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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: | NCT00000916 |
Purpose
This study compares the safety and effectiveness of continuing your current anti-HIV medications to that of adding or switching some of your anti-HIV medications. It will follow the effect of these medication changes, including the addition of hydroxyurea (HU), on long-term viral suppression. Other medications which may be added include didanosine (ddI) and/or stavudine (d4T).
Patients receiving combination antiretroviral therapy with indinavir (IDV), zidovudine (ZDV)(or d4T) and lamivudine (3TC) show viral suppression for two years or more. Discontinuation of one or two of these drugs results in prompt loss of the viral suppression. Other studies show that addition of HU to some reverse transcriptase inhibitor treatments results in increased antiviral effects. This study will provide further information on the effect of adding HU to a treatment regimen with respect to long-term viral suppression.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Lamivudine/Zidovudine Drug: Hydroxyurea Drug: Lamivudine Drug: Stavudine Drug: Zidovudine Drug: Didanosine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Safety Study |
| Official Title: | A Phase II, Randomized Study of the Safety and Efficacy of Hydroxyurea in Subjects on Potent Antiretroviral Therapy With Less Than 200 Copies/ml of HIV RNA in the Plasma |
| Estimated Enrollment: | 399 |
Previous ACTG studies show that discontinuation of one or two of a three-drug regimen (IDV, ZDV, 3TC) leads to prompt loss of viral suppression in the plasma. In this trial, it will be determined whether adding hydroxyurea (HU) to a suppressive regimen increases long term viral suppression. Important safety information on the tolerance of HU regimen will be characterized in asymptomatic patients with viral suppression.
Patients are equally randomized to one of three arms and receive treatment as follows:Arm A: IDV plus ddI plus d4T plus HU placebo. Arm B: IDV plus ddI plus d4T plus HU. Arm C: IDV plus 3TC/ZDV (or d4T plus 3TC). Patients are monitored every 8 weeks with plasma HIV RNA levels and CD4 cell counts.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
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 Univ Med Ctr | |
| Stanford, California, United States, 943055107 | |
| Harbor UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| San Mateo AIDS Program / Stanford Univ | |
| Stanford, California, United States, 943055107 | |
| Willow Clinic | |
| Menlo Park, California, United States, 94025 | |
| United States, Colorado | |
| Univ of Colorado Health Sciences Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 331361013 | |
| United States, Hawaii | |
| Univ of Hawaii | |
| Honolulu, Hawaii, United States, 96816 | |
| United States, Illinois | |
| Northwestern Univ Med School | |
| Chicago, Illinois, United States, 60611 | |
| Louis A Weiss Memorial Hosp | |
| Chicago, Illinois, United States, 60640 | |
| United States, Indiana | |
| Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 462025250 | |
| 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 | |
| Tulane Univ School of Medicine | |
| 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 | |
| United States, Minnesota | |
| Univ of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| 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 | |
| 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 | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| United States, North Carolina | |
| 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 | |
| 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 | |
| MetroHealth Med Ctr | |
| Cleveland, Ohio, United States, 441091998 | |
| United States, Pennsylvania | |
| Univ of Pennsylvania at Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, South Carolina | |
| Julio Arroyo | |
| West Columbia, South Carolina, United States, 29169 | |
| United States, Texas | |
| Univ of Texas Galveston | |
| Galveston, Texas, United States, 775550435 | |
| United States, Washington | |
| Univ of Washington | |
| Seattle, Washington, United States, 98104 | |
| Study Chair: | Havlir D; Richman D | |
| Study Chair: | Collier A | |
| Study Chair: | Hirsch M | |
| Study Chair: | Tebas P |
More Information
| Study ID Numbers: | ACTG A5025 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000916 History of Changes |
| Health Authority: | United States: Federal Government |
|
Drug Therapy, Combination HIV Protease Inhibitors Hydroxyurea |
Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Stavudine Indinavir Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hydroxyurea Hematologic Agents Zidovudine Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents |
Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors RNA Virus Infections Antisickling Agents Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases |
