NCT01830595

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2013

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
9 months until next milestone

Results Posted

Study results publicly available

September 18, 2018

Completed
Last Updated

December 31, 2024

Status Verified

December 1, 2024

Enrollment Period

2.8 years

First QC Date

April 10, 2013

Results QC Date

May 30, 2018

Last Update Submit

December 13, 2024

Conditions

HIV Infection

Outcome Measures

Primary Outcomes (3)

  • Number of Participants With at Least One Side Effect, Adverse Event, and Serious Adverse Event

    Self reported side effects and/or Division of AIDS (DAIDS) criteria will be used for grading adverse events (serious and non-serious)

    During 3 months on Lactoferrin or Placebo (and following washout period)

  • IL-6 & D-dimer Score Changes From Baseline to 3 Months (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 months (Baseline to Month 3 or Month 5 to Month 8)

  • Number of Participants Taking Medication as Assigned

    Number of participants taking medication as assigned at 3 months

    3 months

Other Outcomes (2)

  • Activated Monocyte Phenotype (CD16+)

    3 months

  • sCD163

    3 months

Study Arms (2)

Recombinant Lactoferrin

ACTIVE COMPARATOR

Recombinant lactoferrin will be administered by mouth twice daily

Drug: Recombinant Lactoferrin

Placebo

PLACEBO COMPARATOR

Matched placebo will be administered by mouth twice daily

Drug: Placebo

Interventions

Recombinant LactoferrinDRUG
Recombinant Lactoferrin
PlaceboDRUG
Placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-positive participants receiving Antiretroviral Therapy (ART) for \>1 year
  • HIV RNA level \<200 copies/mL for at least 6 months (≥2 separate values)
  • Age \>40 years

You may not qualify if:

  • Prior cardiovascular disease or stroke
  • Diabetes
  • Rheumatologic Diseases
  • Pregnancy
  • Chronic kidney disease, stage IV or V (creatinine clearance \<30 mL/min/1.73m2)
  • Cirrhosis or end-stage liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (1)

  • Sortino O, Hullsiek KH, Richards E, Rupert A, Schminke A, Tetekpor N, Quinones M, Prosser R, Schacker T, Sereti I, Baker JV. The Effects of Recombinant Human Lactoferrin on Immune Activation and the Intestinal Microbiome Among Persons Living with Human Immunodeficiency Virus and Receiving Antiretroviral Therapy. J Infect Dis. 2019 May 24;219(12):1963-1968. doi: 10.1093/infdis/jiz042.

    PMID: 30721997DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Jason Baker
Organization
Minneapolis Medical Research Foundation
baker@umn.edu
612-873-2705

Study Officials

  • Jason V Baker, MD, MS

    Hennepin Healthcare Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

April 10, 2013

First Posted

April 12, 2013

Study Start

September 1, 2014

Primary Completion

July 1, 2017

Study Completion

January 1, 2018

Last Updated

December 31, 2024

Results First Posted

September 18, 2018

Record last verified: 2024-12

Locations

US(1)