A Study of AZT Plus Human Interferon Alpha in the Treatment of AIDS-Related Kaposi's Sarcoma
Status:
Completed
Trial end date:
1990-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)