL) and Inflammation in Human Immunodeficiency Virus (HIV) Patients (CALIBER) (MK-7110-003). Trials, record NCT03960541. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03960541
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efprezimod Alfa (CD24Fc, MK-7110) Administration to Decrease Low-Density Lipoprotein (LDL) and Inflammation in Human Immunodeficiency Virus (HIV) Patients (CALIBER) (MK-7110-003)
- NCT number
- NCT03960541
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Conditions
- HIV Infections, Dyslipidemias
- Interventions
- Efprezimod alfa (human CD24 extracellular domain and human IgG1 Fc fusion protein), Saline Solution
- First posted
- 2019-05-23
- Last updated
- 2023-02-08
- Results first posted
- 2022-06-08
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | Baseline and Week 6 | LDL-C was measured in participant serum. The percent change from baseline at Week 6 is presented. |
| Primary | Number of Participants With ≥1 Adverse Event (AE) | Up to approximately 28 weeks | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Any worsening of a preexisting condition which is temporally associated with the use of the study treatment is also considered an AE. The number of participants who experienced an AE is presented. |
| Primary | Number of Participants Who Withdrew From Study Treatment Due to an AE | Up to approximately 4 weeks | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Any worsening of a preexisting condition which is temporally associated with the use of the study treatment is also considered an AE. The number of participants who withdrew from study treatment due to an AE is presented. |
| Secondary | Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein-Cholesterol (HDL-C), and Triglycerides | Baseline, Week 6, and Week 28 | Total cholesterol, HDL-C, and triglycerides were measured in participant serum. The percent change from baseline at Weeks 6 and 28 for these lipid panel results is presented. |
| Secondary | Percent Change From Baseline in Cluster of Differentiation 4 (CD4)+ and Cluster of Differentiation 8 (CD8)+ T Cell Percentage | Baseline, Week 6, and Week 28 | The percent change from baseline in the percentage of T Cells in whole blood that are CD4+ and CD8+ at Weeks 6 and 28 was to be presented. |
| Secondary | Percent Change From Baseline in Interferon (IFN)+ Peripheral Blood Mononuclear Cells (PBMCs) | Baseline, Week 6, and Week 28 | The percent change from baseline in the percentage of PBMCs that were INF+ at Weeks 6 and 28 was to be presented. |
| Secondary | Percent Change From Baseline in Tumor Necrosis Factor (TNF)+ Peripheral Blood Mononuclear Cells (PBMCs) | Baseline, Week 6, and Week 28 | The percent change from baseline in the percentage of PBMCs that were TNF+ at Weeks 6 and 28 was to be presented. |
| Secondary | Percent Change From Baseline in Whole Blood Soluble Cluster of Differentiation 14 (sCD14) Concentration | Baseline, Week 6, and Week 28 | The percent change from baseline in sCD14 concentration in whole blood at Weeks 6 and 28 was to be presented. |
| Secondary | Change From Baseline in Human Immunodeficiency Virus (HIV) Proviral Deoxyribonucleic Acid (DNA) | Baseline, Week 6, and Week 28 | Blood was collected at baseline, Week 6, and Week 28 for the determination of the number of copies of HIV proviral DNA in PBMCs. The change from baseline at Weeks 6 and 28 was to be presented. |
| Secondary | Percent Change From Baseline in Troponin I and Troponin T Serum Levels | Baseline and Week 28 | Troponin I and troponin T blood concentrations were to be measured. The percent change from baseline at Week 28 was to be presented. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | Baseline and Week 6 | All randomized participants who received ≥1 dose of study drug. | Percent Change | MEAN |
| PRIMARY | Number of Participants With ≥1 Adverse Event (AE) | Up to approximately 28 weeks | All randomized participants who received ≥1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Withdrew From Study Treatment Due to an AE | Up to approximately 4 weeks | All randomized participants who received ≥1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein-Cholesterol (HDL-C), and Triglycerides | Baseline, Week 6, and Week 28 | All randomized participants who received ≥1 dose of study drug. | Percent Change | MEAN |
| SECONDARY | Percent Change From Baseline in Cluster of Differentiation 4 (CD4)+ and Cluster of Differentiation 8 (CD8)+ T Cell Percentage | Baseline, Week 6, and Week 28 | The intended analysis population was all randomized participants who received ≥1 dose of study drug. Data for this outcome measure could not be collected because the laboratory was unable to run the assay. Therefore, no participants were analyzed. | ||
| SECONDARY | Percent Change From Baseline in Interferon (IFN)+ Peripheral Blood Mononuclear Cells (PBMCs) | Baseline, Week 6, and Week 28 | The intended analysis population was all randomized participants who received ≥1 dose of study drug. Data for this outcome measure could not be collected because the laboratory was unable to run the assay. Therefore, no participants were analyzed. | ||
| SECONDARY | Percent Change From Baseline in Tumor Necrosis Factor (TNF)+ Peripheral Blood Mononuclear Cells (PBMCs) | Baseline, Week 6, and Week 28 | The intended analysis population was all randomized participants who received ≥1 dose of study drug. Data for this outcome measure could not be collected because the laboratory was unable to run the assay. Therefore, no participants were analyzed. | ||
