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| Sponsor: | Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00005106 |
Purpose
The purpose of this study is to look at the effects of different anti-HIV drug combinations on body fat changes in HIV-positive patients who have never received anti-HIV therapy before.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Lamivudine/Zidovudine Drug: Abacavir sulfate Drug: Nelfinavir mesylate Drug: Lamivudine Drug: Stavudine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Safety Study |
| Official Title: | A 96-Week, Randomized, Open-Label, Multicenter Trial to Evaluate the Safety and Tolerability of the Antiretroviral Activity of Stavudine (40mg BID) Plus Lamivudine (150mg BID) Plus Nelfinavir (1250mg BID) Versus Abacavir (300mg BID) Plus Combivir (3TC 150mg/ZDV 300mg BID) Versus Combivir (3TC 150mg/ZDV 300mg BID) Plus Nelfinavir (1250mg BID) in HIV-1 Infected Subjects |
| Estimated Enrollment: | 230 |
| Study Start Date: | September 1999 |
Patients are randomized to receive stavudine plus lamivudine plus nelfinavir, Combivir (zidovudine plus lamivudine) plus nelfinavir, or Combivir plus abacavir. Patients are stratified into 2 groups based on their screening plasma HIV-1 RNA: (1) greater than 1,000 up to 100,000 copies/ml or (2) greater than 100,000 up to 200,000 copies/ml. Measurements and evaluations for assessment of body fat composition, virologic and immunologic outcomes, markers of alterations in carbohydrate and lipid metabolism, and safety are performed at Baseline, Weeks 4, 8, 16, 24, and every 12 weeks thereafter until Week 96 or withdrawal. In addition, health-related quality of life and health care resource utilization data are collected at specified treatment visits.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 352942050 | |
| United States, Arizona | |
| Arizona Clinical Research Ctr Inc | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Highland Gen Hosp / San Francisco Gen Hosp | |
| Oakland, California, United States, 946021018 | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| THE Clinic | |
| Los Angeles, California, United States, 90008 | |
| AIDS Healthcare Foundation | |
| Los Angeles, California, United States, 900276069 | |
| Maxine Liggins | |
| Los Angeles, California, United States, 90042 | |
| Good Samaritan Hosp | |
| Los Angeles, California, United States, 90004 | |
| UCLA Care Ctr | |
| Los Angeles, California, United States, 90095 | |
| Longbeach Memorial Med Ctr | |
| Longbeach, California, United States, 90806 | |
| United States, District of Columbia | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| IDC Research Initiative | |
| Altamonte Springs, Florida, United States, 32701 | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
| Children's Diagnostic Treatment Ctr | |
| Fort Lauderdale, Florida, United States, 33301 | |
| Comprehensive Care Center | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Community Health Care | |
| Fort Lauderdale, Florida, United States, 33306 | |
| South Shore Hosp | |
| Miami, Florida, United States, 33139 | |
| Immunity Care and Research Inc | |
| Plantation, Florida, United States, 33324 | |
| Infectious Disease Research Institute | |
| Tampa, Florida, United States, 33614 | |
| Daniel Seekins | |
| Tampa, Florida, United States, 33607 | |
| Orange County Health Dept | |
| Orlando, Florida, United States, 32805 | |
| United States, Georgia | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| Ponce de Leon Ctr | |
| Atlanta, Georgia, United States, 30308 | |
| Philip Brachman | |
| Atlanta, Georgia, United States, 30309 | |
| United States, Illinois | |
| Rush Presbyterian - Saint Luke's Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| Cook County Hosp | |
| Chicago, Illinois, United States, 60614 | |
| United States, Louisiana | |
| HIV Outpatient Clinics / LA State Univ Med Ctr | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Med Ctr | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Missouri | |
| Univ of Missouri at Kansas City School of Medicine | |
| Kansas City, Missouri, United States, 64108 | |
| United States, New Jersey | |
| South Jersey Infectious Diseases Inc | |
| Somers Point, New Jersey, United States, 08244 | |
| United States, North Carolina | |
| Carolinas Med Ctr | |
| Charlotte, North Carolina, United States, 28232 | |
| WNC Community Health Services | |
| Asheville, North Carolina, United States, 28806 | |
| United States, Ohio | |
| Summa Health System | |
| Akron, Ohio, United States, 44304 | |
| United States, Pennsylvania | |
| MCP Hahnemann Univ Hosp | |
| Philadelphia, Pennsylvania, United States, 19102 | |
| United States, Rhode Island | |
| Miriam Hosp | |
| Providence, Rhode Island, United States, 02906 | |
| United States, Texas | |
| Univ of Texas Southwestern Med Ctr | |
| Dallas, Texas, United States, 75235 | |
| Univ TX San Antonio Health Science Ctr | |
| San Antonio, Texas, United States, 782847881 | |
| Thomas Street Clinic | |
| Houston, Texas, United States, 77009 | |
| United States, Virginia | |
| Hampton Roads Med Specialists | |
| Hampton, Virginia, United States, 23666 | |
More Information
| Study ID Numbers: | 264P, ESS40002 |
| Study First Received: | April 6, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00005106 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Zidovudine Stavudine HIV Protease Inhibitors Lamivudine Nelfinavir |
Reverse Transcriptase Inhibitors Anti-HIV Agents Adipose Tissue Lipodystrophy abacavir |
|
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 Abacavir 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 |