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

Sponsored by:	Pharmacia and Upjohn
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002094

Purpose

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.

Condition	Intervention
HIV Infections	Drug: Atevirdine mesylate

MedlinePlus related topics: AIDS

Drug Information available for: Atevirdine Atevirdine mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002094

Locations

United States, Maryland
Natl Naval Med Ctr
Bethesda, Maryland, United States, 208995000

Sponsors and Collaborators

Pharmacia and Upjohn

More Information

Study ID Numbers:	117A, M/3330/0007
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002094
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Virus Replication
Acquired Immunodeficiency Syndrome
Antiviral Agents

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009