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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborators: |
Bristol-Myers Squibb Glaxo Wellcome |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001045 |
Purpose
To validate that the alteration of codon 215 of reverse transcriptase in plasma virus precedes the increase in viral burden as measured in the peripheral blood and the decline in CD4 count that have been observed in association with clinical failure on zidovudine (AZT). To determine whether alternative regimens of antiretroviral agents alter the course of viral burden as measured in the peripheral blood and CD4 changes in patients with HIV infection. To obtain further data on the safety and immunologic and virologic response to AZT/didanosine/nevirapine.
Of the HIV-1 mutations reported to be associated with zidovudine resistance, the mutation at codon 215 of the reverse transcriptase gene is the most commonly occurring and has the greatest impact on susceptibility. When this mutation appears, a change in drugs may prevent further immunologic and virologic deterioration.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Nevirapine Drug: Zidovudine Drug: Didanosine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Double-Blinded, Randomized Trial Comparing Zidovudine (AZT) Versus AZT Plus Didanosine (ddI) Versus AZT Plus ddI Plus Nevirapine in Asymptomatic Patients on AZT Monotherapy Who Develop a Mutation at Codon 215 of HIV Reverse Transcriptase in Serum/Plasma Viral RNA |
| Estimated Enrollment: | 300 |
Of the HIV-1 mutations reported to be associated with zidovudine resistance, the mutation at codon 215 of the reverse transcriptase gene is the most commonly occurring and has the greatest impact on susceptibility. When this mutation appears, a change in drugs may prevent further immunologic and virologic deterioration.
Initially, all patients receive AZT alone. After detection of a 215 mutation in plasma RNA, patients are randomized to one of three treatment arms: AZT alone, AZT plus ddI, or AZT/ddI plus nevirapine. Patients are followed every 8 weeks and receive treatment for up to 4 years.
AS PER AMENDMENT 5/9/96: All AZT monotherapy options have been eliminated. Patients will be randomized to either Arm II or Arm III, regardless of their codon 215 status. All patients who were randomized to Arm I following a mutation at codon 215 will be rerandomized to Arm II or Arm III. All patients who were randomized to either Arm II or Arm III following a mutation at codon 215 will remain on their initial randomized assignment.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Prior Medication: Required:
Patients must have:
NOTE:
AS PER AMENDMENT 04/03/95:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior condition are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Illicit drug or alcohol abuse.
Contacts and Locations
Hide Study Locations| United States, California | |
| Stanford at Kaiser / Kaiser Permanente Med Ctr | |
| San Francisco, California, United States, 94115 | |
| Stanford Univ Med Ctr | |
| Stanford, California, United States, 943055107 | |
| UCLA CARE Ctr | |
| Los Angeles, California, United States, 90095 | |
| Harbor UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| San Mateo AIDS Program / Stanford Univ | |
| Stanford, California, United States, 943055107 | |
| Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium | |
| San Jose, California, United States, 951282699 | |
| United States, Colorado | |
| Univ of Colorado Health Sciences Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, District of Columbia | |
| Children's Hosp of Washington DC | |
| Washington, District of Columbia, United States, 200102916 | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 20007 | |
| Walter Reed Army Med Ctr | |
| Washington, District of Columbia, United States, 20307 | |
| George Washington Univ / Hershey Med Ctr | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Georgia | |
| Emory Univ Hosp / Pediatrics | |
| Atlanta, Georgia, United States, 30306 | |
| Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr | |
| Atlanta, Georgia, United States, 303652225 | |
| United States, Hawaii | |
| Queens Med Ctr | |
| Honolulu, Hawaii, United States, 96816 | |
| Univ of Hawaii | |
| Honolulu, Hawaii, United States, 96816 | |
| United States, Indiana | |
| Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 462025250 | |
| United States, Iowa | |
| Univ of Iowa Hosp and Clinic | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Maryland | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 21287 | |
| State of MD Div of Corrections / Johns Hopkins Univ Hosp | |
| Baltimore, Maryland, United States, 212052196 | |
| Natl Naval Med Ctr | |
| Bethesda, Maryland, United States, 208995000 | |
| Fitzsimmons Army Med Ctr | |
| Rockville, Maryland, United States, 20850 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Med Ctr | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Minnesota | |
| Univ of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| St Paul Ramsey Med Ctr | |
| St Paul, Minnesota, United States, 55101 | |
| Hennepin County Med Clinic | |
| Minneapolis, Minnesota, United States, 55415 | |
| United States, Nebraska | |
| Univ of Nebraska Med Ctr | |
| Omaha, Nebraska, United States, 681985130 | |
| United States, New York | |
| Univ of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| SUNY / State Univ of New York | |
| Syracuse, New York, United States, 13210 | |
| Montefiore Family Health Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10461 | |
| Bellevue Hosp / New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| Jack Weiler Hosp / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10465 | |
| Bronx Municipal Hosp Ctr/Jacobi Med Ctr | |
| Bronx, New York, United States, 10461 | |
| Montefiore Med Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10467 | |
| Columbia Presbyterian Med Ctr | |
| New York, New York, United States, 100323784 | |
| North Central Bronx Hosp / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10467 | |
| Comprehensive Health Care Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10461 | |
| SUNY / Erie County Med Ctr at Buffalo | |
| Buffalo, New York, United States, 14215 | |
| Adirondack Med Ctr at Saranac Lake | |
| Albany, New York, United States, 122083479 | |
| Mid - Hudson Care Ctr | |
| Albany, New York, United States, 122083479 | |
| Albany Med College / Division of HIV Medicine A158 | |
| Albany, New York, United States, 122083479 | |
| Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| Montefiore Med Ctr Adolescent AIDS Program | |
| Bronx, New York, United States, 10467 | |
| United States, North Carolina | |
| Carolinas Med Ctr | |
| Charlotte, North Carolina, United States, 28203 | |
| Univ of North Carolina | |
| Chapel Hill, North Carolina, United States, 275997215 | |
| Wake County Dept of Health | |
| Raleigh, North Carolina, United States, 27610 | |
| United States, Ohio | |
| Case Western Reserve Univ | |
| Cleveland, Ohio, United States, 44106 | |
| Ohio State Univ Hosp Clinic | |
| Columbus, Ohio, United States, 432101228 | |
| Med College of Ohio | |
| Toledo, Ohio, United States, 43699 | |
| MetroHealth Med Ctr | |
| Cleveland, Ohio, United States, 441091998 | |
| United States, Pennsylvania | |
| Univ of Pennsylvania at Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Thomas Jefferson Univ Hosp | |
| Philadelphia, Pennsylvania, United States, 191075098 | |
| Milton S Hershey Med Ctr | |
| Hershey, Pennsylvania, United States, 170330850 | |
| United States, Tennessee | |
| Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr | |
| Knoxville, Tennessee, United States, 37920 | |
| Vanderbilt Univ Med Ctr | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Wilford Hall Med Ctr | |
| Lackland AFB, Texas, United States, 782365300 | |
| Univ of Texas Galveston | |
| Galveston, Texas, United States, 775550435 | |
| Brooke Army Med Ctr | |
| San Antonio, Texas, United States, 78284 | |
| Puerto Rico | |
| San Juan City Hosp | |
| San Juan, Puerto Rico, 009367344 | |
| Ramon Ruiz Arnau Univ Hosp / Pediatrics | |
| Bayamon, Puerto Rico, 00956 | |
| Study Chair: | Merigan TC | |
| Study Chair: | Mayers DL |
More Information
| Study ID Numbers: | ACTG 244 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001045 History of Changes |
| Health Authority: | United States: Federal Government |
|
Didanosine Drug Therapy, Combination Zidovudine Nevirapine |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors RNA Virus Infections |
Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Nevirapine Didanosine HIV Infections Sexually Transmitted Diseases Lentivirus Infections |