Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients With No Symptoms of the Disease
Status:
Completed
Trial end date:
1998-10-01
Target enrollment:
Participant gender:
Summary
To validate that the alteration of codon 215 of reverse transcriptase in plasma virus
precedes the increase in viral burden as measured in the peripheral blood and the decline in
CD4 count that have been observed in association with clinical failure on zidovudine (AZT).
To determine whether alternative regimens of antiretroviral agents alter the course of viral
burden as measured in the peripheral blood and CD4 changes in patients with HIV infection. To
obtain further data on the safety and immunologic and virologic response to
AZT/didanosine/nevirapine.
Of the HIV-1 mutations reported to be associated with zidovudine resistance, the mutation at
codon 215 of the reverse transcriptase gene is the most commonly occurring and has the
greatest impact on susceptibility. When this mutation appears, a change in drugs may prevent
further immunologic and virologic deterioration.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)