Completed

Filgrastim, Erythropoietin, and Zidovudine for AIDS or Severe ARC Patients

What is being tested

Filgrastim

+ Epoetin alfa

+ Zidovudine

Drug

Who is being recruted

Blood-Borne Infections+14

+ Urogenital Diseases

+ Genital Diseases

From 18 to 65 Years

+19 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

See protocol details

Summary

Principal SponsorAmgen

Last updated: June 24, 2005

Sourced from a government-validated database.Claim as a partner

This study focuses on individuals diagnosed with AIDS or severe AIDS-Related Complex (ARC). The main goal is to evaluate the safety and effectiveness of three drugs: filgrastim (recombinant granulocyte colony stimulating factor; G-CSF), erythropoietin (EPO), and zidovudine (AZT) when given together. The study hopes to understand how these drugs, when combined, can improve the health of patients with AIDS or severe ARC, potentially addressing unmet needs in their treatment. During the study, participants receive daily injections of filgrastim under the skin, along with erythropoietin injections three times a week. Additionally, they take zidovudine. The study examines how well these treatments are tolerated and how they affect various aspects of the patients' health. This includes looking at the impact on neutrophil function and number, and HIV replication, measured by circulating HIV p24 antigen, plasma HIV viremia, and semiquantitative HIV cocultures.

NCT00002255

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.

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.

From 18 to 65 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 DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexHIV Infections

Criteria

3 inclusion criteria required to participate

Concurrent Medication: Allowed: Ganciclovir (DHPG) for treatment of CMV infections

Concurrent Treatment: Allowed: Radiotherapy or laser therapy for Kaposi's sarcoma lesions provided dose does not exceed 3000 rads to any one lesion group and/or greater than 10 cm total body surface area

Patients must have: AIDS or severe ARC

16 exclusion criteria prevent from participating

Any non-FDA approved drug within the previous 2 weeks

Any other non-FDA approved agent that may have antiretroviral activity

Evidence of a primary hematologic or infectious disorder unrelated to infection with the HIV virus

HIV-related dementia or altered mental status that would prohibit 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

UCLA Med Ctr

Los Angeles, United StatesOpen UCLA Med Ctr in Google Maps

CompletedOne Study Center