Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
Initial studies on active immunization of HIV-infected subjects using a gp120-depleted HIV-1 Immunogen: long-term follow-up.
J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Apr 1;11(4):351-64. Unique Identifier : AIDSLINE MED/96183598 Levine AM; Groshen S; Allen J; Munson KM; Carlo DJ; Daigle AE; Ferre F; Jensen FC; Richieri SP; Trauger RJ; Parker JW; Salk PL; Salk J; Division of Hematology, Department of Medicine, University of; Southern California School of Medicine, Los Angeles, USA.
Abstract:
In 1987, exploratory clinical studies were initiated to determine whether the development of AIDS in HIV-infected individuals might be delayed or prevented by immunization with an inactivated HIV preparation. Preclinical studies had shown the preparation to be safe and immunogenic. Twenty-three patients with biopsy-confirmed persistent generalized lymphadenopathy (CDC III) and two with asymptomatic HIV infection and CD4 lymphocyte counts between 135 and 769/mm3 were studied, of whom eight (32%) had additional HIV-related symptoms. Over a 3-year period, they received a median of eight open-label inoculations of 100 micrograms of inactivated gp 120-depleted HIV-1 Immunogen in incomplete Freund's adjuvant (IFA). Clinical, general laboratory, immunologic, and virologic parameters were followed for up to 6 years. No serious treatment-related adverse experiences were reported, nor was accelerated HIV disease progression seen. Twelve patients developed a delayed-type hypersensitivity response (HIV-DTH) to the immunogen and nine showed fourfold or greater increases in anti-p24 antibody titers. In the follow-up period, 10 of the 25 patients developed AIDS and one with Kaposi's sarcoma (KS) at baseline progressed. Of the 12 patients who became HIV-DTH-responsive, one developed an opportunistic infection (OI), occurring approximately 5 years from study onset, and subsequently died. One additional HIV-DTH responder developed KS. Of the 13 patients who remained HIV-DTH-nonresponsive, nine (69%) progressed to AIDS and seven of these have died. Differences were also observed in terms of HIV-DNA copy number, CD4 percentages, and anti-p24 antibody patterns between the HIV-DTH-responsive and -nonresponsive groups, suggesting a more favorable clinical course in the former. HIV-1 Immunogen in IFA appears to be safe and immunogenic. Further studies are indicated to determine clinical efficacy of the HIV Immunogen as well as the significance of the apparent correlation between HIV-DTH responsivity and a more favorable clinical course.
Keywords: Adult AIDS Vaccines/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE CD4 Lymphocyte Count Disease Progression DNA, Viral/BLOOD Follow-Up Studies Human Hypersensitivity, Delayed HIV Antibodies/BLOOD HIV Core Protein p24/BLOOD HIV Envelope Protein gp120 HIV Infections/IMMUNOLOGY/*THERAPY/VIROLOGY HIV-1/*IMMUNOLOGY/ISOLATION & PURIF *Immunotherapy, Active Intradermal Tests Male Middle Age Vaccines, Inactivated/ADMINISTRATION & DOSAGE/THERAPEUTIC USE CLINICAL TRIAL JOURNAL ARTICLE 960730
M9670467
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Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
