Lactoferrin Treatment in HIV Patients

This study has suspended participant recruitment.
Sponsor:
Collaborator:
Ventria Bioscience
Information provided by (Responsible Party):
Jason Baker, Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT01830595
First received: April 10, 2013
Last updated: February 1, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
HIV Infection
Drug: Recombinant Lactoferrin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Recombinant Lactoferrin to Reduce Immune Activation and Coagulation Among HIV Positive Patients

Resource links provided by NLM:


Further study details as provided by Minneapolis Medical Research Foundation:

Primary Outcome Measures:
  • Tolerability [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Self reported side effects

  • Inflammation and Coagulation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Changes in markers of systemic inflammation (e.g., IL-6) and coagulation (e.g., D-dimer) will be compared between treatment groups


Secondary Outcome Measures:
  • Toxicity [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]
    DAIDS criteria will be used for grading adverse events (serious and non-serious)


Other Outcome Measures:
  • Monocyte Activation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Tissue Factor Activity [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2014
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HIV-positive participants receiving 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01830595

Locations
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Jason Baker
Ventria Bioscience
  More Information

No publications provided

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
Study First Received: April 10, 2013
Last Updated: February 1, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 16, 2014