HIV Infections
Conditions
Keywords
Virus Replication, Acquired Immunodeficiency Syndrome, Antiviral Agents
Brief summary
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.
Interventions
Sponsors
Pharmacia and Upjohn
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed