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A Double-Blind, Randomized, Dose Response Study of Three Doses of Delavirdine Mesylate (U-90152S) in Combination with Zidovudine (ZDV) versus ZDV alone in HIV-1 Infected Individuals with CD4 Counts of 200-500mm3 Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about A Double-Blind, Randomized, Dose Response Study of Three Doses of Delavirdine Mesylate (U-90152S) in Combination with Zidovudine (ZDV) versus ZDV alone in HIV-1 Infected Individuals with CD4 Counts of 200-500mm3 conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Double-Blind, Randomized, Dose Response Study of Three Doses of Delavirdine Mesylate (U-90152S) in Combination with Zidovudine (ZDV) versus ZDV alone in HIV-1 Infected Individuals with CD4 Counts of 200-500mm3 Clinical research trials and A Double-Blind, Randomized, Dose Response Study of Three Doses of Delavirdine Mesylate (U-90152S) in Combination with Zidovudine (ZDV) versus ZDV alone in HIV-1 Infected Individuals with CD4 Counts of 200-500mm3 health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as A Double-Blind, Randomized, Dose Response Study of Three Doses of Delavirdine Mesylate (U-90152S) in Combination with Zidovudine (ZDV) versus ZDV alone in HIV-1 Infected Individuals with CD4 Counts of 200-500mm3. A Double-Blind, Randomized, Dose Response Study of Three Doses of Delavirdine Mesylate (U-90152S) in Combination with Zidovudine (ZDV) versus ZDV alone in HIV-1 Infected Individuals with CD4 Counts of 200-500mm3 Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a A Double-Blind, Randomized, Dose Response Study of Three Doses of Delavirdine Mesylate (U-90152S) in Combination with Zidovudine (ZDV) versus ZDV alone in HIV-1 Infected Individuals with CD4 Counts of 200-500mm3 clinical trial. Human subjects frequently get the finest healthcare available for their A Double-Blind, Randomized, Dose Response Study of Three Doses of Delavirdine Mesylate (U-90152S) in Combination with Zidovudine (ZDV) versus ZDV alone in HIV-1 Infected Individuals with CD4 Counts of 200-500mm3 condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Double-Blind, Randomized, Dose Response Study of Three Doses of Delavirdine Mesylate (U-90152S) in Combination with Zidovudine (ZDV) versus ZDV alone in HIV-1 Infected Individuals with CD4 Counts of 200-500mm3 A Double-Blind, Randomized, Dose Response Study of Three Doses of Delavirdine Mesylate (U-90152S) in Combination with Zidovudine (ZDV) versus ZDV alone in HIV-1 Infected Individuals with CD4 Counts of 200-500mm3
A Double-Blind, Randomized, Dose Response Study of Three Doses of Delavirdine Mesylate (U-90152S) in Combination with Zidovudine (ZDV) versus ZDV alone in HIV-1 Infected Individuals with CD4 Counts of 200-500mm3
For Condition: HIV Infections
Status: Completed
Sponsor(s): Pharmacia and Upjohn ,
Synopsis: PART I: To evaluate the safety, tolerance, efficacy, and pharmacokinetics of three fixed doses of delavirdine mesylate (DLV) in combination with zidovudine (AZT) versus AZT alone in HIV-positive patients. PART II: To evaluate the safety, tolerance, efficacy, and pharmacokinetics of ZDV plus 3TC with or without DLV versus ZDV plus DLV in HIV-positive patients.
