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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002094 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E
Official Title ^ICMJE	Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E
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.
Detailed Description
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Open Label
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Atevirdine mesylate
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Male
Ages	18 Years to 45 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002094
Responsible Party
Study ID Numbers ^ICMJE	117A, M/3330/0007
Study Sponsor ^ICMJE	Pharmacia and Upjohn
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	February 1993
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP