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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000841 |
Purpose
To determine the clinical efficacy of indinavir sulfate or placebo in combination with zidovudine ( AZT ) and lamivudine ( 3TC ) in AIDS patients.
Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV disease who have received prior AZT therapy. Since studies suggest that triple drug therapy may have an advantage over both monotherapy and two drug therapy, the combination of indinavir sulfate with AZT and 3TC should be evaluated.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Lamivudine Drug: Stavudine Drug: Zidovudine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Randomized, Double-Blind, Phase III Study of Indinavir Sulfate With Open-Label Zidovudine (AZT) and Lamivudine (3TC) in Subjects With HIV Infection With CD4 Cell Counts <= 200 Cells/mm3 and >= 6 Months of Prior AZT Experience |
| Estimated Enrollment: | 1750 |
Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV disease who have received prior AZT therapy. Since studies suggest that triple drug therapy may have an advantage over both monotherapy and two drug therapy, the combination of indinavir sulfate with AZT and 3TC should be evaluated.
Patients are randomized to receive open-label AZT and 3TC with or without indinavir sulfate for at least 48 weeks. Patients who develop intolerance to AZT or have progressive disease after 24 weeks on study may substitute stavudine ( d4T ) for AZT. Patients are followed at weeks 4, 8, 16, 24, 32, 40, and 48 and every 8 weeks thereafter up to week 96. [AS PER 02/25/97 AMENDMENT: Accrual has been halted because interim analysis has shown triple therapy superior to double-agent therapy. An open label extension phase has been added for the period through 06/30/97. Patients who had been randomized to AZT/3TC are given the option of continuing on assigned ACTG 320 study drugs, crossing over to open-label indinavir, or permanently discontinuing all study therapies and going off study. Patients who were randomized to AZT/3TC plus indinavir or who were crossed to such therapy are given the option of continuing their currently assigned therapies. It is strongly suggested that patients who were on AZT/3TC who wish to receive open-label indinavir consider changing the nucleoside analog component of their regimen if at all possible.] [ AS PER 06/06/97 AMENDMENT: The availability of the current ACTG 320 treatment has been further extended for approximately 12 additional weeks (but not beyond 09/30/97). This extension will allow patients to continue receiving study medications until ACTG 372 is open to accrual (the rollover protocol for subjects originally randomized to the triple drug component of ACTG 320 or who are crossed over due to a confirmed study endpoint is finalized).] [ AS PER 09/15/97 AMENDMENT: Open-label therapy will be provided for no more than 90 days beyond the enrollment of the first subject on ACTG 372.]
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Excluded within 30 days prior to study entry:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Univ of California / San Diego Treatment Ctr | |
| San Diego, California, United States, 921036325 | |
| Stanford at Kaiser / Kaiser Permanente Med Ctr | |
| San Francisco, California, United States, 94115 | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| San Francisco AIDS Clinic / San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| Harbor UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| UCLA CARE Ctr | |
| Los Angeles, California, United States, 90095 | |
| Univ of Southern California / LA County USC Med Ctr | |
| Los Angeles, California, United States, 900331079 | |
| Children's Hosp of Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| Stanford Univ Med Ctr | |
| Stanford, California, United States, 943055107 | |
| San Mateo AIDS Program / Stanford Univ | |
| Stanford, California, United States, 943055107 | |
| United States, Colorado | |
| Mountain States Reg Hemo Ctr / Univ of Colorado | |
| Denver, Colorado, United States, 80262 | |
| Univ of Colorado Health Sciences Ctr | |
| Denver, Colorado, United States, 80262 | |
| Kaiser Permanente Franklin Med Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, District of Columbia | |
| Howard Univ | |
| Washington, District of Columbia, United States, 20059 | |
| George Washington Univ / Hershey Med Ctr | |
| Washington, District of Columbia, United States, 20037 | |
| Georgetown Univ Hosp | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 331361013 | |
| Univ of Miami (Pediatric) | |
| Miami, Florida, United States, 33161 | |
| United States, Georgia | |
| Emory Univ | |
| Atlanta, Georgia, United States, 30308 | |
| 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, Illinois | |
| Chicago Children's Memorial Hosp | |
| Chicago, Illinois, United States, 606143394 | |
| Northwestern Univ Med School | |
| Chicago, Illinois, United States, 60611 | |
| Rush Presbyterian - Saint Luke's Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| Illinois Masonic Med Ctr | |
| Chicago, Illinois, United States, 606575147 | |
| Louis A Weiss Memorial Hosp | |
| Chicago, Illinois, United States, 60640 | |
| United States, Indiana | |
| Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 462025250 | |
| Methodist Hosp of Indiana / Life Care Clinic | |
| Indianapolis, Indiana, United States, 46202 | |
