|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Gilead Sciences |
|---|---|
| Information provided by: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00708162 |
Purpose
The purpose of this study is to compare the safety, tolerability and efficacy of a regimen containing once-daily ritonavir-boosted elvitegravir or twice-daily raltegravir added to a background regimen in HIV-1 infected, antiretroviral treatment-experienced adults who have documented resistance, or at least six months experience prior to screening with two or more different classes of antiretroviral agents.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection |
Drug: elvitegravir Drug: Raltegravir |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL) Each Administered With a Background Regimen in HIV-1 Infected, Antiretroviral Treatment-Experienced Adults |
| Estimated Enrollment: | 700 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Ritonavir-boosted elvitegravir 150 mg QD (ritonavir-boosted elvitegravir 85 mg QD for subjects taking atazanavir/r or lopinavir/r as part of their BR) + BR (N = 350)
|
Drug: elvitegravir
Elvitegravir 85 mg, 150 mg tablets or matching placebo administered orally QD (with ritonavir-boosted PI) to be taken with food.
|
|
2: Active Comparator
Raltegravir 400 mg BID + BR (N = 350)
|
Drug: Raltegravir
Raltegravir 400 mg tablets or matching placebo administered orally BID and to be taken according to the prescribing information.
|
This is a double-blind, double-dummy, multicenter, randomized, active-controlled study to assess the safety and efficacy of a regimen containing ritonavir-boosted elvitegravir versus raltegravir, each administered with a background regimen (BR) containing a fully-active ritonavir-boosted protease inhibitor (PI) and a second single agent in HIV-1 infected, antiretroviral treatment-experienced adults. Subjects will be randomized in a 1:1 ratio to one of the following two treatment arms:
Due to known pharmacokinetic interactions, subjects who are taking atazanavir/r (ATV/r) or lopinavir/r (LPV/r) as part of their BR will receive elvitegravir 85 mg if randomized to Treatment Arm 1.
The BR shall be constructed by the investigator based on viral resistance testing and shall be composed of a fully-active ritonavir-boosted PI and a second single agent.
The fully-active PI is defined by phenotypic resistance analysis. For phenotypic susceptibility, fully active is defined as being below the lower clinical or biological cutoff. The following ritonavir-boosted PIs are allowed to be prescribed by the investigator as part of the BR: atazanavir/r, darunavir/r, fosamprenavir/r, lopinavir/r, or tipranavir/r. Subjects must take their ritonavir dose based on the dosing schedule indicated in the prescribing information for the PI; no additional ritonavir is required to be taken with elvitegravir. No other marketed PIs will be allowed as part of the BR due to unknown pharmacokinetic interactions.
The second single agent may or may not be fully-active and can be one nucleoside or nucleotide reverse transcriptase inhibitor (NRTI), etravirine, maraviroc, or T-20. However, the second single agent must not include an integrase inhibitor; the non-nucleoside reverse transcriptase inhibitors (NNRTI) efavirenz, nevirapine, or delavirdine (due to unknown pharmacokinetic interactions); or fixed-dose combination antiretroviral therapies.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Andrew Plummer | 1-650-522-6173 | Andrew.Plummer@gilead.com |
