HIV InfectionPhase 2NCT01830595

Lactoferrin Treatment in HIV Patients

A Phase 2 study testing Recombinant Lactoferrin in people with HIV Infection, run by Jason Baker at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 40 years and older
Conditions the study is for: HIV Infection
What is being tested?: Recombinant Lactoferrin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 55 participants
Where: 1 siteUnited States
Study dates: Sep 2014to Jan 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

HIV-positive participants receiving Antiretroviral Therapy (ART) for >1 year
HIV RNA level <200 copies/mL for at least 6 months (≥2 separate values)
Age >40 years

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Hennepin County Medical Center
Minneapolis, Minnesota, 55415

Other trials in United States

About this study

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

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

Conditions: HIV Infection
Being tested: Recombinant Lactoferrin, Placebo
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Recombinant LactoferrinDrug
PlaceboDrug

Study groups in NCT01830595
Study group	Role	What they receive
Recombinant Lactoferrin	Active comparator	Recombinant lactoferrin will be administered by mouth twice daily Receives: Drug: Recombinant Lactoferrin
Placebo	Placebo comparator	Matched placebo will be administered by mouth twice daily Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: During 3 months on Lactoferrin or Placebo (and following washout period)
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.
Measured: 3 months (Baseline to Month 3 or Month 5 to Month 8)
Number of Participants Taking Medication as Assigned
Number of participants taking medication as assigned at 3 months
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Jan 2018

First posted12 Apr 2013 (estimated)
Study startSep 2014
Primary completionJul 2017
Study completionJan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01830595
Sponsor's protocol ID: PCC-006
Status last verified: Dec 2024
First submitted: 10 Apr 2013
Last updated: 31 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Sortino O, Hullsiek KH, Richards E, Rupert A, Schminke A, Tetekpor N, Quinones M, Prosser R, Schacker T, Sereti I, Baker JV. The Effects of Recombinant Human Lactoferrin on Immune Activation and the Intestinal Microbiome Among Persons Living with Human Immunodeficiency Virus and Receiving Antiretroviral Therapy. J Infect Dis. 2019 May 24;219(12):1963-1968. doi: 10.1093/infdis/jiz042.
PubMed 30721997

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All HIV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Recombinant Lactoferrin to Reduce Immune Activation and Coagulation Among HIV Positive Patients
ClinicalTrials.gov ID: NCT01830595
Acronym / sponsor ID: PCC-006
Conditions: HIV Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Jason BakerUniversity, hospital or other
Collaborators: Ventria Bioscience
Study start: Sep 2014 (actual)
Primary completion: Jul 2017 (actual)
Study completion: Jan 2018 (actual)
First posted: 12 Apr 2013 (estimated)
Results: Posted 18 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Recombinant Lactoferrin	Active comparator	Drug: Recombinant LactoferrinRecombinant lactoferrin will be administered by mouth twice daily
Placebo	Placebo comparator	Drug: PlaceboMatched placebo will be administered by mouth twice daily

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

HIV-positive participants receiving Antiretroviral Therapy (ART) for >1 year
HIV RNA level <200 copies/mL for at least 6 months (≥2 separate values)
Age >40 years

Key exclusion criteria (6 listed)

Prior cardiovascular disease or stroke
Diabetes
Rheumatologic Diseases
Pregnancy
Chronic kidney disease, stage IV or V (creatinine clearance <30 mL/min/1.73m2)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Recombinant Lactoferrin	Drug	Recombinant Lactoferrin
Placebo	Drug	Placebo

Primary outcome

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

Results and safety

Results posted to the registry on 18 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo First Then Lactoferrin	26	25
Lactoferrin First Then Placebo	28	25

Primary outcome: 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). Count of participants. Unit: Participants

Measure	Placebo n = 54	Recombinant Lactoferrin n = 54
At least one side effect	20	17
At least one adverse event (includes SAE)	12	11
At least one Serious Adverse Event	5	1

Primary outcome: 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). Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo n = 45	Recombinant Lactoferrin n = 45
Value	-0.02 (0.39)	0.06 (.36)

Placebo vs Recombinant Lactoferrin: p = 0.38, t-test, 2 sided

Population analysed: 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.

Primary outcome: Number of Participants Taking Medication as Assigned

Time frame: 3 months. Count of participants. Unit: Participants

Measure	Placebo n = 44	Recombinant Lactoferrin n = 41
Value	40	38

Adverse events

Time frame: 8 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	5 of 54 (9.3%)	10 of 54 (18.5%)	0 of 54
Recombinant Lactoferrin	1 of 54 (1.9%)	10 of 54 (18.5%)	0 of 54

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30721997Sortino O, Hullsiek KH, Richards E, Rupert A, Schminke A, Tetekpor N, Quinones M, Prosser R, Schacker T, Sereti I, Baker JV. The Effects of Recombinant Human Lactoferrin on Immune Activation and the Intestinal Microbiome Among Persons Living with Human Immunodeficiency Virus and Receiving Antiretroviral Therapy. J Infect Dis. 2019 May 24;219(12):1963-1968. doi: 10.1093/infdis/jiz042.

Related trials for HIV Infection

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jason V Baker, MD, MS principal investigator

Hennepin Healthcare Research Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Recombinant Lactoferrin in people with HIV Infection, run by Jason Baker at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01830595, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.