HIV Infections Clinical Trial
Official title:
A Long Term Open Label Rollover Trial Assessing the Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV-1 Infected Subjects
The objective of this study is to determine the long term safety and tolerability of multiple oral doses of tipranavir (Aptivus) and ritonavir with a focus on the long term safety of the development dose (500 mg tipranavir/200 mg ritonavir BID) when administered with other antiretroviral medications.
| Status | Completed |
| Enrollment | 997 |
| Est. completion date | |
| Est. primary completion date | May 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
INCLUSION CRITERIA 1. Ability and willingness to give written informed consent in accordance with institutional and federal guidelines and to comply with the investigational nature of the study and the related requirements. 2. All subjects must have successfully completed participation in a combination tipranavir/ritonavir trial or have confirmed virologic failure in the 1182.12 or 1182.48 trials and are not able to obtain TPV by prescription. Successful completion of participation is defined as conclusion of required subject-weeks on assigned dosing (trial specific) and completion of required visits. 3. Male and female subjects 18 years and over. 4. Presence of Human Immunodeficiency Virus 1 (HIV-1) infection as documented by any licensed Enzyme Linked immunosorbent Assay (ELISA) test kit and confirmed by Western Blot, or HIV-1 culture, or HIV-1 antigen, or plasma HIV 1 Ribonucleic Acid (RNA) or a second antibody test by a method other than ELISA at any time prior to study entry. 5. Adherence to previous tipranavir/ritonavir dosing protocol and adherence to visit requirements of previous protocol (as assessed by principal investigator). 6. Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered to be acceptable if the following apply: - Total Cholesterol =400 mg/dl (<Common Toxicity Criteria (CTC) Grade 2). - Total Triglycerides =750 mg/dl (<Division of AIDS (DAIDS) Grade 2). - Alanine aminotransferase (ALT) =3.0x upper limit of normal (ULN) and Aspartate aminotransferase (AST) =2.5x ULN (<DAIDS Grade 1). - Any Grade Gamma Glutamyl transpeptidase(GGT) is acceptable. - Any Grade creatinine kinase is acceptable as long as there is no concurrent myopathy. - All other laboratory test values =DAIDS Grade 1. EXCLUSION CRITERIA 1. Female subjects who are of reproductive potential who: - Have a positive serum beta human chorionic gonadotropin (B HCG) at Screening/Enrollment Visit. - Are not willing to use a reliable method of barrier contraception (such as diaphragm or condoms). - Are breast-feeding. 2. Subjects who are actively using injection drugs or other substance abuse (such as extensive alcohol or narcotic use) which is considered by the investigator to be a significant impairment to health and to protocol adherence. 3. Any medical condition(s) which, in the opinion of the investigator, would interfere with the subject's ability to participate in or adhere to the requirements of this protocol. 4. History of any illness or drug allergy which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering tipranavir/ritonavir to the subject. 5. Active use of any of the following: - Investigational HIV-1 vaccines. - Any new investigational antiretroviral agent that was not approved for use in the patients prior tipranavir trial. - Medications excluded during the trial period (see Section 4.2). - Herbal medications (e.g., St. John's Wort). 6. Active HIV-related or non HIV-related illness that may be negatively affected by use of tipranavir/ritonavir as determined by the investigator. If a subject must temporarily discontinue tipranavir/ritonavir at the recommendation of the investigator (at the completion of the previous tipranavir trial), then the subject may enroll in 1182.17 once the clinical illness has resolved, and after approval from the Boehringer Ingelheim Clinical Monitor or Local Clinical Monitor. 7. Clinically significant liver disease in the 90 days prior to baseline visit, regardless of baseline AST and/or ALT values. 8. Hypersensitivity to tipranavir or ritonavir. 9. Voluntary discontinuation of antiretroviral therapy (including tipranavir/ritonavir) for more than seven days from completion of previous tipranavir trial. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | 1182.17.5401 Fundacion Huesped | Capital Federal | |
