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 range18 Years
SexMALE
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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…
Trial details
NCT IDNCT00000994
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)