Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E
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To determine the time course of development of resistance to atevirdine mesylate ( U-87201E ) in patients with HIV isolates showing in vitro resistance to zidovudine ( AZT ). To determine the genotype changes in HIV reverse transcriptase associated with in vitro AZT resistance to U-87201E. To determine the genotype and phenotype effects of treatment with a nondideoxynucleoside agent on the alterations of the HIV-1 population associated with in vitro AZT resistance. To determine whether serial passage of patient pre-drug HIV isolates in the presence of U-87201E will generate the resistant mutants that may subsequently emerge in the patients.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients must have:
Enrollment on protocol RV-43 (AZT resistance study).
Development of a primary RV-43 study endpoint-opportunistic infection.
HIV isolate with an AZT IC50 > 50 times that of the sensitive type strain.
Able to swallow tablets without difficulty.
Normal QTc interval on EKG.
Patients with the following symptoms or conditions are excluded:
Clinically significant hypersensitivity to piperazine type drugs (Antepar, Stelazine).
Severe uncontrollable diarrhea or vomiting or known malabsorption.
Other experimental drugs.
AZT, ddI, ddC, foscarnet, immunomodulators or other agents with primary antiretroviral activity (exemptions by principal investigator permitted).
Patients with the following prior conditions are excluded:
History of clinically significant cardiovascular disease or nervous system or muscle disease, including seizures, peripheral neuropathy, dementia, or motor dysfunction.
Experimental drugs within 4 weeks prior to study entry.