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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002094
• Other study ID #: 117A
• Secondary ID: M/3330/0007
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: February 1993
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Atevirdine mesylate

Locations

Country	Name	City	State
United States	Natl Naval Med Ctr	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacia and Upjohn

Country where clinical trial is conducted

United States,