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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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002094
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 1993

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002094 on ClinicalTrials.gov Archive Site
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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
Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E

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.

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Interventional
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Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Atevirdine mesylate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Male
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002094
117A, M/3330/0007
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Pharmacia and Upjohn
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NIH AIDS Clinical Trials Information Service
February 1993

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP