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Safety and efficacy of the peptide-based therapeutic vaccine for HIV-1, Vacc-4x: a phase 2 randomised, double-blind, placebo-controlled trial.

Pollard RB, Rockstroh JK, Pantaleo G, Asmuth DM, Peters B, Lazzarin A, Garcia F, Ellefsen K, Podzamczer D, van Lunzen J, Arastéh K, Schürmann D, Clotet B, Hardy WD, Mitsuyasu R, Moyle G, Plettenberg A, Fisher M, Fätkenheuer G, Fischl M, Taiwo B, Baksaas I, Jolliffe D, Persson S, Jelmert O, Hovden AO, Sommerfelt MA, Wendel-Hansen V, Sørensen B.

Lancet Infect Dis. 2014 Apr;14(4):291-300. doi: 10.1016/S1473-3099(13)70343-8.


A case for preART-adjusted endpoints in HIV therapeutic vaccine trials.

Huang Y, Zhang L, Jolliffe D, Hovden AO, Ökvist M, Pantaleo G, Sommerfelt MA.

Vaccine. 2016 Mar 4;34(10):1282-8. doi: 10.1016/j.vaccine.2016.01.025.


Safety, immunogenicity, and efficacy of the candidate tuberculosis vaccine MVA85A in healthy adults infected with HIV-1: a randomised, placebo-controlled, phase 2 trial.

Ndiaye BP, Thienemann F, Ota M, Landry BS, Camara M, Dièye S, Dieye TN, Esmail H, Goliath R, Huygen K, January V, Ndiaye I, Oni T, Raine M, Romano M, Satti I, Sutton S, Thiam A, Wilkinson KA, Mboup S, Wilkinson RJ, McShane H; MVA85A 030 trial investigators..

Lancet Respir Med. 2015 Mar;3(3):190-200. doi: 10.1016/S2213-2600(15)00037-5.


Intradermal vaccination of HIV-infected patients with short HIV Gag p24-like peptides induces CD4 + and CD8 + T cell responses lasting more than seven years.

Lind A, Sommerfelt M, Holmberg JO, Baksaas I, Sørensen B, Kvale D.

Scand J Infect Dis. 2012 Aug;44(8):566-72. doi: 10.3109/00365548.2011.653581.


Efficacy and safety of efavirenz 400 mg daily versus 600 mg daily: 96-week data from the randomised, double-blind, placebo-controlled, non-inferiority ENCORE1 study.

ENCORE1 Study Group., Carey D, Puls R, Amin J, Losso M, Phanupak P, Foulkes S, Mohapi L, Crabtree-Ramirez B, Jessen H, Kumar S, Winston A, Lee MP, Belloso W, Cooper DA, Emery S.

Lancet Infect Dis. 2015 Jul;15(7):793-802. doi: 10.1016/S1473-3099(15)70060-5. Erratum in: Lancet Infect Dis. 2015 Jul;15(7):761.


Safety, immunogenicity and efficacy assessment of HIV immunotherapy in a multi-centre, double-blind, randomised, Placebo-controlled Phase Ib human trial.

Boffito M, Fox J, Bowman C, Fisher M, Orkin C, Wilkins E, Jackson A, Pleguezuelos O, Robinson S, Stoloff GA, Caparrós-Wanderley W.

Vaccine. 2013 Nov 19;31(48):5680-6. doi: 10.1016/j.vaccine.2013.09.057.


A therapeutic HIV-1 vaccine enhances anti-HIV-1 immune responses in patients under highly active antiretroviral therapy.

Tung FY, Tung JK, Pallikkuth S, Pahwa S, Fischl MA.

Vaccine. 2016 Apr 27;34(19):2225-32. doi: 10.1016/j.vaccine.2016.03.021.


Safety and efficacy of the HVTN 503/Phambili study of a clade-B-based HIV-1 vaccine in South Africa: a double-blind, randomised, placebo-controlled test-of-concept phase 2b study.

Gray GE, Allen M, Moodie Z, Churchyard G, Bekker LG, Nchabeleng M, Mlisana K, Metch B, de Bruyn G, Latka MH, Roux S, Mathebula M, Naicker N, Ducar C, Carter DK, Puren A, Eaton N, McElrath MJ, Robertson M, Corey L, Kublin JG; HVTN 503/Phambili study team..

Lancet Infect Dis. 2011 Jul;11(7):507-15. doi: 10.1016/S1473-3099(11)70098-6. Erratum in: Lancet Infect Dis. 2011 Jul;11(7):495.


Safety and immunogenicity of therapeutic DNA vaccination in individuals treated with antiretroviral therapy during acute/early HIV-1 infection.

Rosenberg ES, Graham BS, Chan ES, Bosch RJ, Stocker V, Maenza J, Markowitz M, Little S, Sax PE, Collier AC, Nabel G, Saindon S, Flynn T, Kuritzkes D, Barouch DH; AIDS Clinical Trials Group A5187 Team..