| Contact: Krzysztofa Konarska, MD | +49.30.30685.3670 | krzysztofa.konarska@parexel.com |
Hide Study Locations| United States, Arizona | |
| Southwest Center for HIV/AIDS | Recruiting |
| Phoenix, Arizona, United States, 85006 | |
| Contact 602-307-5330 | |
| United States, Arkansas | |
| Health for Life Clinic, PLLC | Recruiting |
| Little Rock, Arkansas, United States, 72207 | |
| Contact 501-603-0003 | |
| United States, California | |
| AIDS Healthcare Foundation-Research Center | Recruiting |
| Beverly Hills, California, United States, 90804 | |
| Contact 323-913-1033 | |
| Center for Special Immunology | Recruiting |
| Fountain Valley, California, United States, 92708 | |
| Contact 714-751-5800 | |
| The Living Hope Foundation | Recruiting |
| Long Beach, California, United States, 90813 | |
| Contact 562-624-4943 | |
| Orange Coast Medical Group | Recruiting |
| Newport Beach, California, United States, 92663 | |
| Contact 949-646-1111 | |
| Tony Mills, MD Internal Medicine | Recruiting |
| Los Angeles, California, United States, 90069 | |
| Contact 310-550-2271 | |
| Peter J. Ruane, MD, Inc. | Recruiting |
| Los Angeles, California, United States, 90036 | |
| Contact 323-954-1072 | |
| University of Southern California, AIDS Clinical Trials Unit | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Contact 323-343-8288 | |
| Kaiser Permanente | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact 323-783-7855 | |
| Jeffrey Goodman Special Care Clinic | Recruiting |
| Los Angeles, California, United States, 90028 | |
| Contact 323-993-7500 | |
| East Bay AIDS Center | Recruiting |
| Oakland, California, United States, 94609 | |
| Contact 510-869-8400 | |
| Kaiser Permanente | Recruiting |
| Sacramento, California, United States, 95825 | |
| Contact 916-480-6438 | |
| David J. Shamblaw, MD Inc. | Recruiting |
| San Diego, California, United States, 92103 | |
| Contact 619-260-3456 | |
| Metropolis Medical | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact 415-292-5477 | |
| San Francisco VA Medical Center/UCSF | Recruiting |
| San Francisco, California, United States, 94121 | |
| Contact 415-379-5608 | |
| Alameda County Medical Center | Recruiting |
| Oakland, California, United States, 94602 | |
| Contact 510-437-4373 | |
| Pacific Oaks Medical Group | Recruiting |
| Beverly Hills, California, United States, 90211 | |
| Contact 310-652-2562 | |
| United States, Connecticut | |
| Connecticut Health Care Group | Recruiting |
| Glastonbury, Connecticut, United States, 06033 | |
| Contact 860-657-0764 | |
| Circle Medical LLC | Recruiting |
| Norwalk, Connecticut, United States, 06851 | |
| Contact 203-852-9525 | |
| The Stamford Hospital - Stamford ID | Recruiting |
| Stamford, Connecticut, United States, 06902 | |
| Contact 203-938-1118 | |
| United States, District of Columbia | |
| Whitman-Walker Clinic | Recruiting |
| Washington, District of Columbia, United States, 20009 | |
| Contact 202-745-6142 | |
| The George Washington University Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20037 | |
| Contact 202-741-2234 | |
| United States, Florida | |
| South Florida Clinical Research | Recruiting |
| Atlantis, Florida, United States, 33462 | |
| Contact 561-596-0407 | |
| NorthPoint Medical | Recruiting |
| Fort Lauderdale, Florida, United States, 33308 | |
| Contact 954-772-2411 | |
| Therafirst Medical Centers | Recruiting |
| Fort Lauderdale, Florida, United States, 33308 | |
| Contact 954-564-4222 | |
