A Pilot Study of Stem Cell Mobilization and Harvesting From the Peripheral Blood Using Filgrastim
Filgrastim
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.24 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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 allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
University of Colorado Hospital CRS
Aurora, United States