Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E

Launched by PHARMACIA AND UPJOHN · Aug 30, 2001

Keywords

ClinConnect Summary

No description provided

Gender

MALE

Eligibility 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.