| SECONDARY | Percent Change From Baseline in Whole Blood Soluble Cluster of Differentiation 14 (sCD14) Concentration | Baseline, Week 6, and Week 28 | The intended analysis population was all randomized participants who received ≥1 dose of study drug. Data for this outcome measure could not be collected because the laboratory was unable to run the assay. Therefore, no participants were analyzed. | ||
| SECONDARY | Change From Baseline in Human Immunodeficiency Virus (HIV) Proviral Deoxyribonucleic Acid (DNA) | Baseline, Week 6, and Week 28 | The intended analysis population was all randomized participants who received ≥1 dose of study drug. Data for this outcome measure could not be collected because the laboratory was unable to run the assay. Therefore, no participants were analyzed. | ||
| SECONDARY | Percent Change From Baseline in Troponin I and Troponin T Serum Levels | Baseline and Week 28 | The intended analysis population was all randomized participants who received ≥1 dose of study drug. Results for baseline and/or Week 28 were not quantifiable for any participants, so the change from baseline analysis could not be performed and no participants were analyzed. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | CD24Fc 240 mg | 6.24 | Standard Deviation 6.392 | Percent Change | |
| Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | Placebo | 6.51 | Standard Deviation 19.690 | Percent Change | |
| Number of Participants With ≥1 Adverse Event (AE) | CD24Fc 240 mg | 4 | Participants | ||
| Number of Participants With ≥1 Adverse Event (AE) | Placebo | 4 | Participants | ||
| Number of Participants Who Withdrew From Study Treatment Due to an AE | CD24Fc 240 mg | 0 | Participants | ||
| Number of Participants Who Withdrew From Study Treatment Due to an AE | Placebo | 0 | Participants | ||
| Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein-Cholesterol (HDL-C), and Triglycerides | CD24Fc 240 mg | Percent Change from Baseline in Total Cholesterol at Week 6 | 4.66 | Standard Deviation 5.850 | Percent Change |
| Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein-Cholesterol (HDL-C), and Triglycerides | Placebo | Percent Change from Baseline in Total Cholesterol at Week 6 | 1.53 | Standard Deviation 10.947 | Percent Change |
| Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein-Cholesterol (HDL-C), and Triglycerides | CD24Fc 240 mg | Percent Change from Baseline in HDL-C at Week 6 | 6.69 | Standard Deviation 12.250 | Percent Change |
| Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein-Cholesterol (HDL-C), and Triglycerides | Placebo | Percent Change from Baseline in HDL-C at Week 6 | 0.88 | Standard Deviation 6.655 | Percent Change |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CD24Fc 240 mg | 4 | |
| Overall Study | STARTED | Placebo | 4 | |
| Overall Study | COMPLETED | CD24Fc 240 mg | 4 | |
| Overall Study | COMPLETED | Placebo | 4 | |
| Overall Study | NOT COMPLETED | CD24Fc 240 mg | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events46
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 |
|---|---|---|---|---|---|---|
| other | Glomerular filtration rate decreased | Investigations | CD24Fc 240 mg | 3 | 4 | 4 |
| other | Glomerular filtration rate decreased | Investigations | Placebo | 2 | 4 | 4 |
| other | Blood albumin decreased | Investigations | CD24Fc 240 mg | 2 | 4 | 2 |
| other | Blood albumin decreased | Investigations | Placebo | 0 | 4 | 0 |
| other | Blood cholesterol increased | Investigations | CD24Fc 240 mg | 2 | 4 | 2 |
| other | Blood cholesterol increased | Investigations | Placebo | 2 | 4 | 6 |
| other | Blood glucose increased | Investigations | CD24Fc 240 mg | 2 | 4 | 4 |
| other | Blood glucose increased | Investigations | Placebo | 1 | 4 | 1 |
| other | International normalised ratio increased | Investigations | CD24Fc 240 mg | 1 | 4 | 1 |
| other | International normalised ratio increased | Investigations | Placebo | 2 | 4 | 2 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CD24Fc 240 mg | 0 | 4 |
| Total, all-cause mortality | Placebo | 0 | 4 |
| Total, other adverse events | CD24Fc 240 mg | 4 | 4 |
| Total, other adverse events | Placebo | 4 | 4 |
| Total, serious adverse events | CD24Fc 240 mg | 0 | 4 |
| Total, serious adverse events | Placebo | 0 | 4 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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 |
|---|---|---|---|---|---|
| R44HL145964 | A randomized, placebo-controlled, single-blinded clinical trial to assess safety and efficacy of CD24Fc in controlling cardiovascular disease risks of HIV-infected patients | ZHENG, PAN; KOTTILIL, SHYAMASUNDARAN | ONCOIMMUNE, INC. | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2019 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CD24Fc 240 mg vs Placebo: Number of Participants With ≥1 Adverse Event (AE) | Trial comparisons |
| CD24Fc 240 mg vs Placebo: Number of Participants Who Withdrew From Study Treatment Due to an AE | Trial comparisons |
| CD24Fc 240 mg vs Placebo: deaths from any cause | Trial comparisons |
| CD24Fc 240 mg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03960541
GET https://conductscience.org/api/trials/v1/NCT03960541/registered?page=2