HIV InfectionsNCT00002007
A Pilot Trial Evaluating an Alternating Schedule of Recombinant Human GM-CSF and Azidothymidine in Patients With HIV Infection and Leukopenia
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 evaluate the safety of repeated courses of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) administered subcutaneously to patients with HIV infection and leukopenia. 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?
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have:
- Serum antibody to HIV with or without evidence of HIV antigenemia.
- White blood cells (WBC) = or < 4500 cells/mm3 measured on at least 2 occasions separated by a minimum of 1 week.
- Qualifying indications for AZT therapy.
- Life expectancy = or > 6 months.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Current or past history of malignancy including Kaposi's sarcoma.
- Excessive diarrhea or significant malabsorption.
- If patients have had > 10 percent weight loss within the past 3 months, they should not have malabsorption as evidenced by serum carotene < 75 IU/ml, serum vitamin A < 75 IU/ml, significant malabsorption 4 foul-smelling or greasy stools per day or other criteria.
- Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection (IO).
Show all 35Show fewer
- Less than 1 week since completing treatment of Pneumocystis carinii pneumonia (PCP).
- Active OI requiring systemic treatment.
- Evidence of nutritional deficiencies that may contribute to anemia and/or leukopenia.
- Concurrent Medication:
- Excluded within 4 weeks of study entry:
- Zidovudine (AZT).
- Other antiviral agent associated with leukopenia.
- Investigational drug.
- Immunomodulators.
- Interferon.
- Steroids.
- Excluded within 8 weeks of study entry:
- Ribavirin.
- Excluded within 4 months of study entry:
- Suramin.
- Patients with the following are excluded:
- Current or past history of malignancy including Kaposi's sarcoma.
- Excessive diarrhea or significant malabsorption.
- Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection (OI).
- Less than 1 week since completing treatment of Pneumocystis carinii pneumonia (PCP).
- Evidence of nutritional deficiencies that may contribute to anemia and/or leukopenia.
- Prior Medication:
- Excluded:
- Prophylactic therapy for Pneumocystis carinii pneumonia (PCP) that may cause leukopenia.
- Risk Behavior:
- Excluded:
- Current drug or alcohol abusers.
- Unprotected sexual contact or other activities that may result in reinfection with HIV.
- Patients must be willing to refrain from unprotected sexual contact or other activities that may result in reinfection with HIV.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the safety of repeated courses of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) administered subcutaneously to patients with HIV infection and leukopenia. To determine if administration of GM-CSF will prevent some or all of the hematologic toxicity associated with zidovudine ( AZT ) treatment in patients with pre-existing leukopenia. To assess any clinical and/or virologic benefits from administering alternating weeks of GM-CSF and AZT to patients with symptomatic HIV infection who have a history of cytologically confirmed Pneumocystis carinii pneumonia ( PCP ) or a circulating absolute CD4 lymphocyte count less than 200 cells/mm3.
- Conditions
- HIV Infections, Cytopenias
- Being tested
- Zidovudine, Sargramostim
- Keywords
- Leukopenia, Granulocyte-Macrophage Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, Zidovudine
- Medical subject headings
- HIV Infections, Cytopenia, Leukopenia, 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
- NCT00002007
- Sponsor's protocol ID
- 067C
- Other IDs
- 202
- 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 Trial Evaluating an Alternating Schedule of Recombinant Human GM-CSF and Azidothymidine in Patients With HIV Infection and Leukopenia
- ClinicalTrials.gov ID
- NCT00002007
- Acronym / sponsor ID
- 067C
- Conditions
- HIV Infections, Cytopenias
- Keywords
- Leukopenia, 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 evaluate the safety of repeated courses of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) administered subcutaneously to patients with HIV infection and leukopenia. To determine if administration of GM-CSF will prevent some or all of the hematologic toxicity associated with zidovudine ( AZT ) treatment in patients with pre-existing leukopenia. To assess any clinical and/or virologic benefits from administering alternating weeks of GM-CSF and AZT to patients with symptomatic HIV infection who have a history of cytologically confirmed Pneumocystis carinii pneumonia ( PCP ) or a circulating absolute CD4 lymphocyte count less than 200 cells/mm3.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Serum antibody to HIV with or without evidence of HIV antigenemia.
- White blood cells (WBC) = or < 4500 cells/mm3 measured on at least 2 occasions separated by a minimum of 1 week.
- Qualifying indications for AZT therapy.
- Life expectancy = or > 6 months.
Key exclusion criteria (35 listed)
- Current or past history of malignancy including Kaposi's sarcoma.
- Excessive diarrhea or significant malabsorption.
- If patients have had > 10 percent weight loss within the past 3 months, they should not have malabsorption as evidenced by serum carotene < 75 IU/ml, serum vitamin A < 75 IU/ml, significant malabsorption 4 foul-smelling or greasy stools per day or other criteria.
- Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection (IO).
- Less than 1 week since completing treatment of Pneumocystis carinii pneumonia (PCP).
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 5 inclusion and 35 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.