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Clin. Vaccine Immunol. doi:10.1128/CVI.00165-07
Copyright (c) 2008, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

IMMUNOLOGICAL RESPONSES AND LONG-TERM TREATMENT INTERRUPTION AFTER HIV-1 LIPOPEPTIDE IMMUNIZATION OF HIV-1-INFECTED PATIENTS : THE LIPTHERA STUDY

Tenon Hospital; Paris, France; Cochin Hospital, Paris, France; Cochin Institute, INSERM U567, Paris, France; Saint-Antoine Hospital, Paris, France; Université Pierre et Marie Curie – Paris VI, France; Saint-Louis Hospital, Paris, France

^* To whom correspondence should be addressed. Email: gilles.pialoux{at}tnn.aphp.fr.

	Abstract

Objectives: We studied the time course of immunological and virological markers after HAART interruption in chronically HIV-1-infected patients immunized with an HIV lipopeptide preparation.

Methods: In a prospective open pilot study, 24 HIV-1-infected HAART-treated patients with undetectable plasma viral load (pVL) and CD4⁺ T-cell counts above 350/mm³ were immunized at weeks 0, 3 and 6 with a candidate vaccine consisting of 6 HIV lipopeptides. At week 24, patients with pVL< 1.7 log₁₀ copies/mL were invited to stop taking HAART. Antiretroviral therapy was resumed if pVL rose above 4.47 log₁₀ copies/mL and/or if the CD4⁺ cell count fell below 250/mm³. Immunological and virologic parameters were studied before and after HAART interruption.

Results: The median baseline and nadir CD4+ cell counts were 482 (IQR: 195-826) and 313 (IQR: 1- 481)/mm³, respectively. New specific CD8⁺ cell responses to HIV-1 epitopes were detected after immunization in 13 (57%) of 23 assessable patients.

Twenty-one patients were evaluated 96 weeks after HAART interruption. The median time to pVL rebound was 4 weeks (IQR: 2-6), and the median peak pVL was 4.26 (IQR: 3-5) log₁₀ copies/mL. Thirteen of these 21 patients resumed HAART, a median of 60 weeks after immunization (IQR: 9.2-68.4), when the median pVL was 4.8 (2.9-5.7) log₁₀ cps/mL and the median CD4+ cell count was 551 (156-778)/mm³. Eight patients are still off therapy at 96 weeks, with a median pVL of 4 (IQR: 1.7-4.6) log₁₀ cps/mL and a median CD4+ cell count of 412 (IQR: 299-832)/mm³. No clinical disease progression has occurred.

Conclusions: Despite the lack of a control arm, these findings warrant a randomized study of therapeutic vaccination with HIV lipopeptides, followed by long-term HAART interruption, in AIDS-free chronically infected patients.