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| ID | Type | Description | Link |
|---|---|---|---|
| NR15720C/M61027 |
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The purpose of this study is to compare 2 anti-HIV drug combinations.
Patients are stratified by HIV RNA: 5,000-75,000 vs greater than 75,000 copies/ml by Amplicor assay. Patients are randomized to two arms. Arm A receives SQV plus RTV plus two NRTIs. Arm B receives EFV plus two NRTIs. Patients must take their dose at approximately the same time every day. Patients have the option of taking daily dose in AM or PM. Patients are evaluated for changes in plasma HIV RNA levels and CD4/CD8 counts and for adverse experiences and laboratory determinations. Evaluations are made every 4-8 weeks until Week 48. Patients continuing beyond Week 48 who reach Weeks 60, 72, 84, and common study closure, will be seen at those weeks.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ritonavir | Drug | |||
| Efavirenz | Drug | |||
| Saquinavir | 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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| Name | Affiliation | Role |
|---|---|---|
| JSG Montaner | Principal Investigator | |
| Ann Collier | Study Chair | |
| Danielle Rouleau | Study Chair | |
| Michael Saag | Study Chair | |
| Paul Volberding | Study Chair | |
| Sharon Walmsley | Study Chair | |
| Nicholas Bellos | Study Chair | |
| Alfred Burnside | Study Chair | |
| Stephen Follansbee | Study Chair | |
| Joseph Gathe | Study Chair | |
| Bruce Hathaway |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ of Alabama at Birmingham / AIDS Outpatient Clinic | Birmingham | Alabama | 35294 | United States | ||
| St Mary's Med Ctr |
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| Study Chair |
| Margaret Hoffman-Terry | Study Chair |
| Jazila Mantis | Study Chair |
| Joseph Masci | Study Chair |
| Mahmoud Mustafa | Study Chair |
| John Schrank | Study Chair |
| Malte Schutz | Study Chair |
| Leon Smith | Study Chair |
| Long Beach |
| California |
| 90813 |
| United States |
| UCSF - San Francisco Gen Hosp | San Francisco | California | 94110 | United States |
| Kaiser Foundation Hospital | San Francisco | California | 94118 | United States |
| Georgetown Univ Med Ctr | Washington D.C. | District of Columbia | 20007 | United States |
| Physicans Home Service | Washington D.C. | District of Columbia | 20037 | United States |
| Associates in Research | Fort Myers | Florida | 33901 | United States |
| Univ of Miami / Jackson Memorial Hosp | Miami | Florida | 33136 | United States |
| Illinois Masonic Med Ctr | Chicago | Illinois | 606575147 | United States |
| Saint Michael's Med Ctr / Dept of Infectious Diseases | Newark | New Jersey | 07102 | United States |
| Infectious Disease Specialists of NJ | Union | New Jersey | 07083 | United States |
| Elmhurst Hosp | Elmhurst | New York | 11373 | United States |
| Queens Hospital Center | Jamaica | New York | 11432 | United States |
| LIJMC | New Hyde Park | New York | 11040 | United States |
| East Carolina Univ School of Medicine | Greenville | North Carolina | 27858 | United States |
| Lehigh Valley Hosp | Allentown | Pennsylvania | 18105 | United States |
| Burnside Clinic | Columbia | South Carolina | 29206 | United States |
| Greenville Hospital System | Greenville | South Carolina | 29605 | United States |
| Nicholas Bellos | Dallas | Texas | 75246 | United States |
| Joseph Gathe | Houston | Texas | 77004 | United States |
| Univ of Utah | Salt Lake City | Utah | 84132 | United States |
| Univ of Washington / AIDS Clinical Trial Unit | Seattle | Washington | 98104 | United States |
| Saint Paul's Hosp | Vancouver | British Columbia | Canada |
| Toronto Gen Hosp | Toronto | Ontario | Canada |
| Centre Hospitalier de la Universite de Montreal (CHUM) | Montreal | Quebec | Canada |
| Ponce Univ Hosp | Ponce | 00731 | 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 |
|---|---|
| D019438 | Ritonavir |
| C098320 | efavirenz |
| D019258 | Saquinavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011804 | Quinolines |
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