A Trial of Alternating 2',3'-Dideoxycytidine and Zidovudine in the Treatment of Patients With Advanced HIV Disease
Status:
Completed
Trial end date:
1995-02-01
Target enrollment:
Participant gender:
Summary
To determine the long-term safety and tolerance of four alternating and two intermittent
regimens of zidovudine ( AZT ) and 2',3'-dideoxycytidine ( zalcitabine; ddC ) in the
treatment of patients with advanced HIV disease who have had to discontinue AZT because of
true hematologic intolerance to standard reduced doses of AZT.
AIDS is a serious infectious disease caused by a new family of retrovirus which is spread
primarily through sexual contact and administration of blood or blood products. Individuals
who are infected with HIV could therefore benefit from therapy with an effective anti-AIDS
virus agent. AZT and ddC have both been tested as antiviral agents and their potentially
beneficial effects may be limited by time- and dose-dependent toxicity. A combination regimen
using shorter courses of AZT and ddC might therefore be able to sustain treatment without
producing toxicity. In addition, since the two drugs exhibit their major toxicity on
different organ systems, cumulative or additive toxicity would not be expected.
Phase:
N/A
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)