Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients Wit… (NCT00000687) | Clinical Trial Compass
CompletedPhase 2
Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma
United States60 participants
Plain-language summary
To determine the safety and effectiveness of combining zidovudine (AZT) and interferon alfa-2a (IFN-A2a) in a treatment for Kaposi's sarcoma (KS) in patients who have AIDS. It is hoped with the present study to define the rate at which the treatment affects the tumors and also to assess any toxic effects of the combination treatment over a period of time.
In a recent study, the combination of IFN-A2a and AZT in the treatment of patients with AIDS-associated KS was evaluated and safe doses of both AZT and IFN-A2a were determined. In addition, it appeared that there was a substantial reduction in KS lesions with this therapy. Potential benefits of this combined therapy include resolution of KS lesions, prolonged survival, a decrease in the frequency and severity of opportunistic infections, improvement in CD4 cells, and a decrease in serum p24 antigens.
Who can participate
Age range
12 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
Concurrent Medication:
Allowed:
* Inhalation pentamidine for the prevention of Pneumocystis carinii pneumonia (PCP) at a dose of 300 mg once every 4 weeks.
* AMENDED: Trimethoprim - sulfamethoxazole or dapsone only if on the maintenance phase of the study.
Concurrent Treatment:
Allowed:
* Blood transfusions.
Patients must have a positive antibody to HIV by any federally licensed ELISA test. All lab tests must be within 7 days of entry into the study.
Exclusion Criteria
Concurrent Medication:
Excluded:
* Other antiretroviral agents.
* Immunomodulators.
* Corticosteroids.
* Cytotoxic chemotherapy.
* Aspirin.
* H2 blockers.
* Barbiturates and myelosuppressive drugs should be particularly avoided as they may interfere with the metabolism or enhance the toxicities of either zidovudine or interferon alfa-2a.
* Other experimental medications.
Concurrent Treatment:
Excluded:
* Radiation therapy.
Patients with prior experience of Grade 4 toxicity to zidovudine therapy will be excluded from the study.
Prior Medication:
Excluded:
* Interferon therapy.
* Excluded within 30 days of study entry:
* Immunomodulators.
* Corticosteroids.
* Cytotoxic chemotherapeutic agents.
* Excluded within 14 days of study entry:
* Zidovudine (AZT).
Prior Treatment:
Excluded within 30 days of study entry:
* Blood transfusions.
* Radiation therapy.
Patients may not have any of the following diseases or symptoms:
* Active opportunistic infection associated with AIDS.
*…
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 IDNCT00000687
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)