A Pilot Trial Evaluating an Alternating Schedule of Recombinant Human GM-CSF and Azidothymidine in Patients With HIV Infection and Leukopenia

June 23, 2005 updated by: Sandoz
To evaluate the safety of repeated courses of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) administered subcutaneously to patients with HIV infection and leukopenia. To determine if administration of GM-CSF will prevent some or all of the hematologic toxicity associated with zidovudine ( AZT ) treatment in patients with pre-existing leukopenia. To assess any clinical and/or virologic benefits from administering alternating weeks of GM-CSF and AZT to patients with symptomatic HIV infection who have a history of cytologically confirmed Pneumocystis carinii pneumonia ( PCP ) or a circulating absolute CD4 lymphocyte count less than 200 cells/mm3.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Natl Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients must have:

  • Serum antibody to HIV with or without evidence of HIV antigenemia.
  • White blood cells (WBC) = or < 4500 cells/mm3 measured on at least 2 occasions separated by a minimum of 1 week.
  • Qualifying indications for AZT therapy.
  • Life expectancy = or > 6 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Current or past history of malignancy including Kaposi's sarcoma.
  • Excessive diarrhea or significant malabsorption.
  • If patients have had > 10 percent weight loss within the past 3 months, they should not have malabsorption as evidenced by serum carotene < 75 IU/ml, serum vitamin A < 75 IU/ml, significant malabsorption 4 foul-smelling or greasy stools per day or other criteria.
  • Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection (IO).
  • Less than 1 week since completing treatment of Pneumocystis carinii pneumonia (PCP).
  • Active OI requiring systemic treatment.
  • Evidence of nutritional deficiencies that may contribute to anemia and/or leukopenia.

Concurrent Medication:

Excluded within 4 weeks of study entry:

  • Zidovudine (AZT).
  • Other antiviral agent associated with leukopenia.
  • Investigational drug.
  • Immunomodulators.
  • Interferon.
  • Steroids.
  • Excluded within 8 weeks of study entry:
  • Ribavirin.
  • Excluded within 4 months of study entry:
  • Suramin.

Patients with the following are excluded:

  • Current or past history of malignancy including Kaposi's sarcoma.
  • Excessive diarrhea or significant malabsorption.
  • Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection (OI).
  • Less than 1 week since completing treatment of Pneumocystis carinii pneumonia (PCP).
  • Evidence of nutritional deficiencies that may contribute to anemia and/or leukopenia.

Prior Medication:

Excluded:

  • Prophylactic therapy for Pneumocystis carinii pneumonia (PCP) that may cause leukopenia.

Risk Behavior:

Excluded:

  • Current drug or alcohol abusers.
  • Unprotected sexual contact or other activities that may result in reinfection with HIV.

Patients must be willing to refrain from unprotected sexual contact or other activities that may result in reinfection with HIV.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandoz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

January 1, 1990

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 067C
  • 202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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