Details: PART I: Patients are originally randomized to receive ZDV plus DLV (DLV at 1 of 3 doses) or ZDV plus placebo. AS PER AMENDMENT 3/7/96: PART II: Patients are rerandomized from PART I. Arm I: ZDV plus 3TC plus placebo. Arm II: ZDV plus 3TC plus DLV. Arm III: ZDV plus DLV (DLV at a higher dose than in the original protocol). Arm IV: ZDV plus DLV (no change from original; same treatment as Arm III). AS PER AMENDMENT 1/24/97: Approximately 450 more patients will be enrolled in one of these 3 revised arms on PART II. Half of these new patients will be anti-retroviral naive and half will be anti-retroviral experienced.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 14 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV-1 seropositivity. - CD4 count 200-500 cells/mm3. - No active or acute (onset within the past month) opportunistic infections such as active cryptococcosis, pneumocystis carinii, herpes zoster, histoplasmosis, or cytomegalovirus (CMV). - Consent of parent or guardian if less than 18 years of age. - Understanding of potential risk to fetus related to study participation. - Acceptable medical history, physical exam, EKG, and chest x-ray during screening. NOTE: - Patients with cutaneous Kaposi's sarcoma requiring no systemic therapy are permitted. PER AMENDMENT 3/7/96: - ZDV therapy for 0-6 months prior to study entry. (Part II) Prior Medication: Allowed: - Prior AZT (no more than 6 months total). Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Active tuberculosis that is sensitive to rifampin. - Inability to swallow numerous tablets. - Clinically significant active or acute medical problems, including progressive multifocal leukoencephalopathy, lymphoma, or malignancy requiring systemic therapy. - Clinically significant hypersensitivity to piperazine-type drugs (e.g., Antepar and Stelazine). - Grade 2 or worse baseline organ function. NOTE: - Hemophiliacs with grade 2 bilirubin, alkaline phosphatase, SGOT, or SGPT will be considered if these values have been stable over the past year. NOTE: - Patients with suspected Gilbert's syndrome will be considered if bilirubin is grade 2 or better. Patients with the following prior conditions are excluded: - History of pancreatitis within the past 2 years. - History of clinically significant nervous system or muscle disease, seizure disorder, AIDS dementia, or psychiatric disorder that would preclude study compliance. - History of grade 2 or worse peripheral neuropathy. - Intolerance to AZT in previously treated patients. Prior Medication: Excluded: - More than 6 months total of prior AZT. - Any prior ddC, d4T, 3TC, or ddI. - Prior non-nucleoside reverse transcriptase inhibitors, including L-drugs, nevirapine, TIBO, HEPT, delavirdine, atevirdine, and alpha-APA. - Other investigational antiretroviral medications (including foscarnet) or immunomodulators (including all interferons) within 21 days prior to initial study drug dose. - Prior prophylactic or therapeutic HIV-1 gp120 or 160 vaccines. - Rifampin, rifabutin, astemizole, loratadine, or terfenadine within 21 days prior to initial study drug dose. - Any unapproved investigational medication for any indication within 21 days prior to initial study drug dose. - Any enzyme-inducing drugs known to affect cytochrome P450 3A, (e.g., ketoconazole, fluconazole, isoniazid, itraconazole, etc.) within 21 days prior to initial study drug dose. Active substance abuse.
Total Enrollment: 1250
Location and Contact Information:
CARE Ctr / UCLA Med Ctr
Los Angeles, California, 90095
United States
St Paul Ramsey Med Ctr / HIV Program Office
St. Paul, Minnesota, 55101
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Univ of Michigan Hospitals and Health Ctrs
Ann Arbor, Michigan, 481090378
United States
Univ of Kansas School of Medicine / Univ Hosp
Kansas City, Kansas, 661607354
United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210
United States
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, 275997215
United States
Boston City Hosp / FGH-1
Boston, Massachusetts, 02118
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
Harbor - UCLA Med Ctr
Torrance, California, 90509
United States
Park Plaza Hosp
Houston, Texas, 77004
United States
East Bay AIDS Ctr
Berkeley, California, 94705
United States
Stratogen Health / Independent Research Nurses
Cranston, Rhode Island, 02910
United States
Peachwood Med Ctr
Clovis, California, 93612
United States
Univ of Washington
Seattle, Washington, 98104
United States
Vanderbilt Univ
Nashville, Tennessee, 37212
United States
Univ of Cincinnati / Holmes Hosp
Cincinnati, Ohio, 45267
United States
Univ of Kentucky Med Ctr / Chandler Med Ctr
Lexington, Kentucky, 405360084
United States
Univ of Tennessee
Memphis, Tennessee, 38163
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 352942041
United States
New England Deaconess Hosp
Boston, Massachusetts, 02215
United States
Central Texas Med Foundation
Austin, Texas, 78751
United States
New York Hosp - Cornell Med Ctr
New York City, New York, 10021
United States
Univ of Nebraska Med Ctr / HIV Clinic
Omaha, Nebraska, 681985130
United States
Albany Med College
