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| ID | Type | Description | Link |
|---|---|---|---|
| M97-720 |
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To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when administered orally in antiretroviral-HIV-1 infected subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Group 1, n=32 initiated with ABT-378 & ritonavir; after 3 wks stavudine and lamivudine was added. |
|
| 2 | Active Comparator | Group II patients (n=68) to be randomized after all Group I patients are enrolled and safety analysis is completed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lopinavir/Ritonavir | Drug | Lopinavir, range from 200 mg to 400 mg, every 12 hrs and Ritonavir, range from 100 mg to 200 mg, every 12 hrs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with viral load below the limit of quantitation | 24 weeks | |
| Time to loss of virologic response | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with viral load below the limit of quantitation at each visit | At each visit |
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Inclusion Criteria
Exclusion Criteria
History of:
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| Name | Affiliation | Role |
|---|---|---|
| George Hanna, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Oaks Research | Beverly Hills | California | 90211 | United States | ||
| University of Colorado Health Sciences Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Murphy R, King M, Brun S, Orth K, Hicks C, Eron J, Thommes J, Gulick R, Thompson M, White C, Benson C, Hammer S, Kessler H, Bertz R, Hsu A, Kempf D, Sun E, Japour A. ABT-378/ritonavir therapy in antiretroviral-naive HIV-I infected patients for 24 weeks. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:69 (abstract no 15) | ||
| 11192874 | Background | Murphy RL, Brun S, Hicks C, Eron JJ, Gulick R, King M, White AC Jr, Benson C, Thompson M, Kessler HA, Hammer S, Bertz R, Hsu A, Japour A, Sun E. ABT-378/ritonavir plus stavudine and lamivudine for the treatment of antiretroviral-naive adults with HIV-1 infection: 48-week results. AIDS. 2001 Jan 5;15(1):F1-9. doi: 10.1097/00002030-200101050-00002. |
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| Lamivudine | Drug | 150 mg, every 12 hours |
|
| Stavudine | Drug | 40 mg every 12 hours |
|
| Denver |
| Colorado |
| 80262 |
| United States |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | United States |
| Northwestern University Medical School | Chicago | Illinois | 60611 | United States |
| Rush-Presbyterian-St. Luke's Medical Center | Chicago | Illinois | 60612 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Cornell Clinical Trials Unit - Chelsea Center | New York | New York | 10011 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27516 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | 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 |
|---|---|
| D061466 | Lopinavir |
| C558899 | lopinavir-ritonavir drug combination |
| D019259 | Lamivudine |
| D018119 | Stavudine |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
| D013936 | Thymidine |
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