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A Pilot Study of LTB4 in HIV-1 Infected Adults

This study has been completed.
Sponsor:
Information provided by:
LTB4 Sweden AB
ClinicalTrials.gov Identifier:
NCT00251537
First received: November 9, 2005
Last updated: July 7, 2006
Last verified: July 2006
History of Changes
  Purpose

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.


Condition Intervention Phase
HIV Infections
 Drug: LTB4
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by LTB4 Sweden AB:

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

Estimated Enrollment: 40
Study Start Date: November 2005
Estimated Study Completion Date: August 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female subjects between 18 and 65 years of age
  2. Diagnosis of HIV-1 infection
  3. Plasma HIV RNA level greater or equal to 5,000 copies/mL at the screening visit
  4. 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
  5. No ART within two months of study entry
  6. Karnofsky score equal to or above 80
  7. If female of childbearing potential, a negative serum pregnancy test at screening.
  8. 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
  9. Subject is capable of understanding and signing an informed consent form

Exclusion criteria:

  1. Primary HIV-1 infection
  2. Use of investigational therapy in the preceding month prior to screening visit
  3. Prior screening for entry into this study
  4. Use of G-CSF, GM-CSF, IL-2, IFNs, erythropoietin, systemic or inhaled steroids within one month of the screening visit
  5. HIV-vaccine within one year of the screening visit
  6. Concurrent disease or conditions that may present a risk to the subjects
  7. Females who are pregnant or breast feeding
  8. History of any malignancy or any active malignancy, except cutaneous Kaposis sarcoma
  9. Unexplained temperature of 38.5 degrees Celsius
  10. Chronic diarrhea (>3 liquid stools per day persisting for 15 days) within one month prior to study entry
  11. Calculated creatinine clearance outside normal limits
  12. Urinalysis: hemoglobinuria, present
  13. Liver transaminases > 3 x ULN
  14. Absolute neutrophil count < 500/mm3
  15. Hemoglobin < 8.0g/dL
  16. Platelet count < 75,000/mm3
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00251537

Locations
Canada, British Columbia
Centre for HIV/AIDS, St Pauls Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N3Z5
The Ottawa Hospital (General Campus)
Ottawa, Ontario, Canada, K1H 8L6
University Health Network
Toronto, Ontario, Canada, M5G2M9
Canada, Quebec
Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada, H3G 1A4
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2W 1T8
Centre Hospitalier Universitaire de Quebec
Ste-Foy, Quebec, Canada, G1V 4G2
Sponsors and Collaborators
LTB4 Sweden AB
Investigators
Principal Investigator: Richard Lalonde, MD Montreal Chest Institute, Montreal, Canada
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00251537     History of Changes
Other Study ID Numbers: LTB4 200501
Study First Received: November 9, 2005
Last Updated: July 7, 2006
Health Authority: Canada: Health Canada

Keywords provided by LTB4 Sweden AB:
Pilot study
Randomized
Placebo-controlled
Double-blind
 Effect on viral load
LTB4
HIV-1 infection

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 19, 2013