Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Virus Replication, Acquired Immunodeficiency Syndrome, Antiviral Agents
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.
Sites / Locations
- Natl Naval Med Ctr