| Gary Richmond, MD, PA, Inc. | Recruiting |
| Fort Lauderdale, Florida, United States, 33316 | |
| Contact 954-524-2250 | |
| Broward Health CCC | Recruiting |
| Fort Lauderdale, Florida, United States, 33311 | |
| Contact 954-467-3006 | |
| The Kinder Medical Group | Recruiting |
| Miami, Florida, United States, 33133 | |
| Contact 305-856-2171 | |
| St. Joseph's Comprehensive Research Institute | Recruiting |
| Tampa, Florida, United States, 33614 | |
| Contact 813-870-4760 | |
| Wohlfeiler, Piperato and Associates, LLC | Recruiting |
| North Miami Beach, Florida, United States, 33169 | |
| Contact 305-944-2884 | |
| Orlando Immunology Center | Recruiting |
| Orlando, Florida, United States, 32803 | |
| Contact 407-647-3960 | |
| Infectious Disease of Central Florida | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact 407-246-1946 | |
| Associates In Infectious Diseases | Recruiting |
| Port St. Lucie, Florida, United States, 34952 | |
| Contact 772-398-3311 | |
| University of Miami | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact 305-243-3006 | |
| Treasure Coast Infectious Disease Consultants | Recruiting |
| Vero Beach, Florida, United States, 32960 | |
| Contact 772-978-9556 | |
| Lifeway , Inc. | Recruiting |
| Fort Lauderdale, Florida, United States, 33308 | |
| Contact 954-772-8554 | |
| Barry M. Rodwick, M. D. | Recruiting |
| Safety Harbor, Florida, United States, 34695 | |
| Contact 727-725-9931 | |
| United States, Georgia | |
| AIDS Research Consortium of Atlanta | Recruiting |
| Atlanta, Georgia, United States, 30308 | |
| Contact 404-876-2317 | |
| The Emory Clinic, Inc., Division of Infectious Diseases | Recruiting |
| Atlanta, Georgia, United States, 30308 | |
| Contact 404-686-7893 | |
| Infectious Disease Specialists of Atlanta (IDSA) | Recruiting |
| Decatur, Georgia, United States, 30033 | |
| Contact 404-297-9755 | |
| Mercer Univ. School of Medicine | Recruiting |
| Macon, Georgia, United States, 31201 | |
| Contact 478-301-5837 | |
| Atlanta ID Group | Recruiting |
| Atlanta, Georgia, United States, 30309 | |
| Contact 678-500-2274 | |
| Chatham County Health Department | Recruiting |
| Savannah, Georgia, United States, 31401 | |
| Contact 912-651-2253 | |
| United States, Hawaii | |
| Hawaii AIDS Clinical Research Program HACRP | Recruiting |
| Honolulu, Hawaii, United States, 96316 | |
| Contact 808-737-2751 | |
| United States, Illinois | |
| Howard Brown Health Center | Recruiting |
| Chicago, Illinois, United States, 60613 | |
| Contact 773-388-1600 | |
| Northstar Medical Center | Recruiting |
| Chicago, Illinois, United States, 60657 | |
| Contact 773-296-2400 | |
| The Ruth M. Rothstein CORE Center | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact 312-572-4575 | |
| United States, Kentucky | |
| University of Kentucky Healthcare/Bluegrass Care Clinic | Recruiting |
| Lexington, Kentucky, United States, 40536 | |
| Contact 859-323-6327 | |
| United States, Maryland | |
| University of Maryland, Institute of Human Virology | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact 410-706-4613 | |
| United States, Massachusetts | |
| Community Research Initiative of New England | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact 617-502-1700 | |
| United States, Michigan | |
| Henry Ford Hospital Div of Infectious Disease | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact 313-916-3768 | |
| Wayne State University | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact 313-993-0930 | |
