HIV InfectionsPhase 1NCT00000711
Granulocyte-Macrophage Colony-Stimulating Factor and Zidovudine: A Phase I Study of Concurrent Administration in Patients With AIDS and Severe ARC
A Phase 1 study testing Zidovudine and Sargramostim in people with HIV Infections and Cytopenias, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
To administer colony-stimulating factor (GM-CSF) for 4 weeks to AIDS and advanced AIDS related complex (ARC) patients who have been receiving zidovudine (AZT) therapy, in order to obtain data on short-term effectiveness, safety, toxicity, pharmacokinetics, and tolerance of combined treatment with the two drugs. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- HIV Infections, Cytopenias
- What is being tested?
- Zidovudine and Sargramostim
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento May 1990
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Modest doses of acetaminophen, aspirin, or non-prescription doses of ibuprofen may be used with caution for fever control and mild analgesia. Prolonged use more than 72 hours is not advised without dose supervision.
- All patients should have a documented history of positive HIV antibody by ELISA test. Patients should qualify for zidovudine (AZT) treatment for the following reasons:
- Patients with a prior episode of cytologically confirmed Pneumocystis carinii pneumonia (PCP).
- Patients with a prior episode of any AIDS-defining opportunistic infection and less than 200 T4 cells.
Show all 11Show fewer
- Patients with advanced ARC as defined by mucocutaneous candidiasis and/or unexplained weight loss and less than 200 T4 cells and fever more than 100 degrees F of more than 3 weeks duration; clinical diagnosis of hairy leukoplakia; herpes zoster infection within 3 months of entry; or unexplained diarrhea.
- All patients must have received at least 8 weeks of AZT prior to enrollment and must not have required a dose adjustment for the previous 4 weeks.
- Patients must be willing to sign an informed consent statement.
- Required:
- Zidovudine (AZT) for at least 8 weeks.
Who cannot join
- Co-existing Condition:
- The following patients will be excluded:
- Patients receiving zidovudine (AZT) while enrolled in another protocol.
- Patients with other life-threatening and uncontrolled opportunistic infection.
- Patients with evidence of lymphoma or neoplasm other than indolent Kaposi's sarcoma.
- Dementia that would prevent giving appropriate informed consent.
Show all 19Show fewer
- Concurrent Medication:
- Excluded:
- Acetaminophen or products containing acetaminophen.
- Drugs that are nephrotoxic, are cytotoxic, or decrease blood cell number or function may increase the risk of toxicity.
- Probenecid may inhibit excretion of zidovudine (AZT). Some experimental nucleoside analogs should be avoided.
- The following patients will be excluded:
- Patients receiving zidovudine (AZT) while enrolled in another protocol.
- Patients with other life-threatening and uncontrolled opportunistic infection.
- Patients with evidence of lymphoma or neoplasm other than indolent Kaposi's sarcoma.
- Dementia that would prevent giving appropriate informed consent.
- Prior Medication:
- Excluded within 8 weeks of study entry:
- Prior systemic therapy with an antimetabolite, cytotoxic drug, interferon, immunomodulator, corticosteroid, or nucleoside analog other than zidovudine.
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
About this study
To administer colony-stimulating factor (GM-CSF) for 4 weeks to AIDS and advanced AIDS related complex (ARC) patients who have been receiving zidovudine (AZT) therapy, in order to obtain data on short-term effectiveness, safety, toxicity, pharmacokinetics, and tolerance of combined treatment with the two drugs.
Persons infected with HIV virus may undergo a long latency or persistent virus blood levels which may be present before any symptomatic illness. These individuals could, therefore, benefit from therapy with an effective antiretroviral agent. AZT, which is a powerful inhibitor of human retrovirus, has been approved for management of patients with symptomatic HIV infection. GM-CSF not only stimulates the bone marrow, it enhances the function of mature blood cells and has been found to enhance the ability of AZT to suppress HIV replication in vitro (test tube). Combination therapy with GM-CSF and AZT may lower complications as well as the morbidity and mortality associated with HIV infection.
Read the detailed description
Persons infected with HIV virus may undergo a long latency or persistent virus blood levels which may be present before any symptomatic illness. These individuals could, therefore, benefit from therapy with an effective antiretroviral agent. AZT, which is a powerful inhibitor of human retrovirus, has been approved for management of patients with symptomatic HIV infection. GM-CSF not only stimulates the bone marrow, it enhances the function of mature blood cells and has been found to enhance the ability of AZT to suppress HIV replication in vitro (test tube). Combination therapy with GM-CSF and AZT may lower complications as well as the morbidity and mortality associated with HIV infection.
Colony stimulating factor (GM-CSF) is administered subcutaneously, once a day or every other day, for 4 weeks to AIDS and advanced ARC patients who have been receiving and will continue to receive a constant dose of AZT. Treatment is on an outpatient basis.
- Conditions
- HIV Infections, Cytopenias
- Being tested
- Zidovudine, Sargramostim
- Keywords
- Neutropenia, Drug Evaluation, Drug Therapy, Combination, Granulocyte-Macrophage Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
- Medical subject headings
- HIV Infections, Cytopenia, Neutropenia, 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.
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)
- Study completionMay 1990
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 National Institute of Allergy and Infectious Diseases (NIAID)The 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 1
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Hewitt RG, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000711
- Sponsor's protocol ID
- ACTG 065
- Other IDs
- 11039
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Portmore A, Morse G, Hewitt R, Reichman R. Comparative oral disposition of zidovudine in neutropenic AIDS patients and asymptomatic hemophiliacs. Int Conf AIDS. 1990 Jun 20-23;6(3):196 (abstract no SB442)
Hewitt RG, Morse GD, Lawrence WD, Maliszewski ML, Santora J, Bartos L, Bonnem E, Poiesz B. Pharmacokinetics and pharmacodynamics of granulocyte-macrophage colony-stimulating factor and zidovudine in patients with AIDS and severe AIDS-related complex. Antimicrob Agents Chemother. 1993 Mar;37(3):512-22. doi: 10.1128/AAC.37.3.512.
