XIX International AIDS Conference


THLBB Late Breaker Track B
  Oral Abstract Session : Track B
Venue: Session Room 6
Time: 26.07.2012, 16:30 - 18:00
Co-Chairs: Gerald Friedland, United States
Papa Salif Sow, Senegal
 
 

16:30
THLBB01
Abstract
Powerpoint
Webcast
A randomized multicentre open-label trial to estimate the efficacy and safety of two doses of raltegravir (RAL) to efavirenz (EFV) for the treatment of HIV-TB co-infected patients: results of the ANRS 12 180 Reflate TB trial
B. Grinsztejn1, N. De Castro2,3, V. Arnold4, V. Veloso1, M. Morgado5, J.H. Pilotto6, C. Brites7, J.V. Madruga8, N. Barcellos9, B. Riegel Santos10, C. Vorsatz1, C. Grondin4, M. Santini-Oliveira1, O. Patey11, C. Delaugerre2,3, G. Chêne4, J.-M. Molina2,3, ANRS 12 180 Reflate TB study group
1Instituto de Pesquisa Clinica Evandro Chagas, Fiocruz, Laboratório de Pesquisa Clínica em DST/AIDS, Rio de Janeiro, Brazil, 2University of Paris Diderot, Sorbonne, Paris Cité, INSERM U941, Paris, France, 3Hospital Saint-Louis, AP-HP, Paris, France, 4University Bordeaux, INSERM U897, Bordeaux, France, 5Instituto Oswaldo Cruz-FIOCRUZ, Laboratory of AIDS and Molecular Immunology, Rio de Janeiro, Brazil, 6Hospital Geral de Nova Iguaçu, Departamento de DST/AIDS, Nova Iguaçu, Brazil, 7Hospital Universitário Prof. Edgar Santos, Laboratório de Pesquisa em Doenças Infecciosas, Salvador, Brazil, 8Centro de Referência e Treinamento DST/AIDS, Unidade de Pesquisa, São Paulo, Brazil, 9Health State Secretariat Hospital Sanatório Partenon, Porto Alegre, Brazil, 10Hospital Nossa Senhora da Conceição, Serviço de Infectologia, Porto Alegre, Brazil, 11C.H.G Villeneuve St George, Department of Internal and Tropical Medicine, Villeneuve St George, France
N. De Castro, France

16:43
THLBB02
Abstract
Powerpoint
Webcast
Safety, tolerability and early bactericidal activity in sputum of PNU-100480 (sutezolid) in patients with pulmonary tuberculosis
R.S. Wallis1, A.H. Diacon2, R. Dawson3, A. Venter2, S.O. Friedrich2, D. Paige1, T. Zhu1, A. Silvia1, J. Gobey1, C. Ellery1, Y. Zhang1, E. Kadyszewski1
1Pfizer, Groton, United States, 2Stellenbosch University, Stellenbosch, South Africa, 3U Cape Town, Cape Town, South Africa
R. Wallis, United States

16:56
THLBB03
Abstract
Randomized controlled trial of isoniazid preventive therapy in HIV-infected persons on antiretroviral therapy
M.X. Rangaka1,2,3, A. Boulle1, R.J. Wilkinson2,4, G. van Cutsem1,5, E. Goemaere5, R. Goliath2, R. Titus2, S. Mathee6, G. Maartens7
1University of Cape Town, School of Public Health, Centre for Infectious Disease Epidemiology and Research, Cape Town, South Africa, 2University of Cape Town, Institute of Infectious Diseases and Molecular Medicine, Clinical Infectious Diseases Research Initiative, Cape Town, South Africa, 3London School of Hygiene and Tropical Medicine, (LSHTM), London, United Kingdom, 4Imperial College London, Division of Medicine, London, United Kingdom, 5Medecins Sans Frontieres South Africa, Khayelitsha ART Programme, Khayelitsha, Cape Town, South Africa, 6Provincial Government of the Western Cape, Cape Town, South Africa, 7University of Cape Town, Department of Medicine, Pharmacology Unit, Cape Town, South Africa
M. Rangaka, South Africa

17:09
THLBB04
Abstract
Once-daily dolutegravir (DTG; S/GSK1349572) is non-inferior to raltegravir (RAL) in antiretroviral‑naive adults: 48 week results from SPRING-2 (ING113086)
F. Raffi1, A. Rachlis2, H.-J. Stellbrink3, W.D. Hardy4, C. Torti5, C. Orkin6, M. Bloch7, D. Podzamczer8, V. Pokrovsky9, S. Almond10, D. Margolis11, S. Min11, The SPRING-2 Team
1University of Nantes, Nantes, France, 2Sunnybrook & Women's College Health Sciences Centre, Toronto, Canada, 3IPM Study Center, Hamburg, Germany, 4Cedars-Sinai Medical Center, Los Angeles, United States, 5Azienda Ospedaliera Spedali Civili, Brescia, Italy, 6Royal London Hospital, London, United Kingdom, 7Holdsworth House Medical Practice, Darlinghurst, Australia, 8Hospital Universitari de Bellvitge, Barcelona, Spain, 9Russian Federal Guidance Centre of AIDS, Moscow, Russian Federation, 10GlaxoSmithKline, Mississauga, Canada, 11GlaxoSmithKline, Research Triangle Park, United States
F. Raffi, France

17:22
THLBB05
Abstract
Powerpoint
Webcast
Effect of early versus delayed initiation of antiretroviral therapy (ART) on clinical outcomes in the HPTN 052 randomized clinical trial
B. Grinsztejn1, M. Hosseinipour2, S. Swindells3, H. Ribaudo4, J. Eron5, Y.Q. Chen6, L. Wang6, S.-S. Ou6, M. Anderson6, M. McCauley7, T. Gamble8, N. Kumarasamy9, J. Hakim10, J. Kumwenda11, J. Pilotto12, S. Godbole13, S. Chariyalertsak14, B. Santos15, K. Mayer16, S. Eshleman17, E. Piwowar-Manning18, L. Cottle6, J. Makhema19, L. Mills20, R. Panchia21, I. Sanne22, V. Elharrar23, D. Havlir24, M.S. Cohen5, for the HPTN 052/ACTG Study Team
1Instituto de Pesquisa Clinica Evandro Chagas, Fiocruz, Rio de Janeiro, Brazil, 2UNC Project Malawi and University of North Carolina at Chapel Hill, Lilongwe, Malawi, 3University of Nebraska Medical Center, Omaha, United States, 4Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, United States, 5University of North Carolina School of Medicine, Chapel Hill, United States, 6Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, United States, 7FHI 360, Washington, DC, United States, 8FHI 360, Durham, United States, 9YRG CARE Medical Centre, Chennai, India, 10University of Zimbabwe, Department of Medicine, Harare, Zimbabwe, 11College of Medicine Johns Hopkins Project, Blantyre, Malawi, 12Hospital Geral de Nova Iguaçu and Laboratorio de AIDS e Imunologia Molecular-IOC, Rio de Janeiro, Brazil, 13National AIDS Research Institute (ICMR), Pune, India, 14Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand, 15Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil, 16Fenway Health/Harvard Medical School, Boston, United States, 17Johns Hopkins School of Medicine, Department of Pathology, Baltimore, United States, 18Johns Hopkins University School of Medicine, Department of Pathology, Baltimore, United States, 19Botswana Harvard AIDS Institute, Gaborone, Botswana, 20KEMRI-CDC Research and Public Health Collaboration, CDC Division of HIV/AIDS Prevention, Kisumu, Kenya, 21Perinatal HIV Research Unit (PHRU), University of the Witwatersrand, Johannesburg, South Africa, 22University of Witswatersrand, Department of Medicine, Johannesburg, South Africa, 23National Institute of Allergy and Infectious Diseases, National Insti
B. Grinsztejn, Brazil

17:35
THLBB06
Abstract
Associations of inflammatory markers with AIDS and non-AIDS clinical events after initiation of antiretroviral therapy (ART): AIDS Clinical Trials Group A5224s, a substudy of ACTG A5202
G.A. McComsey1, D. Kitch2, P.E. Sax3, C. Tierney2, N.C. Jahed4, K. Melbourne5, B. Ha6, T.T. Brown7, A. Bloom8, N. Fedarko7, E.S. Daar9, Adult AIDS Clinical Trials Group A5224s
1Case Western Reserve University, Cleveland, United States, 2Harvard School of Public Health, Boston, United States, 3Brigham and Women's Hospital and Harvard Medical School, Boston, United States, 4Social & Scientific Systems, Inc, Silver Spring, United States, 5Gilead Sciences, Foster City, United States, 6GlaxoSmithKline, Research Triangle, United States, 7Johns Hopkins, Baltimore, United States, 8Frontier Science and Technology Research Foundation, Inc., Amherst, United States, 9Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, United States
G. McComsey, United States

Powerpoints presentations
A randomized multicentre open-label trial to estimate the efficacy and safety of two doses of raltegravir (RAL) to efavirenz (EFV) for the treatment of HIV-TB co-infected patients: results of the ANRS 12 180 Reflate TB trial - Nathalie De Castro

Safety, tolerability and early bactericidal activity in sputum of PNU-100480 (sutezolid) in patients with pulmonary tuberculosis - Robert Steven Wallis

Effect of early versus delayed initiation of antiretroviral therapy (ART) on clinical outcomes in the HPTN 052 randomized clinical trial - Beatriz Grinsztejn



