|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Endpoint Classification: Safety Study Masking: Open Label Primary Purpose: Treatment |
| 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
| ClinicalTrials.gov Identifier: | NCT00002258 History of Changes |
| Other Study ID Numbers: | 080A, B104 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Interleukin-3 Recombinant Proteins Leukopenia |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Thrombocytopenia |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |