Strategic Timing of Antiretroviral Treatment (START)
This study is currently recruiting participants.
Verified May 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
University of Minnesota - Clinical and Translational Science Institute
Collaborators:
Copenhagen HIV Programme (CHIP) -- Copenhagen, Denmark
Medical Research Council (MRC) Clinical Trials Unit -- London, United Kingdom
The Kirby Institute for Infection and Immunity in Society
The Institute for Clinical Research at the Veterans Affairs Medical Center -- Washington, D.C., USA
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
German Federal Ministry of Education and Research
NEAT - European AIDS Treatment Network
National Health and Medical Research Council, Australia
Abbott
Bristol-Myers Squibb
Gilead Sciences
GlaxoSmithKline
Merck
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00867048
First received: March 20, 2009
Last updated: May 9, 2013
Last verified: May 2013
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Purpose
Objectives:
- To find out if the chance of developing a serious illness or of getting AIDS is less if patients start taking HIV medicines at a time when their cluster-of-differentiation-4 (CD4)+ cell count is still fairly high, instead of waiting until the CD4+ count is at the level where there is good evidence for starting medicines.
- To learn more about how a strategy of starting HIV medicines early might affect other aspects of care, such as the chances of developing other illnesses or resistance to HIV medicines, the frequency of doctor visits, the cost of medical care, and general health and satisfaction.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection |
Drug: All licensed antiretroviral medications |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Strategic Timing of AntiRetroviral Treatment |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:
Primary Outcome Measures:
- Composite endpoint of AIDS, serious non-AIDS diagnoses, and all-cause mortality [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Components of the composite primary outcome measure [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]
- Specific non-AIDS diagnoses [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]
- Adverse events [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]
- Hospitalization, health-care utilization, quality of life [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
- HIV drug resistance and transmission risk behavior [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]
- Change in neurocognitive function (in a subset of participants) [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
- Obtain a whole blood sample from which DNA will be extracted to study validated genetic variants that determine the risk of the various primary and secondary outcomes assessed in START (in a subset of participants) [ Time Frame: Blood taken at study entry and stored in a central repository indefinitely ] [ Designated as safety issue: No ]
- Evaluate understanding of study information and satisfaction with the consent process among START participants, after receiving information from either a standard or a concise consent form (at a subset of sites) [ Time Frame: Before randomization into START ] [ Designated as safety issue: No ]
- Large and small artery elasticity (in a subset of participants) [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
- Rate of lung function decline (in a subset of participants) [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
- Changes in bone mineral density (in a subset of participants) [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 4000 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Early ART
Initiate ART immediately following randomization
|
Drug: All licensed antiretroviral medications
In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
|
|
Active Comparator: Deferred ART
Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops
|
Drug: All licensed antiretroviral medications
In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
INCLUSION CRITERIA:
- Signed informed consent
- HIV infection documented by a plasma HIV RNA viral load, rapid HIV test or any licensed* ELISA test; and confirmed by another test using a different method including but not limited to a rapid HIV test, Western Blot, HIV culture, HIV antigen, or HIV pro-viral DNA at any time prior to study entry.
- Age greater than or equal to 18 years
- Karnofsky performance score greater than or equal to 80 (an indication that the participant can perform normal activities)
- Perceived life expectancy of at least 6 months
- For women of child-bearing potential, willingness to use contraceptives as described in the product information of the ART drugs they are prescribed
Two CD4+ cell counts greater than 500 cells/mm(3) at least 2 weeks apart within 60 days before randomization
- The term licensed refers to an FDA-approved kit or, for sites located in countries other than the United States, a kit that has been certified or licensed by an oversight body within that country. Confirmation of the initial test result must use a test method that is different than the one used for the initial assessment.
EXCLUSION CRITERIA:
- Any previous use of ART or interleukin-2 (IL-2)
- Diagnosis of any clinical AIDS event before randomization (including esophageal candidiasis and chronic Herpes simplex infection)
- Presence of HIV progression such as oral thrush, unexplained weight loss, or unexplained fever
- Cardiovascular event (myocardial infarction, angioplasty, coronary-artery bypass grafting, stroke) within 6 months before randomization
- Non-AIDS-defining cancer, excluding basal and squamous cell skin cancer, within 6 months before randomization
- Dialysis within 6 months before randomization
- Diagnosis of decompensated liver disease before randomization
- Current imprisonment, or compulsory detention (involuntary incarceration) for treatment of a psychiatric or physical illness
- Current pregnancy or breastfeeding (a negative serum or urine pregnancy test is required within 14 days before randomization for women of child-bearing potential)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867048
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| United States, Alabama | |
| University of Alabama at Birmingham (UAB) | Suspended |
| Birmingham, Alabama, United States, 35233 | |
| United States, California | |
| UCLA CARE-4-Families (LABAC CRS) | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Michele Carter 310-206-4173 mfcarter@mednet.ucla.edu | |
| Principal Investigator: Jaime G. Deville, M.D. | |
| VA Greater Los Angeles Healthcare System | Recruiting |
| Los Angeles, California, United States, 90073 | |
| Contact: Wendy L. Rossen, RN 310-478-3711 ext 48136 wendy.rossen@va.gov | |
| Principal Investigator: Matthew Bi Goetz, MD | |
| University of Southern California | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Contact: Eva Operskalski 323-226-5068 eva@usc.edu | |
| Principal Investigator: LaShonda Spencer | |
| Naval Medical Center San Diego | Recruiting |
| San Diego, California, United States, 92134-1201 | |
| Contact: Sara Echols 619-532-5889 sara.echols@med.navy.mil | |
| Principal Investigator: Mary Bavaro | |
| UCSD Mother-Child-Adolescent Program | Recruiting |
| San Diego, California, United States, 92103 | |
| Contact: Kim Norris 858-534-9204 kanorris@ucsd.edu | |
| Principal Investigator: Stephen Spector, M.D. | |
| United States, Connecticut | |
| Yale University School of Medicine | Recruiting |
| New Haven, Connecticut, United States, 06510 | |
| Contact: Laurie Andrews, RN, MPH 203-785-3557 Laurie.Andrews@yale.edu | |
| Principal Investigator: Gerald H. Friedland, MD | |
| United States, District of Columbia | |
| Washington DC VA Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20422 | |
| Contact: Douglas Thomas, RN, M.Ed. 202-745-8000 ext 7558 Douglas.Thomas4@va.gov | |
| Principal Investigator: Fred M. Gordin, MD | |
| Georgetown University | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Max Menna 202-444-0371 mpm229@georgetown.edu | |
| Principal Investigator: Princy N. Kumar, MD | |
| George Washington University Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20037 | |
| Contact: Amy L. Yi, CCRC, MA 202-741-2863 ayi@mfa.gwu.edu | |
| Principal Investigator: David Parenti | |
| United States, Florida | |
| Children's Diagnostic and Treatment Center, Inc. | Suspended |
| Fort Lauderdale, Florida, United States, 33316 | |
| University of Florida Health Services Center | Recruiting |
| Jacksonville, Florida, United States, 32209 | |
| Contact: Tabetha Gayton 904-244-5331 tabetha.gayton@jax.ufl.edu | |
| Principal Investigator: Laura Armas-Kolostroubis | |
| University of Florida, Jacksonville | Recruiting |
| Jacksonville, Florida, United States, 32206 | |
| Contact: Naja Wilson 904-253-1261 Naja.Wilson@jax.ufl.edu | |
| Principal Investigator: Michael L. Sands, MD, MPH, TM | |
| University of Miami Pediatric Immunology | Suspended |
| Miami, Florida, United States, 33136 | |
| University of Miami | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Tom Tanner, RN 786-416-7546 ttanner@med.miami.edu | |
| Principal Investigator: Michael Kolber, MD | |
| Orlando Immunology Center | Recruiting |
| Orlando, Florida, United States, 32803 | |
| Contact: Beth Bryant 407-647-3960 ext 2137 bbryant@oicorlando.com | |
| Principal Investigator: Edwin DeJesus, MD, FACP | |
| Orange County Health Department/Hug Me | Recruiting |
| Orlando, Florida, United States, 32809 | |
| Contact: Willie Carter 407-858-1400 ext 1216 willie-carter@doh.state.fl.us | |
| Principal Investigator: Gerald Horton, MD | |
| Infectious Diseases Associates NW FL, PA | Recruiting |
| Pensacola, Florida, United States, 32504 | |
| Contact: Ann Be Brown, RN 850-476-3131 abrown@infectioncenter.com | |
| Principal Investigator: Barbara He Wade, MD, FACP | |
| USF Health - HIV Clinical Research Unit | Recruiting |
| Tampa, Florida, United States, 33602 | |
| Contact: Mable Chow, BA 813-307-8015 ext 6460 mable_chow@doh.state.fl.us | |
| Principal Investigator: Charurut Somboonwit, MD | |
| Treasure Coast Infectious Disease Consultants | Recruiting |
| Vero Beach, Florida, United States, 32960 | |
| Contact: Mona White, L.P.N. 772-978-9556 mwhite@verotcid.com | |
| Principal Investigator: Gerald Pierone Jr., MD | |
| United States, Illinois | |
| Lurie Children's Hospital | Recruiting |
| Chicago, Illinois, United States, 60611-2605 | |
| Contact: Margaret An Sanders 312-227-8275 msanders@luriechildrens.org | |
| Principal Investigator: Ram Yogev | |
| Mt. Sinai Hospital | Recruiting |
| Chicago, Illinois, United States, 60608 | |
| Contact: Rohit Kalra 773-580-0445 rkalra@luriechildrens.org | |
| Principal Investigator: Daniel Johnson | |
| University of Illinois at Chicago | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Gabriel Culbert, RN 312-413-8966 gculbe1@uic.edu | |
| Principal Investigator: Richard M. Novak, MD | |
| United States, Louisiana | |
| Tulane University Medical Center | Recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| Contact: Connie Scott, RN, BSN 504-988-1971 lacarp@tulane.edu | |
| Principal Investigator: David M. Mushatt, MD, MPH, TM | |
| United States, Maryland | |
| National Institutes of Health Clinical Center | Recruiting |
| Bethesda, Maryland, United States, 20892-1504 | |
| Contact: Jessica Springer 301-443-7106 springerj@mail.nih.gov | |
| Principal Investigator: Richard T. Davey Jr., MD, FACP | |
| Walter Reed National Military Medical Center | Recruiting |
| Bethesda, Maryland, United States, 20889 | |
| Contact: Irma Barahona, RN, BSN 301-295-6400 Irma.L.Barahona.ctr@health.mil | |
| Principal Investigator: Anuradha Ganesan | |
| United States, Massachusetts | |
| Boston Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Contact: Charlene Gaca 617-414-3514 charlene.gaca@bmc.org | |
| Principal Investigator: Ioana Bica | |
| Community Research Initiative of New England | Recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Contact: Julia Green, BSN, ACRN 617-502-1711 jgreen@crine.org | |
| Principal Investigator: Calvin Cohen, MD, MS | |
| United States, Michigan | |
| Wayne State University | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Martha Farrough, BSN, RN 313-577-3482 mfarrough@med.wayne.edu | |
| Principal Investigator: Rodger D. MacArthur, MD | |
| Henry Ford Health System | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Jonathan Clemmer, RN 313-916-3451 Jclemme1@hfhs.org | |
| Principal Investigator: Norman Markowitz, MD | |
| United States, Minnesota | |
| MMRF, Hennepin County Medical Center | Recruiting |
| Minneapolis, Minnesota, United States, 55415 | |
| Contact: Edie Gunderson, LPN 612-873-7678 Edie.Gunderson@hcmed.org | |
| Principal Investigator: William Ke Henry, MD | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Mary Johnson, SC 507-538-6511 johnson.mary15@mayo.edu | |
| Principal Investigator: Zelalem Temesgen, MD | |
| United States, New Jersey | |
| Cooper University Hospital | Recruiting |
| Camden, New Jersey, United States, 08103 | |
| Contact: Patricia Coburn 856-963-6891 coburn-patricia@cooperhealth.edu | |
| Principal Investigator: John Baxter, MD | |
| New Jersey Medical School Adult Clinical Research Center | Recruiting |
| Newark, New Jersey, United States, 07103 | |
| Contact: Nancy Reilly, RN, ACRN, MS 973-972-1268 reillyna@umdnj.edu | |
| Principal Investigator: Sally Hodder, MD | |
| United States, New York | |
| Montefiore Medical Center | Recruiting |
| Bronx, New York, United States, 10467 | |
| Contact: Daniela Morales 718-920-5904 danmoral@montefiore.org | |
| Principal Investigator: Jonathan Shuter, MD | |
| Bronx-Lebanon Hospital Center | Recruiting |
| Bronx, New York, United States, 10452 | |
| Contact: Rita Sondengam 718-901-6346 rsondeng@bronxleb.org | |
| Principal Investigator: Edward E. Telzak, MD | |
| Cornell CRS | Recruiting |
| New York, New York, United States, 10011 | |
| Contact: Valery Hughes, MS. FNP 212-746-4393 vah9001@med.cornell.edu | |
| Principal Investigator: Timothy Wilkin | |
| SUNY Stony Brook | Suspended |
| Stony Brook, New York, United States, 11794-8111 | |
| United States, North Carolina | |
| UNC AIDS Clinical Trials Unit | Recruiting |
| Chapel Hill, North Carolina, United States, 27514 | |
| Contact: Cheryl J. Marcus 919-843-8761 cjm@med.unc.edu | |
| Principal Investigator: David A. Wohl | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Sara Patillo 919-684-8216 sara.patillo@duke.edu | |
| Principal Investigator: Nathan Thielman | |
| Regional Center for Infectious Disease | Recruiting |
| Greensboro, North Carolina, United States, 27401-1209 | |
| Contact: Kim Epperson, BSN 336-832-3262 kim.epperson@conehealth.com | |
| Principal Investigator: Cornelius Van Dam, MD | |
| Wake County Human Services | Recruiting |
| Raleigh, North Carolina, United States, 27610 | |
| Contact: Cheryl J. Marcus 919-843-8761 cjm@med.unc.edu | |
| Principal Investigator: David A. Wohl | |
| Wake Forest University Health Sciences | Recruiting |
| Winston-Salem, North Carolina, United States, 27157-1042 | |
| Contact: Libyadda J. Mosley, BS 336-716-3266 limosley@wakehealth.edu | |
| Principal Investigator: Aimee Wilkin, MD, MPH | |
| United States, Ohio | |
| The Ohio State University Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Todd L. Lusch 614-293-5282 Todd.Lusch@osumc.edu | |
| Principal Investigator: Susan L. Koletar | |
| United States, Oregon | |
| The Research and Education Group - Portland | Recruiting |
| Portland, Oregon, United States, 97210 | |
| Contact: Suzanne Sweek 503-229-8428 suzanne@reg.org | |
| Principal Investigator: Melissa D. Murphy, MD | |
| United States, Pennsylvania | |
| Temple University | Recruiting |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Contact: Christiane Geisler, RN, ACRN 215-707-8846 christiane.geisler@tuhs.temple.edu | |
| Principal Investigator: Ellen Ma Tedaldi, MD | |
| United States, Tennessee | |
| St. Jude Children's Research Hospital | Recruiting |
| Memphis, Tennessee, United States, 38105-3678 | |
| Contact: Jill Utech 901-595-3490 jill.utech@stjude.org | |
| Principal Investigator: Pat Flynn | |
| United States, Texas | |
| UT Southwestern Clinical Research Unit | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: Tianna Petersen 215-590-0611 Tianna.Petersen@UTSouthwestern.edu | |
| Principal Investigator: Mamta K Jain | |
| University of North Texas Health Science Center | Recruiting |
| Fort Worth, Texas, United States, 76107 | |
| Contact: Isabel Vecino, MD/Clinical 817-321-4946 isabel.vecino@unthsc.edu | |
| Principal Investigator: Stephen Weis, DO | |
| Houston AIDS Research Team CRS | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Hilda Cuervo 713-500-6751 Hilda.cuervo@uth.tmc.edu | |
| Principal Investigator: Roberto C. Arduino, MD | |
| Texas Children's Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Chivon McMullen-Jackson 832-824-1319 cdmcmull@texaschildrens.org | |
| Principal Investigator: William T. Shearer, MD PhD | |
| San Antonio Military Health System | Recruiting |
| San Antonio, Texas, United States, 78234 | |
| Contact: Terry Jo Sjoberg, BS, CCRC 210-916-7843 terry.j.sjoberg.ctr@mail.mil | |
| Principal Investigator: Jason Fr Okulicz, MD | |
| United States, Virginia | |
| Naval Medical Center Portsmouth | Suspended |
| Portsmouth, Virginia, United States, 23708 | |
| Virginia Commonwealth University | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Vicky Watson, RN 804-828-3450 vwatson@mcvh-vcu.edu | |
| Principal Investigator: Daniel E. Nixon, DO, PhD | |
| United States, Wisconsin | |
| AIDS Resource Center of Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States, 53203 | |
| Contact: Sonija Parker 414-805-0708 smparker@mcw.edu | |
| Principal Investigator: Michael Frank, MD | |
| Medical College of Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Sonija Parker 414-805-0708 smparker@mcw.edu | |
| Principal Investigator: Michael Frank, MD | |
| Argentina | |
| Hospital Nacional Profesor Alejandro Posadas | Recruiting |
| El Palomar, Buenos Aires, Argentina | |
| Contact: Lucia Es Daciuk, MD 54.11.44699279 luciadaciuk@yahoo.com.ar | |
| Principal Investigator: Hector En Laplume, MD | |
| Hospital Interzonal General de Agudos Dr. Diego Paroissien | Recruiting |
| La Matanza, Buenos Aires, Argentina | |
| Contact: Maria In Vieni, Psicologyst 54.11.46693440 ivieni@datamarkets.com.ar | |
| Principal Investigator: Eduardo Warley | |
| Instituto CAICI | Recruiting |
| Rosario, Santa Fe, Argentina | |
| Contact: Luciana Peroni 54.341.4248045 administracioncaici@gmail.com | |
| Principal Investigator: Sergio Lupo, MD | |
| Hospital General de Agudos JM Ramos Mejia | Recruiting |
| Buenos Aires, Argentina | |
| Contact: Jose Bruguera 54.911.54178130 jbruguera@hivramos.org.ar | |
| Principal Investigator: Marcelo H. Losso, MD | |
| FUNCEI | Recruiting |
| Buenos Aires, Argentina | |
| Contact: Emiliano Bissio 54.11.48094206 ebissio@fibertel.com.ar | |
| Principal Investigator: Gustavo Da Lopardo, MD | |
| Hospital General de Agudos Teodoro Alvarez | Recruiting |
| Buenos Aires, Argentina | |
| Contact: Sebastian Man 54.911.44147383 manseba@fibertel.com.ar | |
| Principal Investigator: Arnaldo D. Casiro, MD | |
| Hospital Italiano de Buenos Aires | Recruiting |
| Buenos Aires, Argentina | |
| Contact: Marisa de Sanchez, MD 54.11.49590393 marisa.sanchez@hospitalitaliano.org.ar | |
| Principal Investigator: Waldo H. Belloso, MD | |
| Fundacion IDEAA | Recruiting |
| Buenos Aires, Argentina | |
| Contact: Eliana Loiza 54.11.49017133 elianaloiza@yahoo.com.ar | |
| Principal Investigator: Horacio Mingrone | |
| Hospital Rawson | Recruiting |
| Cordoba, Argentina | |
| Contact: Ana Al Crinejo, MD 54.351.4348754 anacrinejo@gmail.com | |
| Principal Investigator: Daniel Om David, MD | |
| CEIN | Suspended |
| Neuquen, Argentina | |
| Australia, New South Wales | |
| Burwood Road General Practice | Recruiting |
| Burwood, New South Wales, Australia, 2134 | |
| Contact: Nam Phan 61.2.9745.2755 nphan82@yahoo.com.au | |
| Principal Investigator: Nicholas Doong, MD | |
| East Sydney Doctors | Recruiting |
| Darlinghurst, New South Wales, Australia, 2010 | |
| Contact: Vicki Leroklis 61.2.9332.2531 vicki@eastsydneydoctors.com.au | |
| Principal Investigator: David Baker, MD | |
| St. Vincent's Hospital | Recruiting |
| Darlinghurst, New South Wales, Australia, 2010 | |
| Contact: Kate Sinn 61.2.8382.3606 ksinn@stvincents.com.au | |
| Principal Investigator: David A. Cooper, MD, DSc | |
| Holdsworth House Medical Practice | Recruiting |
| Darlinghurst, New South Wales, Australia, 2010 | |
| Contact: Trina Vincent 61.2.9331.7228 Trina.Vincent@holdsworthhouse.com.au | |
| Principal Investigator: Mark Bloch | |
| Taylor Square Private Clinic | Recruiting |
| Darlinghurst, New South Wales, Australia, 2010 | |
| Contact: Amrita Patel 61.2.9331.6151 amrita@tspc.com.au | |
| Principal Investigator: Emanuel Vlahakis | |
| Westmead Hospital | Recruiting |
| Westmead, New South Wales, Australia, 2145 | |
| Contact: Janette Taylor 61.2.9845.6230 janette.taylor@sydney.edu.au | |
| Principal Investigator: Dominic Dwyer | |
| Australia, Queensland | |
| Sexual Health and HIV Service - Clinic 2 | Recruiting |
| Brisbane, Queensland, Australia, 4000 | |
| Contact: Abby Gibson 61.7.3837.5622 shhstrials@health.qld.gov.au | |
| Principal Investigator: Mark Kelly, MD | |
| Australia, South Australia | |
| Royal Adelaide Hospital | Recruiting |
| Adelaide, South Australia, Australia, 5000 | |
| Contact: Lyndal Daly 61.8.8222.5635 Lyndal.Daly@health.sa.gov.au | |
| Principal Investigator: David Shaw, MD | |
| Australia, Victoria | |
| Melbourne Sexual Health Centre | Recruiting |
| Melbourne, Victoria, Australia, 3053 | |
| Contact: Julie Silvers 61.3.9341.6262 researchunit@mshc.org.au | |
| Principal Investigator: Tim Read, MD | |
| The Alfred Hospital | Recruiting |
| Melbourne, Victoria, Australia, 3004 | |
| Contact: Peta Hamill 61.3.9276.6908 gaclinresearch@alfred.org.au | |
| Principal Investigator: Jennifer Hoy, MD | |
| Prahran Market Clinic | Recruiting |
| Melbourne, Victoria, Australia, 3181 | |
| Contact: Helen Lau 61.3.9514.0888 helen@prahranmarketclinic.com | |
| Principal Investigator: Norman Roth, MD | |
| Centre Clinic | Recruiting |
| St Kilda, Victoria, Australia, 3182 | |
| Contact: Helen Lau 61.3.9514.0888 helen@prahranmarketclinic.com | |
| Principal Investigator: Ban Ki Tee, MD | |
| Australia, Western Australia | |
| Royal Perth Hospital | Recruiting |
| Perth, Western Australia, Australia, 6000 | |
| Contact: Julie Robinson 61.8.9224.3429 Julie.Robinson3@health.wa.gov.au | |
| Principal Investigator: Martyn French | |
| Austria | |
| University Vienna General Hospital | Recruiting |
| Vienna, Austria | |
| Contact: Veronique Touzeau-Romer, MD 43.1.40.400.42.40 vero_touzeau@yahoo.com | |
| Principal Investigator: Armin Rieger, MD | |
| Otto-Wagner-Spital SMZ /Baumgartner Hoehe | Recruiting |
| Vienna, Austria | |
| Contact: Silvia Schmid 43.1.910.604.21.31 silvia.schmid@wienkav.at | |
| Principal Investigator: Norbert Vetter, MD | |
| Belgium | |
| Institute of Tropical Medicine | Recruiting |
| Antwerp, Belgium | |
| Contact: Lida Van Peterson, RN 32.3.247.64.51 lvanpetersen@itg.be | |
| Principal Investigator: Eric Florence | |
| Centre Hospitalier Universitaire St. Pierre (C.H.U. St. Pierre) | Recruiting |
| Brussels, Belgium | |
| Contact: Kabamba Kabeya, MD 32.2.535.41.31 infectiousdiseases@stpierre-bru.be | |
| Principal Investigator: Nathan Clumeck, MD, PhD | |
| Universitaire Ziekenhuizen Gent | Recruiting |
| Ghent, Belgium | |
| Contact: Tessa James 32.9.332.54.14 tessa.james@uzgent.be | |
| Principal Investigator: Linos Vandekerckhove | |
| Universitair Ziekenhuis Gasthuisberg | Recruiting |
| Leuven, Belgium | |
| Contact: Helga Ceunen 32.16.34.0911 helga.ceunen@uzleuven.be | |
| Principal Investigator: Eric H. Van Wijngaerden | |
| Brazil | |
| SEI - Servicos Especializados em Infectologia | Recruiting |
| Salvador, BA, Brazil, 40110-010 | |
| Contact: Estela Luz 55.71.9986.7515 eluz5@yahoo.com.br | |
| Principal Investigator: Carlos Brites | |
| Center for Infectious Diseases at the UFES | Recruiting |
| Vitoria, ES, Brazil, 29040-091 | |
| Contact: Luciana Neves Passos, PhD 55.27.3335.7188 lunaneves@uol.com.br | |
| Principal Investigator: Tania Reuter, MD | |
| Hospital Escola Sao Francisco de Assis - UFRJ | Recruiting |
| Rio de Janeiro, RJ, Brazil, 20210-030 | |
| Contact: Monica Barbosa de Souza 55.21.2273.9073 monica@ponze.ufrj.br | |
| Principal Investigator: Mauro Schechter, MD, PhD | |
| Ipec/Fiocruz | Recruiting |
| Rio de Janeiro, RJ, Brazil, 21040-900 | |
| Contact: Sandra Cardoso 55.21.3865.3623 sandra.wagner@ipec.fiocruz.br | |
| Principal Investigator: Beatriz Grinsztejn | |
| Instituto de Infectologia Emilio Ribas - IIER | Recruiting |
| Sao Paulo, SP, Brazil, 01246-900 | |
| Contact: Ricardo Au Braga de Castro 55.11.3085.7059 rabcastro@gmail.com | |
| Principal Investigator: Luiz Ca Pereira Jr., MD | |
| Centro de Referencia e Treinamento DST/Aids | Recruiting |
| Sao Paulo, SP, Brazil, 04121-000 | |
| Contact: Gustavo Mizuno, Pharmacist 55.11.5084.0357 gumizuno@ig.com.br | |
| Principal Investigator: Jose Va Ramalho Madruga | |
| Lim 56/Hcfmusp | Recruiting |
| Sao Paulo, SP, Brazil, 05403-000 | |
| Contact: Elisangela M. Gois 55.11.951.555.737 elisangelagois@yahoo.com.br | |
| Principal Investigator: Jorge Casseb, MD, PhD | |
| Chile | |
| Fundacion Arriaran | Recruiting |
| Santiago, Chile | |
| Contact: Gladys E. Allendes, RN 56.2.555.6206 gladys_allendes@yahoo.es | |
| Principal Investigator: Marcelo J. Wolff, MD | |
| Czech Republic | |
| University Hospital Plzen, CZ | Recruiting |
| Plzen, Czech Republic | |
| Contact: Eva Souchova 420.377.402.264 souchova@fnplzen.cz | |
| Principal Investigator: Dalibor Sedlacek, MD PhD | |
| Faculty Hospital Na Bulovce, Prague, Czech Rep. | Recruiting |
| Prague, Czech Republic | |
| Contact: Ladislav Machala, MD., PhD 420.266.082.629 ladimachala@centrum.cz | |
| Principal Investigator: David Jilich, M.D. | |
| Denmark | |
| Arhus Universitetshospital, Skejby | Recruiting |
| Aarhus, Denmark | |
| Contact: Henriette Kristoffersen 45.89.49.83.43 henrikis@rm.dk | |
| Principal Investigator: Lars Oestergaard, MD,PhD, DMSc | |
| Rigshospitalet, Department of Infectious Diseases, M5112 CRS | Recruiting |
| Copenhagen, Denmark | |
| Contact: Lene Pors Jensen 45.35.45.77.52 epiprojekt@rh.regionh.dk | |
| Principal Investigator: Jan Gerstoft, MD | |
| Hvidovre University Hospital, Department of Infectious Diseases CRS | Recruiting |
| Hvidovre, Denmark | |
| Contact: Philippa Collins 45.36.32.30.21 retroprojekt@hvh.regionh.dk | |
| Principal Investigator: Lars Mathiesen, MD | |
| Odense University Hospital | Recruiting |
| Odense, Denmark | |
| Contact: Lene Hergens 45.65.41.24.97 lene.hergens@ouh.regionsyddanmark.dk | |
| Principal Investigator: Court Pedersen, MD | |
| Estonia | |
| West Tallin Central Hospital Infectious Diseases | Recruiting |
| Tallinn, Estonia | |
| Contact: Kristi Ott, MD 372.65.98.520 kristi.ott@keskhaigla.ee | |
| Principal Investigator: Kai Zilmer | |
| Finland | |
| Helsinki University Central Hospital, Div. of Infectious Diseases CRS | Recruiting |
| Helsinki, HUS, Finland | |
| Contact: Outi Debnam 358.50.344.9670 outi.debnam@hus.fi | |
| Principal Investigator: Matti Ristola, MD | |
| France | |
| Hopital Hotel Dieu | Recruiting |
| Paris, Cedex 04, France | |
| Contact: Aline Maignan 33.1.42.34.88.38 aline.maignan@htd.aphp.fr | |
| Principal Investigator: Jean-Paul Viard, MD | |
| Hopital Saint-Antoine | Recruiting |
| Paris, Cedex 12, France | |
| Contact: Benedicte Lefebvre 33.1.49.28.30.44 benedicte.lefebvre@sat.aphp.fr | |
| Principal Investigator: Jerome Pacanowski, MD | |
| Groupe Hospitalier Pitie-Salpetriere | Recruiting |
| Paris, Cedex 13, France | |
| Contact: Yasmine Dudoit 33.1.42.16.41.81 yasmine.dudoit@psl.aphp.fr | |
| Principal Investigator: Cristine Katlama | |
| CHU Cote de Nacre | Recruiting |
| Caen, Cedex, France | |
| Contact: Pascale Goubin 33.2.31.06.50.87 goubin-p@chu-caen.fr | |
| Principal Investigator: Renaud Verdon, MD, PhD | |
| Hopital Antoine Beclere | Recruiting |
| Clamart, Cedex, France | |
| Contact: Mariem Raho-Moussa 33.1.45.37.43.45 mariem.raho-moussa@abc.aphp.fr | |
| Principal Investigator: Francois Boue | |
| Hopital de Bicetre | Recruiting |
| Le Kremlin-Bicetre, Cedex, France | |
| Contact: Martine Mole 33.1.45.21.63.16 martine.mole@bct.aphp.fr | |
| Principal Investigator: Cecile Goujard | |
| Hopital Gustave Dron | Recruiting |
| Tourcoing, Cedex, France | |
| Contact: Raphael Biekre 33.3.20.69.46.17 mec@ch-tourcoing.fr | |
| Principal Investigator: Antoine Cheret | |
| CHU de BESANCON - Hopital Saint Jacques | Recruiting |
| Besancon, France | |
| Contact: Cecile Haffner-Mauvais 33.3.81.21.94.14 chaffner@chu-besancon.fr | |
| Principal Investigator: Bruno Hoen | |
| Hopital Henri Mondor | Recruiting |
| Creteil, France | |
| Contact: Chrystel Chesnel 33.1.49.81.24.65 chrystel.chesnel@hmn.aphp.fr | |
| Principal Investigator: Yves Levy | |
| Hopital Europeen Georges Pompidou | Recruiting |
| Paris, France | |
| Contact: Erika Bourzam 33.1.56.09.33.03 erika.bourzam@egp.aphp.fr | |
| Principal Investigator: Laurence Weiss, MD, PhD | |
| Hopital Saint-Louis | Recruiting |
| Paris, France | |
| Contact: Laurence Schnell-Niedbalski 33.1.42.49.48.52 laurence.schnell@sls.aphp.fr | |
| Principal Investigator: Jean-Michel Molina | |
| Hopital Foch | Recruiting |
| Suresnes, France | |
| Contact: Catherine Majerholc 33.1.46.25.27.11 c.majerholc@hopital-foch.fr | |
| Principal Investigator: David Zucman, MD | |
| Germany | |
| Gemeinschaftspraxis Jessen-Jessen-Stein | Recruiting |
| Berlin, Germany | |
| Contact: Carmen Zedlack, MA 49.30.235.10.745 mail@praxis-jessen.de | |
| Principal Investigator: Heiko Jessen | |
| EPIMED-Gesellschaft fuer epidemiologische und klinische Forschung in der MedizinmbH | Recruiting |
| Berlin, Germany | |
| Contact: Torsten Meier 49.30.13020.2093 torsten.meier@epimed.org | |
| Principal Investigator: Keikawus Arasteh | |
| Medizinische Universitaetsklinik - Bonn, Immunologische Ambulanz CRS | Recruiting |
| Bonn, Germany | |
| Contact: Brigitta Spaeth 49.228.287.19556 Brigitta.Spaeth@ukb.uni-bonn.de | |
| Principal Investigator: Jurgen Rockstroh | |
| Klinik I fur Innere Medizin der Universitat zu Koeln, Studienbuero fuer Infektiologie u. HIV CRS | Recruiting |
| Cologne, Germany | |
| Contact: Eleonore Rund 49.221.478.5860 eleonore.rund@uk-koeln.de | |
| Principal Investigator: Gerd Fatkenheuer, MD | |
| Klinikum Dortmund gGmbH | Recruiting |
| Dortmund, Germany | |
| Contact: Claudia Bachmann 49.231.953.20.703 id.ambulanz@klinikumdo.de | |
| Principal Investigator: Martin Hower | |
| Universitaetsklinikum Duesseldorf | Recruiting |
| Duesseldorf, Germany | |
| Contact: Cecilie Feind 49.211.810.7131 Cecilie.Feind@med.uni-duesseldorf.de | |
| Principal Investigator: Bjorn Jensen, MD | |
| Universitaetsklinikum Erlangen | Recruiting |
| Erlangen, Germany | |
| Contact: Ellen Harrer, MD 49.9131.853.4745 Ellen.Harrer@uk-erlangen.de | |
| Principal Investigator: Thomas Harrer | |
| Klinik fur Dermatologie, Venerologie, Allergologie | Recruiting |
| Essen, Germany | |
| Contact: Heidi Wiehler 49.201.723.3696 Heidi.Wiehler@uk-essen.de | |
| Principal Investigator: Stefan Esser | |
| Johann Wolfgang Goethe - University Hospital, Infektionsambulanz CRS | Recruiting |
| Frankfurt, Germany | |
| Contact: Geetha Sarrach 49.69.6301.4241 Geetha.Sarrach@hivcenter.de | |
| Principal Investigator: Christoph Stephan | |
| University Medical Centre Hamburg-Eppendorf | Recruiting |
| Hamburg, Germany | |
| Contact: Nadine Zerche 49.40.7410.52682 n.zerche@uke.uni-hamburg.de | |
| Principal Investigator: Jan van Lunzen | |
| ICH Study Center | Recruiting |
| Hamburg, Germany | |
| Contact: Susanne Heesch 49.40.2840.7370 mail@ich-studycenter.com | |
| Principal Investigator: Christian Hoffmann, MD | |
| Medizinische Hochschule Hannover | Recruiting |
| Hanover, Germany | |
| Contact: Kirsten Hoeper, RN 49.511.532.5395 hoeper.kirsten@mh-hannover.de | |
| Principal Investigator: Matthias Stoll | |
| Universitaetsklinikum Heidelberg | Recruiting |
| Heidelberg, Germany | |
| Contact: Renate Roger 49.6221.56.38595 renate.roeger@med.uni-heidelberg.de | |
| Principal Investigator: Martin Hartmann, MD | |
| Klinikum der Universitaet Muenchen | Recruiting |
| Munich, Germany | |
| Contact: Ilse Ott 49.895.160.3457 Ilse.Ott@med.uni-muenchen.de | |
| Principal Investigator: Johannes R. Bogner | |
| University Clinic Regensburg, Klinik I Fuer Innere Medizin | Recruiting |
| Regensburg, Germany | |
| Contact: Ramona Kokel 49.941.944.7039 ramona.kokel@ukr.de | |
| Principal Investigator: Bernd Salzberger | |
| University of Wuerzburg, Medizinische Poliklinik, Schwerpunkt Hepatologie/Infektologie CRS | Recruiting |
| Wuerzburg, Germany | |
| Contact: Susanne Wiebecke 49.931.201.40800 Wiebecke_S@klinik.uni-wuerzburg.de | |
| Principal Investigator: Hartwig Klinker, MD | |
| Greece | |
| AHEPA University Hospital | Recruiting |
| Thessaloniki, Central Macedonia, Greece | |
| Contact: Simeon Metallidis 30.2310994654 metallidissimeon@yahoo.gr | |
| Principal Investigator: Pavlos Nikolaidis | |
| Attikon University General Hospital | Recruiting |
| Athens, Greece | |
| Contact: Anastasia Antoniadou 30.2105831000 ananto@med.uoa.gr | |
| Principal Investigator: Antonios Papadopoulos, MD | |
| Korgialenio-Benakio Hellenic Red Cross | Recruiting |
| Athens, Greece | |
| Contact: Maria Chini 30.2106414466 mariachini@gmail.com | |
| Principal Investigator: Marios K. Lazanas, MD, PhD | |
| Hippokration University General Hospital of Athens | Recruiting |
| Athens, Greece | |
| Contact: Ilias Mariolis, MD 30.2132088727 eliasmar@yahoo.com | |
| Principal Investigator: Helen Sambatakou, MD, PhD | |
| Evangelismos General Hospital | Recruiting |
| Athens, Greece | |
| Contact: Vassilis Papastamopoulos, MD 30.2107201242 mel@evaggelismos-hosp.gr | |
| Principal Investigator: Athanasios Skoutelis | |
| Syngros Hospital | Recruiting |
| Athens, Greece | |
| Contact: Vassilios Paparizos, MD 30.2107265240 fountou@otenet.gr | |
| Principal Investigator: Andreas Katsambas, MD, PhD | |
| India | |
| Institute of Infectious Diseases | Suspended |
| Pune, Maharashtra, India, 411037 | |
| YRGCARE Medical Centre VHS, Chennai CRS | Suspended |
| Chennai, Tamil Nadu, India, 600113 | |
| Ireland | |
| Mater Misericordiae University Hospital | Recruiting |
| Dublin, Ireland | |
| Contact: Liz Coghlan 353.1.716.4599 lizcoghlan3@ucd.ie | |
| Principal Investigator: Paddy Mallon | |
| Israel | |
| Rambam Medical Center | Recruiting |
| Haifa, Israel | |
| Contact: Eynat Kedem, MD 972.4.854.3581 e_kedem@rambam.health.gov.il | |
| Principal Investigator: Eynat Kedem, MD | |
| Tel Aviv Sourasky Medical Center | Recruiting |
| Tel Aviv, Israel | |
| Contact: Tamar Levine 972.3.697.3838 tamarl@tlvmc.gov.il | |
| Principal Investigator: Dan Turner | |
| Italy | |
| Ospedale San Raffaele S.r.l. | Recruiting |
| Milan, MI, Italy | |
| Contact: Maria Ri Parisi 39.02.26433646 parisi.mariarita@hsr.it | |
| Principal Investigator: Giuseppe Tambussi, MD | |
| Lazzaro Spallanzani IRCSS | Recruiting |
| Rome, RM, Italy | |
| Contact: Valentina Colasanti 39.06.55170280 valentina.colasanti@inmi.it | |
| Principal Investigator: Andrea Antinori | |
| Luxembourg | |
| Centre Hospitalier de Luxembourg | Recruiting |
| Luxembourg, Luxembourg | |
| Contact: Charlotte Lieunard 352.26.97.08.47 charlotte.lieunard@crp-sante.lu | |
| Principal Investigator: Therese Staub | |
| Malaysia | |
| University Malaya Medical Centre | Recruiting |
| Kuala Lumpur, Federal Territory, Malaysia | |
| Contact: Syahirah Shaharudin 60.3.7949.2622 ext 2260 sya_asya@yahoo.com | |
| Principal Investigator: Raja Is Raja Azwa | |
| Mali | |
| Serefo/Cesac Mali | Recruiting |
| Bamako, Mali | |
| Contact: Mamadou Cisse 223.2023.6477 madci@yahoo.fr | |
| Principal Investigator: Sounkalo Dao | |
| Mexico | |
| INCMNSZ | Recruiting |
| Tlalpan, D.f., Mexico | |
| Contact: Maria Eu Zghaib-Rivero 52.55.5513.3365 marzsvg@gmail.com | |
| Principal Investigator: Juan Sierra Madero | |
| Morocco | |
| University Hospital Centre Ibn Rochd | Recruiting |
| Casablanca, Morocco, 20360 | |
| Contact: Ikbale Erradey, MD 212.5.2248.2066 smi.ibnrochd@gmail.com | |
| Principal Investigator: Kamal Marhoum El Filali, Professor | |
| Nigeria | |
| Institute of Human Virology-Nigeria (IHVN) | Recruiting |
| Abuja, FCT, Nigeria | |
| Contact: Ifeoma Monye 234.803.700.5910 monyeify@yahoo.co.uk | |
| Principal Investigator: Christopher Akolo | |
| Norway | |
| Oslo University Hospital, Ulleval | Recruiting |
| Oslo, Norway | |
| Contact: Camilla El Nielsen 47.2211.9108 camilla.elise.nielsen@ous-hf.no | |
| Principal Investigator: Vidar Ormaasen, MD | |
| Peru | |
| IMPACTA San Miguel | Recruiting |
| Lima, Peru, 32 | |
| Contact: Fanny Garcia Velarde 51.1.562.1600 fgarcia@impactaperu.org | |
| Principal Investigator: Rosa Infante | |
| Asociacion Civil Impacta Salud y Educacion | Recruiting |
| Lima, Peru, 04 | |
| Contact: Romina Chinchay, B.Sc. 51.997.506.696 rchinchay@impactaperu.org | |
| Principal Investigator: Alberto La Rosa, MD | |
| Via Libre | Recruiting |
| Lima, Peru, 01 | |
| Contact: Rosemarie Ayarza 51.1.203.9900 romyayarza@gmail.com | |
| Principal Investigator: Jose Al Hidalgo, MD | |
| Hospital Nacional Guillermo Almenara Irigoyen | Recruiting |
| Lima, Peru, 13 | |
| Contact: Romina Chinchay, B.Sc. 51.997.506.696 rchinchay@impactaperu.org | |
| Principal Investigator: Raul Salazar, MD | |
| Hospital Nacional Edgardo Rebagliati Martins | Recruiting |
| Lima, Peru, 11 | |
| Contact: Monica Del Portal, Engineer 51.1.470.1589 monicadelportal@yahoo.es | |
| Principal Investigator: Fernando Mendo, MD | |
| Poland | |
| Wojewodzki Szpital Specjalistyczny | Recruiting |
| Bialystok, Poland | |
| Contact: Anna Grzeszczuk 48.60.820.84.33 oliwa@umwb.edu.pl | |
| Principal Investigator: Robert Flisiak, MD | |
| Wojewodzki Szpital Zakazny | Recruiting |
| Warsaw, Poland | |
| Contact: Elzbieta Bakowska 48.22.335.53.35 bakowska@zakazny.pl | |
| Principal Investigator: Andrzej Horban, PhD | |
| EMC Instytut Medyczny SA | Recruiting |
| Wroclaw, Poland | |
| Contact: Rafal Pankala 48.66.130.02.34 rafal.pankala@emc-sa.pl | |
| Principal Investigator: Brygida Knysz, MD | |
| Portugal | |
| Hospital de Egas Moniz | Recruiting |
| Lisbon, Portugal | |
| Contact: Teresa Baptista 351.21.043.2362 talberto@chlo.min-saude.pt | |
| Principal Investigator: Kamal Mansinho, MD | |
| Hospital de Santa Maria | Recruiting |
| Lisbon, Portugal | |
| Contact: Manuela Doroana 351.21.793.8043 manuela.doroana@hsm.min-saude.pt | |
| Principal Investigator: Francisco Antunes, MD, PhD | |
| Hospital Curry Cabral | Recruiting |
| Lisbon, Portugal | |
| Contact: Joao Machado 351.21.792.4280 jmmachado@hccabral.min-saude.pt | |
| Principal Investigator: Fernando Maltez | |
| Hospital Joaquim Urbano | Recruiting |
| Oporto, Portugal | |
| Contact: Josefina Mendez 351.22.589.9550 josefinamendezvazquez@gmail.com | |
| Principal Investigator: Rui Sarmento E. Castro | |
| Puerto Rico | |
| San Juan Hospital | Recruiting |
| Rio Piedras, Puerto Rico, 00935 | |
| Contact: Lourdes Angeli 787-765-4186 langeli@sanjuancapital.com | |
| Principal Investigator: Midnela Acevedo-Flores, MD | |
| University of Puerto Rico Pediatric Research Site | Recruiting |
| San Juan, Puerto Rico, 00935-6528 | |
| Contact: Ruth Santos, RN, MPH 787-759-9595 ruth.santos@upr.edu | |
| Principal Investigator: Irma L. Febo | |
| Puerto Rico-AIDS Clinical Trials Unit (PR-ACTU) | Recruiting |
| San Juan, Puerto Rico, 00935 | |
| Contact: Sylvia I. Davila Nieves, MSc 787-767-9192 sylvia.davila@upr.edu | |
| Principal Investigator: Jorge L. Santana Bagur, MD | |
| South Africa | |
| CHRU | Recruiting |
| Johannesburg, Gauteng, South Africa | |
| Contact: Mellissa Hero 27.11.276.8800 mhero@witshealth.co.za | |
| Principal Investigator: Sharlaa Badal-Faesen | |
| 1 Military Hospital | Recruiting |
| Pretoria, Gauteng, South Africa | |
| Contact: Priscilla Jakuja 27.12.651.9500 pjakuja@phidisa.org | |
| Principal Investigator: Mmabatho Ng Dintwe | |
| University KZN | Recruiting |
| Durban, KwaZulu-Natal, South Africa | |
| Contact: Rosie Mngqibisa 27.31.260.4669 Mngqibisa@ukzn.ac.za | |
| Principal Investigator: Sundrapragasen Pillay | |
| DICTU | Recruiting |
| Durban, Kwazulu-Natal, South Africa | |
| Contact: Rosie Mngqibisa 27.31.260.4669 Mngqibisa@ukzn.ac.za | |
| Principal Investigator: Sundrapragasen Pillay | |
| Desmond Tutu HIV Foundation Clinical Trials Unit | Recruiting |
| Cape Town, Western Cape, South Africa | |
| Contact: Maureen Rattley 27.21.650.6964 Maureen.Rattley@hiv-research.org.za | |
| Principal Investigator: Robin Wood, MD | |
