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 - Article Azidothymidine Capsule; AZT Capsule; Compound S Capsule; Retrovir Capsule
Clinical Trial: 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
This study has been completed.
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.
|Condition||Treatment or Intervention||Phase|
|HIV Infections || Drug: Delavirdine mesylate |
|Phase II |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Double-Blind, Safety Study
Expected Total Enrollment: 471
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.
Patients are randomized to receive U-90152/AZT/ddI, U-90152/AZT, U-90152/ddI, or AZT/ddI for 48 weeks.
Ages Eligible for Study: 13 Years and above, Genders Eligible for Study: Both
Concurrent Medication: Required:
- PCP prophylaxis for patients with CD4 count <= 200 cells/mm3.
- 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:
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.
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).
- Systemic corticosteroids for more than 21 consecutive days.
- 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.
- Recombinant EPO or G-CSF.
- Any other investigational drug.
Active drug or alcohol use.
Univ of Alabama at Birmingham, Birmingham, Alabama, 35294, United States
Univ of California / San Diego Treatment Ctr, San Diego, California, 921036325, United States
VA Hosp at San Diego / Pediatrics, San Diego, California, 92161, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr, San Francisco, California, 94115, United States
San Francisco Gen Hosp, San Francisco, California, 941102859, United States
Stanford Univ Med Ctr, Stanford, California, 943055107, United States
Summitt Med Ctr / San Francisco Gen Hosp, Oakland, California, 94609, United States
Univ of Southern California / LA County USC Med Ctr, Los Angeles, California, 900331079, United States
Olive View Med Ctr, Sylmar, California, 91342, United States
USC Univ Hosp & Ambulatory Hlth Care Ctr / USC Med Ctr, Los Angeles, California, 900334508, United States
Denver Dept of Health and Hosps, Denver, Colorado, 80262, United States
Kaiser Permanente Franklin Med Ctr, Denver, Colorado, 80262, United States
Rose Med Ctr, Denver, Colorado, 80262, United States
Yale Univ / New Haven, New Haven, Connecticut, 065102483, United States
District of Columbia
Howard Univ, Washington, District of Columbia, 20059, United States
George Washington Univ / Hershey Med Ctr, Washington, District of Columbia, 20037, United States
Univ of Miami School of Medicine, Miami, Florida, 331361013, United States
Queens Med Ctr, Honolulu, Hawaii, 96816, United States
Univ of Hawaii, Honolulu, Hawaii, 96816, United States
Indiana Univ Hosp, Indianapolis, Indiana, 462025250, United States
Methodist Hosp of Indiana / Life Care Clinic, Indianapolis, Indiana, 46202, United States
Tulane Univ / Charity Hosp of New Orleans, New Orleans, Louisiana, 701122699, United States
Johns Hopkins Hosp, Baltimore, Maryland, 21287, United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp, Baltimore, Maryland, 212052196, United States
Harvard (Massachusetts Gen Hosp), Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Med Ctr, Boston, Massachusetts, 02215, United States
Beth Israel Deaconess - West Campus, Boston, Massachusetts, 02215, United States
Boston Med Ctr, Boston, Massachusetts, 02118, United States
Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial, Worcester, Massachusetts, 01605, United States
Univ of Minnesota, Minneapolis, Minnesota, 55455, United States
St Louis Regional Hosp / St Louis Regional Med Ctr, St. Louis, Missouri, 63112, United States
Montefiore Family Health Ctr / Bronx Municipal Hosp, Bronx, New York, 10461, United States
SUNY / State Univ of New York, Syracuse, New York, 13210, United States
Univ of Rochester Medical Center, Rochester, New York, 14642, United States
Mem Sloan - Kettering Cancer Ctr, New York, New York, 10021, United States
Bellevue Hosp / New York Univ Med Ctr, New York, New York, 10016, United States
Mount Sinai Med Ctr, New York, New York, 10029, United States
Jack Weiler Hosp / Bronx Municipal Hosp, Bronx, New York, 10465, United States
Cornell Univ Med Ctr, New York, New York, 10021, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr, Bronx, New York, 10461, United States
Montefiore Med Ctr / Bronx Municipal Hosp, Bronx, New York, 10467, United States
Bronx Veterans Administration / Mount Sinai Hosp, Bronx, New York, 10468, United States
SUNY / Erie County Med Ctr at Buffalo, Buffalo, New York, 14215, United States
Beth Israel Med Ctr, New York, New York, 10003, United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp, Elmhurst, New York, 11373, United States
SUNY / Health Sciences Ctr at Brooklyn, Brooklyn, New York, 112032098, United States
North Shore Univ Hosp, Manhasset, New York, 11030, United States
North Central Bronx Hosp / Bronx Municipal Hosp, Bronx, New York, 10467, United States
Comprehensive Health Care Ctr / Bronx Municipal Hosp, Bronx, New York, 10461, United States
Columbia Presbyterian Med Ctr, New York, New York, 100323784, United States
Adirondack Med Ctr at Saranac Lake, Albany, New York, 122083479, United States
Mid - Hudson Care Ctr, Albany, New York, 122083479, United States
Albany Med College / Division of HIV Medicine A158, Albany, New York, 122083479, United States
Harlem Hosp Ctr, New York, New York, 10037, United States
Montefiore Adolescent AIDS Prog / Bronx Municipal Hosp, Bronx, New York, 10461, United States
Case Western Reserve Univ, Cleveland, Ohio, 44106, United States
Univ of Cincinnati, Cincinnati, Ohio, 452670405, United States
Ohio State Univ Hosp Clinic, Columbus, Ohio, 432101228, United States
Thomas Jefferson Univ Hosp, Philadelphia, Pennsylvania, 191075098, United States
Julio Arroyo, West Columbia, South Carolina, 29169, United States
Univ of Texas Galveston, Galveston, Texas, 775550435, United States
Univ of Washington, Seattle, Washington, 981224304, United States
Youngstown Hemophilia Ctr / Great Lakes Hemophilia Fdn, Wauwatosa, Wisconsin, 53213, United States
Univ of Puerto Rico, San Juan, 009365067, Puerto Rico
Friedland G, Study Chair
Fischl MA, Study Chair
Pollard R, Study Chair
Click here for more information about Zidovudine
Click here for more information about Didanosine
Click here for more information about Delavirdine mesylate
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Record last reviewed: September 1995
Last Updated: April 7, 2005
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00000803
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005