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| ID | Type | Description | Link |
|---|---|---|---|
| ESS40002 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamivudine/Zidovudine | Drug | |||
| Abacavir sulfate | Drug | |||
| Nelfinavir mesylate | Drug | |||
| Lamivudine | Drug | |||
| Stavudine | Drug |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ of Alabama at Birmingham | Birmingham | Alabama | 352942050 | United States | ||
| Arizona Clinical Research Ctr Inc |
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| Tucson |
| Arizona |
| 85712 |
| United States |
| Longbeach Memorial Med Ctr | Longbeach | California | 90806 | United States |
| Good Samaritan Hosp | Los Angeles | California | 90004 | United States |
| THE Clinic | Los Angeles | California | 90008 | United States |
| AIDS Healthcare Foundation | Los Angeles | California | 900276069 | United States |
| Maxine Liggins | Los Angeles | California | 90042 | United States |
| UCLA Care Ctr | Los Angeles | California | 90095 | United States |
| Highland Gen Hosp / San Francisco Gen Hosp | Oakland | California | 946021018 | United States |
| San Francisco Gen Hosp | San Francisco | California | 94110 | United States |
| Georgetown Univ Med Ctr | Washington D.C. | District of Columbia | 20007 | United States |
| IDC Research Initiative | Altamonte Springs | Florida | 32701 | United States |
| Children's Diagnostic Treatment Ctr | Fort Lauderdale | Florida | 33301 | United States |
| Community Health Care | Fort Lauderdale | Florida | 33306 | United States |
| Comprehensive Care Center | Fort Lauderdale | Florida | 33316 | United States |
| Univ of Miami School of Medicine | Miami | Florida | 33136 | United States |
| South Shore Hosp | Miami | Florida | 33139 | United States |
| Orange County Health Dept | Orlando | Florida | 32805 | United States |
| Immunity Care and Research Inc | Plantation | Florida | 33324 | United States |
| Daniel Seekins | Tampa | Florida | 33607 | United States |
| Infectious Disease Research Institute | Tampa | Florida | 33614 | United States |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | United States |
| Ponce de Leon Ctr | Atlanta | Georgia | 30308 | United States |
| Philip Brachman | Atlanta | Georgia | 30309 | United States |
| Rush Presbyterian - Saint Luke's Med Ctr | Chicago | Illinois | 60612 | United States |
| Cook County Hosp | Chicago | Illinois | 60614 | United States |
| HIV Outpatient Clinics / LA State Univ Med Ctr | New Orleans | Louisiana | 70112 | United States |
| Beth Israel Deaconess Med Ctr | Boston | Massachusetts | 02215 | United States |
| Univ of Missouri at Kansas City School of Medicine | Kansas City | Missouri | 64108 | United States |
| South Jersey Infectious Diseases Inc | Somers Point | New Jersey | 08244 | United States |
| WNC Community Health Services | Asheville | North Carolina | 28806 | United States |
| Carolinas Med Ctr | Charlotte | North Carolina | 28232 | United States |
| Summa Health System | Akron | Ohio | 44304 | United States |
| MCP Hahnemann Univ Hosp | Philadelphia | Pennsylvania | 19102 | United States |
| Miriam Hosp | Providence | Rhode Island | 02906 | United States |
| Univ of Texas Southwestern Med Ctr | Dallas | Texas | 75235 | United States |
| Thomas Street Clinic | Houston | Texas | 77009 | United States |
| Univ TX San Antonio Health Science Ctr | San Antonio | Texas | 782847881 | United States |
| Hampton Roads Med Specialists | Hampton | Virginia | 23666 | United States |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D008060 | Lipodystrophy |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C109078 | lamivudine, zidovudine drug combination |
| C106538 | abacavir |
| D019888 | Nelfinavir |
| D019259 | Lamivudine |
| D018119 | Stavudine |
| ID | Term |
|---|---|
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
| D013936 | Thymidine |
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