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Nucleoside Analogues |
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Clinical Trial: 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
This study has been completed.
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Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| HIV Infections | Drug: Zidovudine Drug: Zalcitabine Drug: Didanosine | Phase II |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Double-Blind, Safety Study
Expected Total Enrollment: 2100
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
Ages Eligible for Study: 12 Years and above, Genders Eligible for Study: Both
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:
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:
Current alcohol abuse.
Location Information
Alabama
Univ of Alabama at Birmingham, Birmingham, Alabama, 35294, United States
California
Univ of California / San Diego Treatment Ctr, San Diego, California, 921036325, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences, La Jolla, California, 920930672, United States
Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr, Sylmar, California, 91342, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr, San Francisco, California, 94115, United States
San Francisco Gen Hosp, San Francisco, California, 941102859, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp, San Francisco, California, 941102859, United States
Stanford Univ Med Ctr, Stanford, California, 943055107, United States
Summitt Med Ctr / San Francisco Gen Hosp, Oakland, California, 94609, United States
UCLA CARE Ctr, Los Angeles, California, 90095, United States
Univ of Southern California / LA County USC Med Ctr, Los Angeles, California, 900331079, United States
Univ of Washington / Children's Hosp of Los Angeles, Los Angeles, California, 90027, United States
Huntington Memorial Hosp / Children's Hosp of Los Angeles, Pasadena, California, 91105, United States
Children's Hosp of Los Angeles, Los Angeles, California, 90027, United States
UCSD / Children's Hosp Los Angeles, Los Angeles, California, 90027, United States
Harbor UCLA Med Ctr, Torrance, California, 90502, United States
San Mateo AIDS Program / Stanford Univ, Stanford, California, 943055107, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium, San Jose, California, 951282699, United States
Olive View Med Ctr, Sylmar, California, 91342, United States
Colorado
Univ Hosp / Univ of Colorado Health Sci Ctr, Denver, Colorado, 80262, United States
Mountain States Reg Hemo Ctr / Univ of Colorado, Denver, Colorado, 80262, United States
Mountain States Hemo Ctr / Univ of Utah, Denver, Colorado, 80262, United States
Saint Joseph's Hosp & Med Ctr / Mtn States Reg Hemo Ctr, Denver, Colorado, 80262, United States
Connecticut
Connecticut Children's Med Ctr, Farmington, Connecticut, 060303805, United States
Yale Univ / New Haven, New Haven, Connecticut, 065102483, United States
District of Columbia
George Washington Univ Med Ctr, Washington, District of Columbia, 20037, United States
Howard Univ, Washington, District of Columbia, 20059, United States
Georgetown Univ Med Ctr, Washington, District of Columbia, 20007, United States
HIV Ctr - District of Columbia Gen Hosp, Washington, District of Columbia, 200072197, United States
George Washington Univ / Hershey Med Ctr, Washington, District of Columbia, 20037, United States
Florida
Univ of Miami School of Medicine, Miami, Florida, 331361013, United States
Georgia
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr, Atlanta, Georgia, 303652225, United States
Hawaii
Univ of Hawaii, Honolulu, Hawaii, 96816, United States
Illinois
Children's Mem Hosp Family Cln / Northwestern Univ Med Schl, Chicago, Illinois, 60611, United States
Northwestern Univ Med School, Chicago, Illinois, 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois, 60612, United States
