A Pilot Study of LTB4 in HIV-1 Infected Adults
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- To assess the effect of 28 days of daily dosing of LTB4 on HIV viral load
- 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
|Study Start Date:||November 2005|
|Estimated Study Completion Date:||August 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00251537
|Canada, British Columbia|
|Centre for HIV/AIDS, St Pauls Hospital|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Hamilton, Ontario, Canada, L8N3Z5|
|The Ottawa Hospital (General Campus)|
|Ottawa, Ontario, Canada, K1H 8L6|
|University Health Network|
|Toronto, Ontario, Canada, M5G2M9|
|Centre hospitalier de l'Université de Montréal|
|Montreal, Quebec, Canada, H2W 1T8|
|Research Institute of the McGill University Health Centre|
|Montreal, Quebec, Canada, H3G 1A4|
|Centre Hospitalier Universitaire de Quebec|
|Ste-Foy, Quebec, Canada, G1V 4G2|
|Principal Investigator:||Richard Lalonde, MD||Montreal Chest Institute, Montreal, Canada|