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| ID | Type | Description | Link |
|---|---|---|---|
| NUCA 3001 |
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To evaluate the safety and efficacy of high-dose lamivudine (3TC) alone versus zidovudine (AZT) alone versus 3TC at high and low doses in combination with AZT in HIV-1 infected patients.
PER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label combination therapy.
Patients are randomized to one of four treatment arms: 3TC alone, AZT alone, low-dose 3TC plus AZT, or high-dose 3TC plus AZT. Patients receive treatment for 32 weeks, with possible extension to 52 weeks.
PER 02/27/95 AMENDMENT: Patients may continue therapy on AZT and low-dose 3TC on an open-label basis. Open-label therapy continues with follow-up every 8 weeks until intolerable toxicity occurs or study terminates.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamivudine | Drug | |||
| Zidovudine | Drug |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Patients with the following prior condition are excluded:
History of intolerance to AZT.
Prior Medication:
Excluded:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Combat Group | Los Angeles | California | 90028 | United States | ||
| San Diego Community Research Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9030391 | Background | Eron JJ Jr. The treatment of antiretroviral-naive subjects with the 3TC/zidovudine combination: a review of North American (NUCA 3001) and European (NUCB 3001) trials. AIDS. 1996 Dec;10 Suppl 5:S11-9. doi: 10.1097/00002030-199612005-00003. | |
| 8853730 | Background | Kuritzkes DR, Quinn JB, Benoit SL, Shugarts DL, Griffin A, Bakhtiari M, Poticha D, Eron JJ, Fallon MA, Rubin M. Drug resistance and virologic response in NUCA 3001, a randomized trial of lamivudine (3TC) versus zidovudine (ZDV) versus ZDV plus 3TC in previously untreated patients. AIDS. 1996 Aug;10(9):975-81. doi: 10.1097/00002030-199610090-00007. |
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| San Diego |
| California |
| 92104 |
| United States |
| Pacific Oaks Med Group | Sherman Oaks | California | 91403 | United States |
| Harbor - UCLA Med Ctr | Torrance | California | 90509 | United States |
| Infectious Disease Research Institute Inc | Tampa | Florida | 33614 | United States |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | United States |
| Chicago Ctr for Clinical Research | Chicago | Illinois | 60607 | United States |
| Louisiana Cardiovascular Research Ctr | New Orleans | Louisiana | 70119 | United States |
| CRI of New England | Brookline | Massachusetts | 02445 | United States |
| Saint Luke's - Roosevelt Hosp Ctr | New York | New York | 10019 | United States |
| Univ of North Carolina School of Medicine | Chapel Hill | North Carolina | 275997215 | United States |
| Med College of Ohio | Toledo | Ohio | 43699 | United States |
| Portland Veterans Adm Med Ctr / Rsch & Education Grp | Portland | Oregon | 97210 | United States |
| Mem Hosp of Rhode Island | Pawtucket | Rhode Island | 02860 | United States |
| Central Texas Med Foundation | Austin | Texas | 78751 | United States |
| Nicholaos Bellos | Dallas | Texas | 75246 | United States |
| Richmond AIDS Consortium | Richmond | Virginia | 23219 | United States |
| Wisconsin Community - Based Research Consortium | Milwaukee | Wisconsin | 53202 | United States |
| Ottawa General Hospital | Ottawa | Ontario | Canada |
| Toronto Hosp | Toronto | Ontario | Canada |
| Montreal Gen Hosp | Montreal | Quebec | Canada |
| Advance Community Health Services Inc | Santurce | 00908 | Puerto Rico |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| D000386 | AIDS-Related Complex |
| 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 |
| D012897 | Slow Virus Diseases |
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| ID | Term |
|---|---|
| D019259 | Lamivudine |
| D015215 | Zidovudine |
| 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 |
| D013936 | Thymidine |
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