Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E
Completed · Not applicable
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002094
- Run by
- Pharmacia and Upjohn
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older, up to 45. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Natl Naval Med Ctr — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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