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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002368 |
Purpose
To evaluate the tolerance, safety, and effectiveness of Viramune in preventing clinical AIDS progression events or death when used in combination with Lamivudine and background nucleoside therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Nevirapine Drug: Lamivudine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Safety Study |
| Official Title: | An International, Double Blind, Randomized, Phase III Study to Evaluate the Tolerance, Safety, and Effectiveness of Viramune (Nevirapine) in Preventing Clinical AIDS Progression Events or Death When Used in Combination With Lamivudine (3TC) and Stable (>= 4 Weeks) Background Nucleoside Therapy |
| Estimated Enrollment: | 2000 |
Eligible patients will be randomized to treatment with either 1) open-label 3TC twice daily plus Viramune once daily for 2 weeks and then with Viramune twice daily; or 2) open label 3TC twice daily plus Viramune placebo once daily for 2 weeks and then twice daily Viramune. Patients will start Viramune and 3TC on study day 0. Patients will be evaluated for development of AIDS progression events at months 1, 2, 3, and 4, and every 2 months thereafter until 18 months after the last patient is enrolled or 24 months, whichever occurs first.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with any of the following conditions or symptoms are excluded:
Patient is enrolled or plans to enroll during the course of this study in another clinical study of an antiretroviral or other agent used to treat HIV-1 infection.
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Radiation therapy.
Patients with any of the following prior conditions and symptoms are excluded:
History of clinically important disease other than HIV-1 infection or related diseases that, in the opinion of the investigator, may put the patient at risk because of participation in this study.
Prior Medication:
Excluded:
Risk Behavior:
Excluded:
Patients who are active chronic alcohol or substance abusers or have an active psychiatric condition sufficient to impair compliance with protocol requirements.
Required:
Patient must be receiving stable nucleoside therapy with at least one agent for >= 4 weeks prior to study day 0. Zidovudine (ZDV), Zidovudine + Dideoxycytidine (ddC), or Zidovudine + Didanosine (ddI) must be used unless prior intolerance precludes ZDV use. Stable use means no change in dose > 50% for any background nucleoside within four weeks prior to study day 0.
NOTE:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Drug Research and Analysis Corp | |
| Montgomery, Alabama, United States, 36104 | |
| United States, California | |
| Harbor - UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| Dr G Michael Wool | |
| Los Angeles, California, United States, 90067 | |
| AIDS Research Ctr / Palo Alto VA Health Care System | |
| Palo Alto, California, United States, 94304 | |
| UCLA School of Medicine / Ctr for Research and Education | |
| Los Angeles, California, United States, 900951793 | |
| AIDS Community Research Consortium | |
| Redwood City, California, United States, 94063 | |
| San Francisco Gen Hosp / UCSF AIDS Program | |
| San Francisco, California, United States, 94110 | |
| ViRx Inc | |
| San Francisco, California, United States, 94109 | |
| United States, Colorado | |
| Dr Miguel Mogyoros / Clinical Research Dept | |
| Denver, Colorado, United States, 80205 | |
| Denver Public Health | |
| Denver, Colorado, United States, 80204 | |
| Infectious Disease Specialists | |
| Colorado Springs, Colorado, United States, 80903 | |
| United States, Delaware | |
| Wilmington Hosp | |
| Wilmington, Delaware, United States, 19801 | |
| United States, District of Columbia | |
| Novum Inc | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Goodgame Med Group | |
| Maitland, Florida, United States, 32751 | |
| Infectious Disease Research Institute Inc | |
| Tampa, Florida, United States, 33614 | |
| North Broward Hosp District | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Palm Beach Research Ctr | |
| West Palm Beach, Florida, United States, 33409 | |
| Anthony LaMarca | |
| Fort Lauderdale, Florida, United States, 33308 | |
| McGregor Clinic / Lee County Public Health Unit | |
| Fort Myers, Florida, United States, 33901 | |
| P Andrew Coley | |
| Jacksonville, Florida, United States, 32216 | |
| Dr Robert Schwartz | |
| Fort Myers, Florida, United States, 33901 | |
| United States, Illinois | |
| Rush Presbyterian / Saint Luke's Med Ctr / Infect Dis | |
| Chicago, Illinois, United States, 60612 | |
| Northwestern Univ / Division of Infectious Diseases | |
| Chicago, Illinois, United States, 60611 | |
| Dr John Pottage | |
| Chicago, Illinois, United States, 60610 | |
| United States, Indiana | |
| Indiana Univ Med School | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| Univ of Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| Dr Daniel H Gervich | |
| Des Moines, Iowa, United States, 50325 | |
| United States, Kentucky | |
| Univ of Kentucky Med Cntr / Dept of Med / Div of ID | |
| Lexington, Kentucky, United States, 40563 | |
| United States, Louisiana | |
| Med Research Ctr | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| New England Med Ctr | |
| Boston, Massachusetts, United States, 02111 | |
| Beth Israel Hosp / Virology Research Clinic | |
| Boston, Massachusetts, United States, 02215 | |
| New England Deaconess Hosp | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Minnesota | |
| International Medicine and Infectious Disease | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, Missouri | |
| Trinity Lutheran Hosp / HIV Program | |
| Kansas City, Missouri, United States, 64108 | |
| United States, New Jersey | |
| Infectious Disease Associates of Central New Jersey | |
| Somerville, New Jersey, United States, 08876 | |
| United States, New York | |
| SUNY / Erie County Med Ctr at Buffalo | |
| Buffalo, New York, United States, 14215 | |
| Saint Vincent Med Ctr | |
| Staten Island, New York, United States, 10310 | |
| Dr David Kaufman | |
| New York, New York, United States, 10014 | |
| United States, Oklahoma | |
| Associates in Med and Mental Health | |
| Tulsa, Oklahoma, United States, 74114 | |
| United States, Oregon | |
| The Research and Education Group | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| Novum Inc | |
| Pittsburgh, Pennsylvania, United States, 152063817 | |
| Hershey Med Ctr / Dept of Med / Div of Hematology | |
| Hershey, Pennsylvania, United States, 17033 | |
| Univ of Pennsylvania / Division of Infectious Diseases | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Rhode Island | |
| Omega Med Research | |
| Providence, Rhode Island, United States, 02907 | |
| United States, South Carolina | |
| Dr Alfred Burnside | |
| Columbia, South Carolina, United States, 29206 | |
| Med Univ of South Carolina / Div of Infect Dis | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| Dr Susie Sargent | |
| Memphis, Tennessee, United States, 38163 | |
| United States, Texas | |
| Walter Gaman | |
| Irving, Texas, United States, 75038 | |
| Houston Clinical Research Network / Div of Montrose Clinic | |
| Houston, Texas, United States, 77006 | |
| Univ of Texas Med Branch / Div of Infectious Dis | |
| Galveston, Texas, United States, 775550835 | |
| Nelson Tebedo Health Resource Ctr | |
| Dallas, Texas, United States, 75219 | |
| United States, Virginia | |
| Hampton Roads Med Specialists | |
| Hampton, Virginia, United States, 23666 | |
| United States, Washington | |
| Advanced Research Management | |
| Seattle, Washington, United States, 981225314 | |
More Information
| Study ID Numbers: | 200E, 1100.1090 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002368 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Acquired Immunodeficiency Syndrome Nevirapine Lamivudine |
Disease Progression Reverse Transcriptase Inhibitors Anti-HIV Agents |
|
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Lamivudine Enzyme Inhibitors Infection Antiviral Agents |
Pharmacologic Actions Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Nevirapine Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections Nucleic Acid Synthesis Inhibitors |