Trial Outcomes & Findings for Lactoferrin Treatment in HIV Patients (NCT NCT01830595)
NCT ID: NCT01830595
Last Updated: 2024-12-31
Results Overview
Self reported side effects and/or Division of AIDS (DAIDS) criteria will be used for grading adverse events (serious and non-serious)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
During 3 months on Lactoferrin or Placebo (and following washout period)
Results posted on
2024-12-31
Participant Flow
One participant was administratively withdrawn prior to receiving medication.
Participant milestones
| Measure |
Placebo First Then Lactoferrin
Participants receive placebo during first period, then Lactoferrin in second period after washout.
|
Lactoferrin First Then Placebo
Participants receive Lactoferrin during first period, then placebo in second period after washout.
|
|---|---|---|
|
First Period
STARTED
|
26
|
28
|
|
First Period
Received at Least One Dose
|
26
|
28
|
|
First Period
COMPLETED
|
25
|
25
|
|
First Period
NOT COMPLETED
|
1
|
3
|
|
Washout
STARTED
|
25
|
25
|
|
Washout
COMPLETED
|
23
|
23
|
|
Washout
NOT COMPLETED
|
2
|
2
|
|
Second Period
STARTED
|
23
|
23
|
|
Second Period
COMPLETED
|
23
|
23
|
|
Second Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo First Then Lactoferrin
Participants receive placebo during first period, then Lactoferrin in second period after washout.
|
Lactoferrin First Then Placebo
Participants receive Lactoferrin during first period, then placebo in second period after washout.
|
|---|---|---|
|
First Period
Withdrawal by Subject
|
1
|
3
|
|
Washout
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=54 Participants
Includes groups randomized to receive placebo first and active drug first.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=54 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=54 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=54 Participants
|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 7.0 • n=54 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
White
|
39 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
African American
|
11 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=54 Participants
|
|
Diastolic Blood Pressure
At Enrollment
|
79.5 mm HG
STANDARD_DEVIATION 10.5 • n=54 Participants • All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.
|
|
Diastolic Blood Pressure
Beginning of Placebo Treatment
|
78.6 mm HG
STANDARD_DEVIATION 9.9 • n=49 Participants • All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.
|
|
Diastolic Blood Pressure
Beginning of Lactoferrin
|
79.3 mm HG
STANDARD_DEVIATION 10.2 • n=51 Participants • All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.
|
|
Systolic Blood Pressure
At Enrollment
|
129.7 mm Hg
STANDARD_DEVIATION 15.4 • n=54 Participants • All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.
|
|
Systolic Blood Pressure
Beginning of Placebo Treatment
|
128.0 mm Hg
STANDARD_DEVIATION 14.9 • n=49 Participants • All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.
|
|
Systolic Blood Pressure
Beginning of Lactoferrin Treatment
|
127.8 mm Hg
STANDARD_DEVIATION 15.6 • n=51 Participants • All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.
|
|
Weight
|
190.0 pounds
STANDARD_DEVIATION 38.1 • n=54 Participants
|
|
Interleukin-6 and D-Dimer Score
At Enrollment
|
-0.00 scores on a scale
STANDARD_DEVIATION 0.38 • n=54 Participants • All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.
|
|
Interleukin-6 and D-Dimer Score
Beginning of Placebo Treatment
|
0.02 scores on a scale
STANDARD_DEVIATION 0.39 • n=49 Participants • All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.
|
|
Interleukin-6 and D-Dimer Score
Beginning of Lactoferrin Treatment
|
-0.02 scores on a scale
STANDARD_DEVIATION 0.45 • n=51 Participants • All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.
|
|
Small Artery Elasticity
At Enrollment
|
6.49 mL/mmHg x 100
STANDARD_DEVIATION 2.91 • n=54 Participants • All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.
|
|
Small Artery Elasticity
Beginning of Placebo Treatment
|
6.79 mL/mmHg x 100
STANDARD_DEVIATION 3.04 • n=49 Participants • All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.
|
|
Small Artery Elasticity
Beginning of Lactoferrin Treatment
|
6.61 mL/mmHg x 100
STANDARD_DEVIATION 2.87 • n=51 Participants • All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.
|
|
Large Artery Elasticity
At Enrollment
|
16.77 mL/mmHg x 10
STANDARD_DEVIATION 5.74 • n=54 Participants • All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.
|
|
Large Artery Elasticity
Beginning of Placebo Treatment
|
17.02 mL/mmHg x 10
STANDARD_DEVIATION 5.56 • n=49 Participants • All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.
