CompletedNot Applicable

A Study of Stem Cells and Filgrastim

United States24 participants

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00001071

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

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