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Lactoferrin Treatment in HIV Patients

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ClinicalTrials.gov Identifier: NCT01830595
Recruitment Status : Completed
First Posted : April 12, 2013
Results First Posted : September 18, 2018
Last Update Posted : October 18, 2018
Sponsor:
Collaborator:
Ventria Bioscience
Information provided by (Responsible Party):
Jason Baker, Minneapolis Medical Research Foundation

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

Condition or disease Intervention/treatment Phase
HIV Infection Drug: Recombinant Lactoferrin Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Recombinant Lactoferrin to Reduce Immune Activation and Coagulation Among HIV Positive Patients
Actual Study Start Date : September 2014
Actual Primary Completion Date : July 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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



Primary Outcome Measures :
  1. Number of Participants With at Least One Side Effect, Adverse Event, and Serious Adverse Event [ Time Frame: During 3 months on Lactoferrin or Placebo (and following washout period) ]
    Self reported side effects and/or Division of AIDS (DAIDS) criteria will be used for grading adverse events (serious and non-serious)

  2. IL-6 & D-dimer Score Changes From Baseline to 3 Months (or Month 5 to Month 8) [ Time Frame: 3 months (Baseline to Month 3 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. Number of Participants Taking Medication as Assigned [ Time Frame: 3 months ]
    Number of participants taking medication as assigned at 3 months


Other Outcome Measures:
  1. Activated Monocyte Phenotype (CD16+) [ Time Frame: 3 months ]
    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).

  2. sCD163 [ Time Frame: 3 months ]
    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).



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830595


Locations
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Jason Baker
Ventria Bioscience
Investigators
Principal Investigator: Jason V Baker, MD, MS Minneapolis Medical Research Foundation
  Study Documents (Full-Text)

Documents provided by Jason Baker, Minneapolis Medical Research Foundation:

Responsible Party: Jason Baker, Associate Professor of Medicine, Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT01830595     History of Changes
Other Study ID Numbers: PCC-006
First Posted: April 12, 2013    Key Record Dates
Results First Posted: September 18, 2018
Last Update Posted: October 18, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Lactoferrin
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-Infective Agents