HIV InfectionsPhase 1NCT00002009
A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
A Phase 1 study testing Sargramostim in people with HIV Infections and Cytopenias, run by Sandoz at 2 sites in United States.
Trial summary
To determine the maximum tolerated dose (MTD) and toxicity of sargramostim (recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF) given by continuous intravenous infusion (CIV) in patients with leukopenia in association with AIDS virus infection. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- HIV Infections, Cytopenias
- What is being tested?
- Sargramostim
- How many people
- Not given
- Where
- 2 sitesUnited 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 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Patients must have:
- Met the CDC criteria for the diagnosis of AIDS.
- Total peripheral blood leukocyte count = or < 3000 cells/mm3 measured on at least two occasions separated by a minimum of one week.
- Must have or have recovered from one or more opportunistic infection.
- Serum antibody to HTLV-III/LAV with or without viremia.
- Anticipated survival of at least 6 months.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- AIDS related complex (ARC).
- History of malignancy other than Kaposi's sarcoma (KS).
- Excessive diarrhea (more than 5 liquid or non-liquid stools per day).
- Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infections.
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- Presence of renal dysfunction.
- Other evidence of primary hematologic or infectious disorders unrelated to AIDS virus infection.
- Patients with the following are excluded:
- AIDS related complex (ARC).
- History of malignancy other than Kaposi's sarcoma (KS).
- Excessive diarrhea (more than 5 liquid or non-liquid stools per day).
- Currently hospitalized or hospitalized within the last 4 weeks for the treatment of an opportunistic infection.
- Dementia or altered mental status that would prohibit the giving and understanding of informed consent.
- Prior Medication:
- Excluded:
- Any marrow suppressive medications such as trimethoprim-sulfamethoxazole combination (TMP-PurposeX) or Fansidar.
- Excluded within 6 weeks of study entry:
- Any investigational drug.
- Prior Treatment:
- Excluded within 6 weeks of study entry:
- Systemic cytotoxic chemotherapy or irradiation.
- Risk Behavior:
- Excluded within 3 months of study entry:
- Regular, excessive use of alcohol, hallucinogens or agents which are addicting.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
UCLA CARE Ctr
Los Angeles, California, 90095
About this study
To determine the maximum tolerated dose (MTD) and toxicity of sargramostim (recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF) given by continuous intravenous infusion (CIV) in patients with leukopenia in association with AIDS virus infection. In addition, single dose and steady state pharmacokinetics will also be determined.
- Conditions
- HIV Infections, Cytopenias
- Being tested
- Sargramostim
- Keywords
- Leukopenia, Drug Evaluation, Granulocyte-Macrophage Colony-Stimulating Factor
- Medical subject headings
- HIV Infections, Cytopenia, Leukopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
- Publications (1)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
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002009
- Sponsor's protocol ID
- 067E
- Other IDs
- 101
- Status last verified
- Jun 1988
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Barbarini G, Garavelli G, Grisorio B, Barbaro G, Giangregorio F. GM-CSF in HIV related leukopenia: efficacy and tolerability of three months therapy on 50 patients. Int Conf AIDS. 1996 Jul 7-12;11(1):313 (abstract no TuB2279)
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/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
- ClinicalTrials.gov ID
- NCT00002009
- Acronym / sponsor ID
- 067E
- Conditions
- HIV Infections, Cytopenias
- Keywords
- Leukopenia, Drug Evaluation, Granulocyte-Macrophage Colony-Stimulating Factor
- 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 maximum tolerated dose (MTD) and toxicity of sargramostim (recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF) given by continuous intravenous infusion (CIV) in patients with leukopenia in association with AIDS virus infection. In addition, single dose and steady state pharmacokinetics will also be determined.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Met the CDC criteria for the diagnosis of AIDS.
- Total peripheral blood leukocyte count = or < 3000 cells/mm3 measured on at least two occasions separated by a minimum of one week.
- Must have or have recovered from one or more opportunistic infection.
- Serum antibody to HTLV-III/LAV with or without viremia.
- Anticipated survival of at least 6 months.
Key exclusion criteria (25 listed)
- AIDS related complex (ARC).
- History of malignancy other than Kaposi's sarcoma (KS).
- Excessive diarrhea (more than 5 liquid or non-liquid stools per day).
- Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infections.
- Presence of renal dysfunction.
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 |
|---|---|---|
| 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.
- BackgroundBarbarini G, Garavelli G, Grisorio B, Barbaro G, Giangregorio F. GM-CSF in HIV related leukopenia: efficacy and tolerability of three months therapy on 50 patients. Int Conf AIDS. 1996 Jul 7-12;11(1):313 (abstract no TuB2279)
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sargramostim in people with HIV Infections and Cytopenias, run by Sandoz at 2 sites 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 6 inclusion and 25 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 2 sites 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 NCT00002009, 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.