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
2 other identifiers
interventional
471
2 countries
32
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
March 1, 1997
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 4, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- 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.
- +5 more criteria
You may not qualify if:
- Co-existing Condition:
- 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.
- +31 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Alabama Therapeutics CRS
Birmingham, Alabama, 35294, 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, 20059, United States
Univ. of Miami AIDS CRS
Miami, Florida, 331361013, United States
Queens Med. Ctr.
Honolulu, Hawaii, 96816, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 462025250, United States
Methodist Hosp. of Indiana
Indianapolis, Indiana, 46202, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, 02114, United States
Bmc Actg Crs
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, 02215, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, 02215, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, 55455, United States
Washington U CRS
St Louis, Missouri, 63110, United States
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, 63112, United States
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, 14215, United States
Cornell University A2201
New York, New York, 10021, 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, 14642, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, 452670405, United States
Case CRS
Cleveland, Ohio, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, 432101228, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States
University of Washington AIDS CRS
Seattle, Washington, 981224304, United States
Puerto Rico-AIDS CRS
San Juan, 009365067, Puerto Rico
Related Publications (5)
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)
BACKGROUNDFreimuth 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)
BACKGROUNDNokta 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)
BACKGROUNDFriedland 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.
PMID: 10428106BACKGROUNDDemeter 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.
PMID: 9052722BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Friedland G
- STUDY CHAIR
Fischl MA
- STUDY CHAIR
Pollard R