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A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3) Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3) conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3) Clinical research trials and A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3) health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3). A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3) Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3) clinical trial. Human subjects often get the best healthcare possible for their A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3) condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3) A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)
A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/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 relative clinical efficacy of zidovudine ( AZT ) plus didanosine (ddI), AZT plus zalcitabine ( ddC ), AZT alternating monthly with ddI, and AZT/ddI plus nevirapine in HIV-infected patients with advanced disease. The rapid emergence of resistant HIV strains has been observed in patients receiving monotherapy with a nucleoside analog or non-nucleoside reverse transcriptase inhibitor. Use of combination therapy with two nucleoside drugs or convergent combination therapy with two nucleosides and a non-nucleoside RT inhibitor may minimize the evolution of these resistant HIV strains. Since toxicity is a major problem in patients with advanced disease who are receiving combination nucleoside therapy, alternating the two drugs may provide a way of retaining several benefits of combination therapy while minimizing the increased toxicity.
Details: The rapid emergence of resistant HIV strains has been observed in patients receiving monotherapy with a nucleoside analog or non-nucleoside reverse transcriptase inhibitor. Use of combination therapy with two nucleoside drugs or convergent combination therapy with two nucleosides and a non-nucleoside RT inhibitor may minimize the evolution of these resistant HIV strains. Since toxicity is a major problem in patients with advanced disease who are receiving combination nucleoside therapy, alternating the two drugs may provide a way of retaining several benefits of combination therapy while minimizing the increased toxicity. Patients are randomized to receive either AZT/ddC, AZT/ddI, AZT alternating monthly with ddI, or AZT/ddI/nevirapine. Patients are evaluated at week 0 and every 4 weeks thereafter for 2 years. Pharmacologic, virologic, and macroneurologic substudies will be conducted. Patients who are already enrolled on protocol ACTG 193 will be given the option of continuing on their originally assigned ACTG 193 therapy for an additional 6 months or undergoing re-randomization to one of the four treatment arms on ACTG 193A.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Efficacy Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Required: - PCP prophylaxis. Allowed: - Erythropoietin maintenance. - G-CSF and GM-CSF. - Prophylaxis for Mycobacterium avium intracellulare. - Antifungal prophylaxis or treatment with specific drugs. - Maintenance therapy for opportunistic infection. - Over-the-counter medications or alternative therapies such as vitamins and herbs. - Antibiotics as clinically indicated. - Steroids for < 21 days for acute problems. - Antipyretics, analgesics, allergy medication, antidepressants, sleep medications, oral contraceptives, or other appropriate medications. Concurrent Treatment: Allowed: - Radiation therapy for cutaneous Kaposi's sarcoma. - Acupuncture. Patients must have: - Documented HIV infection. - CD4 count <= 50 cells/mm3. - Either no prior nucleoside therapy OR a history of prior nucleoside therapy in the absence of high-grade intolerance. - Life expectancy of at least 6 months. - Consent of parent or guardian if < 18 years of age. - Normal chest x-ray at baseline or within 6 months prior to study entry in the absence of new pulmonary or cardiac symptoms (per 12/28/94 amendment). NOTE: - Patients who withdrew from protocol ACTG 193 therapy prior to activation of ACTG 193A are not eligible. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Abnormal baseline chest x-ray. - New pulmonary or cardiac symptoms. - Psychological or emotional problems sufficient to prevent compliance with study medication. Concurrent Medication: Excluded: - Systemic chemotherapy for malignancy. - Acute or induction therapy for opportunistic infection. - Antiretroviral drugs other than study drugs. - Biological response modifiers. - Erythromycin, phenytoin, phenobarbital, warfarin, or coumadin. Patients with the following prior conditions are excluded: - History of recurrent grade 3 or greater toxicity to AZT, ddI, or ddC on two or more occasions. - Evidence of active pulmonary disease within 6 months prior to study entry. - History of grade 3 or worse peripheral neuropathy. - History of acute or chronic pancreatitis. Prior Medication: Excluded: - Prior nevirapine. Excluded within 7 days prior to study entry: - Acute therapy for opportunistic infection (maintenance therapy is permitted). - Acute systemic therapy for a nonopportunistic infection or other medical condition. - Antiretroviral drugs other than AZT, ddI, or ddC. - Biological response modifiers. - d4T therapy. - Nucleosides other than those used in the study. - Antibiotics containing clavulanate potassium. Prior Treatment: Excluded: - More than 4 units of blood in a 30-day period. Active alcohol or drug abuse.