|
|
Large Artery Elasticity
Beginning of Lactoferrin Treatment
|
16.89 mL/mmHg x 10
STANDARD_DEVIATION 5.48 • n=51 Participants • All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.
|
|
Monocyte CD16+
At Enrollment
|
10.55 percent of total monocyte population
STANDARD_DEVIATION 7.11 • n=54 Participants • All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.
|
|
Monocyte CD16+
Beginning of Placebo Treatment
|
10.41 percent of total monocyte population
STANDARD_DEVIATION 7.56 • n=49 Participants • All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.
|
|
Monocyte CD16+
Beginning of Lactoferrin Treatment
|
11.96 percent of total monocyte population
STANDARD_DEVIATION 9.56 • n=51 Participants • All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.
|
|
sCD163
At Enrollment
|
0.21 mg/L
STANDARD_DEVIATION 0.12 • n=54 Participants • All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.
|
|
sCD163
Beginning of Placebo Treatment
|
0.23 mg/L
STANDARD_DEVIATION 0.15 • n=49 Participants • All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.
|
|
sCD163
Beginning of Lactoferrin Treatment
|
0.19 mg/L
STANDARD_DEVIATION 0.10 • n=51 Participants • All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.
|
PRIMARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Placebo
n=54 Participants
Matched placebo will be administered by mouth twice daily
Placebo
|
Recombinant Lactoferrin
n=54 Participants
Recombinant lactoferrin will be administered by mouth twice daily
Recombinant Lactoferrin
|
|---|---|---|
|
Number of Participants With at Least One Side Effect, Adverse Event, and Serious Adverse Event
At least one side effect
|
20 Participants
|
17 Participants
|
|
Number of Participants With at Least One Side Effect, Adverse Event, and Serious Adverse Event
At least one adverse event (includes SAE)
|
12 Participants
|
11 Participants
|
|
Number of Participants With at Least One Side Effect, Adverse Event, and Serious Adverse Event
At least one Serious Adverse Event
|
5 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 3 months (Baseline to Month 3 or Month 5 to Month 8)Population: 45 participants contributed data during phase two. Participants had to attend the first visit (baseline or month 5) and also one follow-up visit in order to contribute data to the analyses.
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.
Outcome measures
| Measure |
Placebo
n=45 Participants
Matched placebo will be administered by mouth twice daily
Placebo
|
Recombinant Lactoferrin
n=45 Participants
Recombinant lactoferrin will be administered by mouth twice daily
Recombinant Lactoferrin
|
|---|---|---|
|
IL-6 & D-dimer Score Changes From Baseline to 3 Months (or Month 5 to Month 8)
|
-0.02 score on a scale
Standard Deviation 0.39
|
0.06 score on a scale
Standard Deviation .36
|
PRIMARY outcome
Timeframe: 3 monthsNumber of participants taking medication as assigned at 3 months
Outcome measures
| Measure |
Placebo
n=44 Participants
Matched placebo will be administered by mouth twice daily
Placebo
|
Recombinant Lactoferrin
n=41 Participants
Recombinant lactoferrin will be administered by mouth twice daily
Recombinant Lactoferrin
|
|---|---|---|
|
Number of Participants Taking Medication as Assigned
|
40 Participants
|
38 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: 45 participants contributed data during phase two. Participants had to attend the first visit (baseline or month 5) and also one follow-up visit in order to contribute data to the analyses. Fewer participants had pre-drug and post-drug cells collected so numbers are less than 45 for this measure.
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).
Outcome measures
| Measure |
Placebo
n=40 Participants
Matched placebo will be administered by mouth twice daily
Placebo
|
Recombinant Lactoferrin
n=39 Participants
Recombinant lactoferrin will be administered by mouth twice daily
Recombinant Lactoferrin
|
|---|---|---|
|
Activated Monocyte Phenotype (CD16+)
|
-0.45 percent of total monocyte population
Standard Deviation 5.44
|
-1.42 percent of total monocyte population
Standard Deviation 9.26
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: 45 participants contributed data during phase two. Participants had to attend the first visit (baseline or month 5) and also one follow-up visit in order to contribute data to the analyses.
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).
