Completed

Assessing Safety and Efficacy of Sargramostim (GM-CSF) and AZT in HIV-Infected Adults with Neutropenia

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Zidovudine

+ Sargramostim

Drug
Who is being recruted

Blood-Borne Infections+20

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+26 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 HIV-infected adults who have developed a condition called neutropenia, which is a low count of a type of white blood cells called neutrophils. This can be a side effect of the antiretroviral medication, zidovudine (AZT). The study aims to evaluate the safety and effectiveness of a drug called sargramostim (GM-CSF) in increasing and maintaining neutrophil counts. This could potentially help HIV-infected adults with neutropenia better tolerate AZT treatment. The study also explores the potential therapeutic benefits of using GM-CSF alongside AZT on the progression of HIV infection and related complications.

NCT00002006
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 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

5 inclusion criteria required to participate
Life expectancy = or > 6 months.
Diagnosis of AIDS or AIDS related complex (ARC).
Neutropenia, due either to zidovudine (AZT) or HIV infection.
Allowed: Minimal local irradiation for tumors.
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21 exclusion criteria prevent from participating
Any investigational drug within 4 weeks of study entry.
Uncorrected nutritional deficiencies that may contribute to neutropenia.
Transfusion within 1 month of study entry.
Antiretroviral agent other than zidovudine (AZT) within 4 weeks of study entry.
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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 1 location

Natl Cancer Institute

Bethesda, United StatesOpen Natl Cancer Institute in Google Maps
CompletedOne Study Center