Clinical Trials ART  TUAB1
Type:
Oral abstract session Back
Venue: Bayside Auditorium B
Time: 11:00 - 12:30, Tuesday, 24.07.2007
Code: TUAB1
Co-Chairs: Jose R Arribas, Spain
Christine Katlama, France
Click here to see a webcast of this session on kaisernetwork.org

    Presentations in this session:
11:00
TUAB101
Abstract
Powerpoint (628 KB)		Comparison of 48-week efficacy and safety of darunavir/ritonavir (DRV/r) with lopinavir/ritonavir (LPV/r) in LPV/r-naïve, treatment-experienced patients: a randomised, controlled phase III trial (TITAN)
Presented by Jose Valdez-Madruga, Brazil
Valdez-Madruga J.1, Berger D.S.2, McMurchie M.3, Suter F.4, Banhegyi D.5, Ruxrungtham K.6, Lefebvre E.7, De Paepe E.8, Tomaka F.9, De Pauw M.8, Vangeneugden T.8, Spinosa-Guzman S.8
1Centro de Referência e Treinamento DST/AIDS, São Paulo, Brazil, 2Northstar Medical Center, Chicago, IL, United States, 3University of Sydney, Sydney, Australia, 4Ospedali Riuniti di Bergamo, Bergamo, Italy, 5Szent Lásló Hospital, Budapest, Hungary, 6Thai Red Cross AIDS Research Centre, Bangkok, Thailand, 7Janssen-Cilag, Tilburg, Netherlands, 8Tibotec BVBA, Mechelen, Belgium, 9Tibotec Inc, Yardley, PA, United States

11:15
TUAB102
Abstract
Powerpoint (124 KB)		ACTG 5211: phase II study of the safety and efficacy of vicriviroc (VCV) in HIV-infected treatment-experienced subjects: 48 week results
Presented by Roy Gulick, United States
Gulick R.1, Su Z.2, Flexner C.3, Hughes M.2, Skolnik P.4, Godfrey C.5, Wilkin T.1, Gross R.6, Krambrink A.2, Coakley E.7, Greaves W.8, Zolopa A.9, Hirsch M.10, Kuritzkes D.10, ACTG 5211 Team
1Weill-Cornell Medical College, New York, United States, 2Harvard School of Public Health, Boston, United States, 3Johns Hopkins University, Baltimore, United States, 4Boston University Medical Center, Boston, United States, 5Division of AIDS, NIH, Bethesda, United States, 6University of Pennsylvania, Philadelphia, United States, 7Monogram Biosciences, Inc., South San Francisco, United States, 8Schering-Plough Research Institute, Kenilworth, United States, 9Stanford University, Palo Alto, United States, 10Harvard Medical School, Boston, United States

11:30
TUAB103
Abstract
Powerpoint (498 KB)		The integrase inhibitor raltegravir alters viral decay kinetics of HIV, significantly reducing the second phase and challenging current hypotheses of viral replication
Presented by John M Murray, Australia
Murray J.M.1, Emery S.1, Kelleher A.1, Law M.1, Hazuda D.2, Nguyen B.-Y.2, Teppler H.2, Cooper D.A.1
1National Centre in HIV Epidemiology and Clinical Research, Sydney, Australia, 2Merck Research Laboratories, North Wales, United States

11:45
TUAB104
Abstract
Powerpoint (216 KB)		Rapid onset and durable antiretroviral effect of raltegravir (MK-0518), a novel HIV-1 integrase inhibitor, as part of combination ART in treatment HIV-1 infected patients: 48-week data
Presented by Martin Markowitz, United States
Markowitz M.1, Nguyen B.-Y.2, Gotuzzo E.3, Mendo F.4, Ratanasuwan W.5, Kovacs C.6, Wan H.2, Gilde L.2, Isaacs R.2, Teppler H.2, and the Protocol 004 Part II Study Team
1Aaron Diamond AIDS Research Center, New York, NY, United States, 2Merck Research Laboratories, West Point, PA, United States, 3Hospital Nacionale Cayetano Heredia, Lima, Peru, 4Hospital Nacionale Edgardo Rebagliati, Lima, Peru, 5Siriraj Hospital, Bangkok, Thailand, 6Canadian Immunodeficiency Research Collaborative, Toronto, Canada

