Lactoferrin Treatment in HIV Patients

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01830595
• Other study ID #: PCC-006
• Status: Completed
• Phase: Phase 2
• Start date: September 2014
• Est. completion date: January 2018

Study information

• Verified date: September 2018
• Source: Minneapolis Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. HIV-positive participants receiving Antiretroviral Therapy (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

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

Drug:
• Recombinant Lactoferrin

• Placebo

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Jason Baker	Ventria Bioscience

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Activated Monocyte Phenotype (CD16+)	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).	3 months
Other	sCD163	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).	3 months
Primary	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)
Primary	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)
Primary	Number of Participants Taking Medication as Assigned	Number of participants taking medication as assigned at 3 months	3 months