Total Enrollment: 1292
Location and Contact Information:
Overall Study Official:
HenryWK, Study Chair,
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401
United States
North Shore Univ Hosp
Manhasset, New York, 11030
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Columbus Children's Hosp
Columbus, Ohio, 432052696
United States
Dartmouth - Hitchcock Med Ctr / Med Ctr Cntrl Massachusetts
Lebanon, New Hampshire, 03756
United States
Saint Clare's Hosp and Health Ctr
New York City, New York, 10019
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Denver Dept of Health and Hosps
Denver, Colorado, 80262
United States
Univ Texas Health Science Ctr / Univ Texas Med School
Houston, Texas, 77030
United States
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640
United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, 37920
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Montefiore Med Ctr Adolescent AIDS Program
Bronx, New York, 10467
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 112032098
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
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
Comprehensive Health Care Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Hennepin County Med Clinic
Minneapolis, Minnesota, 55415
United States
Albany Med College / Division of HIV Medicine A158
Albany, New York, 122083479
United States
North Central Bronx Hosp / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Huntington Memorial Hosp / Children's Hosp of Los Angeles
Pasadena, California, 91105
United States
Rose Med Ctr
Denver, Colorado, 80262
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Olive View Med Ctr
Sylmar, California, 91342
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
Children's Hosp of Los Angeles
Los Angeles, California, 90027
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Northern Wisconsin Hemophilia Ctr / Saint Vincent's Hosp
Green Bay, Wisconsin, 54301
United States
George Washington Univ / Hershey Med Ctr
Washington D.C., District of Columbia, 20037
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Saint Michael's Med Ctr / Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
HIV Ctr - District of Columbia Gen Hosp
Washington D.C., District of Columbia, 200072197
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Robert Wood Johnson Med School / Hershey Med Ctr
New Brunswick, New Jersey, 08903
United States
Univ of South Florida
Tampa, Florida, 33612
United States
Mount Sinai Med Ctr / Hemophilia Treatment Ctr
New York City, New York, 10029
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Adirondack Med Ctr at Saranac Lake
Albany, New York, 122083479
United States
St Paul Ramsey Med Ctr
St. Paul, Minnesota, 55101
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Med Univ of South Carolina / UNC
Charleston, South Carolina, 29425
United States
Univ of Kentucky Lexington
Cincinnati, Ohio, 45267
United States
Mid - Hudson Care Ctr
Albany, New York, 122083479
United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
United States
Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial
Worcester, Massachusetts, 01605
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
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Mountain States Reg Hemo Ctr / Univ of Colorado
Denver, Colorado, 80262
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Montefiore Family Health Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Whitman - Walker Clinic / Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 200072197
United States
Meharry Med College
Nashville, Tennessee, 37203
United States
Samaritan Village Inc / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699
United States
Great Lakes Hemophilia Foundation
Wauwatosa, Wisconsin, 532130127
United States
Med College of Ohio
Toledo, Ohio, 43699
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Yale Univ / New Haven
New Haven, Connecticut, 065102483
United States
Howard Univ
Washington D.C., District of Columbia, 20059
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 191075098
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Univ of Louisville / East Tennesee Comprehensive Hem Ctr
Louisville, Kentucky, 40202
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Columbia Presbyterian Med Ctr
New York City, New York, 100323784
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Girard Med Ctr
Philadelphia, Pennsylvania, 191046073
United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Additional Information:
Study ID Numbers: ACTG 193A;
Study Start Date:
Record last reviewed: October 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000781
Other Hiv Infections Studies:
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2. A Double-Blind, Randomized Parallel Group Study Comparing Procysteine to Placebo in HIV-Infected Patients Who Are Taking Antiretroviral Nucleosides
3. Viracept Expanded Access Program
4. Handheld Computers to Improve Adherence to Anti-HIV Drug Regimens
5. The Safety and Effectiveness of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HVIG) Plus Zidovudine in HIV-Infected Infants
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A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)
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