Trials / Completed
CompletedNCT00002007
A Pilot Trial Evaluating an Alternating Schedule of Recombinant Human GM-CSF and Azidothymidine in Patients With HIV Infection and Leukopenia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Sandoz · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety of repeated courses of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) administered subcutaneously to patients with HIV infection and leukopenia. To determine if administration of GM-CSF will prevent some or all of the hematologic toxicity associated with zidovudine ( AZT ) treatment in patients with pre-existing leukopenia. To assess any clinical and/or virologic benefits from administering alternating weeks of GM-CSF and AZT to patients with symptomatic HIV infection who have a history of cytologically confirmed Pneumocystis carinii pneumonia ( PCP ) or a circulating absolute CD4 lymphocyte count less than 200 cells/mm3.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zidovudine | |
| DRUG | Sargramostim |
Timeline
- First posted
- 2001-08-31
- Last updated
- 2005-06-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00002007. Inclusion in this directory is not an endorsement.