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Brief Report: Safety of Frequent Blood Sampling in Research Participants in an Acute HIV Infection Cohort in Thailand.

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 was initiated on 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 Division of AIDS (National Institute of Allergy and Infectious Diseases) 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, it was 13.0 g/dL. Over 48 weeks, there was a mean increase of 0.2 g/dL among men (P = 0.01) and a decrease of 0.7 g/dL among women (P = 0.03). The overall prevalence of anemia was low, with 7 (3.5%) of 202 fulfilling grade 1 or 2 anemia criteria. CONCLUSIONS:Anemia was rare after frequent phlebotomy in research participants with AHI, before and after antiretroviral therapy. 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.

SUBMITTER: Sacdalan C

PROVIDER: S-EPMC5553234 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Brief Report: Safety of Frequent Blood Sampling in Research Participants in an Acute HIV Infection Cohort in Thailand.

Sacdalan Carlo C Crowell Trevor T Colby Donn D Kroon Eugène E Chan Phillip P Pinyakorn Suteeraporn S Chomchey Nitiya N Prueksakaew Peeriya P Puttamaswin Suwanna S Chintanaphol Michelle M Cheng Theresa T Phanuphak Nittaya N Ananworanich Jintanat J

Journal of acquired immune deficiency syndromes (1999) 20170901 1

<h4>Introduction</h4>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.<h4>Objective</h4>The objective of this study was to describe baseline and longitudinal hemoglobin changes among participants with AHI.<h4>Methods</h4>Participants with AHI (n = 202) were enro ...[more]

PMID: 28452910

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Project description:BackgroundHematological malignancies have continued to be highly prevalent among people living with HIV (PLHIV). This study assessed the occurrence of, risk factors for, and outcomes of hematological and nonhematological malignancies in PLHIV in Asia.MethodsIncidence of malignancy after cohort enrollment was evaluated. Factors associated with development of hematological and nonhematological malignancy were analyzed using competing risk regression and survival time using Kaplan-Meier.ResultsOf 7455 patients, 107 patients (1%) developed a malignancy: 34 (0.5%) hematological [0.08 per 100 person-years (/100PY)] and 73 (1%) nonhematological (0.17/100PY). Of the hematological malignancies, non-Hodgkin lymphoma was predominant (n = 26, 76%): immunoblastic (n = 6, 18%), Burkitt (n = 5, 15%), diffuse large B-cell (n = 5, 15%), and unspecified (n = 10, 30%). Others include central nervous system lymphoma (n = 7, 21%) and myelodysplastic syndrome (n = 1, 3%). Nonhematological malignancies were mostly Kaposi sarcoma (n = 12, 16%) and cervical cancer (n = 10, 14%). Risk factors for hematological malignancy included age >50 vs. ≤30 years [subhazard ratio (SHR) = 6.48, 95% confidence interval (CI): 1.79 to 23.43] and being from a high-income vs. a lower-middle-income country (SHR = 3.97, 95% CI: 1.45 to 10.84). Risk was reduced with CD4 351-500 cells/µL (SHR = 0.20, 95% CI: 0.05 to 0.74) and CD4 >500 cells/µL (SHR = 0.14, 95% CI: 0.04 to 0.78), compared to CD4 ≤200 cells/µL. Similar risk factors were seen for nonhematological malignancy, with prior AIDS diagnosis showing a weak association. Patients diagnosed with a hematological malignancy had shorter survival time compared to patients diagnosed with a nonhematological malignancy.ConclusionsNonhematological malignancies were common but non-Hodgkin lymphoma was more predominant in our cohort. PLHIV from high-income countries were more likely to be diagnosed, indicating a potential underdiagnosis of cancer in low-income settings.

Dataset Information

Brief Report: Safety of Frequent Blood Sampling in Research Participants in an Acute HIV Infection Cohort in Thailand.

Publications

Brief Report: Safety of Frequent Blood Sampling in Research Participants in an Acute HIV Infection Cohort in Thailand.

Similar Datasets

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