CompletedPhase 1

A Study of AZT Plus Human Interferon Alpha in the Treatment of AIDS-Related Kaposi's Sarcoma

United States48 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 AZT and IFN-A or AZT and IFN-A2A when given in combination. To define the maximum tolerated dose (MTD) of each drug in combination and to define doses to be used in Phase II trial. AZT has been found to be effective against the effects of HIV in vitro (test tube) and both interferons have shown antiviral and antitumor effect on Kaposi's sarcoma. It is reasonable to assume that a synergism and an enhanced antitumor response may be seen with combination therapy. A study to evaluate the safety and effectiveness of AZT in the combination with 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 * Patient must have a histologically confirmed diagnosis of Kaposi's sarcoma. * Positive antibody to HIV confirmed by ELISA or Western blot on the same serum. Exclusion Criteria * Active drug or alcohol abuse. Co-existing Condition: Patients with the following complications are excluded: * Active opportunistic infections requiring ongoing therapy. * Pneumocystis carinii pneumonia (PCP) unless recovered must be off therapy within 90 days prior to study. * Clinically significant cardiac disease, including a history of myocardial infarction or arrhythmia. * Concurrent neoplasms other than basal cell carcinoma of skin. * Known sensitivity to polymycin or neomycin. Patients with the following complications are excluded: * Active opportunistic infections requiring ongoing therapy. * Pneumocystis carinii pneumonia (PCP) unless recovered must be off therapy within 90 days prior to study. * Clinically significant cardiac disease, including a history of myocardial infarction or arrhythmia. * Concurrent neoplasms other than basal cell carcinoma of skin. * Known sensitivity to polymycin or neomycin. Prior Medication: Excluded: * Any prior zidovudine (AZT) or interferon alpha protocol participation. * Excluded within 30 days of study entry: * Immunomodulating agents. * Other drugs that can cause neutropenia or significant nephrotoxicity, or systemic anti-infectives. * Excluded within 90 days of study entry: * Antiretroviral agents. * Treatment of Pneumocystis…

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 IDNCT00001113

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Sarcoma, Kaposi trials