| Spain | |
| Hospital Universitari Germans Trias I Pujol, HIV Unit and Retrovirology Lab CRS | Recruiting |
| Badalona, Barcelona, Spain | |
| Contact: Josep Ma Llibre 34.93.497.88.49 jllibre@flsida.org | |
| Principal Investigator: Bonaventura Clotet, MD | |
| Hospital Universitari Mutua Terrassa | Recruiting |
| Terrassa, Barcelona, Spain | |
| Contact: Pablo Velli 34.93.736.50.50 ext 1297 ddalmau@mutuaterrassa.es | |
| Principal Investigator: David Dalmau, MD, PhD | |
| Hospital Universitario Principe de Asturias | Recruiting |
| Alcala de Henares, Madrid, Spain | |
| Contact: Julio de Miguel Prieto, MD 34.91.887.81.00 ext 2445 jdemiguel.hupa@salud.madrid.org | |
| Principal Investigator: Jose Sanz Moreno, MD | |
| Complejo Hospitalario Xeral Cies | Recruiting |
| Vigo, Pontevedra, Spain | |
| Contact: Fernando Warncke Perez 34.98.681.60.26 fernando.warncke@gmail.com | |
| Principal Investigator: Antonio Ocampo Hermida | |
| Hospital del Mar | Recruiting |
| Barcelona, Spain | |
| Contact: Alicia Gonzalez, MD 34.93.248.32.51 agonzalez@parcdesalutar.cat | |
| Principal Investigator: Hernando J. Knobel, MD | |
| Hospital de la Santa Creu i Sant Pau | Recruiting |
| Barcelona, Spain | |
| Contact: Gracia Mateo Garcia, MD 34.93.556.56.24 mmateog@hsp.santpau.cat | |
| Principal Investigator: Pere Domingo, MD, PhD | |
| Hospital Clinico de Barcelona CRS | Recruiting |
| Barcelona, Spain | |
| Contact: Ana González 34.93.227.55.74 AGONZAL1@clinic.ub.es | |
| Principal Investigator: Jose Ma Gatell, MD | |
| Hospital La Princesa, Internal Medicine and Infectious Disease Service CRS | Recruiting |
| Madrid, Spain | |
| Contact: Ignacio de los Santo Gil, MD, PhD 34.91.520.22.36 isantosg@hotmail.com | |
| Principal Investigator: Jesus Sa Sanz, MD, PhD | |
| Hospital Universitario Doce de Octubre | Recruiting |
| Madrid, Spain | |
| Contact: Angel Portillo Fernandez 34.91.779.22.18 portillovih12@gmail.com | |
| Principal Investigator: Rafael Rubio, MD | |
| Hospital Clinico San Carlos | Recruiting |
| Madrid, Spain | |
| Contact: Maria Rodrigo Garcia 34.91.330.30.00 ext 7242 mariarodrigo1982@hotmail.com | |
| Principal Investigator: Vicente Estrada, MD | |
| Hospital Carlos III | Suspended |
| Madrid, Spain | |
| Hospital La Paz | Recruiting |
| Madrid, Spain | |
| Contact: Maria Lu Montes Ramirez, MD, PhD 34.91.727.70.99 mmontesr2001@yahoo.es | |
| Principal Investigator: Jose R. Arribas | |
| Hospital Universitario y Politecnico La Fe | Recruiting |
| Valencia, Spain | |
| Contact: Sandra Cuellar 34.65.178.45.11 sancutov@gmail.com | |
| Principal Investigator: Jose Lopez Aldeguer | |
| Hospital General Universitario de Valencia | Recruiting |
| Valencia, Spain | |
| Contact: Purificacion Rubio Cuevas 34.96.197.22.73 prubio1984@gmail.com | |
| Principal Investigator: Enrique Ortega | |
| Sweden | |
| Sahlgrenska University Hospital | Recruiting |
| Gothenburg, Sweden | |
| Contact: Lissie Johansson 46.31.3435522 lissie.johansson@vgregion.se | |
| Principal Investigator: Magnus Gisslen | |
| Skane University Hospital | Recruiting |
| Malmo, Sweden | |
| Contact: Kristina Tornqvist 46.40.337023 kristina.e.tornqvist@skane.se | |
| Principal Investigator: Camilla Hakangard | |
| Switzerland | |
| University Hospital Basel | Recruiting |
| Basel, Switzerland | |
| Contact: Mirjam De Roche 41.61.265.6545 MDeroche@uhbs.ch | |
| Principal Investigator: Manuel Battegay | |
| Bern University Hospital | Recruiting |
| Bern, Switzerland | |
| Contact: Melanie Meier 41.31.632.8844 melanie.meier@insel.ch | |
| Principal Investigator: Hansjakob Furrer, MD | |
| Unite VIH/SIDA Geneva | Recruiting |
| Geneva, Switzerland | |
| Contact: Olivia Zehfus 41.22.372.9845 olivia.zehfus@hcuge.ch | |
| Principal Investigator: Alexandra Calmy | |
| Ospedale Civico di Lugano | Suspended |
| Lugano, Switzerland | |
| University Hospital Zurich | Recruiting |
| Zurich, Switzerland | |
| Contact: Susan Hochstrasser, Bachlor of S 41.44.255.3752 susan.hochstrasser@usz.ch | |
| Principal Investigator: Nicolas Muller | |
| Thailand | |
| Siriraj Hospital | Recruiting |
| Bangkok Noi, Bangkok, Thailand, 10700 | |
| Contact: Rugee Sriondee 66.2.4197388 tmc278tmc114@yahoo.com | |
| Principal Investigator: Winai Ratanasuwan | |
| Ramathibodi Hospital | Recruiting |
| Bangkok, Thailand, 10400 | |
| Contact: Nutaporn Sanmeema 66.2.2012107 aorairka@hotmail.com | |
| Principal Investigator: Sasisopin Kiertiburanakul | |
| Chulalongkorn University Hospital | Recruiting |
| Bangkok, Thailand, 10330 | |
| Contact: Anchalee Avihingsanon 66.2.2557334 anchalee.a@hivnat.org | |
| Principal Investigator: Kiat Ruxrungtham, MD, MSc | |
| Research Institute for Health Sciences (RIHES) | Recruiting |
| Chiang Mai, Thailand, 50200 | |
| Contact: Panorjit Intachote 66.53.945055 ext 469 panorjit@rihes-cmu.org | |
| Principal Investigator: Khuanchai Supparatpinyo | |
| Sanpatong Hospital | Recruiting |
| Chiang Mai, Thailand, 50120 | |
| Contact: Yaowaluk Siriwarothai 66.53.311404 ext 2118 yaowaluk11128@yahoo.com | |
| Principal Investigator: Virat Klinbuayaem | |
| Chiangrai Prachanukroh Hospital | Recruiting |
| Chiangrai, Thailand, 57000 | |
| Contact: Supawadee Sangian 66.53.371130 ext 2211 npudit@hotmail.com | |
| Principal Investigator: Pacharee Kantipong, MD | |
| Chonburi Regional Hospital | Recruiting |
| Chonburi, Thailand, 20000 | |
| Contact: Uang-aroon Ampunpong, RN 66.38.931101 uang-amp@hotmail.com | |
| Principal Investigator: Chureeratana Bowonwatanuwong, MD | |
| Khon Kaen University, Srinagarind Hospital | Recruiting |
| Khon Kaen, Thailand, 40002 | |
| Contact: Anchalee Tiyabut 66.43.363169 atiyabut@yahoo.com | |
| Principal Investigator: Ploenchan Chetchotisakd, MD | |
| Bamrasnaradura Institute | Recruiting |
| Nonthaburi, Thailand, 11000 | |
| Contact: Supeda Thongyen 66.2.5903631 supeda_t@yahoo.com | |
| Principal Investigator: Wisit Prasithsirikul | |
| Uganda | |
| MRC UVRI Uganda Research Unit on AIDS | Recruiting |
| Entebbe, Uganda | |
| Contact: Bernard Kikaire 256.414.320.284 ben.kikaire@mrcuganda.org | |
| Principal Investigator: Paula Munderi | |
| Joint Clinical Research Center (JCRC) | Recruiting |
| Kampala, Uganda | |
| Contact: Cissy Kityo 256.752.769.168 ckityo@jcrc.co.ug | |
| Principal Investigator: Henry Mugerwa | |
| United Kingdom | |
| Royal Berkshire Hospital | Recruiting |
| Reading, Berkshire, United Kingdom, RG1 5LE | |
| Contact: Siobhan Lynch 44.118.322.7223 siobhan.lynch@royalberkshire.nhs.uk | |
| Principal Investigator: Fabian Chen | |
| The James Cook University Hospital | Recruiting |
| Middlesbrough, Cleveland, United Kingdom, TS4 3BW | |
| Contact: Pauline Spence 44.1642.850850 ext 52589 pauline.spence@stees.nhs.uk | |
| Principal Investigator: David R. Chadwick, PhD, MB, BCh | |
| Royal Bournemouth Hospital | Recruiting |
