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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000810 |
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.
Condition | Intervention | Phase |
HIV Infections |
Drug: Delavirdine mesylate Drug: Zidovudine Drug: Didanosine |
Phase I |
MedlinePlus related topics: | AIDS |
Drug Information available for: | Zidovudine Delavirdine mesylate Delavirdine Didanosine |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S) |
Estimated Enrollment: | 120 |
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.
Patients are randomized to receive U-90152 at one of three doses (treatment arms I through III) or either AZT or ddI (treatment arm IV). Patients on arm IV who are AZT-naive receive AZT; those who are AZT-experienced receive ddI. Treatment continues for 24 weeks.
PER 12/22/94 AMENDMENT: All patients receiving U-90152 have the same starting dose, to attain one of three target trough levels.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
NOTE:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded within 30 days prior to study entry:
Excluded at any time:
Active substance abuse interfering with compliance.
United States, California | |||||
Stanford at Kaiser / Kaiser Permanente Med Ctr | |||||
San Francisco, California, United States, 94115 | |||||
Stanford Univ Med Ctr | |||||
Stanford, California, United States, 943055107 | |||||
United States, Colorado | |||||
Univ of Colorado Health Sciences Ctr | |||||
Denver, Colorado, United States, 80262 | |||||
Kaiser Permanente Franklin Med Ctr | |||||
Denver, Colorado, United States, 80262 | |||||
Rose Med Ctr | |||||
Denver, Colorado, United States, 80262 | |||||
United States, District of Columbia | |||||
Howard Univ | |||||
Washington, District of Columbia, United States, 20059 | |||||
United States, Florida | |||||
Univ of Miami School of Medicine | |||||
Miami, Florida, United States, 331361013 | |||||
United States, Illinois | |||||
Northwestern Univ Med School | |||||
Chicago, Illinois, United States, 60611 | |||||
United States, Indiana | |||||
Indiana Univ Hosp | |||||
Indianapolis, Indiana, United States, 462025250 | |||||
United States, New York | |||||
SUNY / State Univ of New York | |||||
Syracuse, New York, United States, 13210 | |||||
Univ of Rochester Medical Center | |||||
Rochester, New York, United States, 14642 | |||||
SUNY / Erie County Med Ctr at Buffalo | |||||
Buffalo, New York, United States, 14215 | |||||
United States, North Carolina | |||||
Univ of North Carolina | |||||
Chapel Hill, North Carolina, United States, 275997215 | |||||
United States, Ohio | |||||
Ohio State Univ Hosp Clinic | |||||
Columbus, Ohio, United States, 432101228 |
Study Chair: | Para M | |
Study Chair: | Fischl M |
Click here for more information about Zidovudine 
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Click here for more information about Didanosine 
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Click here for more information about Delavirdine mesylate 
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Dereuddre-Bosquet N, Clayette P, Martin M, Fretier P, Jaccard P, Benveniste O, Lebeaut A, Dormont D. IL-10 and HIV-1 infection of human primary monocyte/macrophages. Int Conf AIDS. 1996 Jul 7-12;11(2):75 (abstract no WeA3107)
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Para M, Weinstock M. Retrospective analysis of protease inhibitor efficacy among patients failing a delavirdine regimen. Int Conf AIDS. 1998;12:59 (abstract no 12236)
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Morse G, Para M, Fischl M, Freimuth W. Concentration-targeted (CT) Delavirdine therapy in 82 patients in ACTG 260. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:118
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Para M, Morse G, Fischl M. Plasma protein binding of delavirdine in HIV-infected patients in ACTG 260. Int Conf AIDS. 1996 Jul 7-12;11(2):78 (abstract no WeB3131)
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Demeter L, Shafer R, Para M, Morse G, Freimuth W, Merigan T, Reichman R. Delavirdine (DLV) susceptibility of HIV-1 isolates obtained from patients (pts) receiving DLV monotherapy (ACTG 260). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:113
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Para MF, Fischl M, Meehan P, Morse G, Wood K, Shafer R, Freimuth W, Demeter L, Holden-Wiltse J, Nevin T. ACTG 260: Randomized phase I/II concentration-controlled trial of the anti-HIV activity of delavirdine. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:163
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Demeter LM, Shafer RW, Meehan PM, Holden-Wiltse J, Fischl MA, Freimuth WW, Para MF, Reichman RC. Delavirdine susceptibilities and associated reverse transcriptase mutations in human immunodeficiency virus type 1 isolates from patients in a phase I/II trial of delavirdine monotherapy (ACTG 260). Antimicrob Agents Chemother. 2000 Mar;44(3):794-7.
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Para MF, Meehan P, Holden-Wiltse J, Fischl M, Morse G, Shafer R, Demeter LM, Wood K, Nevin T, Virani-Ketter N, Freimuth WW. ACTG 260: a randomized, phase I-II, dose-ranging trial of the anti-human immunodeficiency virus activity of delavirdine monotherapy. The AIDS Clinical Trials Group Protocol 260 Team. Antimicrob Agents Chemother. 1999 Jun;43(6):1373-8.
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Study ID Numbers: | ACTG 260 |
First Received: | November 2, 1999 |
Last Updated: | July 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00000810 |
Health Authority: | United States: Federal Government |
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