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| ID | Type | Description | Link |
|---|---|---|---|
| 009-01 | |||
| 009-00 |
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This study will see how safe and effective against HIV the drugs L-756423 plus indinavir (IDV) are compared to just IDV when taken with stavudine (d4T) and lamivudine (3TC). The study will also see whether taking 1 large dose of L-756423/IDV once a day is as safe and effective as taking 2 smaller doses twice a day.
Patients are randomized to 1 of 4 treatment arms. In Group 1, patients receive a dose of L-756423/IDV once daily plus IDV placebo. In Group 3, patients receive a lower dose of L-756423/IDV twice daily (with the daily dosage equaling that of Group 1) plus IDV placebo. In Groups 2 and 4, patients receive equal dosages of IDV plus L-756423/IDV placebo. In all 4 groups L-756423 and IDV are blinded to the investigator and patient. All groups receive open-label d4T and 3TC. Patients routinely undergo a physical exam and have blood and urine tests to ensure the drugs' safety and tolerability, which will be evaluated by tabulation of adverse events and clinical assessment of laboratory data. In addition, CD4+ T cell and plasma viral RNA levels are measured to quantify the drugs' antiretroviral activity.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-756423 | Drug | |||
| Indinavir sulfate | Drug | |||
| Lamivudine | Drug | |||
| Stavudine | Drug |
Inclusion Criteria
You may be eligible for this trial if you:
Exclusion Criteria
You may not be eligible for this trial if you:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA School of Medicine / Ctr for Research and Education | Los Angeles | California | 900951793 | United States | ||
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| Georgetown Univ Med Ctr |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| ViRx / Dupont Circle Physicians Group | Washington D.C. | District of Columbia | 20009 | United States |
| Associates in Research | Fort Myers | Florida | 33901 | United States |
| Univ of Miami School of Medicine | Miami | Florida | 33136 | United States |
| Grady Mem Hosp | Atlanta | Georgia | 30308 | United States |
| Rush Presbyterian - Saint Luke's Med Ctr | Chicago | Illinois | 60612 | United States |
| The CORE Ctr | Chicago | Illinois | 60612 | United States |
| Univ of Kentucky Med Ctr | Lexington | Kentucky | 40536 | United States |
| Univ of Kentucky | Lexington | Kentucky | 40536 | United States |
| Beth Israel Deaconess Med Ctr | Boston | Massachusetts | 02215 | United States |
| Henry Ford Hosp | Detroit | Michigan | 48202 | United States |
| NYU Med Ctr / C & D Building | New York | New York | 10016 | United States |
| Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ | New York | New York | 10021 | United States |
| SUNY at Stony Brook / Div of Infectious Disease | Stony Brook | New York | 117948153 | United States |
| The Miriam Hosp | Providence | Rhode Island | 02906 | 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 |
|---|---|
| C122089 | L 756423 |
| D019469 | Indinavir |
| D019259 | Lamivudine |
| D018119 | Stavudine |
| 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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