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| Name | Class |
|---|---|
| Ventria Bioscience | INDUSTRY |
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Our general goal is to evaluate the potential effectiveness of recombinant lactoferrin (1500mg bid) for reducing inflammation among HIV positive participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant Lactoferrin | Active Comparator | Recombinant lactoferrin will be administered by mouth twice daily |
|
| Placebo | Placebo Comparator | Matched placebo will be administered by mouth twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Lactoferrin | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Side Effect, Adverse Event, and Serious Adverse Event | Self reported side effects and/or Division of AIDS (DAIDS) criteria will be used for grading adverse events (serious and non-serious) | During 3 months on Lactoferrin or Placebo (and following washout period) |
| IL-6 & D-dimer Score Changes From Baseline to 3 Months (or Month 5 to Month 8) | The IL-6 & D-dimer score is defined as: 0. 33*log2 IL-6 + 0.16*log2 D-dimer, where IL-6 is measured in pg/mL and D-dimer in ug/mL. Since the biomarkers are on the log2 scale, associations of risk with the IL-6 & D-dimer score are interpreted as "HR(event) per doubling of IL-6 and D-dimer", or "HR(event) per 20% increase in IL-6 and D-dimer"; the score itself is unitless. Among the 3766 study participants for whom the score was developed, the min was -1.7, the max was 2.5. Higher scores are worse. | 3 months (Baseline to Month 3 or Month 5 to Month 8) |
| Number of Participants Taking Medication as Assigned | Number of participants taking medication as assigned at 3 months | 3 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Activated Monocyte Phenotype (CD16+) | The change in CD16+ monocyte subsets will be compared between active and placebo treatment phases. During both the active and placebo treatment phase, all relevant time points are used in calculation of change (i.e., baseline, month 1 and month 3 for phase 1; and similarly months 5, 6 and 8 for phase 2). | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason V Baker, MD, MS | Hennepin Healthcare Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30721997 | Derived | Sortino O, Hullsiek KH, Richards E, Rupert A, Schminke A, Tetekpor N, Quinones M, Prosser R, Schacker T, Sereti I, Baker JV. The Effects of Recombinant Human Lactoferrin on Immune Activation and the Intestinal Microbiome Among Persons Living with Human Immunodeficiency Virus and Receiving Antiretroviral Therapy. J Infect Dis. 2019 May 24;219(12):1963-1968. doi: 10.1093/infdis/jiz042. |
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One participant was administratively withdrawn prior to receiving medication.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo First Then Lactoferrin | Participants receive placebo during first period, then Lactoferrin in second period after washout. |
| FG001 | Lactoferrin First Then Placebo | Participants receive Lactoferrin during first period, then placebo in second period after washout. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Period |
|
| |||||||||||||||||||||
| Washout |
| ||||||||||||||||||||||
| Second Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to receive placebo first and active drug first. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With at Least One Side Effect, Adverse Event, and Serious Adverse Event | Self reported side effects and/or Division of AIDS (DAIDS) criteria will be used for grading adverse events (serious and non-serious) | Posted | Count of Participants | Participants | During 3 months on Lactoferrin or Placebo (and following washout period) |
|
8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matched placebo will be administered by mouth twice daily Placebo | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization due to altered mental status | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Baker | Minneapolis Medical Research Foundation | 612-873-2705 | baker@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 25, 2015 | May 29, 2018 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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|
| sCD163 | The change in blood levels of sCD163 will be compared between active and placebo treatment phases. During both the active and placebo treatment phase, all relevant time points are used in calculation of change (i.e., baseline, month 1 and month 3 for phase 1; and similarly months 5, 6 and 8 for phase 2). | 3 months |
| NOT COMPLETED |
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| NOT COMPLETED |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Diastolic Blood Pressure | All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment. | Mean | Standard Deviation | mm HG |
|
| Systolic Blood Pressure | All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment. | Mean | Standard Deviation | mm Hg |
|
| Weight | Mean | Standard Deviation | pounds |
|
| Interleukin-6 and D-Dimer Score | The IL-6 & D-dimer score is defined as: 0. 33*log2 IL-6 + 0.16*log2 D-dimer, where IL-6 is measured in pg/mL and D-dimer in ug/mL. Since the biomarkers are on the log2 scale, associations of risk with the IL-6 & D-dimer score are interpreted as "Hazard Ratio (HR)(event) per doubling of IL-6 and D-dimer", or "HR(event) per 20% increase in IL-6 and D-dimer"; the score itself is unitless. Among the 3766 study participants for whom the score was developed, the min was -1.7, the max was 2.5. Higher scores are worse. | All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment. | Mean | Standard Deviation | scores on a scale |
