CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed
Drug / intervention
Interferon alfa-2a +2 moredrug
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00001113
NCT00001113Phase 1Completed

A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 31, 2001·Updated Nov 4, 2021

In Brief

A Phase 1 clinical trial evaluating Interferon alfa-2a, Zidovudine, and 1 other intervention for Sarcoma, Kaposi and HIV Infections. Completed, across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
19901991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 31, 2001
Study CompletionMar 1, 1990
TodayJul 2, 2026
Posted 24.8 years ago

Interventions

Interferon alfa-2adrug

Zidovudinedrug

Interferon alfa-n1drug