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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0639 |
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To evaluate the ability of the combination of indinavir, zidovudine, and lamivudine to suppress HIV-1 infection as measured by: (1) the maintenance of HIV-1 serum viral RNA below the limit of detection of the most sensitive validated assay (ultradirect assay) and (2) absence of evidence of infectious virus in lymph node, cerebrospinal fluid (CSF), peripheral mononuclear cells (PBMCs), and semen.
It is hypothesized that the administration of indinavir, zidovudine, and lamivudine will result in:
It is hypothesized that the administration of indinavir, zidovudine, and lamivudine will result in:
All patients receive indinavir plus zidovudine plus lamivudine for at least 96 weeks. If there is no evidence of infectious virus, and patients continue to have serum viral RNA levels below the limit of detection of the ultradirect assay for at least 96 weeks, therapy is continued for an additional 24 weeks. However, during this additional 24 weeks of therapy patients may continue to receive this triple combination drug regimen or make changes to this drug regimen treatment by reducing their number of antiretroviral agents. After 120 weeks, if patients continue to have serum viral RNA levels below the limit of detection of the ultradirect assay, patients discontinue all antiretroviral therapy. However, if there is any evidence of infectious virus, as outlined above, patients do not discontinue therapy. Patients who develop detectable serum viral RNA following discontinuation of therapy are given the option to reinitiate therapy with the triple combination of indinavir, zidovudine and lamivudine. NOTE: Patients who develop an intolerance to zidovudine may use stavudine at doses per body weight at the direction of the investigator.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indinavir sulfate | Drug | |||
| Lamivudine | Drug | |||
| Zidovudine | Drug |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Prior Medication:
Excluded:
Previous antiretroviral therapy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ of Alabama at Birmingham | Birmingham | Alabama | 352942050 | United States | ||
| LAC - USC Med Ctr |
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| Los Angeles |
| California |
| 90033 |
| United States |
| AIDS Community Research Consortium | Redwood City | California | 94063 | United States |
| San Francisco Gen Hosp | San Francisco | California | 94110 | United States |
| Yale Univ School of Medicine / AIDS Program | New Haven | Connecticut | 06510 | United States |
| Rush Presbyterian - Saint Luke's Med Ctr / Infect Dis | Chicago | Illinois | 606123832 | United States |
| Johns Hopkins Hosp | Baltimore | Maryland | 21287 | United States |
| Harvard (Massachusetts Gen Hosp) | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hosp | Boston | Massachusetts | 02115 | United States |
| Fenway Community Health Ctr | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Med Ctr - East Campus | Boston | Massachusetts | 02215 | United States |
| NYU Med Ctr | New York | New York | 10016 | United States |
| Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit | Stony Brook | New York | 117948153 | United States |
| Pitt Treatment Ctr | Pittsburgh | Pennsylvania | 15213 | United States |
| Brown Univ / Miriam Hosp | Providence | Rhode Island | 02906 | United States |
| Saint Paul's Hosp | Vancouver | British Columbia | Canada |
| Montreal Gen Hosp | Montreal | Quebec | Canada |
| 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 |
| 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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