Cook County Hosp, Chicago, Illinois, 60612, United States
Indiana
Indiana Univ Hosp, Indianapolis, Indiana, 462025250, United States
Indiana Univ / Riley Hosp for Children, Indianapolis, Indiana, 46202, United States
Methodist Hosp of Indiana / Life Care Clinic, Indianapolis, Indiana, 46202, United States
Iowa
Great Plains - Hemophilia / Univ of Iowa Hosp & Clinic, Iowa City, Iowa, 52242, United States
Univ of Iowa Hosp and Clinic, Iowa City, Iowa, 52242, United States
Kentucky
Univ of Louisville / East Tennesee Comprehensive Hem Ctr, Louisville, Kentucky, 40202, United States
Louisiana
Charity Hosp / Tulane Univ Med School, New Orleans, Louisiana, 70112, United States
Tulane Univ School of Medicine, New Orleans, Louisiana, 70112, United States
Tulane Med Ctr Hosp, New Orleans, Louisiana, 70112, United States
Tulane Univ / Charity Hosp of New Orleans, New Orleans, Louisiana, 701122699, United States
Maryland
Johns Hopkins Hosp, Baltimore, Maryland, 21287, United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp, Baltimore, Maryland, 212052196, United States
Massachusetts
Harvard (Massachusetts Gen Hosp), Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Med Ctr, Boston, Massachusetts, 02215, United States
Beth Israel Deaconess - West Campus, Boston, Massachusetts, 02215, United States
Boston Med Ctr, Boston, Massachusetts, 02118, United States
Children's Hosp of Boston, Boston, Massachusetts, 021155724, United States
Boston City Hosp / Pediatrics, Boston, Massachusetts, 02118, United States
Baystate Med Ctr of Springfield, Springfield, Massachusetts, 01199, United States
Univ of Massachusetts Med Ctr, Worcester, Massachusetts, 01655, United States
Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial, Worcester, Massachusetts, 01605, United States
Rhode Island Hemophilia Ctr / Med Ctr of Cntrl MA, Worcester, Massachusetts, 01605, United States
Brigham and Women's Hosp, Boston, Massachusetts, 02115, United States
Michigan
Children's Hosp of Michigan, Detroit, Michigan, 48201, United States
Michigan State Univ Hemophilia Comprehensive Care Clinic, Lansing, Michigan, 48912, United States
Minnesota
Univ of Minnesota, Minneapolis, Minnesota, 55455, United States
St Paul Ramsey Med Ctr, St. Paul, Minnesota, 55101, United States
Missouri
St Louis Regional Hosp / St Louis Regional Med Ctr, St. Louis, Missouri, 63112, United States
Nebraska
Nebraska Regional Hemophilia Ctr / Univ of Nebraska Med Ctr, Omaha, Nebraska, 681985130, United States
St Louis Univ Med Ctr / Univ of Nebraska Med Ctr, Omaha, Nebraska, 681985130, United States
Univ of Nebraska Med Ctr, Omaha, Nebraska, 681985130, United States
New Hampshire
Dartmouth - Hitchcock Med Ctr / Med Ctr Cntrl Massachusetts, Lebanon, New Hampshire, 03756, United States
New Jersey
Univ of Medicine & Dentistry of New Jersey / Univ Hosp, Newark, New Jersey, 071032714, United States
Robert Wood Johnson Med School / Hershey Med Ctr, New Brunswick, New Jersey, 08903, United States
UMDNJ - New Jersey Med School, Newark, New Jersey, 07107, United States
New York
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp, Bronx, New York, 10461, United States
Montefiore Family Health Ctr / Bronx Municipal Hosp, Bronx, New York, 10461, United States
Samaritan Village Inc / Bronx Municipal Hosp, Bronx, New York, 10461, United States
Nassau County Med Ctr, East Meadow, New York, 11554, United States
SUNY / State Univ of New York, Syracuse, New York, 13210, United States
SUNY - Stony Brook, Stony Brook, New York, 117948153, United States
Univ of Rochester Medical Center, Rochester, New York, 14642, United States
Bellevue Hosp / New York Univ Med Ctr, New York, New York, 10016, United States
Mem Sloan - Kettering Cancer Ctr, New York, New York, 10021, United States
Mount Sinai Med Ctr, New York, New York, 10029, United States
Jack Weiler Hosp / Bronx Municipal Hosp, Bronx, New York, 10465, United States
Cornell Univ Med Ctr, New York, New York, 10021, United States
Saint Luke's - Roosevelt Hosp Ctr, New York, New York, 10025, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr, Bronx, New York, 10461, 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
SUNY / Erie County Med Ctr at Buffalo, Buffalo, New York, 14215, United States
Mount Sinai Med Ctr / Hemophilia Treatment Ctr, New York, New York, 10029, United States
Beth Israel Med Ctr, New York, New York, 10003, United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp, Elmhurst, New York, 11373, United States
Puerto Genetic Disease Clinic, New York, New York, 10029, United States
Montefiore Med Ctr Adolescent AIDS Program, Bronx, New York, 10467, United States
SUNY / Health Sciences Ctr at Brooklyn, Brooklyn, New York, 112032098, United States
Saint Clare's Hosp and Health Ctr, New York, New York, 10019, United States
North Shore Univ Hosp, Manhasset, New York, 11030, United States
North Central Bronx Hosp / Bronx Municipal Hosp, Bronx, New York, 10467, United States
North Carolina
Wake Med Ctr / Univ of North Carolina, Chapel Hill, North Carolina, 275997215, United States
Carolinas Med Ctr, Charlotte, North Carolina, 28203, United States
Univ of North Carolina, Chapel Hill, North Carolina, 275997215, United States
Moses H Cone Memorial Hosp, Greensboro, North Carolina, 27401, United States
Duke Univ Med Ctr, Durham, North Carolina, 27710, United States
Wake County Dept of Health, Raleigh, North Carolina, 27610, United States
Glaxo Wellcome Inc, Research Triangle Park, North Carolina, 27709, United States
Ohio
Case Western Reserve Univ, Cleveland, Ohio, 44106, United States
Univ of Cincinnati, Cincinnati, Ohio, 452670405, United States
Ohio State Univ Hosp Clinic, Columbus, Ohio, 432101228, United States
Med College of Ohio, Toledo, Ohio, 43699, United States
Northwest Ohio Hemo Treatment Ctr / Great Lakes Hemo Fdn, Toledo, Ohio, 43606, United States
Oregon
Oregon Health Sciences Univ / Children's Hosp of Los Angeles, Portland, Oregon, 97201, United States
Pennsylvania
Milton S Hershey Med Ctr, Hershey, Pennsylvania, 170330850, United States
Hemophilia Ctr of Western PA / Univ of Pittsburgh, Pittsburgh, Pennsylvania, 15219, United States
Univ of Pennsylvania at Philadelphia, Philadelphia, Pennsylvania, 19104, United States
Univ of Pittsburgh Med School / Hershey Med Ctr, Hershey, Pennsylvania, 170330850, United States
Thomas Jefferson Univ Hosp, Philadelphia, Pennsylvania, 191075098, United States
South Carolina
Julio Arroyo, West Columbia, South Carolina, 29169, United States
Med Univ of South Carolina / UNC, Charleston, South Carolina, 29425, United States
Tennessee
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr, Knoxville, Tennessee, 37920, United States
Texas
Univ Texas Health Science Ctr / Univ Texas Med School, Houston, Texas, 77030, United States
Univ of Texas Southwestern Med Ctr of Dallas, Dallas, Texas, 75235, United States
Univ of Texas Galveston, Galveston, Texas, 775550435, United States
Washington
Univ of Washington, Seattle, Washington, 981224304, United States
Wisconsin
Great Lakes Hemophilia Foundation, Wauwatosa, Wisconsin, 532130127, United States
Northern Wisconsin Hemophilia Ctr / Saint Vincent's Hosp, Green Bay, Wisconsin, 54301, United States
Comp Hemo Ctr of Ctrl & N Illinois / Great Lakes Hemo Fdn, Wauwatosa, Wisconsin, 532130127, United States
Youngstown Hemophilia Ctr / Great Lakes Hemophilia Fdn, Wauwatosa, Wisconsin, 53213, United States
Puerto Rico
Univ of Puerto Rico, San Juan, 009365067, Puerto Rico
Katzenstein D, Study Chair
Hammer S, Study Chair
More Information
Click here for more information about Zidovudine
Click here for more information about Zalcitabine
Click here for more information about Didanosine
Publications
Havlir DV, Richman DD. Viral dynamics of HIV: implications for drug development and therapeutic strategies. Ann Intern Med. 1996 Jun 1;124(11):984-94. Review.
