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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 Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on 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 conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. 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 Clinical research trials and 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 healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like 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. 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 Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a 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 clinical trial. Human subjects often obtain the finest healthcare possible for their 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 condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > 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  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
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
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria 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. - 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 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. - 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.
Total Enrollment: 471
Location and Contact Information:
Overall Study Official:
FriedlandG, Study Chair,
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
George Washington Univ / Hershey Med Ctr
Washington D.C., District of Columbia, 20037
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, 212052196
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
Denver Dept of Health and Hosps
Denver, Colorado, 80262
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
Adirondack Med Ctr at Saranac Lake
Albany, New York, 122083479
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, 10468
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 191075098
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
North Central Bronx Hosp / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Mid - Hudson Care Ctr
Albany, New York, 122083479
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Yale Univ / New Haven
New Haven, Connecticut, 065102483
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Montefiore Adolescent AIDS Prog / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
North Shore Univ Hosp
Manhasset, New York, 11030
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial
Worcester, Massachusetts, 01605
United States
Columbia Presbyterian Med Ctr
New York City, New York, 100323784
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
VA Hosp at San Diego / Pediatrics
San Diego, California, 92161
United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 112032098
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, 94609
United States
Kaiser Permanente Franklin Med Ctr
Denver, Colorado, 80262
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Youngstown Hemophilia Ctr / Great Lakes Hemophilia Fdn
Wauwatosa, Wisconsin, 53213
United States
Queens Med Ctr
Honolulu, Hawaii, 96816
United States
Rose Med Ctr
Denver, Colorado, 80262
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
USC Univ Hosp & Ambulatory Hlth Care Ctr / USC Med Ctr
Los Angeles, California, 900334508
United States
Albany Med College / Division of HIV Medicine A158
Albany, New York, 122083479
United States
Comprehensive Health Care Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Montefiore Family Health Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Olive View Med Ctr
Sylmar, California, 91342
United States
Howard Univ
Washington D.C., District of Columbia, 20059
United States
Additional Information:
Study ID Numbers: ACTG 261;
Study Start Date:
Record last reviewed: September 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000803
Other Hiv Infections Studies:
1. A Study of Trimetrexate in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS Not Previously Treated for PCP
2. Vitamin A to Reduce HIV in Vaginal Secretions and Prevent Viral Transmission
3. A Comparison of Two Anti-HIV Treatment Plans
4. The Safety and Effectiveness of Zidovudine Plus Adefovir in HIV-Infected Patients
5. Curb, Alter, Lower, or Manage Stress in HIV: CALMS-HIV
Related Studies:
Other HIV Infections Clinical Trials
Other District of Columbia Clinical Trials
Other Washington D.C. Clinical Trials
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
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