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| ID | Type | Description | Link |
|---|---|---|---|
| AI455-048 |
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To compare the magnitude and durability of the reduction in plasma HIV RNA in the two treatment groups over the first 12 weeks of treatment. To determine the safety of each of the two treatment groups.
Patients will be randomized to either Stavudine (d4T) + Lamivudine (3TC) + Zidovudine placebo or Zidovudine (ZDV) + Lamivudine + Stavudine placebo. Patients whose plasma HIV RNA levels remain >= 500 copies/ml after 8 weeks of blinded double combination therapy will have indinavir added to their treatment regimen at the week 12 visit.
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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
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with any of the following prior conditions or symptoms are excluded:
Prior Medication:
Excluded:
Risk Behavior:
Excluded:
Required:
At least 6 months of prior cumulative ZDV therapy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbor UCLA Med Ctr | Torrance | California | 90502 | United States | ||
| Univ of South Florida |
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| Tampa |
| Florida |
| 33612 |
| United States |
| SUNY at Stony Brook / Division of Infectious Diseases | Stony Brook | New York | 11794 | United States |
| Houston Clinical Research Network / Div of Montrose Clinic | Houston | Texas | 77006 | United States |
| Univ of Utah / School of Medicine / Div of Infect Dis | Salt Lake City | Utah | 84132 | United States |
| Sunnybrook Health Science Ctr | North York | Ontario | Canada |
| Montreal Gen Hosp / Div of Clin Immuno and Allergy | Montreal | Quebec | Canada |
| Univ of Puerto Rico School of Medicine | San Juan | 00927 | Puerto Rico |
| 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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