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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00002411 |
Purpose
The purpose of this study is to compare the safety of didanosine plus stavudine plus nelfinavir (NLF) with that of zidovudine plus lamivudine plus NLF. This study also examines how long these drug combinations are effective in lowering viral load (level of HIV in the blood).
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Nelfinavir mesylate Drug: Lamivudine Drug: Stavudine Drug: Zidovudine Drug: Didanosine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study |
| Official Title: | A Randomized Study of the Long-Term Suppression of Plasma HIV RNA Levels by Triple Combination Regimens in Treatment Naive Subjects |
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Within 15 business days prior to randomization:
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
- Therapy for any co-existing disease that may interfere with patient ability to participate in this study.
Concurrent Treatment:
Excluded:
Therapy for any co-existing disease that may interfere with patient ability to participate in this study.
Patients with the following prior conditions are excluded:
History of acute or chronic pancreatitis.
Prior Medication:
Excluded:
Greater than 4 weeks of nucleoside therapy or greater than 1 week of protease inhibitor therapy.
Prior Treatment:
Excluded:
Therapy for any previous disease that may interfere with patient ability to participate in this study.
Risk Behavior:
Excluded:
Active alcohol or substance abuse that, in the opinion of the investigator, is sufficient to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis.
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Sorra Research Ctr / Med Forum | |
| Birmingham, Alabama, United States, 35203 | |
| United States, Arizona | |
| Body Positive | |
| Phoenix, Arizona, United States, 85016 | |
| United States, California | |
| Harbor UCLA Med Ctr / Research and Educational Institute | |
| Torrance, California, United States, 90502 | |
| UCLA Med Ctr / CARE BH-412 CHS | |
| Los Angeles, California, United States, 90024 | |
| AIDS Healthcare Foundation | |
| Los Angeles, California, United States, 900276069 | |
| Sherman Oaks Hosp Research Institute | |
| Sherman Oaks, California, United States, 91403 | |
| Hill Top Research Inc | |
| Fresno, California, United States, 93710 | |
| West Los Angeles VAMC | |
| Los Angeles, California, United States, 90073 | |
| United States, Connecticut | |
| Yale New Haven Hosp / Nathan Smith Clinic | |
| New Haven, Connecticut, United States, 06504 | |
| United States, District of Columbia | |
| GW Med Ctr / Clinical Trials Unit | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Saint Josephs Hosp | |
| Tampa, Florida, United States, 33602 | |
| Hillsborough County Health Dept | |
| Tampa, Florida, United States, 33602 | |
| Med Alternatives | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Specialty Med Care Ctrs of South Florida Inc | |
| Miami, Florida, United States, 33142 | |
| Urgent Care Ctr | |
| Fort Lauderdale, Florida, United States, 33316 | |
| United States, Illinois | |
| Rush Presbyterian / ST Lukes Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| Northwestern Univ / Div of Infect Diseases | |
| Chicago, Illinois, United States, 60611 | |
| United States, Kansas | |
| Univ of Kansas School of Medicine / Office of Rsch | |
| Wichita, Kansas, United States, 67214 | |
| United States, Kentucky | |
| Ky Clinic Annex #4 / Room 205E / Speed Sort #0284 | |
| Lexington, Kentucky, United States, 405360226 | |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Med Ctr | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| Infectious Disease Assoc of Central Jersey | |
| Somerville, New Jersey, United States, 08876 | |
| NJCRI | |
| Newark, New Jersey, United States, 07103 | |
| United States, New York | |
| SUNY at Stony Brook / Div of Infectious Disease | |
| Stony Brook, New York, United States, 117948153 | |
| St Luke Roosevelt Hosp | |
| New York, New York, United States, 10011 | |
| UCT International | |
| Farmingdale, New York, United States, 11735 | |
| St Mary's Hosp (Univ of Rochester/Infectious Diseases) | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Nalle Clinic / Clinical Research Dept | |
| Charlotte, North Carolina, United States, 28207 | |
| United States, Oklahoma | |
| Associates in Med and Mental Health | |
| Tulsa, Oklahoma, United States, 74114 | |
| United States, Pennsylvania | |
| Stephen P Hauptman | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, South Carolina | |
| Med Univ of South Carolina / Div of Infect Disease | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Texas | |
| Univ of Texas / Med Branch at Galveston | |
| Galveston, Texas, United States, 775550835 | |
| Joseph C Gathe | |
| Houston, Texas, United States, 77004 | |
| Principal Investigator: | . . | . |
More Information
| Study ID Numbers: | 039E, AI454-148 |
| Study First Received: | November 2, 1999 |
| Last Updated: | August 15, 2007 |
| ClinicalTrials.gov Identifier: | NCT00002411 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1 Didanosine Drug Therapy, Combination Zidovudine Stavudine |
Lamivudine RNA, Viral Nelfinavir Anti-HIV Agents Viral Load |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Stavudine Molecular Mechanisms of Pharmacological Action Zidovudine Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Nelfinavir 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 Didanosine HIV Infections Sexually Transmitted Diseases Lentivirus Infections |