| Bournemouth, Dorset, United Kingdom, BH7 7DW | |
| Contact: James Walker 44.1202.704646 james.walker@rbch.nhs.uk | |
| Principal Investigator: Elbushra Herieka | |
| Belfast Health and Social Care Trust (RVH) | Recruiting |
| Belfast, Northern Ireland, United Kingdom, BT12 6BA | |
| Contact: Sinead McKernan 44.28.9063.6484 sinead.mckernan@belfasttrust.hscni.net | |
| Principal Investigator: Carol Emerson | |
| Sheffield Teaching Hospital NHS Foundation Trust | Recruiting |
| Sheffield, South Yorkshire, United Kingdom, S10 2JF | |
| Contact: Lynne Smart 44.114.271.2885 lynne.smart@sth.nhs.uk | |
| Principal Investigator: David Dockrell, MD, FRCPI | |
| Queen Elizabeth Hospital Birmingham | Recruiting |
| Birmingham, West Midlands, United Kingdom, B15 2WB | |
| Contact: Jan Harding 44.121.237.5707 jan.harding@uhb.nhs.uk | |
| Principal Investigator: Jonathan Ross | |
| Birmingham Heartlands Hospital | Recruiting |
| Birmingham, West Midlands, United Kingdom, B9 5SS | |
| Contact: Gerry Gilleran 44.121.424.0644 gerry.gilleran@heartofengland.nhs.uk | |
| Principal Investigator: David White, MD | |
| Coventry and Warwickshire NHS partnership Trust | Recruiting |
| Coventry, West Midlands, United Kingdom, CV1 4FS | |
| Contact: Steven Clay 44.2476.964698 steven.clay@uhcw.nhs.uk | |
| Principal Investigator: Satyajit Das | |
| Brighton and Sussex University Hospitals NHS Trust | Recruiting |
| Brighton, United Kingdom, BN2 1ES | |
| Contact: Nicky Perry 44.1273.523079 nicky.perry@bsuh.nhs.uk | |
| Principal Investigator: Martin Fisher, MD | |
| Gloucestershire Royal Hospital | Recruiting |
| Gloucester, United Kingdom, GL1 3NN | |
| Contact: Elizabeth Jones 44.845.422.6965 Liz.Jones@glos.nhs.uk | |
| Principal Investigator: Andrew De Burgh-Thomas | |
| Leicester Royal Infirmary | Recruiting |
| Leicester, United Kingdom, LE1 5WW | |
| Contact: Linda Mashonganyika 44.116.258.5973 Linda.mashonganyika@uhl-tr.nhs.uk | |
| Principal Investigator: Martin Jo Wiselka, MD | |
| South London Healthcare NHS Trust | Recruiting |
| London, United Kingdom, SE18 4QH | |
| Contact: Sara McNamara 44.20.8836.5760 sara.mcnamara@nhs.net | |
| Principal Investigator: Stephen Kegg | |
| Barts Health NHS Trust | Recruiting |
| London, United Kingdom, E1 1BB | |
| Contact: James Hand 44.20.3594.6773 james.hand@bartshealth.nhs.uk | |
| Principal Investigator: Chloe Orkin | |
| Chelsea and Westminster Hospital | Recruiting |
| London, United Kingdom, SW10 9NH | |
| Contact: Christopher Higgs 44.208.846.6135 chris.higgs@chelwest.nhs.uk | |
| Principal Investigator: Brian Gazzard, MD, PhD | |
| University College London Medical School | Recruiting |
| London, United Kingdom, WC1E 6JB | |
| Contact: Stephen O'Farrell 44.207.310.82055 sofarrell@ucl.ac.uk | |
| Principal Investigator: Ian Williams | |
| Imperial College Healthcare NHS Trust | Recruiting |
| London, United Kingdom, W2 1NY | |
| Contact: Ken Legg 44.20.7886.6790 k.legg@imperial.ac.uk | |
| Principal Investigator: Alan Winston | |
| St. George's Healthcare NHS Trust | Recruiting |
| London, United Kingdom, SW17 0QT | |
| Contact: Olanike Okolo 44.20.8725.3423 olanike.okolo@stgeorges.nhs.uk | |
| Principal Investigator: Phillip Hay | |
| Royal Free London NHS Foundation Trust | Recruiting |
| London, United Kingdom, NW3 2QG | |
| Contact: Anne Carroll 44.20.7941.1836 anne.carroll2@nhs.net | |
| Principal Investigator: Margaret A. Johnson, MD | |
| Guy's and St.Thomas' NHS Foundation Trust | Recruiting |
| London, United Kingdom, SE1 7EH | |
| Contact: Fiona Makia 44.207.188.2608 Fiona.Makia@gstt.nhs.uk | |
| Principal Investigator: Alastair Teague | |
| North Manchester General Hospital | Recruiting |
| Manchester, United Kingdom, M8 5RB | |
| Contact: Yvonne Clowes 44.161.922.3429 yvonne.clowes@pat.mhs.uk | |
| Principal Investigator: Edmund Wilkins | |
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Copenhagen HIV Programme (CHIP) -- Copenhagen, Denmark
Medical Research Council (MRC) Clinical Trials Unit -- London, United Kingdom
The Kirby Institute for Infection and Immunity in Society
The Institute for Clinical Research at the Veterans Affairs Medical Center -- Washington, D.C., USA
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
German Federal Ministry of Education and Research
NEAT - European AIDS Treatment Network
National Health and Medical Research Council, Australia
Abbott
Bristol-Myers Squibb
Gilead Sciences
GlaxoSmithKline
Merck
Tibotec Pharmaceutical Limited
Investigators
| Principal Investigator: | James D Neaton, PhD | University of Minnesota - Clinical and Translational Science Institute |
| Study Chair: | Abdel Babiker, PhD | Medical Research Council Clinical Trials Unit, London |
| Study Chair: | Sean Emery, PhD | National Centre in HIV Epidemiology & Clinical Research, UNSW, Sydney |
| Study Chair: | Fred Gordin, MD | Veterans Affairs Medical Center -- Washington, DC |
| Study Chair: | Jens Lundgren, MD, DMSc | Copenhagen HIV Programme |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT00867048 History of Changes |
| Obsolete Identifiers: | NCT00821171 |
| Other Study ID Numbers: | 0603M83587, U01AI068641, 2008-006439-12 |
| Study First Received: | March 20, 2009 |
| Last Updated: | May 9, 2013 |
| Health Authority: | Argentina: Ministry of Health Australia: National Health and Medical Research Council Austria: Federal Office for Safety in Health Care Belgium: Institutional Review Board Brazil: Ethics Committee Chile: Instituto de Salud Publica de Chile Czech Republic: Ethics Committee Denmark: Ethics Committee Estonia: Research Ethics Committee European Union: European Medicines Agency Finland: Ethics Committee France: National Consultative Ethics Committee for Health and Life Sciences Germany: Ethics Commission Greece: Ethics Committee India: Indian Council of Medical Research Ireland: Research Ethics Committee Israel: Ethics Commission Italy: National Bioethics Committee Luxembourg: Comite National d'Ethique de Recherche Mali: Ministry of Health Mexico: Ethics Committee Morocco: Ministry of Public Health Nigeria: The National Agency for Food and Drug Administration and Control Peru: Ethics Committee Poland: Ethics Committee Portugal: Ethics Committee for Clinical Research South Africa: National Health Research Ethics Council Spain: Ethics Committee Sweden: Regional Ethical Review Board Switzerland: Ethikkommission Thailand: Ethical Committee Uganda: National Council for Science and Technology United Kingdom: Research Ethics Committee United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Federal Government United States: Institutional Review Board |
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
|
highly active antiretroviral therapy (HAART) CD4 Count Early Intervention HIV |
HIV Infection HIV Infections treatment naive |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 16, 2013