| Argentina | 1182.17.5402 Funcei | Capital Federal | |
| Argentina | 1182.17.5403 consultorio externo "PETS" | Capital Federal | |
| Argentina | 1182.17.5404 Infectología | Capital Federal | |
| Argentina | 1182.17.5405 Dpto. de Enfermedades infecciosas (Pabellón 22) | Capital Federal | |
| Argentina | 1182.17.5406 Pabellón de Clínicas 2° Piso | Capital Federal | |
| Australia | 1182.17.401 St. Vincent's Hospital | Darlinghurst | New South Wales |
| Australia | 1182.17.402 Taylor Square Private Clinic | Darlinghurst | New South Wales |
| Australia | 1182.17.405 AIDS Research Initiative | DarlingHurst | New South Wales |
| Australia | 1182.17.407 Holdsworth House General Practice | Darlinghurst | New South Wales |
| Australia | 1182.17.408 407 Doctors Pty Ltd. | Darlinghurst | New South Wales |
| Australia | 1182.17.404 Alfred Hospital | Melbourne | Victoria |
| Australia | 1182.17.403 Albion Street Clinic | Surry Hills | New South Wales |
| Austria | 1182.17.4301 Boehringer Ingelheim Investigational Site | Wien | |
| Belgium | 1182.17.3209 Instituut Tropische Geneeskunde | Antwerpen | |
| Belgium | 1182.17.3201 Boehringer Ingelheim Investigational Site | Bruxelles | |
| Belgium | 1182.17.3202 Boehringer Ingelheim Investigational Site | Bruxelles | |
| Belgium | 1182.17.3207 Boehringer Ingelheim Investigational Site | Gent | |
| Belgium | 1182.17.3210 Centre Hospitalier de Luxembourg | Luxembourg | |
| Brazil | 1182.17.5511 Universidade Federal da Bahia | Canela - Salvador - BA | |
| Brazil | 1182.17.5508 I.I. Emilio Ribas | Cerqueira César, São Paulo - SP | |
| Brazil | 1182.17.5509 (Unidade de Testes Terapêuticos) | Cidade Nova - Rio de Janeiro - RJ | |
| Brazil | 1182.17.5502 Farmácia do Instituto de Pesquisa Evandro Chagas | Manguinhos - Rio de Janeiro - RJ | |
| Brazil | 1182.17.5505 Instituto A-Z de Pesquisa e Ensino da PUC | Mercês - Curitiba - PR | |
| Brazil | 1182.17.5507 Hospital Geral de Nova Iguaçu - Ministério da Saúde | Nova Iguaçu - Rio de Janeiro - RJ | |
| Brazil | 1182.17.5501 Hospital Dia | Sacoma - São Paulo - SP | |
| Brazil | 1182.17.5503 Instituto de Infectologia Emílio Ribas | São Paulo - SP | |
| Brazil | 1182.17.5504 Enfermaria de MI | São Paulo - SP | |
| Brazil | 1182.17.5510 Casa de AIDS | São Paulo, SP | |
| Brazil | 1182.17.5506 Centro de Referência e Treinamento - DST/AIDS | Vila Mariana, Sao Paulo - SP | |
| Canada | 1182.17.913 McMaster University Medical Centre | Hamilton | Ontario |
| Canada | 1182.17.914 Montreal General Hospital - McGill University Health Centre | Monteal | Quebec |
| Canada | 1182.17.903 Montreal Chest Institute, McGill University Health Centre | Montreal | Quebec |
| Canada | 1182.17.904 Clinique Medicale Du Quartier Latin | Montreal | Quebec |
| Canada | 1182.17.915 Clinique medicale l'Actuel | Montreal | Quebec |
| Canada | 1182.17.901 Division of Infectious Diseases | Ottawa | Ontario |
| Canada | 1182.17.905 Canadian Immunodeficiency Research Collaborative Inc. | Toronto | Ontario |
| Canada | 1182.17.906 Infectious Diseases & HIV - St. Michael's Hospital | Toronto | Ontario |
| Canada | 1182.17.907 University Health Network - Toronto General Hospital | Toronto | Ontario |
| Canada | 1182.17.910 Sunnybrook & Women's College Health Science Centre | Toronto | Ontario |
| Canada | 1182.17.902 Downtown Infectious Diseases Clinic | Vancouver | British Columbia |
| Denmark | 1182.17.4505 Boehringer Ingelheim Investigational Site | Aarhus N | |
| Denmark | 1182.17.4501 Boehringer Ingelheim Investigational Site | Copenhagen Ø | |
| Denmark | 1182.17.4502 Boehringer Ingelheim Investigational Site | Hvidovre | |
