HIV InfectionsPhase 2NCT00251537
A Pilot Study of LTB4 in HIV-1 Infected Adults
A Phase 2 study testing LTB4 in people with HIV Infections, run by LTB4 Sweden AB at 7 sites in Canada.
Trial summary
This is a pilot study to assess the safety and antiretroviral activity of a naturally occuring substance known as Leukotriene B4(LTB4). The aim of the study is to determine the effect of LTB4 on viral load during a period of 6 weeks, 4 weeks of active treatment and 2 additional weeks after the end of active treatment… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- LTB4
- How many people
- 40 participants
- Where
- 7 sitesCanada
- Study dates
- Nov 2005to Aug 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects between 18 and 65 years of age
- Diagnosis of HIV-1 infection
- Plasma HIV RNA level greater or equal to 5,000 copies/mL at the screening visit
- A CD4 cell count equal or greater than 250 cells/mm3 and CD4 fraction equal or greater than 14% at the screening visit within one month of study entry
- No ART within two months of study entry
- Karnofsky score equal to or above 80
Show all 9Show fewer
- If female of childbearing potential, a negative serum pregnancy test at screening.
- In the opinion of the investigator, the subject will be able to comply with the requirements of the protocol, including ability to present for all required visits
- Subject is capable of understanding and signing an informed consent form
Who cannot join
- Primary HIV-1 infection
- Use of investigational therapy in the preceding month prior to screening visit
- Prior screening for entry into this study
- Use of G-CSF, GM-CSF, IL-2, IFNs, erythropoietin, systemic or inhaled steroids within one month of the screening visit
- HIV-vaccine within one year of the screening visit
- Concurrent disease or conditions that may present a risk to the subjects
Show all 16Show fewer
- Females who are pregnant or breast feeding
- History of any malignancy or any active malignancy, except cutaneous Kaposis sarcoma
- Unexplained temperature of 38.5 degrees Celsius
- Chronic diarrhea (>3 liquid stools per day persisting for 15 days) within one month prior to study entry
- Calculated creatinine clearance outside normal limits
- Urinalysis: hemoglobinuria, present
- Liver transaminases > 3 x ULN
- Absolute neutrophil count < 500/mm3
- Hemoglobin < 8.0g/dL
- Platelet count < 75,000/mm3
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
McMaster University
Hamilton, Ontario, L8N3Z5
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2W 1T8
Research Institute of the McGill University Health Centre
Montreal, Quebec, H3G 1A4
The Ottawa Hospital (General Campus)
Ottawa, Ontario, K1H 8L6
Centre Hospitalier Universitaire de Quebec
Ste-Foy, Quebec, G1V 4G2
University Health Network
Toronto, Ontario, M5G2M9
Centre for HIV/AIDS, St Pauls Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: A Pilot Study Assessing Safety and Antiretroviral Activity of Intravenously Administered LTB4 in HIV-1 Infected Adults With a CD4 Count Greater Than 250 Cells/mm3 and a Viral Load Greater Than 5,000 Copies/mL, and Who Have Not Received Antiretroviral Therapy Within Two Months
This is a pilot study to assess the safety and antiretroviral activity of a naturally occuring substance known as Leukotriene B4(LTB4). The aim of the study is to determine the effect of LTB4 on viral load during a period of 6 weeks, 4 weeks of active treatment and 2 additional weeks after the end of active treatment for safety follow-up. 40 patients in seven clinics in Canada will be randomized into three treatment arms, either of two doses of LTB4 or placebo. Study drug is administered intravenously once daily. LTB4 can activate and stimulate various white blood cells and by the activation release natural substances in the body and this process is an important part of the body's defense against infections.
Read the detailed description
The objective of this pilot study is to investigate whether LTB4, administered at a dose that provides an increase in alfa-defensin release from neutrophils, can affect HIV viral load in HIV-1 infected individuals. The safety, tolerability and effect will be assessed of 28 days of daily intravenous dosing of LTB4 on HIV viral load. Safety and tolerability will also be assessed.
The study is randomized, double-blind, placebo controlled. All subjects will be randomly assigned to one of three treamtent groups, LTB4 at two different dose levels or corresponding placebo. Treatment duration is 4 weeks and follow-up period is 2 weeks. Subjects will visit the clinic on a daily basis during the treatment period to receive a daily intravenous injection of the study drug. 40 subjects will be enrolled, seven clinics in Canada will participate in the study.
Primary endpoint: Change in viral load over the treatment period of 28 days. Secondary endpoint: CD4, CD8 and neutrophil counts, alfa-defensins and CC-che, mokine release in blood.
