Phase 2
Completed N=54
Lactoferrin Treatment in HIV Patients
Source: ClinicalTrials.gov NCT01830595 ↗Enrolled (actual)
54
Serious AEs
5.6%
Results posted
Sep 2018
Primary outcomePrimary: Number of Participants With at Least One Side Effect, Adverse Event, and Serious Adverse Event — 20; 17; 12; 11 Participants
Summary
Our general goal is to evaluate the potential effectiveness of recombinant lactoferrin (1500mg bid) for reducing inflammation among HIV positive participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With at Least One Side Effect, Adverse Event, and Serious Adverse Event |
20; 17; 12; 11; 5; 1 | — |
| PRIMARY IL-6 & D-dimer Score Changes From Baseline to 3 Months (or Month 5 to Month 8) |
-0.02; 0.06 | 0.38 |
| PRIMARY Number of Participants Taking Medication as Assigned |
40; 38 | — |
Eligibility Criteria
Inclusion Criteria
- HIV-positive participants receiving Antiretroviral Therapy (ART) for >1 year
- HIV RNA level 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
Data sourced from ClinicalTrials.gov (NCT01830595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.