A Study of AZT in HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma (NCT00000994) | Clinical Trial Compass
CompletedPhase 3
A Study of AZT in HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma
United States240 participants
Plain-language summary
To determine whether taking zidovudine (AZT) will change the natural course of HIV infection in patients with AIDS-associated Kaposi's sarcoma (KS) and whether administering AZT at a similar dose but at different intervals will reduce toxicity in a more manageable treatment plan.
Patients infected with AIDS can benefit from therapy with an effective anti-AIDS virus agent. AZT is a drug that is effective in inhibiting the effects of HIV infection. The study will show whether toxicity of AZT can be reduced in a more manageable treatment plan, and whether AZT therapy will delay the development of opportunistic infections and/or KS lesions.
Who can participate
Age range
18 Years
Sex
MALE
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:
* Acute treatment for mucocutaneous candidiasis, localized cutaneous herpes simplex, or localized or disseminated zoster infections.
Concurrent Treatment:
Allowed:
* Blood transfusion for treatment of Grade 3 hemoglobin toxicity if the patient's cardiovascular status is compromised or if the hemoglobin fails to show signs of recovery following withdrawal from the study drug. Toxicity grades according to NIAID Recommendations for Grading Acute and Subacute Toxic Effects (Adults).
Patients must have:
* HIV-related, biopsy-proven Kaposi's sarcoma mucocutaneous lesions without constitutional symptoms.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions will be excluded:
* Symptomatic, visceral Kaposi's sarcoma.
* Lymphedema.
* HIV neurologic disease as determined by a standard neurologic examination and neuropsychological questionnaire.
Concurrent Medication:
Excluded:
* Aspirin or acetaminophen on a regular basis or for longer than 72 hours without approval of investigator.
* Cimetidine.
* Flurazepam.
* Indomethacin.
* Ranitidine.
* Probenecid.
* Drugs causing anemia, neutropenia, or significant risk of nephrotoxicity.
* Prophylaxis or chronic suppression of herpes simplex.
* Treatment of herpes simplex virus cutaneous disease more often than once a month for 5 - 7 days.
Concurrent Treatment:
Excluded:
* Radiation therapy for treatment of Kaposi's sarcoma lesions.
The following pat…
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 IDNCT00000994
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)