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JAIDS Journal of Acquired Immune Deficiency Syndromes:
doi: 10.1097/QAI.0b013e318263277e
Brief Report: Clinical Science

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)

Gotuzzo, Eduardo MD*; Markowitz, Martin MD; Ratanasuwan, Winai MD; Smith, Graham MD§; Prada, Guillermo MD; Morales-Ramirez, Javier O. MD; Strohmaier, Kim M. BS#; Lu, Chengxing PhD**; Bhanja, Sanhita MS**; Nguyen, Bach-Yen MD**; Teppler, Hedy MD**; for the Protocol 004 Study Team

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Abstract: 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.

© 2012 Lippincott Williams & Wilkins, Inc.


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