| Be Well Medical Center | Recruiting |
| Berkley, Michigan, United States, 48072 | |
| Contact 248-544-9300 | |
| United States, Missouri | |
| Southampton Healthcare, Inc. | Recruiting |
| St. Louis, Missouri, United States, 63139 | |
| Contact 314-647-2200 | |
| Washington University School of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact 314-454-8225 | |
| United States, New Jersey | |
| ID Care | Recruiting |
| Hillsborough, New Jersey, United States, 08844 | |
| Contact 908-281-0221 | |
| University of Medicine and Dentistry of New Jersey; University Hospital Infectious Disease Practice | Recruiting |
| Newark, New Jersey, United States, 07103 | |
| Contact 973-972-9070 | |
| Saint Michael's Medical Center | Recruiting |
| Newark, New Jersey, United States, 07102 | |
| Contact 973-877-2663 | |
| South Jersey Infectious Disease | Recruiting |
| Somer Point, New Jersey, United States, 08244 | |
| Contact 609-927-6662 | |
| Garden State Infectious Diseases Associates, PA | Recruiting |
| Voorhees, New Jersey, United States, 08043 | |
| Contact 856-566-3190 | |
| United States, New Mexico | |
| Southwest C.A.R.E. Center | Recruiting |
| Santa Fe, New Mexico, United States, 87505 | |
| Contact 505-989-8200 | |
| United States, New York | |
| Albany Medical College | Recruiting |
| Albany, New York, United States, 12208 | |
| Contact 518-262-6330 | |
| STAR Health Care Center | Recruiting |
| Brooklyn, New York, United States, 11203 | |
| Contact 718-270-4180 | |
| Greiger Clinic | Recruiting |
| Mt. Vernon, New York, United States, 10550 | |
| Contact 914-361-6451 | |
| Montefiore Medical Center | Recruiting |
| Bronx, New York, United States, 10573 | |
| Contact 718-920-2647 | |
| Ricky K. Hsu, MD, PC | Recruiting |
| New York, New York, United States, 10011 | |
| Contact 212-627-7560 | |
| St. Vincent's Catholic Medical Center | Recruiting |
| New York, New York, United States, 10011 | |
| Contact 212-604-2905 | |
| Beth Israel Medical Center | Recruiting |
| New York, New York, United States, 10003 | |
| Contact 212-420-4005 | |
| AIDS Community HealthCenter | Recruiting |
| Rochester, New York, United States, 14604 | |
| Contact 585-244-9000 | |
| Health InnoVations Research | Recruiting |
| New York, New York, United States, 10011 | |
| Contact 212-929-2629 | |
| United States, North Carolina | |
| University of North Carolina/ School of Medicine Division of Infectious Diseases/ AIDS Clinical Trials Unit | Recruiting |
| Chapel Hill, North Carolina, United States, 27514 | |
| Contact 919-843-2723 | |
| Carolinas Medical Center | Recruiting |
| Charlotte, North Carolina, United States, 28207 | |
| Contact 704-355-3823 | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact 919-684-6863 | |
| Brody School of Medicine at East Carolina University | Recruiting |
| Greenville, North Carolina, United States, 27834 | |
| Contact 252-744-5700 | |
| Rosedale Infectious Diseases | Recruiting |
| Huntersville, North Carolina, United States, 28078 | |
| Contact 704-948-8582 | |
| Wake Forest University Health Sciences | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| Contact 336-716-4262 | |
| United States, Ohio | |
| Summa Health CARE Center | Recruiting |
| Akron, Ohio, United States, 44304 | |
| Contact 330-375-4851 | |
| United States, Pennsylvania | |
| Philadelphia FIGHT | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact 215-790-1788 | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact 215-349-8091 | |
