Effects of hydroxychloroquine on immune activation and disease progression among HIV-infected patients not receiving antiretroviral therapy: a randomized controlled trial

Paton, Nicholas I, Goodall, Ruth L, Dunn, David T, Franzen, Samuel, Collaco-Moraes, Yolanda, Gazzard, Brian G, Williams, Ian G, Fisher, Martin J, Winston, Alan, Fox, Julie, Orkin, Chloe, Herieka, Elbushra A, Ainsworth, Jonathan G, Post, Frank A, Wansbrough-Jones, Mark, Kelleher, Peter and The Hydroxychloroquine Trial Team, (2012) Effects of hydroxychloroquine on immune activation and disease progression among HIV-infected patients not receiving antiretroviral therapy: a randomized controlled trial. JAMA : Journal of the American Medical Association, 308 (4). pp. 353-361. ISSN 0098-7484

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Abstract

CONTEXT

Therapies to decrease immune activation might be of benefit in slowing HIV disease progression.

OBJECTIVE

To determine whether hydroxychloroquine decreases immune activation and slows CD4 cell decline.

DESIGN, SETTING, AND PATIENTS

Randomized, double-blind, placebo-controlled trial performed at 10 HIV outpatient clinics in the United Kingdom between June 2008 and February 2011. The 83 patients enrolled had asymptomatic HIV infection, were not taking antiretroviral therapy, and had CD4 cell counts greater than 400 cells/μL.

INTERVENTION

Hydroxychloroquine, 400 mg, or matching placebo once daily for 48 weeks.

MAIN OUTCOME MEASURES

The primary outcome measure was change in the proportion of activated CD8 cells (measured by the expression of CD38 and HLA-DR surface markers), with CD4 cell count and HIV viral load as secondary outcomes. Analysis was by intention to treat using mixed linear models.

RESULTS

There was no significant difference in CD8 cell activation between the 2 groups (-4.8% and -4.2% in the hydroxychloroquine and placebo groups, respectively, at week 48; difference, -0.6%; 95% CI, -4.8% to 3.6%; P = .80). Decline in CD4 cell count was greater in the hydroxychloroquine than placebo group (-85 cells/μL vs -23 cells/μL at week 48; difference, -62 cells/μL; 95% CI, -115 to -8; P = .03). Viral load increased in the hydroxychloroquine group compared with placebo (0.61 log10 copies/mL vs 0.23 log10 copies/mL at week 48; difference, 0.38 log10 copies/mL; 95% CI, 0.13 to 0.63; P = .003). Antiretroviral therapy was started in 9 patients in the hydroxychloroquine group and 1 in the placebo group. Trial medication was well tolerated, but more patients reported influenza-like illness in the hydroxychloroquine group compared with the placebo group (29% vs 10%; P = .03).

CONCLUSION

Among HIV-infected patients not taking antiretroviral therapy, the use of hydroxychloroquine compared with placebo did not reduce CD8 cell activation but did result in a greater decline in CD4 cell count and increased viral replication.

TRIAL REGISTRATION

isrctn.org Identifier: ISRCTN30019040.

Item Type: Article
Schools and Departments: Brighton and Sussex Medical School > Brighton and Sussex Medical School
Subjects: R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine > RA0643 Communicable diseases and public health > RA0644 Individual diseases or groups of diseases, A-Z > RA0644.A25 AIDS. HIV infections
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Depositing User: Ellen Thomas
Date Deposited: 25 Nov 2013 16:17
Last Modified: 25 Nov 2013 16:17
URI: http://sro.sussex.ac.uk/id/eprint/47073
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