A randomized trial assessing the impact of phenotypic resistance testing on antiretroviral therapy.

Academic Article

Abstract

  • OBJECTIVE: To compare the effect of treatment decisions guided by phenotypic resistance testing (PRT) or standard of care (SOC) on short-term virological response. DESIGN: A prospective, randomized, controlled clinical trial conducted in 25 university and private practice centers in the United States. PARTICIPANTS: A total of 272 subjects who failed to achieve or maintain virological suppression (HIV-1-RNA plasma level > 2000 copies/ml) with previous exposure to two or more nucleoside reverse transcriptase inhibitors and one protease inhibitor. INTERVENTIONS: Randomization was to antiretroviral therapy guided by PRT or SOC. MAIN OUTCOME MEASURES: The percentage of subjects with HIV-1-RNA plasma levels less than 400 copies/ml at week 16 (primary); change from baseline in HIV-1-RNA plasma levels and number of "active" (less than fourfold resistance) antiretroviral agents used (secondary). RESULTS: At week 16, using intent-to-treat (ITT) analysis, a greater proportion of subjects had HIV-1-RNA levels less than 400 copies/ml in the PRT than in the SOC arm (P = 0.036, ITT observed; P = 0.079, ITT missing equals failure). An ITT observed analysis showed that subjects in the PRT arm had a significantly greater median reduction in HIV-1-RNA levels from baseline than the SOC arm (P = 0.005 for 400 copies/ml; P = 0.049 for 50 copies/ml assay detection limit). Significantly more subjects in the PRT arm were treated with two or more "active" antiretroviral agents than in the SOC arm (P = 0.003). CONCLUSION: Antiretroviral treatment guided prospectively by PRT led to the increased use of "active" antiretroviral agents and was associated with a significantly better virological response.
  • Published In

  • AIDS  Journal
  • Keywords

  • Adult, Aged, Anti-HIV Agents, CD4 Lymphocyte Count, Drug Resistance, Viral, Female, HIV Infections, HIV Protease Inhibitors, HIV-1, Humans, Male, Middle Aged, Phenotype, Practice Guidelines as Topic, Prospective Studies, RNA, Viral, Reverse Transcriptase Inhibitors, Treatment Outcome, United States, Viral Load
  • Author List

  • Cohen CJ; Hunt S; Sension M; Farthing C; Conant M; Jacobson S; Nadler J; Verbiest W; Hertogs K; Ames M
  • Start Page

  • 579
  • End Page

  • 588
  • Volume

  • 16
  • Issue

  • 4