Completed

G-CSF for Prevention of Grade 4 Neutropenia in HIV Patients

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What is being tested

Filgrastim

Drug
Who is being recruted

Blood-Borne Infections+20

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

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

Patients are randomized to receive subcutaneous G-CSF at one of two different doses or no G-CSF (observation) for 24 weeks. Patients who experience ANC < 500 cells/mm3 on two consecutive occasions at least 24 hours apart prior to completing the 24-week study period will be considered to have reached the primary study endpoint; those in the observation group who reach the primary endpoint prior to week 24 may begin receiving G-CSF for the remainder of the study period. After 24 weeks, patients may continue G-CSF on a compassionate basis at the investigator's discretion.

NCT00002126
Principal SponsorAmgen
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.
Design Details

250 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

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 13 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 DiseasesAgranulocytosisCommunicable DiseasesHematologic DiseasesHemic and Lymphatic DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsLeukocyte DisordersLeukopeniaRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsCytopeniaAcquired Immunodeficiency SyndromeNeutropeniaHIV Infections

Criteria

7 inclusion criteria required to participate
Stable Kaposi's sarcoma is permitted provided patient does not require myelosuppressive therapy (other than interferon) within 4 weeks prior to study entry.
Allowed concurrent medication: Antiretroviral agents (e.g., AZT, ganciclovir, ddI, ddC), trimethoprim-sulfamethoxazole (Bactrim), interferon, and amphotericin B only if patient is on the same dose for at least 14 days prior to study entry (patients may not start or stop these agents within 14 days prior to study entry).
ANC (segmental neutrophils plus bands) >= 750 and < 1000 cells/mm3 within 7 days prior to study entry.
Life expectancy of at least 6 months.
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5 exclusion criteria prevent from participating
Psychiatric, addictive, or other disorder that compromises ability to give informed consent.
Malignancy other than Kaposi's sarcoma and localized basal or squamous cell carcinoma.
G-CSF, other hematopoietic growth factors (except for erythropoietin), or investigational agents within 14 days prior to study entry.
Substance abuse that would compromise compliance.
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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 22 locations

Univ of Alabama at Birmingham / AIDS Outpatient Clinic

Birmingham, United StatesOpen Univ of Alabama at Birmingham / AIDS Outpatient Clinic in Google Maps

Maricopa County Med Ctr

Phoenix, United States

CARE Ctr / UCLA Med Ctr

Los Angeles, United States

UCSF - San Francisco Gen Hosp

San Francisco, United States
Completed22 Study Centers