| Thomas Jefferson University Jefferson Alumni Hall | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact 215-503-8575 | |
| United States, Texas | |
| Nicholaos Bellos, MD, PA | Recruiting |
| Dallas, Texas, United States, 75204 | |
| Contact 214-828-4702 | |
| AIDS Arms/ Peabody Health Center | Recruiting |
| Dallas, Texas, United States, 75215 | |
| Contact 214-421-7848 | |
| North Texas Infectious Disease Consultants | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Contact 214-823-2533 | |
| Presbyterian Hospital of Dallas | Recruiting |
| Dallas, Texas, United States, 75231 | |
| Contact 214-378-5515 | |
| Valley AIDS Council | Recruiting |
| Harlingen, Texas, United States, 78550 | |
| Contact 956-428-2653 | |
| Gordon E. Crofoot, MD, PA | Recruiting |
| Houston, Texas, United States, 77098 | |
| Contact 713-526-0005 | |
| Joseph C. Gathe, JR. MD, F.A.C.P. | Recruiting |
| Houston, Texas, United States, 77478 | |
| Contact 713-526-9821 | |
| Research Access Network | Recruiting |
| Houston, Texas, United States, 77098 | |
| Contact 713-526-7732 | |
| University of Texas Health Science Center at Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact 713-500-6737 | |
| DCOL Center for Clinical Research | Recruiting |
| Longview, Texas, United States, 75605 | |
| Contact 903-238-8854 | |
| Central Texas Clinical Research | Recruiting |
| Austin, Texas, United States, 78705 | |
| Contact 512-480-9660 | |
| Tarrant County Infectious Disease Associates | Recruiting |
| Fort Worth, Texas, United States, 76104 | |
| Contact 817-348-0042 | |
| United States, Virginia | |
| Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID) | Recruiting |
| Annandale, Virginia, United States, 22003 | |
| Contact 703-560-4821 | |
| United States, Washington | |
| EHS Pulmonary and Critical Care | Recruiting |
| Spokane, Washington, United States, 99204 | |
| Contact 509-623-1456 | |
| Australia, New South Wales | |
| Royal Prince Alfred Hospital | Recruiting |
| Camperdown, New South Wales, Australia, 2050 | |
| Contact 61 2 9515 6893 | |
| St. Vincent's Hospital, Sydney | Recruiting |
| Darlinghurst, New South Wales, Australia, 2010 | |
| Contact 0283822049 | |
| Holdsworth House Medical Practice | Recruiting |
| Darlinghurst, New South Wales, Australia, 2010 | |
| Contact 61 2 933 17228 | |
| Ground Zero Medical Centre | Recruiting |
| Darlinghurst, New South Wales, Australia, 2010 | |
| Contact 61 2 9360 7172 | |
| St George Hospital | Recruiting |
| Kogarah, New South Wales, Australia, 2217 | |
| Contact 0293502957 | |
| Immunology/HIV Department | Recruiting |
| Liverpool, New South Wales, Australia, 2170 | |
| Contact 61 2 9827 8022 | |
| Parramatta Sexual Health Clinic | Recruiting |
| Parramatta, New South Wales, Australia, 2150 | |
| Contact 61 2 9843 3124 | |
| East Sidney Doctors | Recruiting |
| Sidney, New South Wales, Australia, 2010 | |
| Contact 61 2 933 22531 | |
| Albion Street Centre | Recruiting |
| Sydney, New South Wales, Australia, 2010 | |
| Contact 61293329694 | |
| Westmead Hospital | Recruiting |
| Wentworthville, New South Wales, Australia, 2145 | |
| Contact 61 2 9845 6694 | |
| Australia, Victoria | |
| Melbourne Sexual Health Centre | Recruiting |
| Carlton, Victoria, Australia, 3053 | |
| Contact 61438399105 | |
| Belgium | |
| Institute of Tropical Medicine | Recruiting |
| Antwerp, Belgium, 2000 | |
| Contact 3232476465 | |
| C.H.U. St Pierre | Recruiting |
| Brussels, Belgium, 1000 | |
