Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E
This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 1993
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.
Drug: Atevirdine mesylate
||Masking: Open Label
Primary Purpose: Treatment
||Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E
|Ages Eligible for Study:
||18 Years to 45 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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.
- 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.
- Experimental drugs within 4 weeks prior to study entry.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002094
|Natl Naval Med Ctr
|Bethesda, Maryland, United States, 208995000 |
Pharmacia and Upjohn
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 1999
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2015
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Reverse Transcriptase Inhibitors