Long-term efficacy and safety of the HIV integrase inhibitor raltegravir in patients with limited treatment options in a phase II study

Jose M. Gatell, Christine Katlama, Beatriz Grinsztejn, Joseph J. Eron, Adriano Lazzarin, Daniel Vittecoq, Charles J. Gonzalez, Robert M. Danovich, Hong Wan, Jing Zhao, Anne R. Meibohm, Kim M. Strohmaier, Charlotte M. Harvey, Robin D. Isaacs, Bach Yen T Nguyen

Research output: Contribution to journalArticle

60 Citations (Scopus)

Abstract

BACKGROUND: Raltegravir in combination therapy has demonstrated potent suppression of HIV-1 with a favorable safety profile. This report provides 96-week efficacy and safety data from Protocol 005, a Phase II study. METHODS: HIV-infected patients with very limited treatment options and failing antiretroviral therapy were randomized to raltegravir 200, 400, or 600 mg or placebo b.i.d., plus optimized background therapy for ≥24 weeks; all patients were then offered open-label raltegravir 400 mg b.i.d. Efficacy measurements included changes in viral load and CD4 count from baseline and percent of patients with HIV-1 RNA

Original languageEnglish
Pages (from-to)456-463
Number of pages8
JournalJournal of Acquired Immune Deficiency Syndromes
Volume53
Issue number4
DOIs
Publication statusPublished - Apr 2010

Fingerprint

HIV Integrase Inhibitors
Safety
HIV-1
Therapeutics
CD4 Lymphocyte Count
Viral Load
Placebos
HIV
RNA
Raltegravir Potassium

Keywords

  • AIDS
  • Antiretroviral therapy
  • HIV
  • Integrase inhibitor
  • Raltegravir
  • Resistance

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

Cite this

Long-term efficacy and safety of the HIV integrase inhibitor raltegravir in patients with limited treatment options in a phase II study. / Gatell, Jose M.; Katlama, Christine; Grinsztejn, Beatriz; Eron, Joseph J.; Lazzarin, Adriano; Vittecoq, Daniel; Gonzalez, Charles J.; Danovich, Robert M.; Wan, Hong; Zhao, Jing; Meibohm, Anne R.; Strohmaier, Kim M.; Harvey, Charlotte M.; Isaacs, Robin D.; Nguyen, Bach Yen T.

In: Journal of Acquired Immune Deficiency Syndromes, Vol. 53, No. 4, 04.2010, p. 456-463.

Research output: Contribution to journalArticle

Gatell, JM, Katlama, C, Grinsztejn, B, Eron, JJ, Lazzarin, A, Vittecoq, D, Gonzalez, CJ, Danovich, RM, Wan, H, Zhao, J, Meibohm, AR, Strohmaier, KM, Harvey, CM, Isaacs, RD & Nguyen, BYT 2010, 'Long-term efficacy and safety of the HIV integrase inhibitor raltegravir in patients with limited treatment options in a phase II study', Journal of Acquired Immune Deficiency Syndromes, vol. 53, no. 4, pp. 456-463. https://doi.org/10.1097/QAI.0b013e3181c9c967
Gatell, Jose M. ; Katlama, Christine ; Grinsztejn, Beatriz ; Eron, Joseph J. ; Lazzarin, Adriano ; Vittecoq, Daniel ; Gonzalez, Charles J. ; Danovich, Robert M. ; Wan, Hong ; Zhao, Jing ; Meibohm, Anne R. ; Strohmaier, Kim M. ; Harvey, Charlotte M. ; Isaacs, Robin D. ; Nguyen, Bach Yen T. / Long-term efficacy and safety of the HIV integrase inhibitor raltegravir in patients with limited treatment options in a phase II study. In: Journal of Acquired Immune Deficiency Syndromes. 2010 ; Vol. 53, No. 4. pp. 456-463.
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