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| ID | Type | Description | Link |
|---|---|---|---|
| BMS 2000 |
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The purpose of this study is to see how safe and effective it is to give multi-drug treatment with indinavir (IDV) plus ritonavir (RTV) plus enteric-coated didanosine (ddI) plus stavudine (d4T) and if there are differences in responses between men and women.
Patients are enrolled in balanced numbers based on gender and stratified by viral load (less than or equal to 10,000, 10,000 to 100,000, or more than 100,000 copies/ml). Prior to therapy, a peer-based patient education intervention is presented. Patients receive a combination of IDV, RTV, enteric-coated ddI, and d4T. Responses to this multi-agent antiretroviral drug regimen are explored based on sex differences. A pharmacokinetic sub-study, balanced so that half of patients are male and half are female, is performed on IDV and RTV for 20 to 25 of the patients. About 20 females are examined for study-drug effects on gonadotropic hormone levels.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indinavir sulfate | Drug | |||
| Ritonavir | Drug | |||
| Stavudine | Drug | |||
| Didanosine | 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 |
|---|---|---|---|---|---|---|
| East Bay AIDS Ctr | Berkeley | California | 94705 | United States | ||
| Univ of Southern California |
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| Los Angeles |
| California |
| 90033 |
| United States |
| UCLA CARE Ctr | Los Angeles | California | 90095 | United States |
| North Broward Hosp District / HIV Clinical Research | Fort Lauderdale | Florida | 33311 | United States |
| Saint Josephs Comprehensive Research Institute | Tampa | Florida | 33607 | United States |
| Louisiana State Univ Med Ctr / HIV Outpatient Clinic | New Orleans | Louisiana | 70112 | United States |
| JSI Research and Training Institute | Boston | Massachusetts | 02210 | United States |
| Univ of Med & Dentistry of New Jersey | Newark | New Jersey | 07103 | United States |
| Beth Israel Med Ctr | New York | New York | 10003 | United States |
| Harlem Hosp Ctr | New York | New York | 10037 | United States |
| Univ of Rochester Med Ctr | Rochester | New York | 14642 | United States |
| Vanderbilt Univ School of Medicine | Nashville | Tennessee | 37212 | United States |
| Univ of Texas Southwestern Med Ctr | Dallas | Texas | 75390 | United States |
| Ponce Univ Hosp | Ponce | 00731 | Puerto Rico |
| Univ of Puerto Rico School of Med | Rio Piedras | 00935 | 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 |
| D019438 | Ritonavir |
| D018119 | Stavudine |
| D016049 | Didanosine |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D015224 | Dideoxynucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D007288 | Inosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012263 | Ribonucleosides |
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