Skip to main content
OpenTrials
Completed

NCT Number: NCT01830595

Lactoferrin Treatment in HIV Patients

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Recombinant Lactoferrin

Drug

Placebo

Drug

Primary outcomes

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

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

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

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

    Time frame: 3 months (Baseline to Month 3 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. Number of Participants Taking Medication as Assigned

    Time frame: 3 months

    Number of participants taking medication as assigned at 3 months

Other outcomes

  1. Activated Monocyte Phenotype (CD16+)

    Time frame: 3 months

    The change in CD16+ monocyte subsets will be compared between active and placebo treatment phases. During both the active and placebo treatment phase, all relevant time points are used in calculation of change (i.e., baseline, month 1 and month 3 for phase 1; and similarly months 5, 6 and 8 for phase 2).

  2. sCD163

    Time frame: 3 months

    The change in blood levels of sCD163 will be compared between active and placebo treatment phases. During both the active and placebo treatment phase, all relevant time points are used in calculation of change (i.e., baseline, month 1 and month 3 for phase 1; and similarly months 5, 6 and 8 for phase 2).

Sponsors and collaborators

Lead sponsor

Jason Baker

Other

Collaborators

  • Ventria Bioscience

Registry information

Official study title

Recombinant Lactoferrin to Reduce Immune Activation and Coagulation Among HIV Positive Patients

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Apr 12, 2013
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.