Albany, New York, 122083479
United States
Saint Vincent's Hosp and Med Ctr
New York City, New York, 10011
United States
Harper Hosp
Detroit, Michigan, 48201
United States
Univ of Rochester Med Ctr
Rochester, New York, 14642
United States
Massachusetts Gen Hosp
Boston, Massachusetts, 02114
United States
Houston Veterans Administration Med Ctr
Houston, Texas, 77030
United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 900331079
United States
Univ of Pennsylvania / HIV Clinic
Philadelphia, Pennsylvania, 19104
United States
Univ Hosp / Univ of Colorado Health Sci Ctr
Denver, Colorado, 80262
United States
Univ of Oklahoma
Oklahoma City, Oklahoma, 73117
United States
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 78284
United States
Univ TX Health Science Ctr
Houston, Texas, 77030
United States
Henry Ford Hosp
Detroit, Michigan, 48202
United States
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, 946021018
United States
Shared Med Research Foundation
Tarzana, California, 91356
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Med Ctr of Vermont Hosp
Burlington, Vermont, 05401
United States
Med Univ of South Carolina
Charleston, South Carolina, 29425
United States
Richmond AIDS Consortium
Richmond, Virginia, 23219
United States
Saint Francis Mem Hosp
San Francisco, California, 94109
United States
Univ of Maryland at Baltimore
Baltimore, Maryland, 21201
United States
Community Health Network
Rochester, New York, 14620
United States
Dallas Veterans Administration Med Ctr
Dallas, Texas, 75216
United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania, 15261
United States
Univ of Wisconsin
Madison, Wisconsin, 53792
United States
Infectious Disease Research Institute Inc
Tampa, Florida, 33614
United States
Pennsylvania State Univ / Hershey Med Ctr
Hershey, Pennsylvania, 17033
United States
Davies Med Ctr
San Francisco, California, 94114
United States
Tulane Univ Med School
New Orleans, Louisiana, 701122699
United States
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
United States
Jersey Shore Med Ctr
Neptune, New Jersey, 07753
United States
St Lukes Medical Group
San Diego, California, 92101
United States
AIDS Consultation Service / Maine Med Ctr
Portland, Maine, 04102
United States
Washington Univ
St. Louis, Missouri, 63110
United States
Brigham and Women's Hosp
Boston, Massachusetts, 02115
United States
UPR School of Medicine
San Juan, , 00936
Puerto Rico
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 117948153
United States
Univ of Miami School of Medicine
Miami, Florida, 33136
United States
Johns Hopkins Hosp
Baltimore, Maryland, 212052196
United States
Oncology and Hematology Association
Philadelphia, Pennsylvania, 19146
United States
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, 64108
United States
UCI Med Ctr
Orange, California, 92668
United States
New York Med College / Westchester County Med Ctr
Valhalla, New York, 10595
United States
Univ of Iowa
Iowa City, Iowa, 52242
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Indiana Univ Infectious Disease Research Clinic
Indianapolis, Indiana, 46202
United States
UCSD / Ctr for Special Immunology
San Diego, California, 92103
United States
Caremark Inc
Palm Beach Gardens, Florida, 33410
United States
Carolinas Med Ctr
Charlotte, North Carolina, 28204
United States
UCD Med Ctr / AIDS and Related Disorders Clinic
Sacramento, California, 95817
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Infectious Disease Rsch Consortium of GA / SE Clin Resources
Atlanta, Georgia, 30345
United States
ViRx Inc
San Francisco, California, 94103
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
AIDS Community Research Consortium
Redwood City, California, 94063
United States
Los Angeles County / Health Research Assoc / Drew Med Ctr
Los Angeles, California, 90059
United States
Community Research Initiative on AIDS
New York City, New York, 10001
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Univ of Illinois
Chicago, Illinois, 60612
United States
Additional Information:
Study ID Numbers: 228B; M/3331/0021
Study Start Date:
Record last reviewed: July 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002124
Other Hiv Infections Studies:
1. Effects on the Immune System of Anti-HIV Drugs in Patients Recently Infected with HIV
2. A Phase I Study of Recombinant CD4(rCD4) in Patients With AIDS and AIDS-Related Complex
3. A Phase I/II, Open Label Study to Evaluate the Antiviral Potential of Combination Zidovudine and 2' 3'-Dideoxyinosine (Didanosine) in Patients With Asymptomatic HIV Disease
4. A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3
5. A Study to Test If Giving Remune (an HIV Vaccine) Can Improve the Immune Systems of HIV-Positive Patients Who Are Also Participating in ACTG 328
Related Studies:
Other HIV Infections Clinical Trials
Other Missouri Clinical Trials
Other Kansas City Clinical Trials
A Double-Blind, Randomized, Dose Response Study of Three Doses of Delavirdine Mesylate (U-90152S) in Combination with Zidovudine (ZDV) versus ZDV alone in HIV-1 Infected Individuals with CD4 Counts of 200-500mm3
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