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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Atevirdine mesylate
Sponsored by
Pharmacia and Upjohn
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Virus Replication, Acquired Immunodeficiency Syndrome, Antiviral Agents

Eligibility Criteria

18 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Pharmacia and Upjohn
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1. Study Identification

Unique Protocol Identification Number
NCT00002094
Brief Title
Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E
Official Title
Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E
Study Type
Interventional

2. Study Status

Record Verification Date
February 1993
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pharmacia and Upjohn

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Virus Replication, Acquired Immunodeficiency Syndrome, Antiviral Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atevirdine mesylate

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Natl Naval Med Ctr
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
208995000
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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