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Issues in the design of trials comparing management strategies for heavily pretreated patients

Andrew N Phillips1, Cal Cohen, Jens D Lundgren

  • 1Royal Free Centre for HIV Medicine and Department of Primary Care and Population Sciences, Royal Free and University College Medical School, London, UK. a.phillips@pcps.ucl.ac.uk

Current Opinion in HIV and AIDS
|April 18, 2009
PubMed
Abstract

Insights

For heavily pretreated patients with drug-resistant HIV, treatment interruptions are harmful. Genotypic resistance testing aids in selecting new regimens, but optimal management strategies require further research.

Area of Science:

  • Antiviral Therapy Research
  • HIV Management Strategies
  • Drug Resistance Studies

Background:

  • Optimal management for heavily pretreated HIV patients with multidrug resistance and unattainable viral suppression is unclear.
  • Previous trials focused on treatment interruptions, multidrug regimens, or resistance testing for regimen selection.

Purpose of the Study:

  • To review current strategies for managing HIV patients with multidrug resistance.
  • To identify challenges and future directions for clinical trials in this patient population.

Main Methods:

  • Review of existing literature on strategic management approaches for drug-resistant HIV.
  • Analysis of trial outcomes related to treatment interruptions, multidrug regimens, and genotypic resistance testing.

Main Results:

  • Treatment interruption before a new regimen increases the risk of clinical disease compared to no interruption.
  • Multidrug ('mega-highly active antiretroviral therapy') regimens have not definitively improved overall outcomes.
  • Genotypic resistance testing is a valuable tool for selecting new antiretroviral regimens.

Conclusions:

  • Designing future trials for drug-resistant HIV management faces challenges in strategy generalizability, endpoint selection, and trial flexibility.
  • Further research is needed to establish optimal, adaptable management strategies for these complex cases.

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