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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Atevirdine mesylate

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Locations

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Natl Naval Med Ctr

Bethesda, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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M/3330/0007

Identifier Type: -

Identifier Source: secondary_id

117A