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| ID | Type | Description | Link |
|---|---|---|---|
| COLA 4005 |
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The purpose of this study is to compare the safety and effectiveness of 2 dosing schedules (once daily vs twice daily) of lamivudine (3TC) given with stavudine (d4T) and either indinavir (IDV) or nelfinavir (NFV) for 24 weeks.
Patients are randomized to 1 of 2 groups. Group 1 receives 3TC qd plus d4T plus either IDV or NFV. Group 2 receives 3TC bid plus d4T plus either IDV or NFV. Patients are evaluated for drug tolerance, medication adherence, and genotypic and phenotypic resistance.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indinavir 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 |
|---|---|---|---|---|---|---|
| AIDS Healthcare Foundation | Los Angeles | California | 90027 | United States | ||
| Palo Alto Veterans Affairs Health Care System |
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| Palo Alto |
| California |
| 94304 |
| United States |
| Dupont Circle Physicians Group | Washington D.C. | District of Columbia | 200091104 | United States |
| IDC Research Initiative | Altamonte Springs | Florida | 32701 | United States |
| North Broward Hosp District | Fort Lauderdale | Florida | 33316 | United States |
| Steinhart Medical Associates | Miami | Florida | 33133 | United States |
| Northwestern Univ Med School | Chicago | Illinois | 60611 | United States |
| Saint Vincents Hosp | New York | New York | 10011 | United States |
| St Lukes - Roosevelt Hosp Ctr | New York | New York | 10019 | United States |
| MCP Hahnemann Univ Hosp | Philadelphia | Pennsylvania | 19102 | United States |
| Southwest Infectious Disease Association / PA | Dallas | Texas | 75225 | United States |
| Univ TX Galveston Med Branch | Galveston | Texas | 77550 | United States |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| 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 |
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| ID | Term |
|---|---|
| D019469 | Indinavir |
| D019888 | Nelfinavir |
| D019259 | Lamivudine |
| D018119 | Stavudine |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
| D013936 | Thymidine |
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