Completed

Recombinant Human GM-CSF and Azidothymidine for HIV Infection and Leukopenia

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+18

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

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 patients with HIV infection and leukopenia, a condition characterized by low white blood cell count. The main goal is to evaluate the safety of sargramostim, also known as recombinant human GM-CSF, when given repeatedly to these patients. The study also aims to understand if GM-CSF can prevent some or all of the hematologic toxicity, or blood-related side effects, associated with another HIV medication, zidovudine (AZT), in patients who already have leukopenia. Additionally, the study explores any potential clinical and/or virologic benefits of administering alternating weeks of GM-CSF and AZT to patients with symptomatic HIV infection who have a history of Pneumocystis carinii pneumonia (PCP) or a low CD4 lymphocyte count.

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 DiseasesCommunicable DiseasesHematologic DiseasesHemic and Lymphatic DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsLeukocyte DisordersRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsCytopeniaAcquired Immunodeficiency SyndromeLeukopeniaHIV Infections

Criteria

4 inclusion criteria required to participate
Life expectancy = or > 6 months

Qualifying indications for AZT therapy

Serum antibody to HIV with or without evidence of HIV antigenemia

White blood cells (WBC) = or < 4500 cells/mm3 measured on at least 2 occasions separated by a minimum of 1 week

18 exclusion criteria prevent from participating
Active OI requiring systemic treatment

Current drug or alcohol abusers

Current or past history of malignancy including Kaposi's sarcoma

Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection (IO)

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

Natl Cancer Institute

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