HIV InfectionsPhase 1NCT00002258
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
A Phase 1 study testing Interleukin-3 in people with HIV Infections and Cytopenias, run by Sandoz at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Cytopenias
- What is being tested?
- Interleukin-3
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have:
- HIV seropositivity by Western blot.
- Advanced ARC or AIDS as defined by CDC.
- Cytopenia defined as total peripheral leukocyte count of < 3,000 cells/mm3 or platelet count of < 100,000 cells/mm3 or serum hemoglobin < 10 g/dl.
- Anticipated life expectancy = or > 6 months.
- Ambulatory.
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- Willing to sign informed consent.
- Willing to forego use of any other investigational therapies except ddI.
- Prior Medication:
- Allowed > 2 weeks prior to study entry:
- zidovudine.
- Allowed > 4 weeks prior to study entry:
- systemic cytotoxic chemotherapy; investigational drugs; medications known to be myelosuppressive as ganciclovir, trimethoprim/sulfamethoxazole or dapsone.
- Allowed > 6 weeks prior to study entry:
- other hemopoietic growth factor treatment as GM-CSF, EPO.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Active opportunistic infection.
- Symptoms of CNS disease referable to HIV infection.
- Dementia or altered mental status that would prohibit giving and understanding informed consent.
- Systemic chemotherapy.
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- Investigational therapies other than ddI.
- Medications with known myelosuppressive effects such as ganciclovir, trimethoprim/sulfamethoxazole or dapsone or AZT.
- Other hematopoietic growth factor treatments as GM-CSF, G-CSF, or EPO.
- Prophylactic therapy for pneumocystis or oral thrush.
- ddI.
- Corticosteroids or topical corticosteroid creams.
- Patients may not have:
- Life expectancy < 6 months.
- Active drug or alcohol abuse.
- Active opportunistic infections.
- Treatment with any other investigational drugs except ddI within 4 weeks of study entry.
- Dementia or altered mental state that prohibits giving informed consent.
- Symptoms of CNS disease referable to HIV infection.
- Major surgery within 4 weeks of study entry.
- History of major pulmonary or cardiac disease.
- History of any prior malignancy other than Kaposi's sarcoma or noninvasive subcutaneous carcinoma.
- Documented allergic disorder such as asthma, history of anaphylaxis, atopy, serum sickness, or bronchospasm.
- Not allowed within 2 weeks prior to study entry:
- zidovudine (AZT).
- Not allowed within 4 weeks prior to study entry:
- systemic cytotoxic chemotherapy; investigational drugs other than ddI; medications known to be myelosuppressive as ganciclovir, trimethoprim/sulfamethoxazole or dapsone.
- Not allowed within 6 weeks prior to study entry:
- other hematopoietic growth factor treatment as GM-CSC, G-CSF, EPO.
- Radiation therapy or major surgery within 4 weeks of study entry.
- Active drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
New England Deaconess Hosp
Boston, Massachusetts, 02215
About this study
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.
- Conditions
- HIV Infections, Cytopenias
- Being tested
- Interleukin-3
- Keywords
- Interleukin-3, Recombinant Proteins, Leukopenia, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Thrombocytopenia
- Medical subject headings
- HIV Infections, Cytopenia, Leukopenia, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleukin-3Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002258
- Sponsor's protocol ID
- 080A
- Other IDs
- B104
- Status last verified
- Nov 1992
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Scadden DT, Levine JD, Bresnahan J, Gere J, McGrath J, Wang Z, Resta DJ, Young D, Hammer SM. In vivo effects of interleukin 3 in HIV type 1-infected patients with cytopenia. AIDS Res Hum Retroviruses. 1995 Jun;11(6):731-40. doi: 10.1089/aid.1995.11.731.
PubMed 7576933Levine AM, Li P, Cheung T, Tulpule A, Von Roenn J, Nathwani BN, Ratner L. Chemotherapy consisting of doxorubicin, bleomycin, vinblastine, and dacarbazine with granulocyte-colony-stimulating factor in HIV-infected patients with newly diagnosed Hodgkin's disease: a prospective, multi-institutional AIDS clinical trials group study (ACTG 149). J Acquir Immune Defic Syndr. 2000 Aug 15;24(5):444-50. doi: 10.1097/00126334-200008150-00009.
PubMed 11035615
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00002258
- Acronym / sponsor ID
- 080A
- Conditions
- HIV Infections, Cytopenias
- Keywords
- Interleukin-3, Recombinant Proteins, Leukopenia, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Thrombocytopenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- HIV seropositivity by Western blot.
- Advanced ARC or AIDS as defined by CDC.
- Cytopenia defined as total peripheral leukocyte count of < 3,000 cells/mm3 or platelet count of < 100,000 cells/mm3 or serum hemoglobin < 10 g/dl.
- Anticipated life expectancy = or > 6 months.
- Ambulatory.
Key exclusion criteria (31 listed)
- Active opportunistic infection.
- Symptoms of CNS disease referable to HIV infection.
- Dementia or altered mental status that would prohibit giving and understanding informed consent.
- Systemic chemotherapy.
- Investigational therapies other than ddI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interleukin-3 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 7576933Scadden DT, Levine JD, Bresnahan J, Gere J, McGrath J, Wang Z, Resta DJ, Young D, Hammer SM. In vivo effects of interleukin 3 in HIV type 1-infected patients with cytopenia. AIDS Res Hum Retroviruses. 1995 Jun;11(6):731-40. doi: 10.1089/aid.1995.11.731.
- Background: PubMed 11035615Levine AM, Li P, Cheung T, Tulpule A, Von Roenn J, Nathwani BN, Ratner L. Chemotherapy consisting of doxorubicin, bleomycin, vinblastine, and dacarbazine with granulocyte-colony-stimulating factor in HIV-infected patients with newly diagnosed Hodgkin's disease: a prospective, multi-institutional AIDS clinical trials group study (ACTG 149). J Acquir Immune Defic Syndr. 2000 Aug 15;24(5):444-50. doi: 10.1097/00126334-200008150-00009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Interleukin-3 in people with HIV Infections and Cytopenias, run by Sandoz at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002258, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.