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| ID | Type | Description | Link |
|---|---|---|---|
| ESS40010 |
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The purpose of this study is to see if the findings of increased lactic acid and abnormal fat distribution get better when d4T is replaced with abacavir, abacavir plus lamivudine, or Combivir (a pill containing lamivudine plus zidovudine) in HIV-positive patients taking anti-HIV therapy including stavudine (d4T).
Patients are allocated as follows: a) zidovudine-naive patients switch Combivir for d4t and b) zidovudine-experienced or -intolerant patients switch abacavir for d4t. Providers may choose between Combivir or abacavir as a switch for d4t when screening lactate levels are 2.2 mmol/L or more. Additionally, providers may choose to switch a maximum of 2 drugs, one of which must be d4t, in the regimen. Each patient receives 48 weeks of therapy. Visits are made at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48. Tests, including biopsies, are performed to measure changes in body fat distribution and changes in lactate levels. Virologic and immunologic outcomes, changes in physical signs of lipodystrophy, changes in self-reports of health-related quality-of-life survey and the Body Image Questionnaire, changes in lipid profile and other markers of metabolism, and safety parameters are evaluated also.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamivudine/Zidovudine | Drug | |||
| Abacavir sulfate | Drug | |||
| Lamivudine | 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 |
|---|---|---|---|---|---|---|
| THE Clinic | Los Angeles | California | 90008 | United States | ||
| Tower Infectious Disease Med Ctr |
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| Los Angeles |
| California |
| 90048 |
| United States |
| St Lukes Medical Group | San Diego | California | 92101 | United States |
| UCSD Treatment Ctr | San Diego | California | 921036329 | United States |
| Dupont Circle Physicians Group | Washington D.C. | District of Columbia | 200091104 | United States |
| North Broward Hosp District / HIV Clinical Research | Fort Lauderdale | Florida | 33311 | United States |
| Duval County Health Department | Jacksonville | Florida | 32206 | United States |
| Infectious Disease Research Institute Inc | Tampa | Florida | 33614 | United States |
| Northstar Med Clinic | Chicago | Illinois | 60657 | United States |
| Jersey Shore Med Ctr | Neptune City | New Jersey | 07753 | United States |
| South Jersey Infectious Diseases Inc | Somers Point | New Jersey | 08244 | United States |
| Infectious Disease Specialists of NJ | Union | New Jersey | 07083 | United States |
| Infectious Diseases Assoc of Brooklyn | Brooklyn | New York | 11215 | United States |
| Long Island College Hospital | Brooklyn | New York | 11217 | United States |
| Mt Vernon Hospital | Mount Vernon | New York | 10550 | United States |
| Dr Lawrence Fontana | New York | New York | 10003 | United States |
| Liberty Medical / Cabrini Hospital / Dept of Infec Diseases | New York | New York | 10003 | United States |
| Howard Grossman | New York | New York | 10011 | United States |
| Boriken Neighborhood Health Center | New York | New York | 10035 | United States |
| Bronx Veterans Affairs Med Ctr | The Bronx | New York | 10468 | United States |
| Univ of North Carolina / SOCA | Chapel Hill | North Carolina | 275997030 | United States |
| Summa Health System | Akron | Ohio | 44304 | United States |
| Case Western Reserve Univ | Cleveland | Ohio | 44106 | United States |
| Philadelphia Veterans Administration Med Ctr | Philadelphia | Pennsylvania | 19104 | United States |
| Anderson Clinical Research | Pittsburgh | Pennsylvania | 15221 | United States |
| Central Texas Clinical Research | Austin | Texas | 78705 | United States |
| Gathe, Joseph, M.D. | Houston | Texas | 77004 | United States |
| Diversified Med Practices, PA | Houston | Texas | 77027 | United States |
| Univ of Texas / Med School at Houston | Houston | Texas | 77030 | United States |
| Hampton Roads Med Specialists | Hampton | Virginia | 23666 | United States |
| Swedish Med Ctr | Seattle | Washington | 98122 | 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 |
| D019259 | Lamivudine |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
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