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The purpose of this study is to compare the safety, tolerability and antiviral activity between once-daily (QD) and twice-daily (BID) dosing of lopinavir/ritonavir and to further characterize the pharmacokinetics of once-daily dosing of lopinavir/ritonavir.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lopinavir/ritonavir | Drug | |||
| Tenofovir DF | Drug | |||
| Emtricitabine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with plasma HIV RNA level below 50 copies/mL at week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Brun, M.D. | Global Project Head, Antiviral Global Project Team | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Body Positive | Phoenix | Arizona | 85006 | United States | ||
| Pacific Oaks Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18190257 | Derived | Podsadecki TJ, Vrijens BC, Tousset EP, Rode RA, Hanna GJ. Decreased adherence to antiretroviral therapy observed prior to transient human immunodeficiency virus type 1 viremia. J Infect Dis. 2007 Dec 15;196(12):1773-8. doi: 10.1086/523704. |
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| Beverly Hills |
| California |
| 90211 |
| United States |
| Orange County Center for Special Immunology | Fountain Valley | California | 92708 | United States |
| Living Hope Clinical Foundation | Long Beach | California | 90813 | United States |
| AIDS Healthcare Foundation Research Center | Los Angeles | California | 90027 | United States |
| IDS Research Initiative | Altamonte Springs | Florida | 32701 | United States |
| South Florida Clinical Research | Atlantis | Florida | 33462 | United States |
| Comprehensive Care Center | Fort Lauderdale | Florida | 33311 | United States |
| Gary J. Richmond, MD | Fort Lauderdale | Florida | 33316 | United States |
| Associates in Research | Fort Myers | Florida | 33901 | United States |
| Morris, Sklaver, Mestre & Denney, M.D., PA | Plantation | Florida | 33317 | United States |
| Health Positive | Safety Harbor | Florida | 34695 | United States |
| Infectious Disease Research Institute, Inc. | Tampa | Florida | 33614 | United States |
| Treasure Coast Infectious Disease Consultants | Vero Beach | Florida | 32960 | United States |
| AIDS Research Consortium of Atlanta Inc. | Atlanta | Georgia | 30308 | United States |
| Donna E. Sweet, MD | Wichita | Kansas | 67214 | United States |
| Drs. Combs and Lutz | New Orleans | Louisiana | 70115 | United States |
| St. Michael's Medical Center | Newark | New Jersey | 07102-9880 | United States |
| Polari Medical Group | New York | New York | 10011 | United States |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157-1042 | United States |
| Akron Infectious Disease, Inc. | Akron | Ohio | 44304 | United States |
| Associates in Medical and Mental Health, P.C. | Tulsa | Oklahoma | 74114 | United States |
| The Research & Education Group | Portland | Oregon | 97209-2535 | United States |
| Philadelphia FIGHT | Philadelphia | Pennsylvania | 19107 | United States |
| Triangle Medical | Philadelphia | Pennsylvania | 19107 | United States |
| Central Texas Clinical Research | Austin | Texas | 78705 | United States |
| Joseph C. Gathe, Jr, MD | Houston | Texas | 77004 | United States |
| Southampton Medical Group | Houston | Texas | 77098 | United States |
| Hampton Roads Medical Specialists | Hampton | Virginia | 23666 | United States |
| Ground Zero Medical Centre / AIDS Research Initiative | Darlinghurst | New South Wales | 2010 | Australia |
| Holdsworth House General Practice | Darlinghurst | New South Wales | 2010 | Australia |
| Hopital Saint Louis | Paris | Cedex 10 | 75475 | France |
| Hopital Saint Antoine | Paris | Cedex 12 | 75571 | France |
| Hopital Tenon | Paris | Cedex 20 | 75970 | France |
| CHU Kremlin Bicetre | Le Kremlin-BicĂȘtre | 94272 | France |
| Hopital l'Archet | Nice | 06202 | France |
| Hopital Bichat | Paris | 75018 | France |
| Klinik I fur Innere Medizin der Universitat zu Koln | Cologne | D-505924 | Germany |
| Klinikum J.W. Goethe Universitat | Frankfurt | D-60590 | Germany |
| Tan Tock Seng Hospital | Tan Tock Seng | 308433 | Singapore |
| Hospital Germans Trias I Pujol | Badalona | 08916 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
| Hospital Vall D'Hebron | Barcelona | 08035 | Spain |
| L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital La Paz | Madrid | 28046 | Spain |
| Hospital de Mostolesi | Madrid | 28935 | Spain |
| Brighton General Hospital | E. Sussex | BN2 3EW | United Kingdom |
| Royal Free Hospital | London | NW3 2QG | United Kingdom |
| The Caldecot Centre King's Healthcare NHS Trust | London | SE5 9RS | United Kingdom |
| St. Stephen's Centre Chelsea & Westminster Hospital | London | SW10 9TH | United Kingdom |
| St. Mary Hospital | London | W2 1NY | United Kingdom |
| 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 |
|---|---|
| D061466 | Lopinavir |
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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