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Lactoferrin Treatment in HIV Patients

Primary Purpose

HIV Infection

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Recombinant Lactoferrin
Placebo
Sponsored by
Jason Baker
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. HIV-positive participants receiving Antiretroviral Therapy (ART) for >1 year
  2. HIV RNA level <200 copies/mL for at least 6 months (≥2 separate values)
  3. Age >40 years

Exclusion Criteria:

  1. Prior cardiovascular disease or stroke
  2. Diabetes
  3. Rheumatologic Diseases
  4. Pregnancy
  5. Chronic kidney disease, stage IV or V (creatinine clearance <30 mL/min/1.73m2)
  6. Cirrhosis or end-stage liver disease

Sites / Locations

  • Hennepin County Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Recombinant Lactoferrin

Placebo

Arm Description

Recombinant lactoferrin will be administered by mouth twice daily

Matched placebo will be administered by mouth twice daily

Outcomes

Primary Outcome Measures

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)
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.
Number of Participants Taking Medication as Assigned
Number of participants taking medication as assigned at 3 months

Secondary Outcome Measures

Full Information

First Posted
April 10, 2013
Last Updated
September 21, 2018
Sponsor
Jason Baker
Collaborators
Ventria Bioscience
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1. Study Identification

Unique Protocol Identification Number
NCT01830595
Brief Title
Lactoferrin Treatment in HIV Patients
Official Title
Recombinant Lactoferrin to Reduce Immune Activation and Coagulation Among HIV Positive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jason Baker
Collaborators
Ventria Bioscience

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Our general goal is to evaluate the potential effectiveness of recombinant lactoferrin (1500mg bid) for reducing inflammation among HIV positive participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recombinant Lactoferrin
Arm Type
Active Comparator
Arm Description
Recombinant lactoferrin will be administered by mouth twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matched placebo will be administered by mouth twice daily
Intervention Type
Drug
Intervention Name(s)
Recombinant Lactoferrin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of Participants With at Least One Side Effect, Adverse Event, and Serious Adverse Event
Description
Self reported side effects and/or Division of AIDS (DAIDS) criteria will be used for grading adverse events (serious and non-serious)
Time Frame
During 3 months on Lactoferrin or Placebo (and following washout period)
Title
IL-6 & D-dimer Score Changes From Baseline to 3 Months (or Month 5 to Month 8)
Description
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.
Time Frame
3 months (Baseline to Month 3 or Month 5 to Month 8)
Title
Number of Participants Taking Medication as Assigned
Description
Number of participants taking medication as assigned at 3 months
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Activated Monocyte Phenotype (CD16+)
Description
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).
Time Frame
3 months
Title
sCD163
Description
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).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV-positive participants receiving Antiretroviral Therapy (ART) for >1 year HIV RNA level <200 copies/mL for at least 6 months (≥2 separate values) Age >40 years Exclusion Criteria: Prior cardiovascular disease or stroke Diabetes Rheumatologic Diseases Pregnancy Chronic kidney disease, stage IV or V (creatinine clearance <30 mL/min/1.73m2) Cirrhosis or end-stage liver disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason V Baker, MD, MS
Organizational Affiliation
Hennepin Healthcare Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30721997
Citation
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.
Results Reference
derived

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Lactoferrin Treatment in HIV Patients

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