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| Sponsor: | Merck |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002430 |
Purpose
The purpose of this study is to compare two different anti-HIV drug combinations, one that contains nelfinavir (NFV) and one that does not. The best dosing schedule for indinavir (IDV) also will be studied.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Nelfinavir mesylate Drug: Lamivudine Drug: Stavudine |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | A Multicenter, Open-Label, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate/d4T/3TC Versus Indinavir Sulfate/Nelfinavir Mesylate/d4T/3TC in HIV-Infected Individuals |
| Estimated Enrollment: | 220 |
Patients are stratified by screening plasma viral RNA results (50,000 copies/ml or below vs above 50,000 copies/ml) and randomized to 1 of 2 treatment arms. Group 1 receives IDV 3 times daily plus d4T/3TC twice daily. Group 2 receives IDV/NFV/d4T/3TC twice daily. Patients remain on study medications for 24 weeks and are seen at the clinic once every 4 weeks after entering the study. At each clinic visit, blood samples are taken to evaluate CD4 cell count and plasma HIV RNA levels.
Eligibility| Ages Eligible for Study: | 16 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 School of Med | |
| Montgomery, Alabama, United States, 36116 | |
| United States, California | |
| AIDS Community Research Consortium | |
| Redwood City, California, United States, 94063 | |
| Harbor - UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| Pacific Horizons Med Group | |
| San Francisco, California, United States, 94115 | |
| Robert Scott MD | |
| Oakland, California, United States, 94609 | |
| Ocean View Internal Medicine | |
| Long Beach, California, United States, 90803 | |
| Kaiser Foundation Hospital | |
| San Francisco, California, United States, 94118 | |
| Tower ID Med Associates | |
| Los Angeles, California, United States, 90048 | |
| AIDS Healthcare Foundation | |
| Los Angeles, California, United States, 90027 | |
| Oasis Clinic / King Drew Med Ctr | |
| Los Angeles, California, United States, 90059 | |
| Saint Francis Mem Hosp / HIV Care Unit | |
| San Francisco, California, United States, 94109 | |
| United States, Colorado | |
| Denver Public Health Dept | |
| Denver, Colorado, United States, 80204 | |
| United States, Connecticut | |
| Blick Med Associates | |
| Stamford, Connecticut, United States, 06901 | |
| United States, District of Columbia | |
| Physicans Home Service | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| IDC Research Initiative | |
| Altamonte Springs, Florida, United States, 32701 | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
| Hillsborough County Health Dept | |
| Tampa, Florida, United States, 33602 | |
| United States, Georgia | |
| Emory Univ | |
| Atlanta, Georgia, United States, 30308 | |
| Harold Katner MD | |
| Macon, Georgia, United States, 31202 | |
| United States, Idaho | |
| Thomas Coffman MD | |
| Boise, Idaho, United States, 83712 | |
| United States, Illinois | |
| Northwestern Univ Med Ctr | |
| Chicago, Illinois, United States, 60611 | |
| Univ of Illinois | |
| Chicago, Illinois, United States, 60612 | |
| Chicago Ctr for Clinical Research | |
| Chicago, Illinois, United States, 60610 | |
| United States, Kentucky | |
| Kentucky Clinical Research | |
| Lexington, Kentucky, United States, 40504 | |
| United States, Louisiana | |
| Louisiana State Univ Med Ctr / Tulane Med School | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maine | |
| AIDS Consultation Service / Maine Med Ctr | |
| Portland, Maine, United States, 04102 | |
| United States, Maryland | |
| Institute of Human Virology | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| JSI Research and Training Institute | |
| Boston, Massachusetts, United States, 02210 | |
| United States, New Jersey | |
| Education & Research Building | |
| Camden, New Jersey, United States, 08103 | |
| NJCRI | |
| Newark, New Jersey, United States, 07103 | |
| Infectious Disease Specialists of NJ | |
| Union, New Jersey, United States, 07083 | |
| United States, New York | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| Community Health Network | |
| Rochester, New York, United States, 14620 | |
| Liberty Med Group | |
| New York, New York, United States, 10016 | |
| Brookdale Univ Hosp and Med Ctr | |
| Brooklyn, New York, United States, 112123198 | |
| James Jones MD | |
| New York, New York, United States, 10019 | |
| United States, North Carolina | |
| Wake Forest Univ School of Medicine | |
| Winston Salem, North Carolina, United States, 27157 | |
| 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 | |
| Fanno Creek Clinic | |
| Portland, Oregon, United States, 97219 | |
| United States, Pennsylvania | |
| Anderson Clinical Research / Inc | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, South Carolina | |
| Burnside Clinic | |
| Columbia, South Carolina, United States, 29206 | |
| United States, Tennessee | |
| Vanderbilt Univ Med Ctr | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Oak Lawn Physicians Group | |
| Dallas, Texas, United States, 75219 | |
| Univ TX Galveston Med Branch | |
| Galveston, Texas, United States, 77555 | |
| United States, Washington | |
| Infections Ltd / Physicians Med Ctr | |
| Tacoma, Washington, United States, 98405 | |
More Information
| Study ID Numbers: | 246R, 079-02, CRX454 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002430 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination HIV Protease Inhibitors Lamivudine Indinavir |
Reverse Transcriptase Inhibitors Anti-HIV Agents Nelfinavir |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Stavudine Slow Virus Diseases Indinavir Molecular Mechanisms of Pharmacological Action 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 HIV Infections Sexually Transmitted Diseases Lentivirus Infections |