| Denmark | 1182.17.4504 Boehringer Ingelheim Investigational Site | Odense | |
| France | 1182.17.33011 Hôpital Pellegrin | Bordeaux cedex | |
| France | 1182.17.33019 Hôpital Saint André | Bordeaux cedex | |
| France | 1182.17.33020 Hôpital Côte de Nacre | Caen cedex 5 | |
| France | 1182.17.33007 Hôpital Antoine Beclere | Clamart | |
| France | 1182.17.33008 Hôpital de l'Hôtel Dieu | Lyon cedex 2 | |
| France | 1182.17.33023 Hôpital Edouard Herriot | Lyon cedex 3 | |
| France | 1182.17.33012 Hôpital de la Conception | Marseille cedex 5 | |
| France | 1182.17.33013 Hôpital Sainte Marguerite | Marseille cedex 9 | |
| France | 1182.17.00336 Hôpital Hôtel Dieu | Nantes cedex 1 | |
| France | 1182.17.33010 Hôpital de l'Archet | Nice cedex 3 | |
| France | 1182.17.00333 Hôpital Saint Louis | Paris | |
| France | 1182.17.00334 Hôpital de la Pitié Salpêtrière | Paris | |
| France | 1182.17.33014 Hôpital Saint Antoine | Paris | |
| France | 1182.17.33024 Groupe Hospitalier Cochin | Paris cedex 14 | |
| France | 1182.17.33022 Hôpital Européen Georges Pompidou | Paris cedex 15 | |
| France | 1182.17.00335 Hôpital Bichat Claude Bernard | Paris cedex 18 | |
| France | 1182.17.00331 Hôpital Tenon | Paris cedex 20 | |
| France | 1182.17.33018 Hôpital de Pontchaillou | Rennes cedex 9 | |
| France | 1182.17.33016 Hôpital Civil | Strasbourg cedex | |
| France | 1182.17.00332 Hôpital du Chalucet | Toulon | |
| France | 1182.17.33017 Hôpital Brabois Adultes | Vandoeuvre les Nancy | |
| France | 1182.17.33021 Hôpital Paul Brousse | Villejuif cedex | |
| Germany | 1182.17.4911 Arzt für Innere Medizin | Aachen | |
| Germany | 1182.17.4901 Epimed GmbH c/o | Berlin | |
| Germany | 1182.17.4902 Charite, Campus Virchow-Klinikum | Berlin | |
| Germany | 1182.17.4918 Rheinische Friedrich-Wilhelm-Universität | Bonn | |
| Germany | 1182.17.4906 ID-Ambulanz Klinikum Dortmund | Dortmund | |
| Germany | 1182.17.4912 Universitätsklinikum Düsseldorf | Düsseldorf | |
| Germany | 1182.17.4914 Arzt für Innere Medizin | Düsseldorf | |
| Germany | 1182.17.4908 Universitätskliniken Erlangen | Erlangen | |
| Germany | 1182.17.4904 Universitätsklinikum Essen | Essen | |
| Germany | 1182.17.4924 Klinikum der J. W.-Goethe-Universität | Frankfurt/Main | |
| Germany | 1182.17.4928 Facharzt für Innere Medizin/Rheumatologie | Freiburg | |
| Germany | 1182.17.4930 Universitätsklinikum Freiburg | Freiburg/Breisgau | |
| Germany | 1182.17.4916 Medizinisches Versorgungszentrum Hamburg | Hamburg | |
| Germany | 1182.17.4929 Universitätsklinikum Eppendorf | Hamburg | |
| Germany | 1182.17.4931 IPM Study Center GmbH | Hamburg | |
| Germany | 1182.17.4920 Abteilung Klinische Immunologie | Hannover | |
| Germany | 1182.17.4909 Universitätsklinikum Heidelberg | Heidelberg | |
| Germany | 1182.17.4905 Universitätsklinik Köln | Köln | |
| Germany | 1182.17.4926 Internist | Köln | |
| Germany | 1182.17.4923 Facharzt für Innere Medizin, | Mannheim | |
| Germany | 1182.17.4907 Medizinische Poliklinik | München | |
| Germany | 1182.17.4910 MUC Research GmbH | München | |
| Germany | 1182.17.4915 Klinium Natruper Holz | Osnabrück | |
| Germany | 1182.17.4921 Arzt für Allgemeinmedizin | Stuttgart | |
| Greece | 1182.17.3001 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1182.17.3002 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1182.17.3003 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1182.17.3004 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1182.17.3007 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1182.17.3010 Boehringer Ingelheim Investigational Site | Patras | |
| Greece | 1182.17.3009 Boehringer Ingelheim Investigational Site | Thessaloniki | |
| Italy | 1182.17.0409 Ospedale Santa Maria Annunziata | Antella (fi) | |
| Italy | 1182.17.0413 Ospedale di Circolo di Busto | Busto Arsizio (va) | |
| Italy | 1182.17.0384 Azienda Ospedaliera Arcispedale S. Anna | Ferrara | |
| Italy | 1182.17.0397 Ospedale San Martino | Genova | |
| Italy | 1182.17.0412 S.C. Malattie Infettive | Genova | |
