Trial record 14 of 28 for:    " April 07, 2013":" May 07, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Lactoferrin Treatment in HIV Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Minneapolis Medical Research Foundation
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: August 22, 2014
Last verified: August 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: August 2014
Estimated Primary Completion Date: March 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

  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
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 ClinicalTrials.gov identifier: NCT01830595

Contacts
Contact: Jason Baker, MD, MS 612-873-2705 baker459@umn.edu
Contact: Rachel Prosser, PhD 612-873-2877 Rachel.Prosser@hcmed.org

Locations
United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Rachel Prosser, PhD    612-873-2877    rachel.prosser@hcmed.org   
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: August 22, 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
Lactoferrin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014