Expired Study
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Bethesda, Maryland 20899


Purpose:

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.


Criteria:

Inclusion Criteria 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. Exclusion Criteria Co-existing Condition: 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. - Symptomatic hyperlipidemia. Concurrent Medication: Excluded: - 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. Prior Medication: Excluded: - Experimental drugs within 4 weeks prior to study entry.


NCT ID:

NCT00002094


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20899
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 25, 2017

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