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Published on: December 1, 2011
Growth patterns reflect response to antiretroviral therapy in HIV-positive infants: potential utility in
D K Benjamin1, W C Miller, R W Ryder
1Duke Clinical Research Institute, Durham, North Carolina 27715, USA. danny.benjamin@duke.edu
Insights
A clinical predictive model using physical exams can effectively monitor HIV progression in children, similar to costly lab tests. This approach offers a viable alternative for resource-limited settings.
Area of Science:
- Pediatric infectious diseases
- Clinical epidemiology
- HIV/AIDS research
Background:
- Laboratory monitoring guides antiretroviral therapy (ART) for HIV-infected children in the US.
- ART is expanding to developing countries, but costly lab monitoring poses challenges.
- Creative monitoring approaches are needed for resource-limited settings.
Purpose of the Study:
- To assess the utility of physical examinations in predicting clinical progression of HIV in children.
- To develop and evaluate a clinical predictive model for monitoring HIV progression.
- To compare the performance of the clinical model with HIV RNA viral load changes in diagnosing ART failure.
Main Methods:
- Retrospective cohort study using data from Pediatric AIDS Clinical Trials Group Protocol 300.
- Development of a clinical predictive model incorporating treatment regimen, age, and height velocity.
- Comparison of the clinical model's diagnostic utility against changes in HIV RNA viral load.
Main Results:
- A three-level clinical predictive model demonstrated significant likelihood ratios for predicting clinical progression.
- The clinical model's performance was comparable to using changes in HIV RNA viral load for diagnosing ART failure.
- The model was most relevant for children aged 36 months or younger on monotherapy or dual therapy.
Conclusions:
- A simple clinical predictive model can effectively predict HIV progression in children initiating ART.
- The physical examination-based model offers a cost-effective alternative to laboratory monitoring in resource-limited settings.
- Further international and prospective validation is recommended, especially considering diverse growth patterns in undernourished children.
Abstract:
Laboratory monitoring of HIV-infected children is the current standard of care in the United States to guide the appropriate use of antiretroviral therapy (ART). Although ART is becoming a reality in some developing countries, laboratory monitoring of ART is costly, necessitating creative approaches to monitoring. As an initial step to guide monitoring of HIV progression in low resource settings, we assessed the utility of the physical examination to predict clinical progression of HIV. We conducted a retrospective cohort study of HIV-infected children using data from Pediatric AIDS Clinical Trials Group Protocol 300. We developed a clinical predictive model, and compared the utility of the clinical model to the change in HIV RNA viral load as diagnostic tests of ART failure. The clinical model incorporated treatment regimen, age, and height velocity: a three-level clinical predictive model provided likelihood ratios of 0.3, 3.9, and 14. For decline in RNA the likelihood ratios were 0.2 (> 1 log decline), 1.4, and 3.5 (> log increase). We developed a simple clinical predictive model that was able to predict clinical progression of HIV after initiation of new ART. The clinical model performed similarly to using changes in HIV RNA viral load. These data should be validated internationally and prospectively, because the test subjects were from a resource rich environment and growth patterns in undernourished children may be impacted differently by HIV and its treatment. The model was most pertinent to children 36 months of age or younger, and was conducted in children receiving monotherapy and dual therapy.
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