|
| Small Artery Elasticity | All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment. | Mean | Standard Deviation | mL/mmHg x 100 |
|
| Large Artery Elasticity | All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment. | Mean | Standard Deviation | mL/mmHg x 10 |
|
| Monocyte CD16+ | All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment. | Mean | Standard Deviation | percent of total monocyte population |
|
| sCD163 | All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment. | Mean | Standard Deviation | mg/L |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | IL-6 & D-dimer Score Changes From Baseline to 3 Months (or Month 5 to Month 8) | The IL-6 & D-dimer score is defined as: 0. 33*log2 IL-6 + 0.16*log2 D-dimer, where IL-6 is measured in pg/mL and D-dimer in ug/mL. Since the biomarkers are on the log2 scale, associations of risk with the IL-6 & D-dimer score are interpreted as "HR(event) per doubling of IL-6 and D-dimer", or "HR(event) per 20% increase in IL-6 and D-dimer"; the score itself is unitless. Among the 3766 study participants for whom the score was developed, the min was -1.7, the max was 2.5. Higher scores are worse. | 45 participants contributed data during phase two. Participants had to attend the first visit (baseline or month 5) and also one follow-up visit in order to contribute data to the analyses. | Posted | Mean | Standard Deviation | score on a scale | 3 months (Baseline to Month 3 or Month 5 to Month 8) |
|
|
|
|
| Primary | Number of Participants Taking Medication as Assigned | Number of participants taking medication as assigned at 3 months | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Other Pre-specified | Activated Monocyte Phenotype (CD16+) | The change in CD16+ monocyte subsets will be compared between active and placebo treatment phases. During both the active and placebo treatment phase, all relevant time points are used in calculation of change (i.e., baseline, month 1 and month 3 for phase 1; and similarly months 5, 6 and 8 for phase 2). | 45 participants contributed data during phase two. Participants had to attend the first visit (baseline or month 5) and also one follow-up visit in order to contribute data to the analyses. Fewer participants had pre-drug and post-drug cells collected so numbers are less than 45 for this measure. | Posted | Mean | Standard Deviation | percent of total monocyte population | 3 months |
|
|
|
|
| Other Pre-specified | sCD163 | The change in blood levels of sCD163 will be compared between active and placebo treatment phases. During both the active and placebo treatment phase, all relevant time points are used in calculation of change (i.e., baseline, month 1 and month 3 for phase 1; and similarly months 5, 6 and 8 for phase 2). | 45 participants contributed data during phase two. Participants had to attend the first visit (baseline or month 5) and also one follow-up visit in order to contribute data to the analyses. | Posted | Mean | Standard Deviation | mg/L | 3 months |
|
|
|
|
| 54 |
| 5 |
| 54 |
| 10 |
| 54 |
| EG001 | Recombinant Lactoferrin | Recombinant lactoferrin will be administered by mouth twice daily Recombinant Lactoferrin | 0 | 54 | 1 | 54 | 10 | 54 |
| Hospitalization due to chest pain | Cardiac disorders | Non-systematic Assessment |
|
| Hospitalization due to COPD | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| hospitalization for confusion, disorientation, shakiness, unsteady gait and vomiting | General disorders | Non-systematic Assessment |
|
| Hospitalization for drug use | Nervous system disorders | Non-systematic Assessment |
|
| Hospitalized for syncope episode | Vascular disorders | Non-systematic Assessment |
|
| Chills | General disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Decreased appetite | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Insomnia | Nervous system disorders | Non-systematic Assessment |
|
| Elevated CK | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Elevated AST | General disorders | Systematic Assessment |
|
| Skin infection | Infections and infestations | Non-systematic Assessment |
|
| Bone | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | broke left arm |
|
| Fatigue, cough and sore throat | Infections and infestations | Non-systematic Assessment |
|
| Bone spur on spine | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| surgery on rotator cuff | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| torn rotator cuff | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
|
| right leg pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| nausea | General disorders | Non-systematic Assessment |
|
| abdominal pain | General disorders | Non-systematic Assessment |
|
| Cough and respiratory congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Upper Respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sinus Infection | Infections and infestations | Non-systematic Assessment |
|
| Sinus pain and congestion | Infections and infestations | Non-systematic Assessment |
|
| Cough, congestion, sinus pressure, fatigue | Infections and infestations | Non-systematic Assessment |
|
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |