AEGiS-14IAC: Therapeutic immunization with an inactivated HIV-1 immunogen in naïve patients initiating antiretroviral treatment: final results of a phase II, double-blind, placebo-controlled study.

3. Subjects were randomised to receive an immunoge" /> AEGiS-14IAC: Therapeutic immunization with an inactivated HIV-1 immunogen in naïve patients initiating antiretroviral treatment: final results of a phase II, double-blind, placebo-controlled study.

14th International AIDS Conference

Barcelona, Spain - July 7-12, 2002

Therapeutic immunization with an inactivated HIV-1 immunogen in naïve patients initiating antiretroviral treatment: final results of a phase II, double-blind, placebo-controlled study.

Int Conf AIDS 2002 Jul 7-12; 14:(abstract no. LbPeA9004)

Moreno S, Gonzalez-Lahoz J, Perez-Molina JA, Pena JM, Rubio R, Podzamczer D, Clotet V, Viciana P, Maradona JA, Blazquez, Barros, Ocana I, Quereda C, Gatell JM, Fernandez-Cruz E
Hospital Ramon y Cajal, Madrid, Spain

BACKGROUND: To date, no clinical study has shown virological efficacy of an HIV-1 therapeutic vaccine.

METHODS: Multicenter, double-blind clinical trial in asymptomatic, HIV-infected adults, with no prior antiretroviral therapy and with CD4 counts between 300 and 700/mm³. Subjects were randomised to receive an immunogen (Remune) or placebo. All the patients began therapy with a 2 drug regimen that could be switched to a fixed 3 drug regimen according to predefined criteria. Primary efficacy endpoints were virological and/or immunological failure.

RESULTS: Among 243 patients enrolled, 118 and 121 were followed in the Remune and IFA groups, respectively. A similar proportion of patients in the two groups were switched to HAART (51% Remune, 52% IFA) and had similar compliance. A primary endpoint was reached in 85 (36%) subjects (30% in the Remune and 41% in the placebo group). Cox analysis showed a significant reduction in the risk of developing virological failure in patients receiving the immunogen when controlling for baseline viral load (RR 0.63, 95%CI 0.41-0.97, p=0.034), or for baseline viral load and CD4 cell count strata (RR 0.62, 95%CI 0.40-0.95, p=0.029). Of special note, the immunogen elicited significantly higher levels of HIV-1 gag/pol-specific CTL precursors that correlated negatively with viral load (R=-0.58, p<0.05). None of the Remune-treated patients who developed high levels of CTL precursors had virological failure (p<0.001). The imunogen was well tolerated, with no discontinuations due to adverse events.

CONCLUSIONS: This study shows for the first time that the addition of an HIV-1 immunogen to antiretroviral therapy confers a beneficial effect on virological suppression, most likely by enhancing specific antiviral immune responses.

Keywords: AEGIS, HIV-1, AIDS Vaccines, Immunization, CD4 Lymphocyte Count, Vaccination, HIV Infections, Viral Load, Antiretroviral Therapy, Highly Active, Double-Blind Method, HIV Seropositivity, HIV Envelope Protein gp120, Clinical Trials, Antigens, Clinical Trials, Phase I, remune, Adult, Human, therapy, immunology, virology, drug therapy

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