- Conditions
- HIV Infections
- Being tested
- LTB4
- Keywords
- Pilot study, Randomized, Placebo-controlled, Double-blind, Effect on viral load, LTB4, HIV-1 infection
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTB4Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of 28 days of daily dosing of LTB4 on HIV viral load
Secondary outcomes (4)
To assess safety and tolerability of 28 days of daily dosing
To assess effects on CD4 and CD8 counts of 28 days of daily dosing
To assess effects on neutrophil counts of 28 days of dosing
To assess effects on release of alfa-defensins and CC-chemokines in blood on day s 1, 14 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2005 (estimated)
- Study startNov 2005
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- LTB4 Sweden AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard Lalonde, MD, Principal investigator, Montreal Chest Institute, Montreal, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251537
- Sponsor's protocol ID
- LTB4 200501
- Status last verified
- Jul 2006
- First submitted
- 9 Nov 2005
- Last updated
- 10 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Assessing Safety and Antiretroviral Activity of Intravenously Administered LTB4 in HIV-1 Infected Adults With a CD4 Count Greater Than 250 Cells/mm3 and a Viral Load Greater Than 5,000 Copies/mL, and Who Have Not Received Antiretroviral Therapy Within Two Months
- ClinicalTrials.gov ID
- NCT00251537
- Acronym / sponsor ID
- LTB4 200501
- Conditions
- HIV Infections
- Keywords
- Pilot study, Randomized, Placebo-controlled, Double-blind, Effect on viral load, LTB4, HIV-1 infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- LTB4 Sweden ABIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Study completion
- Aug 2006
- First posted
- 10 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to assess the safety and antiretroviral activity of a naturally occuring substance known as Leukotriene B4(LTB4). The aim of the study is to determine the effect of LTB4 on viral load during a period of 6 weeks, 4 weeks of active treatment and 2 additional weeks after the end of active treatment for safety follow-up. 40 patients in seven clinics in Canada will be randomized into three treatment arms, either of two doses of LTB4 or placebo. Study drug is administered intravenously once daily. LTB4 can activate and stimulate various white blood cells and by the activation release natural substances in the body and this process is an important part of the body's defense against infections.
Detailed description
The objective of this pilot study is to investigate whether LTB4, administered at a dose that provides an increase in alfa-defensin release from neutrophils, can affect HIV viral load in HIV-1 infected individuals. The safety, tolerability and effect will be assessed of 28 days of daily intravenous dosing of LTB4 on HIV viral load. Safety and tolerability will also be assessed.
The study is randomized, double-blind, placebo controlled. All subjects will be randomly assigned to one of three treamtent groups, LTB4 at two different dose levels or corresponding placebo. Treatment duration is 4 weeks and follow-up period is 2 weeks. Subjects will visit the clinic on a daily basis during the treatment period to receive a daily intravenous injection of the study drug. 40 subjects will be enrolled, seven clinics in Canada will participate in the study.
Primary endpoint: Change in viral load over the treatment period of 28 days. Secondary endpoint: CD4, CD8 and neutrophil counts, alfa-defensins and CC-che, mokine release in blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female subjects between 18 and 65 years of age
- Diagnosis of HIV-1 infection
- Plasma HIV RNA level greater or equal to 5,000 copies/mL at the screening visit
- A CD4 cell count equal or greater than 250 cells/mm3 and CD4 fraction equal or greater than 14% at the screening visit within one month of study entry
- No ART within two months of study entry
Key exclusion criteria (16 listed)
- Primary HIV-1 infection
- Use of investigational therapy in the preceding month prior to screening visit
- Prior screening for entry into this study
- Use of G-CSF, GM-CSF, IL-2, IFNs, erythropoietin, systemic or inhaled steroids within one month of the screening visit
- HIV-vaccine within one year of the screening visit
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 |
|---|---|---|
| LTB4 | Drug | – |
Primary outcome
To assess the effect of 28 days of daily dosing of LTB4 on HIV viral load
4 secondary outcomes
To assess safety and tolerability of 28 days of daily dosing
To assess effects on CD4 and CD8 counts of 28 days of daily dosing
To assess effects on neutrophil counts of 28 days of dosing
To assess effects on release of alfa-defensins and CC-chemokines in blood on day s 1, 14 and 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2006.
Related trials for HIV Infections
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.
Richard Lalonde, MD principal investigator
Montreal Chest Institute, Montreal, Canada
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LTB4 in people with HIV Infections, run by LTB4 Sweden AB at 7 sites in Canada.
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 9 inclusion and 16 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 10 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the effect of 28 days of daily dosing of LTB4 on HIV viral load. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2006.