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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Antiretroviral agents and prevention of malaria in HIV-infected ugandan children
New England Journal of Medicine, Volume 367, No. 22, Year 2012
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Description
BACKGROUND: Human immunodeficiency virus (HIV) protease inhibitors show activity against Plasmodium falciparum in vitro. We hypothesized that the incidence of malaria in HIV-infected children would be lower among children receiving lopinavir-ritonavir-based antiretroviral therapy (ART) than among those receiving nonnucleoside reverse-transcriptase inhibitor (NNRTI)-based ART. METHODS:We conducted an open-label trial in which HIV-infected children 2 months to 5 years of age who were eligible for ART or were currently receiving NNRTI-based ART were randomly assigned to either lopinavir-ritonavir-based ART or NNRTI-based ART and were followed for 6 months to 2 years. Cases of uncomplicated malaria were treated with artemether-lumefantrine. The primary end point was the incidence of malaria. RESULTS: We enrolled 176 children, of whom 170 received the study regimen: 86 received NNRTI-based ART, and 84 lopinavir-ritonavir-based ART. The incidence of malaria was lower among children receiving the lopinavir-ritonavir-based regimen than among those receiving the NNRTI-based regimen (1.32 vs. 2.25 episodes per person-year; incidence-rate ratio, 0.59; 95% confidence interval [CI], 0.36 to 0.97; P = 0.04), as was the risk of a recurrence of malaria after treatment with artemether-lumefantrine (28.1% vs. 54.2%; hazard ratio, 0.41; 95% CI, 0.22 to 0.76; P = 0.004). The median lumefantrine level on day 7 after treatment for malaria was significantly higher in the lopinavir-ritonavir group than in the NNRTI group. In the lopinavir-ritonavir group, lumefantrine levels exceeding 300 ng per milliliter on day 7 were associated with a reduction of more than 85% in the 63-day risk of recurrent malaria. A greater number of serious adverse events occurred in the lopinavir-ritonavir group than in the NNRTI group (5.6% vs. 2.3%, P = 0.16). Pruritus occurred significantly more frequently in the lopinavir-ritonavir group, and elevated alanine aminotransferase levels significantly more frequently in the NNRTI group. CONCLUSIONS: Lopinavir-ritonavir-based ART as compared with NNRTI-based ART reduced the incidence of malaria by 41%, with the lower incidence attributable largely to a significant reduction in the recurrence of malaria after treatment with artemether-lumefantrine. Lopinavir-ritonavir-based ART was accompanied by an increase in serious adverse events. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT00978068.) Copyright © 2012 Massachusetts Medical Society.
Authors & Co-Authors
Achan, Jane
Uganda, Kampala
Makerere University College of Health Sciences
Kakuru, Abel
Uganda, Kampala
Makerere University College of Health Sciences
Ikilezi, Gloria
Uganda, Kampala
Makerere University College of Health Sciences
Ruel, Theodore D.
United States, San Francisco
University of California, San Francisco
Clark, Tamara D.
United States, San Francisco
Ucsf School of Medicine
Nsanzabana, Christian
United States, San Francisco
Ucsf School of Medicine
Charlebois, Edwin D.
United States, San Francisco
Ucsf School of Medicine
Aweeka, Francesca T.
United States, San Francisco
University of California, San Francisco
Dorsey, Grant M.
United States, San Francisco
Ucsf School of Medicine
Rosenthal, Philip Jon
United States, San Francisco
Ucsf School of Medicine
Havlir, Diane V.
United States, San Francisco
Ucsf School of Medicine
Kamya, Moses Robert K.
Uganda, Kampala
Makerere University College of Health Sciences
Statistics
Citations: 106
Authors: 12
Affiliations: 3
Identifiers
Doi:
10.1056/NEJMoa1200501
ISSN:
00284793
e-ISSN:
15334406
Research Areas
Environmental
Infectious Diseases
Maternal And Child Health
Study Design
Cohort Study