NCT00002258

Brief Summary

To determine the safety, tolerability and maximum tolerated dose of SDZ ILE 964 administered by daily subcutaneous injections in patients infected with human immunodeficiency virus (HIV) who have cytopenias (low blood cell counts). To obtain information about the biologic effects of SDZ ILE 964 administration in improving blood counts in HIV-infected patients. To obtain information about the effects of SDZ ILE-964 administration on both parameters of HIV replication and on residual immunologic function.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

November 1, 1992

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV InfectionsCytopenias

Keywords

Interleukin-3Recombinant ProteinsLeukopeniaAcquired Immunodeficiency SyndromeAIDS-Related ComplexThrombocytopenia

Interventions

Interleukin-3DRUG

Eligibility Criteria

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

You may qualify if:

  • Patients must have:
  • HIV seropositivity by Western blot.
  • Advanced ARC or AIDS as defined by CDC.
  • Cytopenia defined as total peripheral leukocyte count of \< 3,000 cells/mm3 or platelet count of \< 100,000 cells/mm3 or serum hemoglobin \< 10 g/dl.
  • Anticipated life expectancy = or \> 6 months.
  • Ambulatory.
  • Willing to sign informed consent.
  • Willing to forego use of any other investigational therapies except ddI.
  • Prior Medication:
  • Allowed \> 2 weeks prior to study entry:
  • zidovudine.
  • Allowed \> 4 weeks prior to study entry:
  • systemic cytotoxic chemotherapy; investigational drugs; medications known to be myelosuppressive as ganciclovir, trimethoprim/sulfamethoxazole or dapsone.
  • Allowed \> 6 weeks prior to study entry:
  • other hemopoietic growth factor treatment as GM-CSF, EPO.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Active opportunistic infection.
  • Symptoms of CNS disease referable to HIV infection.
  • Dementia or altered mental status that would prohibit giving and understanding informed consent.
  • Systemic chemotherapy.
  • Investigational therapies other than ddI.
  • Medications with known myelosuppressive effects such as ganciclovir, trimethoprim/sulfamethoxazole or dapsone or AZT.
  • Other hematopoietic growth factor treatments as GM-CSF, G-CSF, or EPO.
  • Prophylactic therapy for pneumocystis or oral thrush.
  • ddI.
  • Corticosteroids or topical corticosteroid creams.
  • Patients may not have:
  • Life expectancy \< 6 months.
  • Active drug or alcohol abuse.
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New England Deaconess Hosp

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

  • Scadden DT, Levine JD, Bresnahan J, Gere J, McGrath J, Wang Z, Resta DJ, Young D, Hammer SM. In vivo effects of interleukin 3 in HIV type 1-infected patients with cytopenia. AIDS Res Hum Retroviruses. 1995 Jun;11(6):731-40. doi: 10.1089/aid.1995.11.731.

    PMID: 7576933BACKGROUND

  • Levine AM, Li P, Cheung T, Tulpule A, Von Roenn J, Nathwani BN, Ratner L. Chemotherapy consisting of doxorubicin, bleomycin, vinblastine, and dacarbazine with granulocyte-colony-stimulating factor in HIV-infected patients with newly diagnosed Hodgkin's disease: a prospective, multi-institutional AIDS clinical trials group study (ACTG 149). J Acquir Immune Defic Syndr. 2000 Aug 15;24(5):444-50. doi: 10.1097/00126334-200008150-00009.

    PMID: 11035615BACKGROUND

MeSH Terms

Conditions

HIV InfectionsCytopeniaLeukopeniaAcquired Immunodeficiency SyndromeAIDS-Related ComplexThrombocytopenia

Interventions

Interleukin-3

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte DisordersSlow Virus DiseasesBlood Platelet Disorders

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsInterleukinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1992-11

Locations

US(1)