Outcome measures
| Measure |
Placebo
n=45 Participants
Matched placebo will be administered by mouth twice daily
Placebo
|
Recombinant Lactoferrin
n=45 Participants
Recombinant lactoferrin will be administered by mouth twice daily
Recombinant Lactoferrin
|
|---|---|---|
|
sCD163
|
-0.01 mg/L
Standard Deviation 0.06
|
0.03 mg/L
Standard Deviation 0.11
|
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
Recombinant Lactoferrin
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=54 participants at risk
Matched placebo will be administered by mouth twice daily
Placebo
|
Recombinant Lactoferrin
n=54 participants at risk
Recombinant lactoferrin will be administered by mouth twice daily
Recombinant Lactoferrin
|
|---|---|---|
|
Psychiatric disorders
Hospitalization due to altered mental status
|
1.9%
1/54 • 8 months
|
0.00%
0/54 • 8 months
|
|
Cardiac disorders
Hospitalization due to chest pain
|
1.9%
1/54 • 8 months
|
0.00%
0/54 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization due to COPD
|
1.9%
1/54 • 8 months
|
0.00%
0/54 • 8 months
|
|
General disorders
hospitalization for confusion, disorientation, shakiness, unsteady gait and vomiting
|
1.9%
1/54 • 8 months
|
0.00%
0/54 • 8 months
|
|
Nervous system disorders
Hospitalization for drug use
|
1.9%
1/54 • 8 months
|
0.00%
0/54 • 8 months
|
|
Vascular disorders
Hospitalized for syncope episode
|
0.00%
0/54 • 8 months
|
1.9%
1/54 • 8 months
|
Other adverse events
| Measure |
Placebo
n=54 participants at risk
Matched placebo will be administered by mouth twice daily
Placebo
|
Recombinant Lactoferrin
n=54 participants at risk
Recombinant lactoferrin will be administered by mouth twice daily
Recombinant Lactoferrin
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
1.9%
1/54 • 8 months
|
0.00%
0/54 • 8 months
|
|
General disorders
Chills
|
1.9%
1/54 • 8 months
|
0.00%
0/54 • 8 months
|
|
Gastrointestinal disorders
Diarrhea
|
3.7%
2/54 • 8 months
|
0.00%
0/54 • 8 months
|
|
General disorders
Decreased appetite
|
1.9%
1/54 • 8 months
|
0.00%
0/54 • 8 months
|
|
General disorders
Fatigue
|
1.9%
1/54 • 8 months
|
0.00%
0/54 • 8 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/54 • 8 months
|
1.9%
1/54 • 8 months
|
|
Nervous system disorders
Insomnia
|
1.9%
1/54 • 8 months
|
0.00%
0/54 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Elevated CK
|
1.9%
1/54 • 8 months
|
1.9%
1/54 • 8 months
|
|
General disorders
Elevated AST
|
1.9%
1/54 • 8 months
|
0.00%
0/54 • 8 months
|
|
Infections and infestations
Skin infection
|
1.9%
1/54 • 8 months
|
0.00%
0/54 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Bone
|
0.00%
0/54 • 8 months
|
1.9%
1/54 • 8 months
|
|
Infections and infestations
Fatigue, cough and sore throat
|
0.00%
0/54 • 8 months
|
1.9%
1/54 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Bone spur on spine
|
0.00%
0/54 • 8 months
|
1.9%
1/54 • 8 months
|
|
Musculoskeletal and connective tissue disorders
surgery on rotator cuff
|
0.00%
0/54 • 8 months
|
1.9%
1/54 • 8 months
|
|
Musculoskeletal and connective tissue disorders
torn rotator cuff
|
0.00%
0/54 • 8 months
|
1.9%
1/54 • 8 months
|
|
Ear and labyrinth disorders
tinnitus
|
0.00%
0/54 • 8 months
|
1.9%
1/54 • 8 months
|
|
Musculoskeletal and connective tissue disorders
right leg pain
|
0.00%
0/54 • 8 months
|
1.9%
1/54 • 8 months
|
|
General disorders
nausea
|
1.9%
1/54 • 8 months
|
0.00%
0/54 • 8 months
|
|
General disorders
abdominal pain
|
1.9%
1/54 • 8 months
|
0.00%
0/54 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough and respiratory congestion
|
1.9%
1/54 • 8 months
|
0.00%
0/54 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory infection
|
0.00%
0/54 • 8 months
|
1.9%
1/54 • 8 months
|
|
Infections and infestations
Sinus Infection
|
1.9%
1/54 • 8 months
|
0.00%
0/54 • 8 months
|
|
Infections and infestations
Sinus pain and congestion
|
1.9%
1/54 • 8 months
|
0.00%
0/54 • 8 months
|
|
Infections and infestations
Cough, congestion, sinus pressure, fatigue
|
0.00%
0/54 • 8 months
|
1.9%
1/54 • 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place