NCT00251537

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_2 hiv-infections

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_2 hiv-infections

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

July 10, 2006

Status Verified

July 1, 2006

First QC Date

November 9, 2005

Last Update Submit

July 7, 2006

Conditions

HIV Infections

Keywords

Pilot studyRandomizedPlacebo-controlledDouble-blindEffect on viral loadLTB4HIV-1 infection

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

LTB4DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Centre for HIV/AIDS, St Pauls Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

McMaster University

Hamilton, Ontario, L8N3Z5, Canada

Location

The Ottawa Hospital (General Campus)

Ottawa, Ontario, K1H 8L6, Canada

Location

University Health Network

Toronto, Ontario, M5G2M9, Canada

Location

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2W 1T8, Canada

Location

Research Institute of the McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

Location

Centre Hospitalier Universitaire de Quebec

Ste-Foy, Quebec, G1V 4G2, Canada

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Leukotriene B4

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

LeukotrienesArachidonic AcidsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsFatty Acids, EssentialAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Richard Lalonde, MD

    Montreal Chest Institute, Montreal, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 9, 2005

First Posted

November 10, 2005

Study Start

November 1, 2005

Study Completion

August 1, 2006

Last Updated

July 10, 2006

Record last verified: 2006-07

Locations

CA(7)