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CD4/CD8 T-cell ratio predicts HIV infection in infants: the National Heart, Lung, and Blood Institute P2C2 Study.

ABSTRACT: BACKGROUND:In resource-poor regions of the world, HIV virologic testing is not available. OBJECTIVE:We sought to evaluate the diagnostic usefulness of the CD4/CD8 T-cell ratio in predicting HIV infection in infants. METHODS:Data from the 3- and 9-month visits for non-breast-fed infants born to HIV-infected mothers enrolled (1990-1994) in the Pediatric Pulmonary and Cardiac Complications of Vertically Transmitted HIV Infection Study (mother-to-child transmission of HIV, 17%) were analyzed. Data from the 3-month visit for infants enrolled (1985-1996) in the Perinatal AIDS Collaborative Transmission Study (mother-to-child transmission of HIV, 18%) were used for validation. RESULTS:At 3 months of age, data were available on 79 HIV-infected and 409 uninfected non-breast-fed infants in the Pediatric Pulmonary and Cardiac Complications of Vertically Transmitted HIV Infection Study. The area under the curve (AUC) of the receiver operating characteristic curve at 3 months was higher for the CD4/CD8 ratio compared with the CD4(+) T-cell count (AUC, 0.83 and 0.75; P = .03). The mean CD4/CD8 ratio at the 3-month visit was 1.7 for HIV-infected infants and 3.0 for uninfected infants. A CD4/CD8 ratio of 2.4 at 3 months of age was almost 2.5 times more likely to occur in an HIV-infected infant compared with an uninfected infant (test sensitivity, 81%; posttest probability of HIV, 33%). Model performance in the Centers for Disease Control and Prevention Perinatal AIDS Collaborative Transmission Study validation test (224 HIV-infected and 1015 uninfected 3-month-old infants) was equally good (AUC, 0.78 for CD4/CD8 ratio). CONCLUSION:The CD4/CD8 T-cell ratio is a more sensitive predictor of HIV infection in infants than the CD4(+) T-cell count. CLINICAL IMPLICATIONS:The CD4/CD8 T-cell ratio can be used with caution to predict HIV infection in children.

SUBMITTER: Shearer WT

PROVIDER: S-EPMC4271194 | biostudies-literature | 2007 Dec

REPOSITORIES: biostudies-literature

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CD4/CD8 T-cell ratio predicts HIV infection in infants: the National Heart, Lung, and Blood Institute P2C2 Study.

Shearer William T WT Pahwa Savita S Read Jennifer S JS Chen Jian J Wijayawardana Sameera R SR Palumbo Paul P Abrams Elaine J EJ Nesheim Stephen R SR Yin Wanrong W Thompson Bruce B Easley Kirk A KA

The Journal of allergy and clinical immunology 20071017 6

<h4>Background</h4>In resource-poor regions of the world, HIV virologic testing is not available.<h4>Objective</h4>We sought to evaluate the diagnostic usefulness of the CD4/CD8 T-cell ratio in predicting HIV infection in infants.<h4>Methods</h4>Data from the 3- and 9-month visits for non-breast-fed infants born to HIV-infected mothers enrolled (1990-1994) in the Pediatric Pulmonary and Cardiac Complications of Vertically Transmitted HIV Infection Study (mother-to-child transmission of HIV, 17%) ...[more]

PMID: 17920669

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Project description:BACKGROUND:Rapid publication of clinical trials is essential in order for the findings to yield maximal benefits for public health and scientific progress. Factors affecting the speed of publication of the main results of government-funded trials have not been well characterized. METHODS:We analyzed 244 extramural randomized clinical trials of cardiovascular interventions that were supported by the National Heart, Lung, and Blood Institute (NHLBI). We selected trials for which data collection had been completed between January 1, 2000, and December 31, 2011. Our primary outcome measure was the time between completion of the trial and publication of the main results in a peer-reviewed journal. RESULTS:As of March 31, 2012, the main results of 156 trials (64%) had been published (Kaplan-Meier median time to publication, 25 months, with 57% published within 30 months). Trials that focused on clinical events were published more rapidly than those that focused on surrogate measures (median, 9 months vs. 31 months; P<0.001). The only independent predictors of more rapid publication were a focus on clinical events rather than surrogate end points (adjusted publication rate ratio, 2.11; 95% confidence interval, 1.26 to 3.53; P=0.004) and higher costs of conducting the trial, up to a threshold of approximately $5 million (P<0.001). The 37 trials that focused on clinical events and cost at least $5 million accounted for 67% of the funds spent on clinical trials but received 82% of the citations. After adjustment of the analysis for a focus on clinical events and for cost, trial results that were classified as positive were published more quickly than those classified as negative. CONCLUSIONS:Results of less than two thirds of NHLBI-funded randomized clinical trials of cardiovascular interventions were published within 30 months after completion of the trial. Trials that focused on clinical events were published more quickly than those that focused on surrogate end points. (Funded by the National Heart, Lung, and Blood Institute.).

Dataset Information

CD4/CD8 T-cell ratio predicts HIV infection in infants: the National Heart, Lung, and Blood Institute P2C2 Study.

Publications

CD4/CD8 T-cell ratio predicts HIV infection in infants: the National Heart, Lung, and Blood Institute P2C2 Study.

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