| Contact 3225354131 | |
| Hôpital Erasme | Recruiting |
| Brussels, Belgium, 1070 | |
| Contact 3225558181 | |
| CHU de Charleroi-Hopital civil | Recruiting |
| Charleroi, Belgium, 6000 | |
| Contact 3271922305 | |
| Centre Hospitalier Universitaire de Liège | Recruiting |
| Liege, Belgium, 4000 | |
| Contact 3243668457 | |
| Canada | |
| University of Manitoba - Health Sciences Centre | Recruiting |
| Winnipeg, Canada, R3A 1R9 | |
| Contact 2047873633 | |
| Canada, British Columbia | |
| Downtown Infectious Diseases Clinic | Recruiting |
| Vancouver, British Columbia, Canada, V35 4N9 | |
| Contact 6046426429 | |
| British Columbia Centre for Excellence in HIV/AIDS | Recruiting |
| Vancouver, British Columbia, Canada, V6Z 1Y6 | |
| Contact 6048068036 | |
| Canada, Nova Scotia | |
| Queen Elizabeth II Health Sciences Centre | Recruiting |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Contact 9024735553 | |
| Canada, Ontario | |
| Canadian Immunodeficiency Research Collaborative (CIRC) Inc. | Recruiting |
| Toronto, Ontario, Canada, M5B 1L6 | |
| Contact 415-465-7936 | |
| CascAids Research | Recruiting |
| Toronto, Ontario, Canada, M4T 3A7 | |
| Contact 4169660178 | |
| Sunnybrook Health Sciences Centre | Recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Contact 4164804689 | |
| University Health Network, Toronto General Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2N2 | |
| Contact 4163403871 | |
| Canada, Quebec | |
| Immunodeficiency Service, McGill University Health Centre (MUHC) | Recruiting |
| Montreal, Quebec, Canada, H2X 2P4 | |
| Contact 5148432090 | |
| Clinique medicale l'Actuel | Recruiting |
| Montreal, Quebec, Canada, H2L 4P9 | |
| Contact 514-524-3250 | |
| France | |
| Hopital de Bicentre - Service de medecine Interne et Immunologie | Recruiting |
| Le Kremlin Bicetre, France, 94270 | |
| Contact 33145212891 | |
| University Hospital of Montpellier - Gui de Chauliac | Recruiting |
| Montpellier, France, 34295 | |
| Contact 33467337220 | |
| CHU Nantes | Recruiting |
| Nantes, France, 44093 | |
| Contact 33210083110 | |
| APHP Hopital Bichat-Claude Bernard | Recruiting |
| Paris, France, 75018 | |
| Contact 330140257807 | |
| Hopital Saint Antoine - Infectious Desease Department | Recruiting |
| Paris, France, 75012 | |
| Contact 33149283044 | |
| Hopital Pitie Salpetriere - Infectious Deseases Department | Recruiting |
| Paris, France, 75013 | |
| Contact 014216013042 | |
| Hopital Saint Louis | Recruiting |
| Paris, France, 75010 | |
| Contact 33142499065 | |
| Hopital Tenon | Recruiting |
| Paris, France, 75020 | |
| Contact 33156017436 | |
| C.H.U. de Nice - Hopital de l'Archet 1 | Recruiting |
| Nice, France, 06202 | |
| Contact 33492035467 | |
| CHU Bordeaux | Recruiting |
| Pessac, France, 33604 | |
| Contact 33557656483 | |
| Centre Hospitalier Intercommunal Service Infectiologie | Recruiting |
| Toulon, France, 83056 | |
| Contact 33494227741 | |
| Hopital Purpan - Service of Infectious Diseases | Recruiting |
| Toulouse, France, 31059 | |
| Contact 33561772150 | |
| Germany | |
| Universitatsklinikum Bonn | Recruiting |
| Bonn, Germany, 53125 | |
| Contact 4922828715758 | |
| Universitatsklinikum Dusseldorf | Recruiting |
| Dusseldorf, Germany, 40225 | |
| Contact 492118118942 | |
| Universitatklinikum Essen | Recruiting |
| Essen, Germany, 45122 | |
| Contact 492017233696 | |
| Klinikum der Universitat zu Koln | Recruiting |
| Koln, Germany, 50937 | |
| Contact 492214785860 | |
