HIV InfectionsNCT00002281
A Study of Granulocyte Colony-Stimulating Factor Plus Recombinant Erythropoietin Plus Zidovudine in Patients With AIDS or AIDS-Related Complex
A study testing Filgrastim, Epoetin alfa and Zidovudine in people with HIV Infections and Cytopenias, run by Amgen at 1 site in United States.
Trial summary
To evaluate the safety, tolerance and biological activity of filgrastim (granulocyte colony-stimulating factor; G-CSF) given by daily subcutaneous (SC) injection prior to and concomitantly with erythropoietin (EPO) and zidovudine (AZT) in patients with AIDS or severe AIDS related complex (ARC). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections, Cytopenias
- What is being tested?
- Filgrastim, Epoetin alfa and Zidovudine
- How many people
- 24 participants
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Treatment:
- Allowed:
- Radiation or laser therapy to Kaposi's sarcoma lesions provided the dose does not exceed 3000 rads to any one lesion group and/or greater than 10 cm2 total body surface area.
- Patients must have:
- A diagnosis of AIDS or AIDS related complex (ARC) as defined by current CDC guidelines.
- Life expectancy > 6 months.
- Defined blood cell counts that may be achieved by transfusion.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- History of malignancy other than Kaposi's sarcoma (KS).
- Presence of > 50 cutaneous KS lesions or progression of KS over the previous 30 days.
- Presence of opportunistic infection requiring ongoing therapy with known bone marrow suppressive agents.
- History of cardiovascular disease.
Show all 41Show fewer
- History of seizures.
- HIV related dementia or altered mental status that would prohibit the giving and understanding of informed consent.
- Presence of iron deficiency anemia as defined by serum ferritin < 30 ng or iron to TIBC ratio < 15 percent.
- A PT > 15 and a PTT > 40 unless due to a documented circulating lupus anticoagulant.
- Concurrent Medication:
- Excluded:
- Trimethoprim / sulfamethoxazole.
- Fansidar.
- Non-FDA approved antiretrovirals.
- Hyperimmunization with polio virus.
- Ribavirin.
- Isoprinosine.
- Dextran sulfate.
- Fu zheng herbs.
- AL 721 or its congeners.
- Imuthiol.
- Interferons.
- Chronic use of acyclovir (> 10 days out of 30 days).
- = or > 3g/day oral vitamin C.
- Patients with the following are excluded:
- Co-existing conditions and symptoms described in Patient Exclusion Co-existing Conditions.
- Prior Medication:
- Excluded within 2 weeks of study entry:
- Any non-FDA approved drug.
- Excluded within 4 weeks of study entry:
- Systemic cytotoxic chemotherapy for Kaposi's sarcoma.
- Investigational agents.
- Excluded:
- Colony stimulating factors.
- Prior Treatment:
- Excluded within 4 weeks of study entry:
- Radiation therapy for Kaposi's sarcoma exceeding 3000 rads to any one lesion group and/or greater than 10 cm2 total body surface area.
- Risk Behavior:
- Excluded within 3 months of study entry:
- Regular excessive use of alcohol, hallucinogens or other psychotropic agents which are possibly addicting.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Phase I/II Study of Recombinant Granulocyte Colony-Stimulating Factor (r-metHuG-CSF) and Recombinant Erythropoietin (rHuEPO) Given Subcutaneously Along With Zidovudine (AZT) to Patients With AIDS or ARC
To evaluate the safety, tolerance and biological activity of filgrastim (granulocyte colony-stimulating factor; G-CSF) given by daily subcutaneous (SC) injection prior to and concomitantly with erythropoietin (EPO) and zidovudine (AZT) in patients with AIDS or severe AIDS related complex (ARC). To evaluate the safety, tolerance, and biological activity of EPO given 3 times weekly by SC injection concomitantly with G-CSF and prior to and concomitantly with AZT in patients with AIDS or severe ARC. To study the safety and tolerance of 3 dose levels of AZT given to patients with AIDS or severe ARC concomitantly treated with G-CSF and EPO. To study the effect of G-CSF alone and in combination with EPO on HIV replication in vivo as measured by circulating HIV p24 antigen, plasma HIV viremia and semiquantitative HIV cocultures.
