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Status:

COMPLETED

A Pilot Study of LTB4 in HIV-1 Infected Adults

Lead Sponsor:

LTB4 Sweden AB

Conditions:

HIV Infections

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

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...

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 infecte...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2005

    Trial Type :

    INTERVENTIONAL

    End Date :

    August 1 2006

    Estimated Enrollment :

    40 Patients enrolled

    Trial Details

    Trial ID

    NCT00251537

    Start Date

    November 1 2005

    End Date

    August 1 2006

    Last Update

    July 10 2006

    Active Locations (7)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (7 locations)

    1

    Centre for HIV/AIDS, St Pauls Hospital

    Vancouver, British Columbia, Canada, V6Z 1Y6

    2

    McMaster University

    Hamilton, Ontario, Canada, L8N3Z5

    3

    The Ottawa Hospital (General Campus)

    Ottawa, Ontario, Canada, K1H 8L6

    4

    University Health Network

    Toronto, Ontario, Canada, M5G2M9