Rapporteur report

Track B report by Dr. Federico Pulido


THLBB  Oral Abstract Session:  Late Breaker Track B

 THLBB01.  A randomized multicentre open-label trial to estimate the efficacy and safety of two doses of raltegravir (RAL) to efavirenz (EFV) for the treatment of HIV-TB co-infected patients: results of the ANRS 12 180 Reflate TB trial

 In this phase II study, with 51 evaluable patients per arm, high rates of success (Viral load <50 copies/mL, ITT M=F, D/C=F) were achieved at week 24  with raltegravir 400 mg bid (76%) or 800 mg bid (78%) and EFV 600 mg qd (63%) in combination with TDF and 3TC, in patients receiving a rifampin-containing TB treatment. In the context of HIV and TB co-infection, raltegravir (400 mg bid or 800 mg bid) had a good safety profile. Less virological failure and less resistance with raltegravir 8oo mg bid, but optimal raltegravir dose yet to be defined based on PK sub-study and W48 follow-up data.

 THLBB02 Safety, tolerability and early bactericidal activity in sputum of PNU-100480 (sutezolid) in patients with pulmonary tuberculosis

Phase IIa study of a new antituberculosis drug (sutezolid, PNU-100480). Fifty nine patients with pulmonary TB (3 HIV+) were randomized to PNU 600 mg bid (n=25), 1200 mg QD (n=25) or the standard 4 drugs (HREZ, n=9) for 14 days. Both PNU dosing schedules resulted in significant log CFU reductions from baseline over the 14 day period of treatment, with a trend toward superior responses with BID dosing.  Fourteen PNU-treated TB patients (7/50) presented ALT increases, resolved after discontinuing the drug.

THLBB03  Randomized controlled trial of isoniazid preventive therapy in HIV-infected persons on antiretroviral therapy

M. Rangaka, from South Africa presented this randomized study comparing isoniazid 12 months (n=662) vs. placebo (n=667) with 4 ys follow-up,  in HIV-infected persons on antiretroviral therapy without active TB,. There was a 37% reduction in the rate of incident TB for those in the INH treatment group (2.3 x100 PY) compared to those who were receiving ART alone (3.6 x100 PY). However, those on INH had more discontinuations due to grade 3-4 raised ALT (Risk Ratio=2.13), and the study did not demonstrate differences on mortality.

 THLBB04 Once-daily dolutegravir (DTG; S/GSK1349572) is non-inferior to raltegravir (RAL) in antiretroviralnaive adults: 48 week results from SPRING-2 (ING113086)

F. Raffi, from France presented the 48 weeks data of the first phase III study with DTG (a new integrase inhibitor dosed once daily). ATR naïve patients were randomized to receive blinded DTG 50 mg QD or RAL 800 mg bid, both with 2 nukes selected by investigators (TDF/FTC  60%; ABC/3TC 40%). Rates of viral load<50 copies/mL at 48 weeks, Snapshot analysis, primary endpoint) showed non-inferiority of DTG (88%) vs. RAL (85%).  Both regimens were well tolerated without differences between arms. No patient on DTG developed mutations of resistance (1 patient on RAL developed resistance to RAL and nukes, and 3 other with mutations to nukes).

 THLBB05  Effect of early versus delayed initiation of antiretroviral therapy (ART) on clinical outcomes in the HPTN 052 randomized clinical trial

B. Grinsztejn, from Brazil presented the updated results of the HPTN 052 study, comparing the clinical evolution of ARV-naïve patients with CD4 count 350-550/µL, randomized to start therapy (immediate group, n=875) or to delay therapy until CD4+ <250/µL or AIDS (Delayed). There was a trend towards a shorter time to a primary clinical event (AIDS and non-AIDS defining) with delayed compared to immediate therapy (HR=1.4, p=0.07). Delayed therapy was associated with a significantly shorter time to AIDS events and TB. Non-AIDS defining events were rare and similar between arms. The overall incidence of clinical events was significantly lower in patients on immediate therapy (IRR=0.8, P=0.02)

THLBB06 Associations of inflammatory markers with AIDS and non-AIDS clinical events after initiation of antiretroviral therapy (ART): AIDS Clinical Trials Group A5224s, a substudy of ACTG A5202

In this substudy of ACTG A5202, the possible associations between serum levels of several biomarkes are analyzed in 269 ART-naïve patients starting treatment with TDF/FTC or ABC/3TC plus EFV or ATV/r. Higher levels of several inflammatory biomarkers (hrCRP, IL6, sTNF-RI and II) were associated independently of CD4 count with increased risk of AIDS and non-AIDS events, however the small number of events, short follow up  and large number of analyses performed make difficult to obtain definitive conclusions about the clinical relevance of the found associations.  




   

    The organizers reserve the right to amend the programme.


Contact Us | Site map © 2012 International AIDS Society