12:00
TUAB105
AbstractThis abstract has been enhanced with Abstract Plus!
Powerpoint (446 KB)		The metabolic profile of TMC278, an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI)
Presented by Kiat Ruxrungtham, Thailand
Ruxrungtham K.1, Bellos N.2, Morales-Ramirez J.3, Timerman A.4, Madruga J.5, Katabira E.6, Vanveggel S.7, Peeters M.7, Stevens M.7, Williams P.7, Woodfall B.7, Boven K.8
1Thai Red Cross AIDS Research Centre, Bangkok, Thailand, 2Southwest Infectious Disease Associates, Dallas, TX, United States, 3Clinical Research, San Juan, Puerto Rico, 4Hospital Heliopolis, São Paulo, Brazil, 5Centro de Referência e Treinamento DST-AIDS, São Paulo, Brazil, 6Makerere University, Kampala, Uganda, 7Tibotec BVBA, Mechelen, Belgium, 8Tibotec Inc., Yardley, PA, United States

12:15
TUAB106
Abstract		Potent antiretroviral activity of the once-daily CCR5 antagonist INCB009471 over 14 days of monotherapy
Presented by Calvin Cohen, United States
Cohen C.1, DeJesus E.2, Mills A.3, Pierone, Jr. G.4, Kumar P.5, Ruane P.6, Elion R.7, Fusco G.8, Levy R.8, Solomon K.8, Erickson-Viitanen S.8
1Community Research Initiative of New England, Boston, United States, 2Orlando Immunology Center, Orlando, United States, 3Anthony Mills MD, Inc., Los Angeles, United States, 4Treasure Coast Infectious Disease Consultants, Vero Beach, United States, 5Georgetown University Medical Center, Washington DC, United States, 6Peter Ruane, MD, Inc, Los Angeles, United States, 7CARE-ID, Washington, DC, United States, 8Incyte Corporation, Wilmington, United States


Audio files:
  1. audio file - high quality (mp3 format, 39.8 MB)
  2. audio file - low quality (mp3 format, 20 MB)

Rapporteur report

Track B: Clinical Research, Treatment and Care report by Sean Emery

New classes of antiretroviral therapy (ART) and new ways of using existing drugs are an important means through which continuous improvements in clinical outcome are realised in the clinical management of HIV infection. Research also offers an opportunity to examine aspects of host-pathogen interactions.

 

Presentations today provided insights into the safety, efficacy and tolerability of CCR5 inhibitors (vicriviroc) and integrase inhibitors (raltegravir) as new agents. New insights into HIV replication were offered. Data describing the metabolic profile of TMC-278 were summarised and a new CCR5 inhibitor (INCB009471) was described following completion of an early phase clinical trial. The session also included data presentations from completed trials that have already been published in The Lancet for ritonavir boosted darunavir compared with ritonavir boosted lopinavir.

 

Data from a phase II randomised trial of vicriviroc (VCV) in patients with extensive prior ART use indicated biological activity and an acceptable safety profile at two of the three doses studied when VCV was added to an optimised background regimen (OBR) of other ART (Gulick). Given the absence of any r/tipranavir or r/darunavir use in the OBR it is difficult to interpret these data in terms of where VCV might be considered clinically indicated.

 

Week 48 data from a phase II trial of raltegravir in treatment naïve subjects compared to a regimen of Truvada plus efavirenz illustrates highly potent and sustained suppression of HIV replication in recipients of RLV (Markowitz). In a limited number of virologic failures in recipients of RLV (5/160 patients=3%) carefully characterisation of HIV integrase mutations revealed signature changes at locations 151, 155, 232 and 230 in only three patients. In other patients point mutations associated with reduced susceptibility to TDF/FTC were present. RLV was safe and well tolerated.

 

Sophisticated mathematical modelling of the decay kinetics of plasma HIV RNA in the raltegravir trial revealed extremely potent suppression of HIV replication (Murray). The kinetic analysis further challenged the current dogma that attempts to describe the origins of replicating virus in the setting of combination antiretroviral therapy.

 

Improvements in the extent to which antiretrovirals promote an atherogenic profile of serum lipid fractions are important advances. Ruxrungtham et al described more favourable lipid changes for recipients of TMC-278 compared with EFV recipients as part of an ongoing randomised trial. These differences were not entirely consistent for all of the known lipid fractions that confer risk for cardiovascular outcomes.

 

Cohen et al provided data illustrating promise of further development of a new CCR5 inhibitor (INCB009471).


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