Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S)
NCT ID: NCT00000810
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
120 participants
INTERVENTIONAL
1996-01-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Delavirdine mesylate
Zidovudine
Didanosine
Eligibility Criteria
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Inclusion Criteria
Allowed:
* PCP prophylaxis.
* Topical antifungal agents, clotrimazole troches, nystatin oral suspension, topical ketoconazole, and oral fluconazole.
* Acyclovir (\<= 1000 mg/day) as maintenance therapy for herpes simplex virus.
* Recombinant erythropoietin and G-CSF.
* Antibiotics for bacterial infections, unless specifically excluded.
* Symptomatic treatment such as antipyretics, analgesics, nonsteroidal anti-inflammatory agents, and antiemetics.
* Antacids.
Patients must have:
* HIV-1 infection.
* CD4 count 200 - 500 cells/mm3.
* Either no prior antiretroviral therapy or discontinued AZT monotherapy 3 or more weeks prior to study entry.
NOTE:
* Half of patients should be antiretroviral naive.
Prior Medication:
Allowed:
* Prior AZT.
Exclusion Criteria
Patients with the following symptoms or conditions are excluded:
* Malignancy other than minimal Kaposi's sarcoma.
Concurrent Medication:
Excluded:
* Rifabutin.
* Rifampin.
* Terfenadine.
* Astemizole.
* Loratadine.
* Trifluoperazine.
* Piperazine citrate.
* Any acute or chronic therapy for CMV, MAC, toxoplasmosis, or disseminated fungal infection.
* Non-study antiretroviral therapies, interferons, biologic response modifiers, and HIV vaccines.
* Systemic corticosteroids for more than 21 consecutive days.
* Foscarnet.
* Systemic cytotoxic chemotherapy for a malignancy.
Patients with the following prior conditions are excluded:
* History of pancreatitis (in patients who received prior AZT).
* History of grade 2 or worse peripheral neuropathy (in patients who received prior AZT).
* History of hypersensitivity to BHAP compounds (e.g., trifluoperazine - Stelazine, piperazine citrate - Antepar).
Prior Medication:
Excluded within 30 days prior to study entry:
* Any investigational medication.
* Interferon.
* Interleukin.
* Rifabutin.
* Rifampin.
* Terfenadine.
* Astemizole.
* Loratadine.
* Trifluoperazine.
* Piperazine citrate.
Excluded at any time:
* Prior ddI, ddC, d4T, or 3TC.
* Prior foscarnet.
* Prior BHAP compound or other non-nucleoside RT inhibitor.
Active substance abuse interfering with compliance.
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Para M
Role: STUDY_CHAIR
Fischl M
Role: STUDY_CHAIR
Locations
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Stanford CRS
Stanford, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
Howard University Hosp., Div. of Infectious Diseases, ACTU
Washington D.C., District of Columbia, United States
Univ. of Miami AIDS CRS
Miami, Florida, United States
Northwestern University CRS
Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States
Unc Aids Crs
Chapel Hill, North Carolina, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States
Countries
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References
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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)
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)
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
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)
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
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
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. doi: 10.1128/AAC.44.3.794-797.2000.
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. doi: 10.1128/AAC.43.6.1373.
Other Identifiers
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11237
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 260
Identifier Type: -
Identifier Source: org_study_id