Completed

SDZ ILE-964 Safety, Tolerance, and Biological Effects in HIV Patients With Cytopenia

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What is being tested

Interleukin-3

Drug
Who is being recruted

Blood-Borne Infections+21

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+30 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorSandoz
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on evaluating a drug called SDZ ILE-964 in HIV-infected individuals who have cytopenias, a condition characterized by low blood cell counts. The main goal is to understand the safety and tolerability of this drug when given through daily subcutaneous injections. The study is important because it aims to find a potential treatment that could improve blood counts in HIV patients, which could subsequently enhance their quality of life and overall health. During the study, participants receive SDZ ILE-964 through daily injections under the skin. The effects of the drug on blood counts, HIV replication, and remaining immune function are carefully monitored. This helps researchers understand how the drug works and whether it brings any improvements. The study also seeks to determine the maximum tolerated dose of the drug, ensuring that future treatments are as safe and effective as possible.

NCT00002258
Principal SponsorSandoz
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

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

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesBlood Platelet DisordersCommunicable DiseasesHematologic DiseasesHemic and Lymphatic DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsLeukocyte DisordersRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsCytopeniaAcquired Immunodeficiency SyndromeAIDS-Related ComplexLeukopeniaThrombocytopeniaHIV Infections

Criteria

10 inclusion criteria required to participate
Advanced ARC or AIDS as defined by CDC
Ambulatory
Anticipated life expectancy = or > 6 months
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
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20 exclusion criteria prevent from participating
Active drug or alcohol abuse
Active opportunistic infection
Corticosteroids or topical corticosteroid creams
Dementia or altered mental status that would prohibit giving and understanding informed consent
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

New England Deaconess Hosp

Boston, United StatesOpen New England Deaconess Hosp in Google Maps
CompletedOne Study Center