A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in th… (NCT00000725) | Clinical Trial Compass
CompletedPhase 1
A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma
United States56 participants
Plain-language summary
To evaluate the safety and toxicity of combination therapy for AIDS-associated Kaposi's sarcoma with zidovudine (AZT) and two kinds of interferon alpha. The two kinds are interferon alpha (IFN-A) and interferon alpha-2A (recombinant) (IFN-A2A). To define the pharmacokinetics of both AZT and IFN-A or IFN-A2A when given in combination; to define the maximum tolerated dose of each drug in combination and to define doses to be used in Phase II trials. AZT has been found to inhibit both the in vitro (in test tube) and cell killing effects of HIV, and both interferons (IFN-A and IFN-A2A) have shown antiviral and antitumor effect in Kaposi's sarcoma. It is reasonable to assume that a synergistic effect and enhanced antitumor response may be seen with combination therapy. A study to evaluate the safety and efficacy of AZT in combination with IFN-A or IFN-A2A is warranted.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Patients must have biopsy-proven AIDS-associated Kaposi's sarcoma.
* Evidence of HIV infection as manifested by a positive antibody test.
Exclusion Criteria
* Active drug or alcohol abuse.
Co-existing Condition:
Excluded are patients with:
* Active opportunistic infections requiring ongoing therapy.
* Excluded within 90 days of study entry:
* Must be off therapy for Pneumocystis carinii pneumonia (PCP) unless recovered.
* Clinically significant cardiac disease, including a history of myocardial infarction or arrhythmia.
* Concurrent neoplasms other than basal cell carcinoma of the skin.
* Known hypersensitivity to polymycin B or neomycin.
Excluded are patients with:
* Active opportunistic infections requiring ongoing therapy.
* Excluded within 90 days of study entry:
* Must be off therapy for Pneumocystis carinii pneumonia (PCP) unless recovered.
* Clinically significant cardiac disease, including a history of myocardial infarction or arrhythmia.
* Concurrent neoplasms other than basal cell carcinoma of the skin.
* Known hypersensitivity to polymycin B or neomycin.
Prior Medication:
Excluded:
* Interferon.
* Zidovudine (AZT).
* Excluded within 30 days of study entry:
* Any biologic modifiers, corticosteroids, cytotoxic chemotherapeutic agents.
* Other drugs which can cause neutropenia or significant nephrotoxicity.
* Rifampin or rifampin derivatives, or systemic anti-infectives.
* Excluded within 90 days of study entry:
* Other antiviral agents…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00000725
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)