HIV InfectionsNCT00002263
A Pilot Study to Evaluate the Effects of Subcutaneously Administered Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor in Pediatric HIV-Infected Patients With Neutropenia Secondary to Azidothymidine
A study testing Zidovudine and Sargramostim in people with HIV Infections and Cytopenias, run by Sandoz at 1 site in United States.
Trial summary
To assess the safety and efficacy of subcutaneous sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the granulocyte count in HIV-infected children who have developed granulocytopenia as a result of continuous intravenous ( CIV ) zidovudine ( AZT ). Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- HIV Infections, Cytopenias
- What is being tested?
- Zidovudine and Sargramostim
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Concurrent Medication:
- Allowed:
- Zidovudine (AZT) on NIAID 86-C-175.
- Patients must have:
- Diagnosis of perinatal or transfusion acquired AIDS or AIDS related complex.
- Granulocytopenia (< or = to 800 cells/mm3) associated with the administration of AZT on protocol NIAID 86-C-175.
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- Life expectancy > 3 months.
- Functioning indwelling central venous access device in place.
- Prior Medication:
- Allowed within 48 hours of study entry:
- Prophylactic antibiotics.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Critically ill or clinically unstable.
- Significant, active opportunistic or other infection requiring specific drug therapy at time of study entry.
- Ongoing IV alimentation.
- Uncorrected nutritional deficiencies that may contribute to anemia and/or leukopenia.
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- Past history of or current evidence for any chronic hematologic disorder other than hemophilia A or B, anemia of chronic disease or anemia related to HIV infection.
- Malignancy likely to require systemic treatment during study.
- Patients with the following are excluded:
- Critically ill, clinically unstable, or with concomitant diseases listed in Patient Exclusion Co-existing Conditions.
- Hypersensitivity to zidovudine (AZT) or any other nucleoside analog.
- Prior Medication:
- Excluded within 48 hours of study entry:
- Antibiotics.
- Excluded within 30 days of study entry:
- Antiretroviral agents other than zidovudine (AZT).
- Acyclovir.
- Ganciclovir.
- Any investigational drug.
- Immunomodulating drugs.
- Cytolytic chemotherapeutic agents.
- Corticosteroids.
- Immunoglobulin preparations.
- Excluded within 4 months of study entry:
- Suramin.
- Prior Treatment:
- Excluded within 6 months of study entry:
- Bone marrow transplantation.
- Excluded within 4 weeks of study entry:
- Lymphocyte transfusions.
- Radiation therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Natl Cancer Institute / HIV / AIDS Malignancy Branch
Bethesda, Maryland, 20892
About this study
To assess the safety and efficacy of subcutaneous sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the granulocyte count in HIV-infected children who have developed granulocytopenia as a result of continuous intravenous ( CIV ) zidovudine ( AZT ). To assess the short-term and long-term effects of concomitant GM-CSF on other hematologic parameters. To assess the potential therapeutic benefit of concomitant GM-CSF and AZT on the natural history of HIV infection and associated infectious complications.
- Conditions
- HIV Infections, Cytopenias
- Being tested
- Zidovudine, Sargramostim
- Keywords
- Pilot Projects, Neutropenia, Granulocyte-Macrophage Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, Zidovudine
- Medical subject headings
- HIV Infections, Cytopenia, Neutropenia, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZidovudineDrug
SargramostimDrug
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.
- 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 N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002263
- Sponsor's protocol ID
- 067B
- Other IDs
- 206
- Status last verified
- Jan 1990
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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 Pilot Study to Evaluate the Effects of Subcutaneously Administered Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor in Pediatric HIV-Infected Patients With Neutropenia Secondary to Azidothymidine
- ClinicalTrials.gov ID
- NCT00002263
- Acronym / sponsor ID
- 067B
- Conditions
- HIV Infections, Cytopenias
- Keywords
- Pilot Projects, Neutropenia, Granulocyte-Macrophage Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, Zidovudine
- 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 assess the safety and efficacy of subcutaneous sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the granulocyte count in HIV-infected children who have developed granulocytopenia as a result of continuous intravenous ( CIV ) zidovudine ( AZT ). To assess the short-term and long-term effects of concomitant GM-CSF on other hematologic parameters. To assess the potential therapeutic benefit of concomitant GM-CSF and AZT on the natural history of HIV infection and associated infectious complications.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Zidovudine (AZT) on NIAID 86-C-175.
- Diagnosis of perinatal or transfusion acquired AIDS or AIDS related complex.
- Granulocytopenia (< or = to 800 cells/mm3) associated with the administration of AZT on protocol NIAID 86-C-175.
- Life expectancy > 3 months.
- Functioning indwelling central venous access device in place.
Key exclusion criteria (31 listed)
- Critically ill or clinically unstable.
- Significant, active opportunistic or other infection requiring specific drug therapy at time of study entry.
- Ongoing IV alimentation.
- Uncorrected nutritional deficiencies that may contribute to anemia and/or leukopenia.
- Past history of or current evidence for any chronic hematologic disorder other than hemophilia A or B, anemia of chronic disease or anemia related to HIV infection.
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 |
|---|---|---|
| Zidovudine | Drug | – |
| Sargramostim | 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.
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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 study testing Zidovudine and Sargramostim 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 11 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.
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?
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.