- Conditions
- HIV Infections, Cytopenias
- Being tested
- Filgrastim, Epoetin alfa, Zidovudine
- Keywords
- Injections, Subcutaneous, Erythropoietin, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
- Medical subject headings
- HIV Infections, Cytopenia, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgrastimDrug
Epoetin alfaDrug
ZidovudineDrug
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 (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002281
- Sponsor's protocol ID
- 061A
- Other IDs
- GCSF-8808-109
- Status last verified
- Jan 1990
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Miles SA, Mitsuyasu RT, Moreno J, Baldwin G, Alton NK, Souza L, Glaspy JA. Combined therapy with recombinant granulocyte colony-stimulating factor and erythropoietin decreases hematologic toxicity from zidovudine. Blood. 1991 May 15;77(10):2109-17.
PubMed 1709368
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
- An Open Label Phase I/II Study of Recombinant Granulocyte Colony-Stimulating Factor (r-metHuG-CSF) and Recombinant Erythropoietin (rHuEPO) Given Subcutaneously Along With Zidovudine (AZT) to Patients With AIDS or ARC
- ClinicalTrials.gov ID
- NCT00002281
- Acronym / sponsor ID
- 061A
- Conditions
- HIV Infections, Cytopenias
- Keywords
- Injections, Subcutaneous, Erythropoietin, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- AmgenIndustry (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 evaluate the safety, tolerance and biological activity of filgrastim (granulocyte colony-stimulating factor; G-CSF) given by daily subcutaneous (SC) injection prior to and concomitantly with erythropoietin (EPO) and zidovudine (AZT) in patients with AIDS or severe AIDS related complex (ARC). To evaluate the safety, tolerance, and biological activity of EPO given 3 times weekly by SC injection concomitantly with G-CSF and prior to and concomitantly with AZT in patients with AIDS or severe ARC. To study the safety and tolerance of 3 dose levels of AZT given to patients with AIDS or severe ARC concomitantly treated with G-CSF and EPO. To study the effect of G-CSF alone and in combination with EPO on HIV replication in vivo as measured by circulating HIV p24 antigen, plasma HIV viremia and semiquantitative HIV cocultures.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Radiation or laser therapy to Kaposi's sarcoma lesions provided the dose does not exceed 3000 rads to any one lesion group and/or greater than 10 cm2 total body surface area.
- A diagnosis of AIDS or AIDS related complex (ARC) as defined by current CDC guidelines.
- Life expectancy > 6 months.
- Defined blood cell counts that may be achieved by transfusion.
Key exclusion criteria (41 listed)
- History of malignancy other than Kaposi's sarcoma (KS).
- Presence of > 50 cutaneous KS lesions or progression of KS over the previous 30 days.
- Presence of opportunistic infection requiring ongoing therapy with known bone marrow suppressive agents.
- History of cardiovascular disease.
- History of seizures.
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 |
|---|---|---|
| Filgrastim | Drug | – |
| Epoetin alfa | Drug | – |
| Zidovudine | 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 1709368Miles SA, Mitsuyasu RT, Moreno J, Baldwin G, Alton NK, Souza L, Glaspy JA. Combined therapy with recombinant granulocyte colony-stimulating factor and erythropoietin decreases hematologic toxicity from zidovudine. Blood. 1991 May 15;77(10):2109-17.
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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 Filgrastim, Epoetin alfa and Zidovudine in people with HIV Infections and Cytopenias, run by Amgen 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 7 inclusion and 41 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?
On the ClinicalTrials.gov record for NCT00002281, which also lists 1 linked publication.
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.