PLoS One. 2010 May 10;5(5):e10555. doi: 10.1371/journal.pone.0010555.


Efficacy of 400 mg efavirenz versus standard 600 mg dose in HIV-infected, antiretroviral-naive adults (ENCORE1): a randomised, double-blind, placebo-controlled, non-inferiority trial.

ENCORE1 Study Group., Puls R, Amin J, Losso M, Phanuphak P, Nwizu C, Orrell C, Young B, Shahar E, Wolff M, Gazzard B, Read T, Hill A, Cooper DA, Emery S.

Lancet. 2014 Apr 26;383(9927):1474-82. doi: 10.1016/S0140-6736(13)62187-X. Erratum in: Lancet. 2014 Apr 26;383(9927):1464.


Safety and immunogenicity of an adjuvanted protein therapeutic HIV-1 vaccine in subjects with HIV-1 infection: a randomised placebo-controlled study.

Harrer T, Plettenberg A, Arastéh K, Van Lunzen J, Fätkenheuer G, Jaeger H, Janssens M, Burny W, Collard A, Roman F, Loeliger A, Koutsoukos M, Bourguignon P, Lavreys L, Voss G.

Vaccine. 2014 May 7;32(22):2657-65. doi: 10.1016/j.vaccine.2013.10.030.


Efficacy and safety of raltegravir for treatment of HIV for 5 years in the BENCHMRK studies: final results of two randomised, placebo-controlled trials.

Eron JJ, Cooper DA, Steigbigel RT, Clotet B, Gatell JM, Kumar PN, Rockstroh JK, Schechter M, Markowitz M, Yeni P, Loutfy MR, Lazzarin A, Lennox JL, Strohmaier KM, Wan H, Barnard RJ, Nguyen BY, Teppler H; BENCHMRK Study Teams..

Lancet Infect Dis. 2013 Jul;13(7):587-96. doi: 10.1016/S1473-3099(13)70093-8.


Safety and immunogenicity of a candidate therapeutic vaccine, p24 virus-like particle, combined with zidovudine, in asymptomatic subjects. Community HIV Research Network Investigators.

Kelleher AD, Roggensack M, Jaramillo AB, Smith DE, Walker A, Gow I, McMurchie M, Harris J, Patou G, Cooper DA.

AIDS. 1998 Jan 22;12(2):175-82.


Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study.

Raffi F, Rachlis A, Stellbrink HJ, Hardy WD, Torti C, Orkin C, Bloch M, Podzamczer D, Pokrovsky V, Pulido F, Almond S, Margolis D, Brennan C, Min S; SPRING-2 Study Group..

Lancet. 2013 Mar 2;381(9868):735-43. doi: 10.1016/S0140-6736(12)61853-4.


Boosters of a therapeutic HIV-1 vaccine induce divergent T cell responses related to regulatory mechanisms.

Lind A, Brekke K, Sommerfelt M, Holmberg JO, Aass HC, Baksaas I, Sørensen B, Dyrhol-Riise AM, Kvale D.

Vaccine. 2013 Sep 23;31(41):4611-8. doi: 10.1016/j.vaccine.2013.07.037.


Greater viral rebound and reduced time to resume antiretroviral therapy after therapeutic immunization with the ALVAC-HIV vaccine (vCP1452).

Autran B, Murphy RL, Costagliola D, Tubiana R, Clotet B, Gatell J, Staszewski S, Wincker N, Assoumou L, El-Habib R, Calvez V, Walker B, Katlama C; ORVACS Study Group..

AIDS. 2008 Jul 11;22(11):1313-22. doi: 10.1097/QAD.0b013e3282fdce94.


HLA- and dose-dependent immunogenicity of a peptide-based HIV-1 immunotherapy candidate (Vacc-4x).

Kran AM, Sørensen B, Nyhus J, Sommerfelt MA, Baksaas I, Bruun JN, Kvale D.

AIDS. 2004 Sep 24;18(14):1875-83.


HIV-1 Reservoir Dynamics after Vaccination and Antiretroviral Therapy Interruption Are Associated with Dendritic Cell Vaccine-Induced T Cell Responses.

Andrés C, Plana M, Guardo AC, Alvarez-Fernández C, Climent N, Gallart T, León A, Clotet B, Autran B, Chomont N, Gatell JM, Sánchez-Palomino S, García F.

J Virol. 2015 Sep;89(18):9189-99. doi: 10.1128/JVI.01062-15.


Safety and efficacy of the HIV-1 integrase inhibitor raltegravir (MK-0518) in treatment-experienced patients with multidrug-resistant virus: a phase II randomised controlled trial.

Grinsztejn B, Nguyen BY, Katlama C, Gatell JM, Lazzarin A, Vittecoq D, Gonzalez CJ, Chen J, Harvey CM, Isaacs RD; Protocol 005 Team..

Lancet. 2007 Apr 14;369(9569):1261-9.

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