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.
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 1993
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.
Drug: Atevirdine mesylate
||Masking: Open Label
Primary Purpose: Treatment
||Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E
|Ages Eligible for Study:
||18 Years to 45 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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.
- 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.
- Experimental drugs within 4 weeks prior to study entry.
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002094
|Natl Naval Med Ctr
|Bethesda, Maryland, United States, 208995000 |
Pharmacia and Upjohn
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 1999
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 19, 2014
Acquired Immunodeficiency Syndrome
Immune System Diseases
Immunologic Deficiency Syndromes
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Reverse Transcriptase Inhibitors