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| ID | Type | Description | Link |
|---|---|---|---|
| NUCA 3002 |
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To evaluate the safety and efficacy of low and high doses of lamivudine ( 3TC ) in combination with zidovudine ( AZT ) and zalcitabine ( dideoxycytidine; ddC ) in combination with AZT.
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 three treatment arms: low-dose 3TC plus AZT, high-dose 3TC plus AZT, or ddC plus AZT. Treatment continues 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 | |||
| Zalcitabine | Drug |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Required:
Required:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Combat Group | Los Angeles | California | 90028 | United States | ||
| San Diego Community Research Group |
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| San Diego |
| California |
| 92104 |
| United States |
| ViRx Inc | San Francisco | California | 94103 | 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 |
| Boston City Hosp / FGH-1 | Boston | Massachusetts | 02118 | United States |
| Nassau County Med Ctr | East Meadow | New York | 11554 | United States |
| Saint Luke's - Roosevelt Hosp Ctr | New York | New York | 10019 | United States |
| Nalle Clinic | Charlotte | North Carolina | 28207 | United States |
| Duke Univ Med Ctr | Durham | North Carolina | 27710 | United States |
| Portland Veterans Adm Med Ctr / Rsch & Education Grp | Portland | Oregon | 97210 | United States |
| Milton S Hershey Med Ctr | Hershey | Pennsylvania | 17033 | United States |
| Central Texas Med Foundation | Austin | Texas | 78751 | United States |
| Univ of Texas Southwestern Med Ctr of Dallas | Dallas | Texas | 75235 | United States |
| Nicholaos Bellos | Dallas | Texas | 75246 | United States |
| Houston Clinical Research Network | Houston | Texas | 77006 | 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 |
| Hosp Regional de Ponce - Area Vieja | Ponce | 00731 | 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 |
| D016047 | Zalcitabine |
| ID | Term |
|---|---|
| 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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