| Italy | 1182.17.0411 Presidio Ospedaliero "A. Manzoni" | Lecco | |
| Italy | 1182.17.0389 Reparto Malattie Infettive | Macerata | |
| Italy | 1182.17.0393 Fondazione Centro S. Raffaele del Monte Tabor | Milano | |
| Italy | 1182.17.0386 Policlinico Universitario | Modena | |
| Italy | 1182.17.0388 Ospedale A. Cotugno | Napoli | |
| Italy | 1182.17.0385 IRCCS Policlinico San Matteo | Pavia | |
| Italy | 1182.17.0394 IRCCS Policlinico San Matteo | Pavia | |
| Italy | 1182.17.0395 Azienda Policlinico Umberto I | Roma | |
| Italy | 1182.17.0419 I Cattedra Malattie Infettive | Roma | |
| Italy | 1182.17.0387 Ospedale Amedeo di Savoia | Torino | |
| Italy | 1182.17.0398 Ospedale Amedeo di Savoia | Torino | |
| Italy | 1182.17.0415 U.O.A. Malattie Infettive B | Torino | |
| Mexico | 1182.17.5201 Centro Médico La Raza IMSS | Col. La Raza, Mexico | |
| Mexico | 1182.17.5203 Hospital Civil Nuevo de Guadalajara | Guadalajara | |
| Mexico | 1182.17.5206 Centro Medico San Vicente | Monterrey, N.l., Mexico | |
| Netherlands | 1182.17.3101 Boehringer Ingelheim Investigational Site | Amsterdam | |
| Netherlands | 1182.17.3108 Boehringer Ingelheim Investigational Site | Groningen | |
| Netherlands | 1182.17.3105 Boehringer Ingelheim Investigational Site | Nijmegen | |
| Netherlands | 1182.17.202 Boehringer Ingelheim Investigational Site | Rotterdam | |
| Portugal | 1182.17.3502 Hospital Condes Castro Guimarães | Cascais | |
| Spain | 1182.17.705 Hospital Germans Trias i Pujol | Badalona | |
| Spain | 1182.17.701 Hospital Clínico y Provincial de Barcelona | Barcelona | |
| Spain | 1182.17.703 Hospital 12 de Octubre | Madrid | |
| Spain | 1182.17.704 Hospital Ramón y Cajal. | Madrid | |
| Spain | 1182.17.710 Hospital Gregorio Maranon | Madrid | |
| Spain | 1182.17.712 Hospital Clínico San Carlos | Madrid | |
| Spain | 1182.17.717 Hospital Clínico Universitario Vírgen de la Victoria | Malaga | |
| Spain | 1182.17.713 Hospital Universitario Vírgen del Rocío | Sevilla | |
| Spain | 1182.17.714 Hospital General Universitario de Valencia | Valencia | |
| Spain | 1182.17.720 Hospital La Fe | Valencia | |
| Spain | 1182.17.718 Complejo Hospitalario Xeral - Cíes | Vigo | |
| Switzerland | 1182.17.4101 DIM / Abteilung für Infektiologie | Basel | |
| Switzerland | 1182.17.4104 Département de médicine interne Div. Des maladies infectieus | Genève | |
| Switzerland | 1182.17.4103 DIM / Abteilung für Infektiologie | St. Gallen | |
| Switzerland | 1182.17.4102 Departement für Innere Medizin | Zürich | |
| United Kingdom | 1182.17.4405 Boehringer Ingelheim Investigational Site | Brighton | |
| United Kingdom | 1182.17.4411 Boehringer Ingelheim Investigational Site | Liverpool | |
| United Kingdom | 1182.17.4404 Boehringer Ingelheim Investigational Site | London | |
| United Kingdom | 1182.17.4406 Boehringer Ingelheim Investigational Site | London | |
| United Kingdom | 1182.17.4408 Boehringer Ingelheim Investigational Site | London | |
| United Kingdom | 1182.17.4409 Boehringer Ingelheim Investigational Site | London | |
| United Kingdom | 1182.17.4414 Boehringer Ingelheim Investigational Site | London | |
| United Kingdom | 1182.17.4418 Boehringer Ingelheim Investigational Site | London | |
| United Kingdom | 1182.17.4407 | Portsmouth | |
| United States | 1182.17.134 Summa Health System | Akron | Ohio |
| United States | 1182.17.79 Boehringer Ingelheim Investigational Site | Albany | New York |
| United States | 1182.17.4 Boehringer Ingelheim Investigational Site | Ann Arbor | Michigan |
| United States | 1182.17.10 Boehringer Ingelheim Investigational Site | Annandale | Virginia |
| United States | 1182.17.77 Boehringer Ingelheim Investigational Site | Atlanta | Georgia |
| United States | 1182.17.67 Boehringer Ingelheim Investigational Site | Baltimore | Maryland |
| United States | 1182.17.89 Boehringer Ingelheim Investigational Site | Berkeley | California |
| United States | 1182.17.86 Boehringer Ingelheim Investigational Site | Bethesda | Maryland |
