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
NCT ID: NCT00000803
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
PHASE2
471 participants
INTERVENTIONAL
1997-03-31
Brief Summary
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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.
Detailed Description
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Patients are randomized to receive U-90152/AZT/ddI, U-90152/AZT, U-90152/ddI, or AZT/ddI for 48 weeks.
Conditions
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Keywords
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Study Design
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TREATMENT
DOUBLE
Interventions
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Delavirdine mesylate
Zidovudine
Didanosine
Eligibility Criteria
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Inclusion Criteria
Required:
* PCP prophylaxis for patients with CD4 count \<= 200 cells/mm3.
Allowed:
* Topical antifungal agents.
* Oral ketoconazole, fluconazole, and itraconazole for candidiasis or disseminated fungal infections.
* Isoniazid, ethambutol, pyrazinamide, clofazimine, ciprofloxacin, and clarithromycin for acute or maintenance therapy for mycobacterial disease (also clarithromycin for MAC prophylaxis).
* Acute or maintenance therapy for toxoplasmosis.
* Acute or maintenance therapy with acyclovir (no more than 1000 mg/day) for herpes simplex virus infection.
* rEPO and rG-CSF.
* Antibiotics for bacterial infections (except rifampin and rifabutin).
* Antipyretics, analgesics, nonsteroidal anti-inflammatory agents, antiemetics, and methadone.
Concurrent Treatment:
Allowed for cutaneous Kaposi's sarcoma:
* Localized radiation therapy.
* Limited intralesional therapy.
Patients must have:
* HIV infection.
* CD4 count 100 - 500 cells/mm3.
* Prior cumulative monotherapy of \<= 6 months (may have taken either AZT or ddI, but not both) OR no prior antiretroviral therapy.
Exclusion Criteria
Patients with the following symptoms or conditions are excluded:
* Malignancy (other than basal or squamous cell carcinoma of the skin, Stage 1 or 2 cervical intraepithelial neoplasia, or minimal Kaposi's sarcoma).
* Considered to be unlikely to comply with study requirements.
Concurrent Medication:
Excluded:
* Antiretroviral therapies and biologic response modifiers (except for study medications, rEPO, and rG-CSF).
* Rifampin.
* Rifabutin.
* Terfenadine.
* Astemizole.
* Loratadine.
* Quinidine.
* Digitoxin.
* 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 intolerance to AZT at \<= 600 mg/day or ddI at \<= 400 mg/day or discontinuation of either drug for toxicity.
* History of intolerance to trifluoperazine or piperazine citrate (per amendment).
* History of pancreatitis.
* History of grade 2 or worse peripheral neuropathy.
* Unexplained temperature \>= 38.5 C on any 7 days within the past 30 days.
* Chronic diarrhea on any 15 days during the past 30 days.
Prior Medication:
Excluded:
* Prior foscarnet as induction or maintenance therapy.
* Prior U-90152.
* Prior ddC or d4T.
* Prior AZT/ddI in combination or taken separately at different times.
* Prior non-nucleoside reverse transcriptase inhibitors (nevirapine, atevirdine, etc.).
* Prior protease inhibitors (although patients from ACTG 282 are eligible).
* HIV-1 vaccine within the past 21 days.
* Acute treatment for a serious infection or for any opportunistic infection within the past 14 days.
Excluded within the past 30 days:
* Interferon or interleukin.
* Rifampin.
* Rifabutin.
* Terfenadine.
* Astemizole.
* Loratadine.
* Recombinant EPO or G-CSF.
* Hydroxyurea.
* SPV-30.
* Any other investigational drug.
Active drug or alcohol use.
13 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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Friedland G
Role: STUDY_CHAIR
Fischl MA
Role: STUDY_CHAIR
Pollard R
Role: STUDY_CHAIR
Locations
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Alabama Therapeutics CRS
Birmingham, Alabama, United States
USC CRS
Los Angeles, California, United States
Stanford CRS
Palo Alto, California, United States
Ucsd, Avrc Crs
San Diego, California, United States
Ucsf Aids Crs
San Francisco, 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
Queens Med. Ctr.
Honolulu, Hawaii, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States
Methodist Hosp. of Indiana
Indianapolis, Indiana, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States
Bmc Actg Crs
Boston, Massachusetts, United States
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, United States
Washington U CRS
St Louis, Missouri, United States
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, United States
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, United States
Cornell University A2201
New York, New York, United States
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, United States
Memorial Sloan-Kettering Cancer Ctr.
New York, New York, United States
NY Univ. HIV/AIDS CRS
New York, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States
Case CRS
Cleveland, Ohio, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States
University of Washington AIDS CRS
Seattle, Washington, United States
Puerto Rico-AIDS CRS
San Juan, , Puerto Rico
Countries
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References
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Griffit B, Morse G, Demeter L, Bassett R, Hughes M, Friedland G. Relationship between delavirdine (DLV) plasma levels, HIV RNA responses and DLV resistance during combination therapy with zidovudine (ZDV), and didanosine (ddI). Int Conf AIDS. 1998;12:52 (abstract no 12206)
Freimuth WW, Chuang-Stein CJ, Greenwald CA, Wathen LK, Edge-Padbury BA, Cox SR, Daenzer CL, Wang Y, Carberry PA. Delavirdine (DLV) combined with zidovudine (ZDV) or didanosine (ddI) produces sustained reduction in viral burden and increases in CD4 count in early and advanced HIV-1 infection. Int Conf AIDS. 1996 Jul 7-12;11(1):22 (abstract no MoB295)
Nokta M, Turk P. Partial restoration of HIV specific neutralizing activity (NA) of HIV infected patients receiving antiretrovial therapy: DDI/delaviridine (DLV), AZT/DLV, DDI/AZT or DDI/AZT/DLV. Int Conf AIDS. 1998;12:516 (abstract no 31108)
Friedland GH, Pollard R, Griffith B, Hughes M, Morse G, Bassett R, Freimuth W, Demeter L, Connick E, Nevin T, Hirsch M, Fischl M. Efficacy and safety of delavirdine mesylate with zidovudine and didanosine compared with two-drug combinations of these agents in persons with HIV disease with CD4 counts of 100 to 500 cells/mm3 (ACTG 261). ACTG 261 Team. J Acquir Immune Defic Syndr. 1999 Aug 1;21(4):281-92. doi: 10.1097/00126334-199908010-00005.
Demeter LM, Meehan PM, Morse G, Gerondelis P, Dexter A, Berrios L, Cox S, Freimuth W, Reichman RC. HIV-1 drug susceptibilities and reverse transcriptase mutations in patients receiving combination therapy with didanosine and delavirdine. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Feb 1;14(2):136-44. doi: 10.1097/00042560-199702010-00006.
Other Identifiers
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11238
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 261
Identifier Type: -
Identifier Source: org_study_id