| IFI-Institute | Recruiting |
| Hamburg, Germany, 20099 | |
| Contact 49401818859780 | |
| Ambulanzzentrum am Universitatsklinikum Hamburg Eppendorf | Recruiting |
| Hamburg, Germany, 20251 | |
| Contact 4940428032831 | |
| Medizinische Universitatsklinik Kiel | Recruiting |
| Kiel, Germany, 24116 | |
| Contact 4934116971207 | |
| Klinikum der J.W. Goethe-Universitat | Recruiting |
| Frankfurt, Germany, 60590 | |
| Contact 496963017680 | |
| MUC Research | Recruiting |
| Munich, Germany, 80335 | |
| Contact 49895587030 | |
| Italy | |
| Ospedali Riuniti Di Bergamo | Recruiting |
| Bergamo, Italy, 24128 | |
| Contact 39 35269893 | |
| Spedali Civili di Brescia | Recruiting |
| Brescia, Italy, 25137 | |
| Contact 39 0303996629 | |
| Ospedale Luigi Sacco | Recruiting |
| Milan, Italy, 20157 | |
| Contact 39 0239042668 | |
| Fondazione Centro San Raffaele del Monte Tabor | Recruiting |
| Milan, Italy, 20127 | |
| Contact 39 0224637940 | |
| Ospedale L. Sacco | Recruiting |
| Milan, Italy, 20157 | |
| Contact 393488031941 | |
| Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani I.R.C.C.S. | Recruiting |
| Rome, Italy, 00149 | |
| Contact 39 0655170348 | |
| Universita' Cattolica Del Sacro Cuore | Recruiting |
| Rome, Italy, 00168 | |
| Contact 39 0630154945 | |
| Universita La Sapienza Policlinico Umberto I | Recruiting |
| Rome, Italy, 00161 | |
| Contact 39 0649970313 | |
| Mexico, D.F. | |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMYNSZ) | Recruiting |
| Mexico, D.F., Mexico, 14000 | |
| Contact 525555133365 | |
| Mexico, Guanajuato | |
| Hospital Regional de Leon Guanajuato | Recruiting |
| Leon, Guanajuato, Mexico, 31320 | |
| Contact 524771310037 | |
| Mexico, Jalisco | |
| Hospital Civil de Guadalajara | Recruiting |
| Guadalajara, Jalisco, Mexico, 44280 | |
| Contact 523336143801 | |
| Mexico, San Luis Potsi | |
| Hospital Central Morones Prieto | Recruiting |
| San Luis Potosi, San Luis Potsi, Mexico, 78240 | |
| Contact 524448172360 | |
| Netherlands | |
| Erasmus Medisch Centrum | Recruiting |
| Rotterdam, Netherlands, 3000CA | |
| Contact 31107033510 | |
| Portugal | |
| Hospital Fernando Fonseca | Recruiting |
| Amadora, Portugal, 2720-276 | |
| Contact 35121 4345552 | |
| Hospital de Santa Maria | Recruiting |
| Lisbon, Portugal, 1649-035 | |
| Contact 35121 7975171 | |
| Hospital Pulido Valente | Not yet recruiting |
| Lisbon, Portugal, 1769-001 | |
| Contact 35121 7548572 | |
| Hospital Santo Antonio dos Capuchos | Recruiting |
| Lisbon, Portugal, 1150-069 | |
| Contact 35191 2288422 | |
| Hospital de Sao Joao | Recruiting |
| Porto, Portugal, 42020-451 | |
| Contact 35122 5512389 | |
| Puerto Rico | |
| Instituto de Investigacion Cientifica del Sur | Recruiting |
| Ponce, Puerto Rico, 00731 | |
| Contact 787-840-2944 | |
| Clinical Research Puerto Rico, Inc. | Recruiting |
| San Juan, Puerto Rico, 00909 | |
| Contact (787) 723-5945 | |
| HOPE Clinical Research | Recruiting |
| San Juan, Puerto Rico, 00909 | |
| Contact 787-268-7078 | |
| VA Caribbean healthcare System | Recruiting |
| San Juan, Puerto Rico, 00921 | |
| Contact 787-641-7582 | |
| University of Puerto Rico, School of Medicine, Proyecto ACTU | Recruiting |
| San Juan, Puerto Rico, 00936 | |
| Contact 787-767-9192 | |
| Spain | |
| Hospital General Universitario de Alicante | Recruiting |
| Alicante, Spain, 03010 | |
| Contact 34965937882 | |
| Hospital Universitario Germans Trias i Pujol | Recruiting |
| Barcelona, Spain, 08916 | |
| Contact 34934978849 | |
