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| ID | Type | Description | Link |
|---|---|---|---|
| 094-00 | |||
| CRX463 |
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The purpose of this study is to see whether taking indinavir (IDV) plus ritonavir (RTV) plus stavudine (d4T) plus lamivudine (3TC) 2 times each day is safe and can lower the level of HIV in the blood.
Patients take IDV plus RTV plus d4T plus 3TC twice daily for 24 weeks. Every 4 weeks, patients have physical exams and laboratory tests of blood and urine, and CD4 cell counts and plasma viral RNA are measured. At Week 24, the proportion of patients with plasma viral RNA below 400 copies/ml is determined to identify any clinically meaningful antiretroviral activity for the drug regimen. An observed response proportion of 80% or higher will be considered clinically meaningful.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indinavir sulfate | Drug | |||
| Ritonavir | Drug | |||
| Lamivudine | Drug | |||
| Stavudine | Drug |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Apogee Med Group |
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| San Diego |
| California |
| 92101 |
| United States |
| Univ of California at San Francisco Gen Hosp | San Francisco | California | 94110 | United States |
| HIV Institute / Davies Med Ctr | San Francisco | California | 94114 | United States |
| Kaiser Foundation Hospital | San Francisco | California | 94118 | United States |
| Univ of Miami School of Medicine | Miami | Florida | 33136 | United States |
| AIDS Research Alliance - Chicago | Chicago | Illinois | 60657 | United States |
| Tulane Univ School of Medicine | New Orleans | Louisiana | 70112 | United States |
| CRI New England | Brookline | Massachusetts | 02146 | United States |
| SUNY Health Sciences Ctr | Brooklyn | New York | 11203 | United States |
| Chelsea Village Med Ctr | New York | New York | 10014 | United States |
| Liberty Med Group | New York | New York | 10016 | United States |
| St Lukes / Roosevelt Hosp / HIV Center | New York | New York | 10019 | United States |
| Mount Sinai Med Ctr | New York | New York | 10029 | United States |
| Bronx Lebanon Hosp Ctr | The Bronx | New York | 10456 | United States |
| Montefiore Med Ctr | The Bronx | New York | 10467 | United States |
| Mark Watkins | Philadelphia | Pennsylvania | 19107 | United States |
| Univ of Texas / Thomas Street Clinic | 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 |
|---|---|
| D019469 | Indinavir |
| D019438 | Ritonavir |
| D019259 | Lamivudine |
| D018119 | Stavudine |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| 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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