|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |
| Brief 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 |
| 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 |
| Brief Summary | 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. |
| Detailed Description | |
| Study Phase | Phase I |
| Study Type † | Interventional |
| Study Design † | Treatment, Open Label, Safety Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | HIV Infections Cytopenias |
| Intervention † | Drug: Interleukin-3 |
| MEDLINE PMIDs | 7576933, 11035615 |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | |
| Start Date † | |
| Completion Date | |
| Eligibility Criteria † | 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. |
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00002258 |
| Organization ID | 080A |
| Secondary IDs †† | B104 |
| Study Sponsor † | Sandoz Inc. |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | November 1992 |
| First Received Date † | November 2, 1999 |
| Last Updated Date | June 23, 2005 |