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Sustained efficacy and safety of raltegravir after 5 years of combination antiretroviral therapy as initial treatment of HIV-1 infection: final results of a randomized, controlled, phase II study (Protocol 004).

Author(s): Gotuzzo E, Markowitz M, Ratanasuwan W, Smith G, Prada G, Morales-Ramirez JO, Strohmaier KM, Lu C, Bhanja S, Nguyen BY, Teppler H; Protocol 004 Study Team.

Collaborators: Baker D, Bloch M, Cooper D, Finlayson R, Workman C, Kovacs C, Smith G, Tsoukas C, Afani A, Perez J, Alvarez C, Prada G, Gotuzzo E, Mendo F, Morales-Ramirez J, Santana-Bagur J, Ratanasuwan W, Thitivichianlert S, Albrect M, Campbell T, Hicks C, Kumar P, Liporace R, Little S, Markowitz M, Steigbigel R, Tashima K.

Affiliation(s): Department to de Enfermedades Infecciosas y Tropicales, Hospital Nacional Cayetano Heredia, Lima, Peru.

Publication date & source: 2012, J Acquir Immune Defic Syndr. , 61(1):73-7

Raltegravir as initial HIV therapy was examined in a double-blind study; 160 patients were randomized to raltegravir (400 mg bid after dose-ranging), 38 to efavirenz, both with tenofovir/lamivudine. At week 240, HIV-RNA remained <50 copies per milliliter in 68.8% (raltegravir) versus 63.2% (efavirenz), and CD4 increases were 302 versus 276 cells per microliter, respectively. Early HIV-RNA decline predicted later CD4 increases in both groups. Raltegravir resistance was observed in 3 of 10 raltegravir recipients with virologic failure. Few drug-related adverse events were reported after week 48. Raltegravir had minimal effect on laboratory values, including lipids. Raltegravir with tenofovir/lamivudine showed durable efficacy and good tolerability over 5 years.

Page last updated: 2013-02-10

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