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REMUNE® CLINICAL TRIALS IN THAILAND PROTOCOL 2101A
Full enrollment of 30 volunteers from the Ramathibodi Hospital was completed in February 1996. All subjects received four doses of HIV-1 Immunogen (REMUNE®) once a month for four months from March through June 1996. Study data was published in the medical journal Vaccine. Publication: Vaccine 1997. Vol. 16, No. 3, 142-149 Safety and Immunogenicity of REMUNE® in HIV-1 Infected Thai Subjects Anuwat Limsuwan, Vina Churdboonchart, Ronald B. Moss, Worachart Sirawaraporn, Reungpung Sutthent, Buranaj Smutharaks, David Glidden, Richard Trauger, Georgia Theofan and Dennis Carlo Abstract The safety and immunogenicity of REMUNE®, an HIV-specific immune based therapy for HIV infection, was evaluated in a cohort of 30 HIV infected subjects in Thailand. This therapy utilizes a gp120 depleted inactivated virus (HZ321), which exhibits a high degree of conservation with core antigens of both type B' and E strains of HIV, the predominant Thailand isolates. The treatment was well tolerated, with no serious adverse events reported over the course of the 4-month trial. Treatment in which four doses were administered with REMUNE® appeared to boost HIV-specific immune responses, with approximately 75% of the treated subjects demonstrating an increase in either the repertoire or the intensity of the serological response to HIV as measured by Western blot. CD4%, viral load, and weight remained stable over the course of the 4-month study relative to baseline values. Viral subtyping of this cohort revealed a predominance of type 'E'. These data suggest that REMUNE® is safe and immunogenic in seropositive Thai subjects and supports further study of the therapeutic potential of REMUNE® to treat HIV-1 infection.? 1997 Elsevier Science Ltd. All rights reserved PROTOCOL 2101A/F1 Extension: One-Year Follow Up Study Population 30 Volunteers previously enrolled in P2101A All 30 volunteers from the open-label safety and immunogenicity test (P2101A) were followed up to one year and given additional four doses of HIV-1 Immunogen (REMUNE®) at 3-month intervals, from Week 24 through Week 60. The findings of this extension study was published in the journal AIDS. Publication: AIDS 1998. Vol. 12:1521-1527 Effect of HIV-specific immune-based therapy in subjects infected with HIV-1 subtype in Thailand Vina Churdboonchart, Ronald B. Moss, Worachart Sirawaraporn, Buranaj Smutharaks, Reungpung Sutthent, Fred C. Jensen, Prawut Vacharak, Janet Grimes, Georgia Theofan and Dennis J. Carlo Abstract Objective: To examine the effect of treatment with an inactivated, gp120 depleted, HIV-1 immunogen (Remune) in 30 Thai subjects infected with HIV-1 subtype E. Design: Sixty-week open-label study. Methods: Thirty HIV-positive volunteers with CD4 cell counts > 300 x 106/l were given intramuscular injections of Remune into the triceps muscle on day 1 and then at weeks 4, 8, 12, 24, 36, 48 and 60. Results: Treatment with Remune was well-tolerated and augmented HIV-1 specific immune responses. Furthermore, subjects had a significant increase in CD4 cell count (P < 0.0001), CD4 cell percentage (P < 0.0001), CD8 cell percentage (P < 0.0001), and body weight (P < 0.0001) compared with pretreatment levels. Fourteen subjects with detectable viral load at day 1 showed a decrease at week 60 (P = 0.04). Retrospective Western blot analysis showed 23 subjects with increased intensity of antibody bands and 15 patients showed development of new reactivities to HIV proteins, especially towards p17 and p15. Conclusion: These results indicate that HIV-specific immune-based therapeutic approaches such as Remune should be further examined in countries with different clades of HIV-1 and where access to antiviral drug therapies is limited. ®1998 Lippincott-Raven Publishers | ||
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