Completed

A Study of Stem Cells and Filgrastim

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

Filgrastim

Drug
Who is being recruted

HIV Infections

Over 18 Years
How is the trial designed

Treatment Study

Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
Sourced from a government-validated database.Claim as a partner

To determine the safety of stem cell harvesting after administration of filgrastim ( G-CSF ) to mobilize bone marrow stem cells into the peripheral blood in patients at various stages of HIV-1 infection as well as in HIV-negative volunteers. To determine the surface phenotypic and functional characteristics as well as the viral load in the stem cells obtained following this procedure. Patients and volunteers receive seven daily subcutaneous injections of G-CSF. On days 5 and 6 of drug administration, patients have peripheral blood mononuclear cells harvested by leukapheresis. HIV-positive patients are stratified into three cohorts based on CD4 count and presence of symptoms. If no increase in number of harvested stem cells and no grade 4 bone pain toxicity occur in two of the first three patients in a cohort, then the last three patients in that cohort will receive a dose escalation. Patients are followed for 24 weeks.

Official TitleA Pilot Study of Stem Cell Mobilization and Harvesting From the Peripheral Blood Using Filgrastim 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
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
24 patients to be enrolledTotal 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 sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Criteria

Inclusion Criteria Concurrent Medication: Allowed: * PCP prophylaxis. * Antiretroviral therapy in patients with CD4 counts \<= 500 cells/mm3. * Narcotic analgesics for grade 3/4 bone pain toxicity. Patients must have: * HIV infection. * HIV infected patients with CD4 count \> 500 cells/mm3 must be asymptomatic. Patients with CD4 count 200-500 cells/mm3 may be either asymptomatic or symptomatic but must not have AIDS. Patients with CD4 count \< 200 cells/mm3 may or may not have AIDS-defining conditions. * No antiretroviral therapy within the past 30 days in patients with asymptomatic disease and CD4 count \> 500 cells/mm3. * Stable antiretroviral therapy for the past 60 days if CD4 count \<= 500 cells/mm3. * Suitable venous access. Prior Medication: Allowed: * Prior antiretroviral therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Current malignancy. * Any medication condition that interferes with study evaluation. * Known hypersensitivity to E. coli-derived proteins (e.g., insulin, human growth hormones). Concurrent Medication: Excluded: * Acute treatment for serious opportunistic infection. * Systemic cytotoxic chemotherapy. Concurrent Treatment: Excluded: * Systemic radiation therapy. Patients with the following prior conditions are excluded: * Prior malignancy. * Leukapheresis or lymphopheresis within the past 180 days. * Significant active CNS disease or seizures within the past year. Prior Medication: Excluded: * G-CSF or GM-CSF within the past 6 months. * Investigational antiretrovirals within the past 30 days. * Treatment for opportunistic infection within the past 14 days. Active alcohol or substance abuse.



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 2 locations
Suspended
UCLA CARE Center CRSLos Angeles, United StatesSee the location
Suspended
University of Colorado Hospital CRSAurora, United States

Completed2 Study Centers