| United States | 1182.17.111 Boehringer Ingelheim Investigational Site | Boston | Massachusetts |
| United States | 1182.17.63 Boehringer Ingelheim Investigational Site | Boston | Massachusetts |
| United States | 1182.17.118 Early Intervention Program (EIP) Clinic | Camden | New Jersey |
| United States | 1182.17.136 Boehringer Ingelheim Investigational Site | Chicago | Illinois |
| United States | 1182.17.70 Boehringer Ingelheim Investigational Site | Chicago | Illinois |
| United States | 1182.17.95 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio |
| United States | 1182.17.23 Boehringer Ingelheim Investigational Site | Columbia | South Carolina |
| United States | 1182.17.26 Boehringer Ingelheim Investigational Site | Columbus | Ohio |
| United States | 1182.17.116 Boehringer Ingelheim Investigational Site | Dallas | Texas |
| United States | 1182.17.142 Boehringer Ingelheim Investigational Site | Dallas | Texas |
| United States | 1182.17.16 Nelson-Tebedo Clinic | Dallas | Texas |
| United States | 1182.17.115 Boehringer Ingelheim Investigational Site | Detroit | Michigan |
| United States | 1182.17.6 Boehringer Ingelheim Investigational Site | Detroit | Michigan |
| United States | 1182.17.53 Boehringer Ingelheim Investigational Site | Durham | North Carolina |
| United States | 1182.17.93 Boehringer Ingelheim Investigational Site | East Orange | New Jersey |
| United States | 1182.17.36 Boehringer Ingelheim Investigational Site | Evanston | Illinois |
| United States | 1182.17.126 Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida |
| United States | 1182.17.8 Boehringer Ingelheim Investigational Site | Fort Myers | Florida |
| United States | 1182.17.60 Boehringer Ingelheim Investigational Site | Fountain Valley | California |
| United States | 1182.17.24 Hackensack University Medical Center | Hackensack | New Jersey |
| United States | 1182.17.34 ID Care, Inc. | Hillsborough | New Jersey |
| United States | 1182.17.122 Boehringer Ingelheim Investigational Site | Houston | Texas |
| United States | 1182.17.68 Boehringer Ingelheim Investigational Site | Houston | Texas |
| United States | 1182.17.54 Boehringer Ingelheim Investigational Site | Huntersville | North Carolina |
| United States | 1182.17.1 Boehringer Ingelheim Investigational Site | Indianapolis | Indiana |
| United States | 1182.17.62 Boehringer Ingelheim Investigational Site | Kansas City | Missouri |
| United States | 1182.17.59 Boehringer Ingelheim Investigational Site | Las Vegas | Nevada |
| United States | 1182.17.102 Boehringer Ingelheim Investigational Site | Lexington | Kentucky |
| United States | 1182.17.106 Boehringer Ingelheim Investigational Site | Los Angeles | California |
| United States | 1182.17.15 Boehringer Ingelheim Investigational Site | Los Angeles | California |
| United States | 1182.17.40 Tower ID Medical | Los Angeles | California |
| United States | 1182.17.46 Boehringer Ingelheim Investigational Site | Los Angeles | California |
| United States | 1182.17.47 University of Southern California | Los Angeles | California |
| United States | 1182.17.73 Boehringer Ingelheim Investigational Site | Los Angeles | California |
| United States | 1182.17.21 Boehringer Ingelheim Investigational Site | Louisville | Kentucky |
| United States | 1182.17.69 Boehringer Ingelheim Investigational Site | Macon | Georgia |
| United States | 1182.17.11 Boehringer Ingelheim Investigational Site | Memphis | Tennessee |
| United States | 1182.17.131 Boehringer Ingelheim Investigational Site | Miami | Florida |
| United States | 1182.17.22 Boehringer Ingelheim Investigational Site | Miami | Florida |
| United States | 1182.17.100 Boehringer Ingelheim Investigational Site | Milwaukee | Wisconsin |
| United States | 1182.17.103 Boehringer Ingelheim Investigational Site | Mount Vernon | New York |
| United States | 1182.17.18 Vanderbilt AIDS Clinical Trials Center | Nashville | Tennessee |
| United States | 1182.17.105 Pollari Medical Group | New York | New York |
| United States | 1182.17.130 Boehringer Ingelheim Investigational Site | New York | New York |