| Hospital de la Santa Creu i Sant Pau | Recruiting |
| Barcelona, Spain, 08025 | |
| Contact 34935565624 | |
| Hospital Clinic i Provincial de Barcelona | Recruiting |
| Barcelona, Spain, 08036 | |
| Contact 34609889132 | |
| Hospital Reina Sofia | Recruiting |
| Cordoba, Spain, 14004 | |
| Contact 34957011636 | |
| Hospital General Universitario del Elche | Recruiting |
| Elche, Spain, 03203 | |
| Contact 34966679154 | |
| Hospital Doce De Octubre | Recruiting |
| Madrid, Spain, 28041 | |
| Contact 34913908361 | |
| Hospital Universitario La Paz | Recruiting |
| Madrid, Spain, 28046 | |
| Contact 34912071676 | |
| Hospital General Universitario Gregorio Maranon | Recruiting |
| Madrid, Spain, 28007 | |
| Contact 34915868591 | |
| Hospital Ramon y Cajal | Recruiting |
| Madrid, Spain, 28034 | |
| Contact 34913368710 | |
| Hospital Doce De Octubre | Recruiting |
| Madrid, Spain, 28041 | |
| Contact 34913908202 | |
| Hospital Clinico San Cecilio | Recruiting |
| Granada, Spain, 18014 | |
| Contact 34958270200 | |
| Hospital La Princesa | Not yet recruiting |
| Madrid, Spain, 28006 | |
| Contact 34 915202200 | |
| Hospital Virgen de la Victoria | Recruiting |
| Malaga, Spain, 29010 | |
| Contact 34951032593 | |
| Hospital Universitario de Canarias | Recruiting |
| Santa Cruz de Tenerife, Spain, 38320 | |
| Contact 34922678681 | |
| Hospital Virgen del Rocio | Recruiting |
| Sevilla, Spain, 41013 | |
| Contact 34955012000 | |
| Complexo Hospitalario Xeral-Cies (Chuvi) Vigo | Recruiting |
| Vigo, Spain, 36204 | |
| Contact 34986816000 | |
| Switzerland | |
| Universitatsspital Zurich | Recruiting |
| Zurich, Switzerland, CH-8091 | |
| Contact 41442553826 | |
| United Kingdom | |
| North Manchester General Hospital | Recruiting |
| Manchester, United Kingdom, M8 6RB | |
| Contact 441617202733 | |
| Royal Liverpool University Hospital | Recruiting |
| Liverpool, United Kingdom, L7 8XP | |
| Contact 441517955560 | |
| Royal Free and University College Medical School | Recruiting |
| London, United Kingdom, WC1E 6JB | |
| Contact 442073809946 | |
| Imperial College Healthcare NHS Trust, St. Mary's Campus | Recruiting |
| London, United Kingdom, W2 1NY | |
| Contact 442078861603 | |
| RIDU, Western General Hospital | Recruiting |
| Edinburgh, United Kingdom, EH4 2XU | |
| Contact 441315372842 | |
| Study Director: | Steven Chuck, MD | Gilead Sciences |
More Information
| Responsible Party: | Gilead Sciences, Inc. ( Steven Chuck, MD, Senior Director, Clinical Research ) |
| Study ID Numbers: | GS-US-183-0145, EudraCT Number:2007-004225-26 |
| Study First Received: | June 30, 2008 |
| Last Updated: | November 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00708162 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Australia: Human Research Ethics Committee; Belgium: Federal Agency for Medicinal Products and Health Products; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Ireland: Irish Medicines Board; Italy: Ministry of Health; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Portugal: National Pharmacy and Medicines Institute; Spain: Spanish Agency of Medicines; Switzerland: Swissmedic; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
HIV HIV I Treatment Experienced |
|
Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Infection Antiviral Agents |
Pharmacologic Actions Immunologic Deficiency Syndromes Protease Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Ritonavir Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |
