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CompletedNCT00002094Updated Jun 24, 2005

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

An interventional study of Atevirdine mesylate in HIV Infections, sponsored by Pharmacia and Upjohn. Completed at 1 site in United States. Open to male participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Pharmacia and Upjohn · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Ages
18 Years to 45 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • HIV Infections

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Keywords

  • Virus Replication
  • Acquired Immunodeficiency Syndrome
  • Antiviral Agents
03

In context

HIV Infections

4,259 studies on the registry are indexed under HIV Infections; 241 are open to participants now.

Browse HIV Infections studies →

Lead sponsor

Pharmacia and Upjohn is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Masking
None (open label)

Interventions

  • DrugAtevirdine mesylate
06

Study locations

1 site
  • Natl Naval Med Ctr
    Bethesda, Maryland 208995000, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002094
Lead sponsor
Pharmacia and Upjohn
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 1993. You cannot join it, but the record below documents what was studied.

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