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Brief Report: Safety of frequent blood sampling in research participants in an acute HIV infection cohort in Thailand.

Brief Report: Safety of frequent blood sampling in research participants in an acute HIV infection cohort in Thailand.
Author Information (click to view)

Sacdalan C, Crowell TA, Colby DJ, Kroon E, Chan P, Pinyakorn S, Chomchey N, Prueksakaew P, Puttamaswin S, Chintanaphol M, Cheng T, Phanuphak N, Ananworanich J, ,


Sacdalan C, Crowell TA, Colby DJ, Kroon E, Chan P, Pinyakorn S, Chomchey N, Prueksakaew P, Puttamaswin S, Chintanaphol M, Cheng T, Phanuphak N, Ananworanich J, , (click to view)

Sacdalan C, Crowell TA, Colby DJ, Kroon E, Chan P, Pinyakorn S, Chomchey N, Prueksakaew P, Puttamaswin S, Chintanaphol M, Cheng T, Phanuphak N, Ananworanich J, ,

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Journal of acquired immune deficiency syndromes (1999) 2017 04 26() doi 10.1097/QAI.0000000000001436

Abstract
INTRODUCTION
Anemia is a potential adverse effect of phlebotomy during participation in research. Clinical studies of acute HIV infection (AHI) require frequent phlebotomy to maximize scientific yield, but this participant population may also be at increased risk for anemia and other adverse events.

OBJECTIVE
The objective of this study was to describe baseline and longitudinal hemoglobin changes among participants with AHI.

METHODS
Participants with AHI (n=202) were enrolled in a prospective cohort study in Thailand. AHI was diagnosed using pooled nucleic acid testing and sequential HIV antibody immunoassays. Antiretroviral therapy (ART) was initiated upon enrollment. During 48 weeks of study participation, a total of 629 ml of blood was drawn over 14 visits. Hemoglobin levels were measured serially and abnormalities were graded using the DAIDS adverse event table.

RESULTS
AHI was diagnosed at a median of 18 days after infection. Mean hemoglobin at enrollment of male participants was 14.8 g/dL and for females was 13.0 g/dL. Over 48 weeks, there was a mean increase of 0.2 g/dL among males (p=0.01) and a decrease of 0.7 g/dL among females (p=0.03). The overall prevalence of anemia was low, with 7 (3.5%) of 202 fulfilling grade 1 or 2 anemia criteria.

CONCLUSION
Anemia was rare after frequent phlebotomy in research participants with AHI, before and after ART. Given that the blood volume drawn from this study did not pose substantial clinical risk, increasing the volume of blood drawn for research purposes in acute HIV-infected research participants could be considered for future studies.

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