Hammer SM, Katzenstein DA, Hughes MD, Gundacker H, Schooley RT, Haubrich RH, Henry WK, Lederman MM, Phair JP, Niu M, Hirsch MS, Merigan TC. A trial comparing nucleoside monotherapy with combination therapy in HIV-infected adults with CD4 cell counts from 200 to 500 per cubic millimeter. AIDS Clinical Trials Group Study 175 Study Team. N Engl J Med. 1996 Oct 10;335(15):1081-90.
Simpson DM, Katzenstein DA, Hughes MD, Hammer SM, Williamson DL, Jiang Q, Pi JT. Neuromuscular function in HIV infection: analysis of a placebo-controlled combination antiretroviral trial. AIDS Clinical Group 175/801 Study Team. AIDS. 1998 Dec 24;12(18):2425-32.
[No authors listed] Zidovudine, didanosine, and zalcitabine in the treatment of HIV infection: meta-analyses of the randomised evidence. HIV Trialists' Collaborative Group. Lancet. 1999 Jun 12;353(9169):2014-25.
Katzenstein DA, Hughes MD, Albrecht M, Liou SH, Murphy R, Balfour H, Para M, Hammer S. Virologic and CD4 cell response to zidovudine or zidovudine and lamivudine following didanosine treatment of human immunodeficiency virus infection. AIDS Res Hum Retroviruses. 2001 Feb 10;17(3):203-10.
Justice AC, Holmes W, Gifford AL, Rabeneck L, Zackin R, Sinclair G, Weissman S, Neidig J, Marcus C, Chesney M, Cohn SE, Wu AW. Development and validation of a self-completed HIV symptom index. J Clin Epidemiol. 2001 Dec;54 Suppl 1:S77-90.
Katzenstein DA, Hammer SM, Hughes MD, Gundacker H, Jackson JB, Fiscus S, Rasheed S, Elbeik T, Reichman R, Japour A, Merigan TC, Hirsch MS. The relation of virologic and immunologic markers to clinical outcomes after nucleoside therapy in HIV-infected adults with 200 to 500 CD4 cells per cubic millimeter. AIDS Clinical Trials Group Study 175 Virology Study Team. N Engl J Med. 1996 Oct 10;335(15):1091-8.
Fiscus SA, Hughes MD, Lathey JL, Pi T, Jackson B, Rasheed S, Elbeik T, Reichman R, Japour A, Byington R, Scott W, Griffith BP, Katzenstein DA, Hammer SM. Changes in virologic markers as predictors of CD4 cell decline and progression of disease in human immunodeficiency virus type 1-infected adults treated with nucleosides. AIDS Clinical Trials Group Protocol 175 Team. J Infect Dis. 1998 Mar;177(3):625-33.
Currier JS, Spino C, Grimes J, Wofsy CB, Katzenstein DA, Hughes MD, Hammer SM, Cotton DJ. Differences between women and men in adverse events and CD4+ responses to nucleoside analogue therapy for HIV infection. The Aids Clinical Trials Group 175 Team. J Acquir Immune Defic Syndr. 2000 Aug 1;24(4):316-24.
Kastrissios H, Suarez JR, Katzenstein D, Girard P, Sheiner LB, Blaschke TF. Characterizing patterns of drug-taking behavior with a multiple drug regimen in an AIDS clinical trial. AIDS. 1998 Dec 3;12(17):2295-303.
Lathey JL, Hughes MD, Fiscus SA, Pi T, Jackson JB, Rasheed S, Elbeik T, Reichman R, Japour A, D'Aquila RT, Scott W, Griffith BP, Hammer SM, Katzenstein DA. Variability and prognostic values of virologic and CD4 cell measures in human immunodeficiency virus type 1-infected patients with 200-500 CD4 cells/mm(3) (ACTG 175). AIDS Clinical Trials Group Protocol 175 Team. J Infect Dis. 1998 Mar;177(3):617-24.
Record last reviewed: January 2003
Last Updated: April 7, 2005
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00000625
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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