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)

J Acquir Immune Defic Syndr. 2012 Sep 1;61(1):73-7. doi: 10.1097/QAI.0b013e318263277e.

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.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Anti-Retroviral Agents / administration & dosage*
  • Anti-Retroviral Agents / adverse effects*
  • Antiretroviral Therapy, Highly Active / adverse effects
  • Antiretroviral Therapy, Highly Active / methods
  • CD4 Lymphocyte Count
  • Double-Blind Method
  • Drug-Related Side Effects and Adverse Reactions / epidemiology
  • Female
  • HIV Infections / drug therapy*
  • HIV Infections / virology
  • HIV-1 / isolation & purification*
  • Humans
  • Male
  • Middle Aged
  • Pyrrolidinones / administration & dosage*
  • Pyrrolidinones / adverse effects*
  • RNA, Viral / blood
  • Raltegravir Potassium
  • Treatment Outcome
  • Viral Load

Substances

  • Anti-Retroviral Agents
  • Pyrrolidinones
  • RNA, Viral
  • Raltegravir Potassium