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A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3 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 Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3 conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3 Clinical research trials and A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3 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 Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3. A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3 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 Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3 clinical trial. Human subjects often obtain the finest healthcare possible for their A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3 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 Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3 A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3
A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Bristol-Myers Squibb,Glaxo Wellcome
Synopsis: To determine the efficacy and safety of zidovudine ( AZT ) versus didanosine ( ddI ), AZT plus ddI, and AZT plus zalcitabine ( ddC ) in preventing disease progression in HIV-infected patients with CD4 counts of 200-500 cells/mm3.
Details: Patients are randomized to receive AZT alone, AZT and ddI, AZT and ddC, or ddI alone for at least 2 years. Patients who develop AIDS or whose CD4 count falls to 50 percent or less of baseline are crossed over to another treatment arm. PER AMENDMENT 4/5/95: Study treatment will be available until 10/31/95 at the latest for patients still taking study medications on 4/30/95, so that follow-up trials may be completed and approved.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - PCP prophylaxis, M. tuberculosis prophylaxis, short courses of acyclovir, chronic suppressive acyclovir, pneumovax or Hib vaccine, antibiotics, rEPO and G-CSF for grade 3 or worse anemia and neutropenia, systemic corticosteroids for < 21 days, regularly prescribed medications, and vitamins or herbal therapies. Patients must have: - HIV infection without AIDS with CD4 200-500 cells/mm3. PER AMENDMENT 4/5/95: - Patients must have remained on ACTG 175 study treatment through 4/30/95 and meet toxicity management criteria for continuing treatment. Subjects taking ACTG 175 crossover treatment are eligible. Exclusion Criteria Co-existing Condition: Patients with the following conditions are excluded: - Current AIDS-related condition other than minimal KS, grade 2 or worse peripheral neuropathy, and malignancy requiring systemic therapy. Concurrent Medication: Excluded: - Other anti-HIV drugs, biologic response modifiers other than rEPO and G-CSF, systemic cytotoxic chemotherapy, chronic systemic corticosteroids, or any drug that affects AZT glucuronidation or clearance. Concurrent Treatment: Excluded: - Radiotherapy other than limited local therapy to skin. Patients with the following prior conditions are excluded: - AIDS-related condition other than minimal KS; intolerance to AZT, ddI, or ddC at study doses; and acute or chronic pancreatitis. Prior Medication: Excluded: - Acute therapy for an infection or other medical illness within the past 14 days. Current alcohol abuse.
Total Enrollment: 2100
Location and Contact Information:
Overall Study Official:
KatzensteinD, Study Chair,
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Olive View Med Ctr
Sylmar, California, 91342
United States
Children's Mem Hosp Family Cln / Northwestern Univ Med Schl
Chicago, Illinois, 60611
United States
Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial
Worcester, Massachusetts, 01605
United States
Nebraska Regional Hemophilia Ctr / Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Saint Clare's Hosp and Health Ctr
New York City, New York, 10019
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Univ of Louisville / East Tennesee Comprehensive Hem Ctr
Louisville, Kentucky, 40202
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
United States
Carolinas Med Ctr
Charlotte, North Carolina, 28203
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Indiana Univ / Riley Hosp for Children
Indianapolis, Indiana, 46202
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Mountain States Hemo Ctr / Univ of Utah
Denver, Colorado, 80262
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Montefiore Family Health Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
SUNY - Stony Brook
Stony Brook, New York, 117948153
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Univ of Washington / Children's Hosp of Los Angeles
Los Angeles, California, 90027
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
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Oregon Health Sciences Univ / Children's Hosp of Los Angeles
Portland, Oregon, 97201
United States
Children's Hosp of Los Angeles
Los Angeles, California, 90027
United States
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
Atlanta, Georgia, 303652225
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Michigan State Univ Hemophilia Comprehensive Care Clinic
Lansing, Michigan, 48912
