Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00002094|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Atevirdine mesylate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (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|
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 45 Years (Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002094
|United States, Maryland|
|Natl Naval Med Ctr|
|Bethesda, Maryland, United States, 208995000|
|Other Study ID Numbers:||
|First Posted:||August 31, 2001 Key Record Dates|
|Last Update Posted:||June 24, 2005|
|Last Verified:||February 1993|
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
RNA Virus Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action