Lactoferrin Treatment in HIV Patients

Recombinant Lactoferrin to Reduce Immune Activation and Coagulation Among HIV Positive Patients

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

Study Overview

• Status: Completed
• Conditions: HIV Infection
• Intervention / Treatment: Drug: Placebo; Drug: Recombinant Lactoferrin

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Recombinant Lactoferrin; Recombinant lactoferrin will be administered by mouth twice daily	Drug: Recombinant Lactoferrin
PLACEBO_COMPARATOR: Placebo; Matched placebo will be administered by mouth twice daily	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Jason Baker
• Collaborators: Ventria Bioscience
• Investigators: Principal Investigator: Jason V Baker, MD, MS, Hennepin Healthcare Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2014
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): January 1, 2018

Study Registration Dates

• First Submitted: April 10, 2013
• First Submitted That Met QC Criteria: April 11, 2013
• First Posted (ESTIMATE): April 12, 2013

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2018
• Last Update Submitted That Met QC Criteria: September 21, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Anti-Infective Agents; Lactoferrin
• Other Study ID Numbers: PCC-006