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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR DELAVIRDINE MESYLATE

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Clinical Trials for Delavirdine Mesylate

Trial ID Title Status Sponsor Phase Summary
NCT00000803 A Phase II Double-Blind Study of Delavirdine Mesylate ( U-90152 ) in Combination With Zidovudine ( AZT ) and/or Didanosine ( ddI ) Versus AZT and ddI Combination Therapy Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 To determine the safety and anti-HIV activity of delavirdine mesylate ( U-90152 ) in combination with zidovudine ( AZT ) and/or didanosine ( ddI ) versus AZT/ddI combination. U-90152 has demonstrated anti-HIV activity. Since the combination of this drug with either AZT or ddI has synergistic inhibitory activity against HIV-1 in vitro, and triple therapy appears to have greater inhibitory activity against HIV-1 in vitro than dual therapy, the use of U-90152 in combination with AZT and/or ddI may improve the benefits of these drugs in persons with HIV disease.
NCT00000810 Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S) Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 PRIMARY: To study the safety and tolerance of delavirdine mesylate ( U-90152 ) monotherapy. To compare the anti-HIV activity of three blood concentration levels of this agent with nucleoside analog monotherapy, either zidovudine ( AZT ) or didanosine ( ddI ), based on the reduction of HIV viral burden. SECONDARY: To use pharmacokinetic parameters to assess the relationship between daily drug exposure and antiviral activity and toxicity of the U-90152, AZT, and ddI monotherapy. To assess anti-HIV activity using other disease markers. Data suggest that bisheteroarylpiperazines (BHAPs) such as delavirdine mesylate are potent and safe anti-HIV agents and may have different biological behavior than other currently available non-nucleoside RT inhibitors.
NCT00000882 Virologic and Immunologic Activity of Continued Lamivudine (3TC) vs Delavirdine (DLV) in Combination With Indinavir (IDV) and Zidovudine (ZDV) or Stavudine (d4T) in 3TC-Experienced Subjects Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 To compare the proportion of patients in the 2 zidovudine (ZDV)-containing arms who have a plasma HIV RNA concentration below the limit of detection (defined as 500 copies/ml or less) at Weeks 20 and 24 [AS PER AMENDMENT 8/24/98: HIV RNA concentration below the limit of detection is now defined as 200 copies/ml or less]. To compare the safety and tolerability of the different treatment regimens. To compare the decrease in plasma HIV-1 RNA and the change in CD4 count from baseline to the average of Weeks 20 and 24 [AS PER AMENDMENT 12/19/97: and to the average of Weeks 44 and 48; AS PER AMENDMENT 8/24/98: and the average of Weeks 88 and 96] in the 2 ZDV-containing arms. To study the emergence of resistance to ZDV, lamivudine (3TC), stavudine (d4T), delavirdine (DLV), and indinavir (IDV) in treated patients. To correlate the antiviral and immunologic activity and emergence of drug resistance with pharmacologic parameters of study drugs. To delineate the pharmacokinetic interactions of IDV and DLV. [AS PER AMENDMENT 12/19/97: To delineate the possible development of cellular resistance to nucleoside analogs and the consequences of switching nucleoside study drugs on intracellular phosphorylation.] To document rates and patterns of adherence over the course of the study, from day of randomization through 48 weeks. [AS PER AMENDMENT 8/24/98: To define long-term durability of the virologic activity of the different treatment regimens, as defined by the proportion of patients with plasma HIV-1 RNA levels that remains below the limit of detection. To define long-term tolerability of the different treatment regimens.] Although a change in reverse transcriptase (RT) inhibitors is recommended when adding or changing protease inhibitors in a treatment regimen, the choice of available RT inhibitors is often limited by prior exposure, toxicity, or pharmacologic interaction with the protease inhibitors. This study addresses the question of whether to continue 3TC or substitute the nonnucleoside reverse transcriptase inhibitor (NNRTI) DLV when adding IDV to therapy for patients previously treated with ddI or d4T plus 3TC who have greater than 500 copies/ml of plasma HIV-1 RNA. Although the activity of DLV as monotherapy or in combination with nucleoside reverse transcriptase inhibitors is of limited duration due to rapid emergence of resistance, it is possible that DLV will contribute significantly to the activity of 3-drug regimens that include a new RT inhibitor plus a protease inhibitor.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Delavirdine Mesylate

Condition Name

Condition Name for Delavirdine Mesylate
Intervention Trials
HIV Infections 18
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Condition MeSH

Condition MeSH for Delavirdine Mesylate
Intervention Trials
HIV Infections 18
Infection 1
Acquired Immunodeficiency Syndrome 1
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Clinical Trial Locations for Delavirdine Mesylate

Trials by Country

Trials by Country for Delavirdine Mesylate
Location Trials
United States 183
Puerto Rico 6
Germany 1
United Kingdom 1
Spain 1
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Trials by US State

Trials by US State for Delavirdine Mesylate
Location Trials
California 12
New York 9
Colorado 9
Ohio 9
Illinois 8
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Clinical Trial Progress for Delavirdine Mesylate

Clinical Trial Phase

Clinical Trial Phase for Delavirdine Mesylate
Clinical Trial Phase Trials
Phase 3 4
Phase 2 6
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Delavirdine Mesylate
Clinical Trial Phase Trials
Completed 15
Terminated 2
Withdrawn 1
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Clinical Trial Sponsors for Delavirdine Mesylate

Sponsor Name

Sponsor Name for Delavirdine Mesylate
Sponsor Trials
Pharmacia and Upjohn 9
National Institute of Allergy and Infectious Diseases (NIAID) 6
Hoffmann-La Roche 2
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Sponsor Type

Sponsor Type for Delavirdine Mesylate
Sponsor Trials
Industry 14
NIH 6
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