Completed

Emergence of Drug Resistance in HIV-1 Patients Taking Oral U-87201E

What is being tested

Atevirdine mesylate

Drug

Who is being recruted

Blood-Borne Infections+13

+ Urogenital Diseases

+ Genital Diseases

From 18 to 45 Years

+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

See protocol details

Summary

Principal SponsorPharmacia and Upjohn

Last updated: June 24, 2005

Sourced from a government-validated database.Claim as a partner

This study focuses on HIV-1 infected patients who show resistance to a drug called zidovudine (AZT). The main goal is to understand how another drug, atevirdine mesylate (U-87201E), can help in these cases. The study aims to track the development of resistance to U-87201E over time. It also seeks to identify changes in the HIV virus's genetic makeup that are associated with AZT resistance and how these changes respond to U-87201E. This research is important as it could provide insights into how to better treat HIV patients who have developed resistance to certain medications. During the study, participants will take U-87201E orally. The researchers will monitor the patients to see how the virus evolves and adapts to this new drug. They will also investigate how the drug affects the virus's genetic material and behavior. The study will involve lab tests where the patient's HIV isolates are exposed to U-87201E to observe if and how resistance develops. The results of this study could potentially lead to improved treatment strategies for HIV patients.

NCT00002094

Principal SponsorPharmacia and Upjohn

Last updated: June 24, 2005

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeHIV Infections

Criteria

5 inclusion criteria required to participate

Able to swallow tablets without difficulty

Development of a primary RV-43 study endpoint-opportunistic infection

Enrollment on protocol RV-43 (AZT resistance study)

HIV isolate with an AZT IC50 > 50 times that of the sensitive type strain

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7 exclusion criteria prevent from participating

AZT, ddI, ddC, foscarnet, immunomodulators or other agents with primary antiretroviral activity (exemptions by principal investigator permitted)

Clinically significant hypersensitivity to piperazine type drugs (Antepar, Stelazine)

Experimental drugs within 4 weeks prior to study entry

History of clinically significant cardiovascular disease or nervous system or muscle disease, including seizures, peripheral neuropathy, dementia, or motor dysfunction

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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Natl Naval Med Ctr

Bethesda, United StatesOpen Natl Naval Med Ctr in Google Maps

CompletedOne Study Center