PubMed 8460920Wang GJ, Zhao J, Tomasi D, Kojori ES, Wang R, Wiers CE, Caparelli EC, Volkow ND. Effect of combined naltrexone and bupropion therapy on the brain's functional connectivity. Int J Obes (Lond). 2018 Nov;42(11):1890-1899. doi: 10.1038/s41366-018-0040-2. Epub 2018 Feb 23.
PubMed 29535451
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Granulocyte-Macrophage Colony-Stimulating Factor and Zidovudine: A Phase I Study of Concurrent Administration in Patients With AIDS and Severe ARC
- ClinicalTrials.gov ID
- NCT00000711
- Acronym / sponsor ID
- ACTG 065
- Conditions
- HIV Infections, Cytopenias
- Keywords
- Neutropenia, Drug Evaluation, Drug Therapy, Combination, Granulocyte-Macrophage Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- May 1990 (actual)
- 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 administer colony-stimulating factor (GM-CSF) for 4 weeks to AIDS and advanced AIDS related complex (ARC) patients who have been receiving zidovudine (AZT) therapy, in order to obtain data on short-term effectiveness, safety, toxicity, pharmacokinetics, and tolerance of combined treatment with the two drugs.
Persons infected with HIV virus may undergo a long latency or persistent virus blood levels which may be present before any symptomatic illness. These individuals could, therefore, benefit from therapy with an effective antiretroviral agent. AZT, which is a powerful inhibitor of human retrovirus, has been approved for management of patients with symptomatic HIV infection. GM-CSF not only stimulates the bone marrow, it enhances the function of mature blood cells and has been found to enhance the ability of AZT to suppress HIV replication in vitro (test tube). Combination therapy with GM-CSF and AZT may lower complications as well as the morbidity and mortality associated with HIV infection.
Detailed description
Persons infected with HIV virus may undergo a long latency or persistent virus blood levels which may be present before any symptomatic illness. These individuals could, therefore, benefit from therapy with an effective antiretroviral agent. AZT, which is a powerful inhibitor of human retrovirus, has been approved for management of patients with symptomatic HIV infection. GM-CSF not only stimulates the bone marrow, it enhances the function of mature blood cells and has been found to enhance the ability of AZT to suppress HIV replication in vitro (test tube). Combination therapy with GM-CSF and AZT may lower complications as well as the morbidity and mortality associated with HIV infection.
Colony stimulating factor (GM-CSF) is administered subcutaneously, once a day or every other day, for 4 weeks to AIDS and advanced ARC patients who have been receiving and will continue to receive a constant dose of AZT. Treatment is on an outpatient basis.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Modest doses of acetaminophen, aspirin, or non-prescription doses of ibuprofen may be used with caution for fever control and mild analgesia. Prolonged use more than 72 hours is not advised without dose supervision.
- All patients should have a documented history of positive HIV antibody by ELISA test. Patients should qualify for zidovudine (AZT) treatment for the following reasons:
- Patients with a prior episode of cytologically confirmed Pneumocystis carinii pneumonia (PCP).
- Patients with a prior episode of any AIDS-defining opportunistic infection and less than 200 T4 cells.
- Patients with advanced ARC as defined by mucocutaneous candidiasis and/or unexplained weight loss and less than 200 T4 cells and fever more than 100 degrees F of more than 3 weeks duration; clinical diagnosis of hairy leukoplakia; herpes zoster infection within 3 months of entry; or unexplained diarrhea.
Key exclusion criteria (19 listed)
- Patients receiving zidovudine (AZT) while enrolled in another protocol.
- Patients with other life-threatening and uncontrolled opportunistic infection.
- Patients with evidence of lymphoma or neoplasm other than indolent Kaposi's sarcoma.
- Dementia that would prevent giving appropriate informed consent.
- Acetaminophen or products containing acetaminophen.
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 4 Nov 2021.
- BackgroundPortmore A, Morse G, Hewitt R, Reichman R. Comparative oral disposition of zidovudine in neutropenic AIDS patients and asymptomatic hemophiliacs. Int Conf AIDS. 1990 Jun 20-23;6(3):196 (abstract no SB442)
- Background: PubMed 8460920Hewitt RG, Morse GD, Lawrence WD, Maliszewski ML, Santora J, Bartos L, Bonnem E, Poiesz B. Pharmacokinetics and pharmacodynamics of granulocyte-macrophage colony-stimulating factor and zidovudine in patients with AIDS and severe AIDS-related complex. Antimicrob Agents Chemother. 1993 Mar;37(3):512-22. doi: 10.1128/AAC.37.3.512.
- Derived from this study: PubMed 29535451Wang GJ, Zhao J, Tomasi D, Kojori ES, Wang R, Wiers CE, Caparelli EC, Volkow ND. Effect of combined naltrexone and bupropion therapy on the brain's functional connectivity. Int J Obes (Lond). 2018 Nov;42(11):1890-1899. doi: 10.1038/s41366-018-0040-2. Epub 2018 Feb 23.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Hewitt RG study chair
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 Zidovudine and Sargramostim in people with HIV Infections and Cytopenias, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 19 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 4 Nov 2021. 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 NCT00000711, which also lists 3 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 4 Nov 2021.