| Division of Inf Diseases/ Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| Univ of Iowa Hosp and Clinic | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Louisiana | |
| Charity Hosp / Tulane Univ Med School | |
| New Orleans, Louisiana, United States, 70112 | |
| Tulane Univ School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| Tulane Med Ctr Hosp | |
| New Orleans, Louisiana, United States, 70112 | |
| 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 | |
| United States, Massachusetts | |
| Harvard (Massachusetts Gen Hosp) | |
| Boston, Massachusetts, United States, 02114 | |
| Beth Israel Deaconess - West Campus | |
| Boston, Massachusetts, United States, 02215 | |
| Boston Med Ctr | |
| Boston, Massachusetts, United States, 02118 | |
| Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial | |
| Worcester, Massachusetts, United States, 01605 | |
| 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, Missouri | |
| St Louis Regional Hosp / St Louis Regional Med Ctr | |
| St Louis, Missouri, United States, 63112 | |
| United States, Nebraska | |
| Univ of Nebraska Med Ctr | |
| Omaha, Nebraska, United States, 681985130 | |
| United States, New York | |
| St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr | |
| New York, New York, United States, 10021 | |
| Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| North Shore Univ Hosp | |
| Great Neck, New York, United States, 11021 | |
| Manhattan Veterans Administration / New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| Univ of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Bellevue Hosp / New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| Mem Sloan - Kettering Cancer Ctr | |
| New York, New York, United States, 10021 | |
| SUNY / State Univ of New York | |
| Syracuse, New York, United States, 13210 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| Cornell Univ Med Ctr | |
| New York, New York, United States, 10021 | |
| Mount Sinai Med Ctr / Pediatrics | |
| New York, New York, United States, 10029 | |
| Bronx Veterans Administration / Mount Sinai Hosp | |
| Bronx, New York, United States, 10468 | |
| SUNY / Erie County Med Ctr at Buffalo | |
| Buffalo, New York, United States, 14215 | |
| Mount Sinai Med Ctr / Hemophilia Treatment Ctr | |
| New York, New York, United States, 10029 | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| Saint Clare's Hosp and Health Ctr | |
| New York, New York, United States, 10019 | |
| Kaplan Cancer Ctr / New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| Montefiore Med Ctr Adolescent AIDS Program | |
| Bronx, New York, United States, 10467 | |
| United States, North Carolina | |
| Central Prison/Women's Prison in Raleigh / NC | |
| Raleigh, North Carolina, United States, 276260540 | |
| Carolinas Med Ctr | |
| Charlotte, North Carolina, United States, 28203 | |
| Univ of North Carolina | |
| Chapel Hill, North Carolina, United States, 275997215 | |
| Moses H Cone Memorial Hosp | |
| Greensboro, North Carolina, United States, 27401 | |
| Duke Univ Med Ctr | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Case Western Reserve Univ | |
| Cleveland, Ohio, United States, 44106 | |
| Univ of Cincinnati | |
| Cincinnati, Ohio, United States, 452670405 | |
| Ohio State Univ Hosp Clinic | |
| Columbus, Ohio, United States, 432101228 | |
| Columbus Children's Hosp | |
| Columbus, Ohio, United States, 432052696 | |
| Univ of Kentucky Lexington | |
| Cincinnati, Ohio, United States, 45267 | |
| United States, Pennsylvania | |
| Thomas Jefferson Univ Hosp | |
| Philadelphia, Pennsylvania, United States, 191075098 | |
| Milton S Hershey Med Ctr | |
| Hershey, Pennsylvania, United States, 170330850 | |
| United States, South Carolina | |
| Julio Arroyo | |
| West Columbia, South Carolina, United States, 29169 | |
| Med Univ of South Carolina | |
| Charleston, South Carolina, United States, 294253312 | |
| United States, Tennessee | |
| Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr | |
| Knoxville, Tennessee, United States, 37920 | |
| Meharry Med College | |
| Nashville, Tennessee, United States, 37203 | |
| Vanderbilt Univ Med Ctr | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Univ Texas Health Science Ctr / Univ Texas Med School | |
| Houston, Texas, United States, 77030 | |
| Univ of Texas Galveston | |
| Galveston, Texas, United States, 775550435 | |
| United States, Washington | |
| Univ of Washington | |
| Seattle, Washington, United States, 981224304 | |
| United States, Wisconsin | |
| Great Lakes Hemophilia Foundation | |
| Wauwatosa, Wisconsin, United States, 532130127 | |
| Puerto Rico | |
| Ramon Ruiz Arnau Univ Hosp / Pediatrics | |
| Bayamon, Puerto Rico, 00956 | |
| Univ of Puerto Rico | |
| San Juan, Puerto Rico, 009365067 | |
| Study Chair: | Hammer SM | |
| Study Chair: | Squires KE | |
| Study Chair: | Fischl MA |
More Information
| Study ID Numbers: | ACTG 320 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000841 History of Changes |
| Health Authority: | United States: Federal Government |
|
Drug Therapy, Combination Acquired Immunodeficiency Syndrome Antiviral Agents Zidovudine |
Stavudine HIV Protease Inhibitors Lamivudine Indinavir |
|
Antimetabolites Anti-Infective Agents Communicable Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Stavudine Indinavir Molecular Mechanisms of Pharmacological Action Zidovudine Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections |
Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |
