Lactoferrin Treatment in HIV Patients

Phase 2

Completed

• Conditions: HIV Infection
• Interventions: Drug: Placebo; Drug: Recombinant Lactoferrin

• Registration Number: NCT01830595
• Lead Sponsor: Jason Baker

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-10
• Study First Submitted QC: 2013-04-11
• Study First Posted: 2013-04-12
• Study Start: 2014-09
• Primary Completion: 2017-07
• Study Completion: 2018-01
• Results First Submitted: 2018-05-30
• Results First Submitted QC: 2018-09-14
• Results First Posted: 2018-09-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matched placebo will be administered by mouth twice daily
Recombinant Lactoferrin	Recombinant Lactoferrin	Recombinant lactoferrin will be administered by mouth twice daily

Primary Outcome Measures

Name	Time	Method
Number of Participants Taking Medication as Assigned	3 months	Number of participants taking medication as assigned at 3 months
Number of Participants With at Least One Side Effect, Adverse Event, and Serious Adverse Event	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)
IL-6 & D-dimer Score Changes From Baseline to 3 Months (or Month 5 to Month 8)	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.

Trial Locations

Locations (1)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States