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| Sponsor: | Sandoz Inc. |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002258 |
Purpose
To determine the safety, tolerability and maximum tolerated dose of SDZ ILE 964 administered by daily subcutaneous injections in patients infected with human immunodeficiency virus (HIV) who have cytopenias (low blood cell counts). To obtain information about the biologic effects of SDZ ILE 964 administration in improving blood counts in HIV-infected patients. To obtain information about the effects of SDZ ILE-964 administration on both parameters of HIV replication and on residual immunologic function.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Cytopenias |
Drug: Interleukin-3 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Safety Study |
| Official Title: | A Phase I, Open Label Trial to Evaluate the Safety, Tolerance and Biological Effects of SDZ ILE-964 (Recombinant Human Interleukin-3, RhIL-3) in HIV Infected Patients With Cytopenia |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Prior Medication:
Allowed > 2 weeks prior to study entry:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Systemic chemotherapy.
Prophylactic therapy for pneumocystis or oral thrush.
Patients may not have:
Not allowed within 2 weeks prior to study entry:
Radiation therapy or major surgery within 4 weeks of study entry.
Active drug or alcohol abuse.
Contacts and Locations
More Information
| Study ID Numbers: | 080A, B104 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002258 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Interleukin-3 Recombinant Proteins Leukopenia |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Thrombocytopenia |
|
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |