Granulocyte-Macrophage Colony-Stimulating Factor and Zidovudine: A Phase I Study of Concurrent Administration in Patients With AIDS and Severe ARC
2 other identifiers
interventional
60
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
May 1, 1990
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 4, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215, United States
Related Publications (3)
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)
BACKGROUNDHewitt 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.
PMID: 8460920BACKGROUNDWang 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.
PMID: 29535451DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hewitt RG
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
May 1, 1990
Last Updated
November 4, 2021
Record last verified: 2021-10