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A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3 Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3 conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3 Clinical research trials and A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3 healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3. A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3 Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3 clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3 condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.

Home > "A" Clinical Trials Conditions > A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3

A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3



A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3

For Condition: HIV Infections
Status: Completed
Sponsor(s): Pharmacia and Upjohn ,
Synopsis: To evaluate the safety, tolerance, pharmacokinetics, and efficacy of delavirdine mesylate (U-90152S) in combination with didanosine (ddI) versus ddI alone in HIV-positive patients.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 14 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - AZT. Patients must have: - HIV-1 seropositivity. - CD4 count <= 300 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. 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 ddI in previous treated patients. Prior Medication: Excluded: - More than 4 months total of prior ddI. - Any prior ddC, d4T, or 3TC. - Prior nonnucleoside 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. Required: - AZT therapy at some time prior to screening. Active substance abuse.
Total Enrollment: 

Location and Contact Information:

Georgetown Univ Med Ctr
Washington D.C.,  District of Columbia,  20007
United States
 

Children's Hosp of Philadelphia
Philadelphia,  Pennsylvania,  19104
United States
 

Vanderbilt Univ
Nashville,  Tennessee,  37212
United States
 

Community Research Initiative on AIDS
New York City,  New York,  10001
United States
 

Univ of Maryland at Baltimore
Baltimore,  Maryland,  21201
United States
 

Los Angeles County - USC Med Ctr
Los Angeles,  California,  900331079
United States
 

Baystate Med Ctr of Springfield
Springfield,  Massachusetts,  01199
United States
 

Univ of Tennessee
Memphis,  Tennessee,  38163
United States
 

Univ of Cincinnati / Holmes Hosp
Cincinnati,  Ohio,  45267
United States
 

Duke Univ Med Ctr
Durham,  North Carolina,  27710
United States
 

New York Hosp - Cornell Med Ctr
New York City,  New York,  10021
United States
 

ViRx Inc
San Francisco,  California,  94103
United States
 

CARE Ctr / UCLA Med Ctr
Los Angeles,  California,  90095
United States
 

Park Plaza Hosp
Houston,  Texas,  77004
United States
 

Central Texas Med Foundation
Austin,  Texas,  78751
United States
 

Oncology and Hematology Association
Philadelphia,  Pennsylvania,  19146
United States
 

St Paul Ramsey Med Ctr / HIV Program Office
St. Paul,  Minnesota,  55101
United States
 

Henry Ford Hosp
Detroit,  Michigan,  48202
United States
 

Univ of Kentucky Med Ctr / Chandler Med Ctr
Lexington,  Kentucky,  405360084
United States
 

Univ of Missouri at Kansas City School of Medicine
Kansas City,  Missouri,  64108
United States
 

Los Angeles County / Health Research Assoc / Drew Med Ctr
Los Angeles,  California,  90059
United States
 

Univ of Wisconsin
Madison,  Wisconsin,  53792
United States
 

Beth Israel Med Ctr
New York City,  New York,  10003
United States
 

Univ TX Health Science Ctr
Houston,  Texas,  77030
United States
 

Davies Med Ctr
San Francisco,  California,  94114
United States
 

Univ of North Carolina School of Medicine
Chapel Hill,  North Carolina,  275997215
United States
 

Univ of Illinois
Chicago,  Illinois,  60612
United States
 

AIDS Consultation Service / Maine Med Ctr
Portland,  Maine,  04102
United States
 

Med Ctr of Vermont Hosp
Burlington,  Vermont,  05401
United States
 

Univ of Nebraska Med Ctr / HIV Clinic
Omaha,  Nebraska,  681985130
United States
 

Univ of Pennsylvania / HIV Clinic
Philadelphia,  Pennsylvania,  19104
United States
 

AIDS Community Research Consortium
Redwood City,  California,  94063
United States
 