| United States | 1182.17.3 Division of Infectious Diseases | New York | New York |
| United States | 1182.17.42 Beth Israel Medical Center | New York | New York |
| United States | 1182.17.5 Boehringer Ingelheim Investigational Site | New York | New York |
| United States | 1182.17.7 Boehringer Ingelheim Investigational Site | New York | New York |
| United States | 1182.17.94 Boehringer Ingelheim Investigational Site | New York | New York |
| United States | 1182.17.87 Boehringer Ingelheim Investigational Site | Norwalk | Connecticut |
| United States | 1182.17.9 Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma |
| United States | 1182.17.64 Boehringer Ingelheim Investigational Site | Orlando | Florida |
| United States | 1182.17.110 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania |
| United States | 1182.17.99 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania |
| United States | 1182.17.39 MDS Pharma Services | Phoenix | Arizona |
| United States | 1182.17.75 Boehringer Ingelheim Investigational Site | Phoenix | Arizona |
| United States | 1182.17.30 Boehringer Ingelheim Investigational Site | Portland | Maine |
| United States | 1182.17.135 Boehringer Ingelheim Investigational Site | Rochester | New York |
| United States | 1182.17.97 Boehringer Ingelheim Investigational Site | San Antonio | Texas |
| United States | 1182.17.114 Boehringer Ingelheim Investigational Site | San Diego | California |
| United States | 1182.17.128 Boehringer Ingelheim Investigational Site | San Diego | California |
| United States | 1182.17.37 Boehringer Ingelheim Investigational Site | San Francisco | California |
| United States | 1182.17.58 Boehringer Ingelheim Investigational Site | San Francisco | California |
| United States | 1182.17.96 Boehringer Ingelheim Investigational Site | San Francisco | California |
| United States | 1182.17.50 Boehringer Ingelheim Investigational Site | Santa Fe | New Mexico |
| United States | 1182.17.129 Boehringer Ingelheim Investigational Site | Sarasota | Florida |
| United States | 1182.17.51 Boehringer Ingelheim Investigational Site | South Miami | Florida |
| United States | 1182.17.74 Boehringer Ingelheim Investigational Site | Springfield | Massachusetts |
| United States | 1182.17.31 Boehringer Ingelheim Investigational Site | Stony Brook | New York |
| United States | 1182.17.92 Boehringer Ingelheim Investigational Site | Tacoma | Washington |
| United States | 1182.17.125 Boehringer Ingelheim Investigational Site | Tampa | Florida |
| United States | 1182.17.132 Boehringer Ingelheim Investigational Site | Tampa | Florida |
| United States | 1182.17.76 Boehringer Ingelheim Investigational Site | Tampa | Florida |
| United States | 1182.17.52 Boehringer Ingelheim Investigational Site | Vero Beach | Florida |
| United States | 1182.17.112 Boehringer Ingelheim Investigational Site | Washington | District of Columbia |
| United States | 1182.17.43 Boehringer Ingelheim Investigational Site | Washington | District of Columbia |
| United States | 1182.17.65 Boehringer Ingelheim Investigational Site | Washington | District of Columbia |
| United States | 1182.17.32 University of Kansas School of Medicine - Wichita | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, France, Germany, Greece, Italy, Mexico, Netherlands, Portugal, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Haemoglobin | NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. | End of Trial (>288 weeks) | No |
| Primary | Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - White Blood Cell ct. | NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. | End of Trial (>288 weeks) | No |
| Primary | Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Platelets | NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. | End of Trial (>288 weeks) | No |
| Primary | Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Prothrombin Time | NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. | End of Trial (>288 weeks) | No |
