Back to resultsA Pilot Study of LTB4 in HIV-1 Infected Adults
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
LTB4
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Pilot study, Randomized, Placebo-controlled, Double-blind, Effect on viral load, LTB4, HIV-1 infection
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion criteria: 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 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
Sites / Locations
- Centre for HIV/AIDS, St Pauls Hospital
- McMaster University
- The Ottawa Hospital (General Campus)
- University Health Network
- Centre hospitalier de l'Université de Montréal
- Research Institute of the McGill University Health Centre
- Centre Hospitalier Universitaire de Quebec
Outcomes
Primary Outcome Measures
To assess the effect of 28 days of daily dosing of LTB4 on HIV viral load
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00251537
Brief Title
A Pilot Study of LTB4 in HIV-1 Infected Adults
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
LTB4 Sweden AB
4. Oversight
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Pilot study, Randomized, Placebo-controlled, Double-blind, Effect on viral load, LTB4, HIV-1 infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
LTB4
Primary Outcome Measure Information:
Title
To assess the effect of 28 days of daily dosing of LTB4 on HIV viral load
Secondary Outcome Measure Information:
Title
To assess safety and tolerability of 28 days of daily dosing
Title
To assess effects on CD4 and CD8 counts of 28 days of daily dosing
Title
To assess effects on neutrophil counts of 28 days of dosing
Title
To assess effects on release of alfa-defensins and CC-chemokines in blood on day s 1, 14 and 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Lalonde, MD
Organizational Affiliation
Montreal Chest Institute, Montreal, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for HIV/AIDS, St Pauls Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3Z5
Country
Canada
Facility Name
The Ottawa Hospital (General Campus)
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada
Facility Name
Centre hospitalier de l'Université de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Research Institute of the McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of LTB4 in HIV-1 Infected Adults
We'll reach out to this number within 24 hrs