Virologic and regimen termination surrogate end points in AIDS clinical trials

P B Gilbert ¹, V DeGruttola , S M Hammer

⁰Department of Biostatistics, Harvard School of Public Health, 655 Huntington Ave, Boston, MA 02115, USA. pgilbert@hsph.harvard.edu

Jama +

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February 15, 2001

View abstract on PubMed

Summary

Measuring human immunodeficiency virus (HIV) RNA suppression is common, but composite end points better capture treatment costs like drug resistance and toxicity. Choosing the right end point depends on trial goals.

Area Of Science

Virology
Clinical Trials
Pharmacology

Background

Plasma human immunodeficiency virus (HIV) RNA levels are a common surrogate for disease progression in antiretroviral therapy trials.
This virologic end point may not fully account for treatment-related toxicities or the development of multidrug resistance, impacting future therapeutic options.

Purpose Of The Study

To discuss the advantages and disadvantages of using purely virologic end points versus composite regimen termination end points in HIV clinical trials.
To evaluate the suitability of different primary end points for assessing antiretroviral therapy efficacy and patient outcomes.

Main Methods

Comparative analysis of purely virologic end points and composite regimen termination end points.
Discussion of pros and cons for each end point type in the context of HIV disease progression and treatment.

Main Results

Purely virologic end points, while useful, do not always reflect critical treatment consequences like drug resistance or toxicity.
Composite end points, incorporating virologic failure or treatment-related regimen changes, offer a broader assessment of treatment costs.

Conclusions

The selection of a primary end point should align with the specific clinical objectives of the trial.
While a purely virologic end point is often preferred, analyzing both virologic and composite end points can provide a more comprehensive interpretation of study results.
Further long-term clinical outcome studies are necessary to identify the most predictive surrogate end points for HIV treatment efficacy.

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