Trials / Completed
CompletedNCT00002009
A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Sandoz · Industry
- Sex
- Male
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
To determine the maximum tolerated dose (MTD) and toxicity of sargramostim (recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF) given by continuous intravenous infusion (CIV) in patients with leukopenia in association with AIDS virus infection. In addition, single dose and steady state pharmacokinetics will also be determined.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sargramostim |
Timeline
- First posted
- 2001-08-31
- Last updated
- 2005-06-24
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00002009. Inclusion in this directory is not an endorsement.