Lactoferrin Treatment in HIV Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Minneapolis Medical Research Foundation
Ventria Bioscience
Information provided by (Responsible Party):
Jason Baker, Minneapolis Medical Research Foundation Identifier:
First received: April 10, 2013
Last updated: May 4, 2016
Last verified: May 2016
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: September 2014
Estimated Primary Completion Date: December 2016 (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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01830595

Contact: Jason Baker, MD, MS 612-873-2705
Contact: Rachel Prosser, PhD 612-873-2877

United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Rachel Prosser, PhD    612-873-2877   
Sponsors and Collaborators
Jason Baker
Ventria Bioscience
  More Information

Responsible Party: Jason Baker, Associate Professor of Medicine, Minneapolis Medical Research Foundation Identifier: NCT01830595     History of Changes
Other Study ID Numbers: PCC-006 
Study First Received: April 10, 2013
Last Updated: May 4, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anti-Infective Agents processed this record on May 26, 2016