The Effectiveness of Three Drug Combinations in HIV-Infected Patients Who Have Taken Zidovudine for More Than 12 Weeks
Status:
Completed
Trial end date:
1997-11-01
Target enrollment:
Participant gender:
Summary
To compare the effect of stavudine (d4T) alone or with zidovudine (AZT) versus didanosine
(ddI) alone or with AZT on CD4 counts, HIV RNA levels, and viral load in HIV-infected
patients [AS PER AMENDMENT 3/21/97: To compare the effects of d4T alone versus ddI alone
versus AZT plus ddI]. To compare the safety of d4T/AZT. AS PER AMENDMENT 3/21/97: To evaluate
the pharmacokinetic interactions of AZT and d4T both at an extracellular and intracellular
level.
Although AZT and ddI can delay the advancement of HIV disease, the benefit of either of these
drugs has proven to be only temporary. d4T, a new nucleoside analog with a favorable toxicity
profile and demonstrated activity against HIV, offers an additional therapeutic option. It is
reasonably assumed that the benefit of an antiretroviral agent in terms of delaying clinical
disease progression is directly related to its ability to achieve and sustain viral
suppression; thus, this study measures effects on viral load and CD4 count.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)