Harbor - UCLA Med Ctr
Torrance,  California,  90509
United States
 

Jersey Shore Med Ctr
Neptune,  New Jersey,  07753
United States
 

Univ of Massachusetts Med Ctr
Worcester,  Massachusetts,  01655
United States
 

Community Health Network
Rochester,  New York,  14620
United States
 

UPR School of Medicine
San Juan,  ,  00936
Puerto Rico
 

Saint Vincent's Hosp and Med Ctr
New York City,  New York,  10011
United States
 

East Bay AIDS Ctr
Berkeley,  California,  94705
United States
 

Houston Veterans Administration Med Ctr
Houston,  Texas,  77030
United States
 

Tulane Univ Med School
New Orleans,  Louisiana,  701122699
United States
 

Univ of Alabama at Birmingham
Birmingham,  Alabama,  352942041
United States
 

New England Deaconess Hosp
Boston,  Massachusetts,  02215
United States
 

Med Univ of South Carolina
Charleston,  South Carolina,  29425
United States
 

George Washington Univ Med Ctr
Washington D.C.,  District of Columbia,  20037
United States
 

Buckley Braffman Stern Med Associates
Philadelphia,  Pennsylvania,  19107
United States
 

Univ of Michigan Hospitals and Health Ctrs
Ann Arbor,  Michigan,  481090378
United States
 

Mem Hosp of Rhode Island
Pawtucket,  Rhode Island,  02860
United States
 

Brigham and Women's Hosp
Boston,  Massachusetts,  02115
United States
 

Univ of Rochester Med Ctr
Rochester,  New York,  14642
United States
 

Washington Univ
St. Louis,  Missouri,  63110
United States
 

Infectious Disease Rsch Consortium of GA / SE Clin Resources
Atlanta,  Georgia,  30345
United States
 

Harper Hosp
Detroit,  Michigan,  48201
United States
 

Univ Hosp / Univ of Colorado Health Sci Ctr
Denver,  Colorado,  80262
United States
 

Infectious Disease Research Institute Inc
Tampa,  Florida,  33614
United States
 

Univ of Kansas School of Medicine
Wichita,  Kansas,  67214
United States
 

Massachusetts Gen Hosp
Boston,  Massachusetts,  02114
United States
 

Albany Med College
Albany,  New York,  122083479
United States
 

UCSD / Ctr for Special Immunology
San Diego,  California,  92103
United States
 

Pennsylvania State Univ / Hershey Med Ctr
Hershey,  Pennsylvania,  17033
United States
 

Univ of Pittsburgh Med School
Pittsburgh,  Pennsylvania,  15261
United States
 

Rush Presbyterian - Saint Luke's Med Ctr
Chicago,  Illinois,  60612
United States
 

Univ of Miami School of Medicine
Miami,  Florida,  33136
United States
 

Caremark Inc
Palm Beach Gardens,  Florida,  33410
United States
 

Mount Sinai Med Ctr
New York City,  New York,  10029
United States
 

Univ TX San Antonio Health Science Ctr
San Antonio,  Texas,  78284
United States
 

Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland,  Oregon,  97210
United States
 

Univ of Washington
Seattle,  Washington,  98104
United States
 

Carolinas Med Ctr
Charlotte,  North Carolina,  28204
United States
 

Richmond AIDS Consortium
Richmond,  Virginia,  23219
United States
 

California Med Research Group
Fresno,  California,  93726
United States
 

Univ of Iowa
Iowa City,  Iowa,  52242
United States
 

St Lukes Medical Group
San Diego,  California,  92101
United States
 

New York Med College / Westchester County Med Ctr
Valhalla,  New York,  10595
United States
 

UCI Med Ctr
Orange,  California,  92668
United States
 

UCD Med Ctr / AIDS and Related Disorders Clinic
Sacramento,  California,  95817
United States
 

Univ of Kansas School of Medicine / Univ Hosp
Kansas City,  Kansas,  661607354
United States
 

Indiana Univ Infectious Disease Research Clinic
Indianapolis,  Indiana,  46202
United States
 

SUNY / Health Sciences Ctr at Stony Brook
Stony Brook,  New York,  117948153
United States
 

SUNY / Erie County Med Ctr at Buffalo
Buffalo,  New York,  14215
United States
 

Dallas Veterans Administration Med Ctr
Dallas,  Texas,  75216
United States
 

Shared Med Research Foundation
Tarzana,  California,  91356
United States
 

Saint Francis Mem Hosp
San Francisco,  California,  94109
United States
 

Boston City Hosp / FGH-1
Boston,  Massachusetts,  02118
United States
 


Additional Information:
Study ID Numbers:
  228A;  M/3331/0017
Study Start Date: 
Record last reviewed: November 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002123

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3. A Study of Two Anti-HIV Drug Combinations

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