| Primary | Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Sodium | NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. | End of Trial (>288 weeks) | No |
| Primary | Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Potassium | NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. | End of Trial (>288 weeks) | No |
| Primary | Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Calcium | NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. | End of Trial (>288 weeks) | No |
| Primary | Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Phosphate | NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. | End of Trial (>288 weeks) | No |
| Primary | Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Carbon Dioxide | NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. | End of Trial (>288 weeks) | No |
| Primary | Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Aspartate Aminotransferase (AST/GOT,SGOT) | NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. | End of Trial (>288 weeks) | No |
| Primary | Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alanine Aminotransferase (ALT/GPT,SGPT) | NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. | End of Trial (>288 weeks) | No |
| Primary | Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alkaline Phosphatase | NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. | End of Trial (>288 weeks) | No |
| Primary | Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Amylase | NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. | End of Trial (>288 weeks) | No |
| Primary | Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatine Phosphokinase | NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. | End of Trial (>288 weeks) | No |
| Primary | Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Lipase | NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. | End of Trial (>288 weeks) | No |
| Primary | Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Glucose | NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. | End of Trial (>288 weeks) | No |
| Primary | Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Cholesterol, Total | NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. | End of Trial (>288 weeks) | No |
| Primary | Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatinine | NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. | End of Trial (>288 weeks) | No |
| Primary | Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Bilirubin, Total | NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. | End of Trial (>288 weeks) | No |
| Primary | Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Triglycerides | NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. | End of Trial (>288 weeks) | No |
| Primary | Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Uric Acid | NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. | End of Trial (>288 weeks) | No |
| Primary | Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Albumin | NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. | End of Trial (>288 weeks) | No |
| Primary | Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 -Low-density Lipoprotein (LDL) | NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. | End of Trial (>288 weeks) | No |
| Primary | Number of Patients With Adverse Events Leading to Death | NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. | End of Trial (>288 weeks) | Yes |
| Secondary | Change From Baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) Viral Load - Last Observation Carried Forward (LOCF) | Change from baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) viral load with last observation carried forward (LOCF) | Baseline to 192-240 week time interval | No |
| Secondary | Change From Baseline in CD4 Cell Count (LOCF) | Change from baseline in CD4 cell count with last observation carried forward(LOCF). | Baseline to 192-240 week time interval | No |
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