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Wake Med Ctr / Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Univ Texas Health Science Ctr / Univ Texas Med School
Houston, Texas, 77030
United States
Huntington Memorial Hosp / Children's Hosp of Los Angeles
Pasadena, California, 91105
United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, 212052196
United States
Brigham and Women's Hosp
Boston, Massachusetts, 02115
United States
St Louis Univ Med Ctr / Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
United States
Dartmouth - Hitchcock Med Ctr / Med Ctr Cntrl Massachusetts
Lebanon, New Hampshire, 03756
United States
UMDNJ - New Jersey Med School
Newark, New Jersey, 07107
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Mount Sinai Med Ctr / Hemophilia Treatment Ctr
New York City, New York, 10029
United States
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401
United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 191075098
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Youngstown Hemophilia Ctr / Great Lakes Hemophilia Fdn
Wauwatosa, Wisconsin, 53213
United States
Comp Hemo Ctr of Ctrl & N Illinois / Great Lakes Hemo Fdn
Wauwatosa, Wisconsin, 532130127
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Glaxo Wellcome Inc
Research Triangle Park, North Carolina, 27709
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Hemophilia Ctr of Western PA / Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15219
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
North Central Bronx Hosp / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Saint Joseph's Hosp & Med Ctr / Mtn States Reg Hemo Ctr
Denver, Colorado, 80262
United States
Rhode Island Hemophilia Ctr / Med Ctr of Cntrl MA
Worcester, Massachusetts, 01605
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Samaritan Village Inc / Bronx Municipal Hosp
Bronx, New York, 10461
United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 112032098
United States
Wake County Dept of Health
Raleigh, North Carolina, 27610
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Northern Wisconsin Hemophilia Ctr / Saint Vincent's Hosp
Green Bay, Wisconsin, 54301
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Howard Univ
Washington D.C., District of Columbia, 20059
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Robert Wood Johnson Med School / Hershey Med Ctr
New Brunswick, New Jersey, 08903
United States
Yale Univ / New Haven
New Haven, Connecticut, 065102483
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr
Sylmar, California, 91342
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Mountain States Reg Hemo Ctr / Univ of Colorado
Denver, Colorado, 80262
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Montefiore Med Ctr Adolescent AIDS Program
Bronx, New York, 10467
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Univ of Pittsburgh Med School / Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
George Washington Univ / Hershey Med Ctr
Washington D.C., District of Columbia, 20037
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
Great Plains - Hemophilia / Univ of Iowa Hosp & Clinic
Iowa City, Iowa, 52242
United States
Nassau County Med Ctr
East Meadow, New York, 11554
United States
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Med Univ of South Carolina / UNC
Charleston, South Carolina, 29425
United States
Univ Hosp / Univ of Colorado Health Sci Ctr
Denver, Colorado, 80262
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Connecticut Children's Med Ctr
Farmington, Connecticut, 060303805
United States
Med College of Ohio
Toledo, Ohio, 43699
United States
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, 10468
United States
Tulane Med Ctr Hosp
New Orleans, Louisiana, 70112
United States
HIV Ctr - District of Columbia Gen Hosp
Washington D.C., District of Columbia, 200072197
United States
Great Lakes Hemophilia Foundation
Wauwatosa, Wisconsin, 532130127
United States
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, 94609
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, 37920
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
UCSD / Children's Hosp Los Angeles
Los Angeles, California, 90027
United States
Northwest Ohio Hemo Treatment Ctr / Great Lakes Hemo Fdn
Toledo, Ohio, 43606
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
St Paul Ramsey Med Ctr
St. Paul, Minnesota, 55101
United States
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, 52242
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Puerto Genetic Disease Clinic
New York City, New York, 10029
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
United States
North Shore Univ Hosp
Manhasset, New York, 11030
United States
Additional Information:
Study ID Numbers: ACTG 175;
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000625
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3. A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients
4. Safety and Effectiveness of CD4-IgG2 in HIV-Positive Children
5. Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis carinii Pneumonia in Pediatric HIV Infection
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A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3
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