Lactoferrin Treatment in HIV Patients
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|ClinicalTrials.gov Identifier: NCT01830595|
Recruitment Status : Completed
First Posted : April 12, 2013
Results First Posted : September 18, 2018
Last Update Posted : October 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection||Drug: Recombinant Lactoferrin Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Recombinant Lactoferrin to Reduce Immune Activation and Coagulation Among HIV Positive Patients|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||January 2018|
Active Comparator: Recombinant Lactoferrin
Recombinant lactoferrin will be administered by mouth twice daily
Drug: Recombinant Lactoferrin
Placebo Comparator: Placebo
Matched placebo will be administered by mouth twice daily
- 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)
- 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.
- Number of Participants Taking Medication as Assigned [ Time Frame: 3 months ]Number of participants taking medication as assigned at 3 months
- 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).
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830595
|United States, Minnesota|
|Hennepin County Medical Center|
|Minneapolis, Minnesota, United States, 55415|
|Principal Investigator:||Jason V Baker, MD, MS||Hennepin Healthcare Research Institute|