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| ID | Type | Description | Link |
|---|---|---|---|
| 069-00 |
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To demonstrate that the antiviral activity and safety/tolerability of a test regimen of indinavir is equivalent to that of a control regimen of indinavir when each is coadministered with zidovudine (ZDV) (or stavudine, d4T) and lamivudine (3TC) for 24 weeks to protease inhibitor- and 3TC-naive HIV-1-seropositive patients. To characterize the steady-state pharmacokinetic profiles of indinavir, ZDV (or d4T), and 3TC in the presence of each other, for both the control and test regimen groups.
Patients are randomized to 1 of 2 arms:
Arm A: Indinavir plus ZDV plus 3TC. Arm B: Indinavir (test dose) plus ZDV plus 3TC. NOTE: d4T may be substituted for zidovudine for toxicity management. Patients are stratified based on prior use of nucleoside analogs (naive vs experienced to ZDV, dideoxyinosine [ddI], dideoxycytidine [ddC], and d4T) and screening viral RNA results (lower than 50,000 copies/mL vs more than 50,000 copies/mL).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indinavir sulfate | Drug | |||
| Lamivudine | Drug | |||
| Stavudine | Drug | |||
| Zidovudine | Drug |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Prior Medication:
Excluded:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ of Alabama at Birmingham | Birmingham | Alabama | 352942050 | United States | ||
| LAC/USC Med Ctr |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10997402 | Background | Haas DW, Arathoon E, Thompson MA, de Jesus Pedro R, Gallant JE, Uip DE, Currier J, Noriega LM, Lewi DS, Uribe P, Benetucci L, Cahn P, Paar D, White AC Jr, Collier AC, Ramirez-Ronda CH, Harvey C, Chung MO, Mehrotra D, Chodakewitz J, Nguyen BY; Protocol 054/069 Study Teams. Comparative studies of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine. AIDS. 2000 Sep 8;14(13):1973-8. doi: 10.1097/00002030-200009080-00013. |
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| Los Angeles |
| California |
| 90033 |
| United States |
| Kaiser Med Ctr | San Francisco | California | 94110 | United States |
| Wilmington Hosp / Med Ctr of Delaware | Wilmington | Delaware | 19899 | United States |
| Georgetown Univ Med Ctr | Washington D.C. | District of Columbia | 20007 | United States |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | United States |
| Cook County Hosp | Chicago | Illinois | 60612 | United States |
| Johns Hopkins Hosp | Baltimore | Maryland | 21287 | United States |
| Washington Univ | St Louis | Missouri | 63108 | United States |
| Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit | Stony Brook | New York | 117948153 | United States |
| Allegheny Univ Hosp | Philadelphia | Pennsylvania | 19129 | United States |
| Pittsburgh Treatment Ctr / Univ of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | United States |
| Brown Univ / Miriam Hosp | Providence | Rhode Island | 02906 | United States |
| Vanderbilt Univ Med Ctr | Nashville | Tennessee | 372321302 | United States |
| Univ of Washington / AIDS Clinical Trial Unit | Seattle | Washington | 98104 | 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 |
| D019259 | Lamivudine |
| D018119 | Stavudine |
| D015215 | Zidovudine |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 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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