Lactoferrin Treatment in HIV Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01830595
Recruitment Status : Completed
First Posted : April 12, 2013
Last Update Posted : December 22, 2016
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 : 56 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
Study Start Date : September 2014
Actual Primary Completion Date : December 2016

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. Tolerability [ Time Frame: 3 months ]
    Self reported side effects

  2. Inflammation and Coagulation [ Time Frame: 3 months ]
    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 :
  1. Toxicity [ Time Frame: 3 Months ]
    DAIDS criteria will be used for grading adverse events (serious and non-serious)

Other Outcome Measures:
  1. Monocyte Activation [ Time Frame: 3 months ]
  2. Tissue Factor Activity [ Time Frame: 3 months ]

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 identifier (NCT number): NCT01830595

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

Responsible Party: Jason Baker, Associate Professor of Medicine, Minneapolis Medical Research Foundation Identifier: NCT01830595     History of Changes
Other Study ID Numbers: PCC-006
First Posted: April 12, 2013    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
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