Publication: Long-term follow-up of HIV-1-infected Thai patients immunized with remune monotherapy
Issued Date
2001-01-01
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ISSN
15284336
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2-s2.0-0034795426
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Mahidol University
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SCOPUS
Bibliographic Citation
HIV Clinical Trials. Vol.2, No.5 (2001), 391-398
Suggested Citation
W. Sukeepaisarncharoen, V. Churdboonchart, S. Kulpradist, B. I. Na Ayudthya, S. Rugpao, V. Chandeying, W. Sirawaraporn, D. Carlo, R. B. Moss Long-term follow-up of HIV-1-infected Thai patients immunized with remune monotherapy. HIV Clinical Trials. Vol.2, No.5 (2001), 391-398. doi:10.1310/Q5XX-A5CH-XTB9-FN33 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/26863
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Title
Long-term follow-up of HIV-1-infected Thai patients immunized with remune monotherapy
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Abstract
Purpose: The purpose of this 2-year follow-up study was to investigate the long-term effect of Remune as monotherapy for HIV-1 infection. Background: Participants previously enrolled in the phase II double-blind, randomized, adjuvant-controlled study of the HIV-1 Immunogen (Remune) were followed for 2 years. Open-label immunization with Remune monotherapy was given to each participant every 12 weeks. Remune, a gp 120-depleted HIV-1 that was inactivated in beta-propiolactone and irradiation, was emulsified with mineral oil (incomplete Freund's adjuvant). Method: In Study 2101B, the effect of four doses of Remune given every 12 weeks over 40 weeks was compared to placebo in 297 asymptomatic type E HIV-infected patients [Churdboonchart et al., 2000]. A group of 17 volunteers were separated into a subset study and another 57 were excluded from analysis due to discontinuation or addition of other treatments. This 2-year follow-up study continued with open-label dosing of HIV-1 Immunogen every 12 weeks for the remaining 223 patients. Changes in CD4+ cells, CD8+ cells, and body weight were monitored at each patient visit. Results: Overall, immunizations were safe; common adverse events were tolerable injection site reactions. CD4+ T-cell counts remained stable over the 132-week observation period for this cohort with a slight increase of 36.01 cells/μL. CD8+ T-cell counts showed an increase from baseline during the follow-up period (415.21 cells/μL). Furthermore, we also observed an increase in body weight from baseline (1.08 kg) at week 132. In addition, baseline CD4 count appeared to predict CD4 count at week 132 (slope = 0.31, p < .0001). Conclusion: These results suggest that long-term treatment of HIV-1 infection with Remune monotherapy is safe and results in a stabilization of CD4+ counts. Furthermore, it is likely that HIV-1 therapeutic immunization may show its greatest clinical benefit in participants with higher CD4+ cell counts. Such an approach may have important ramifications in developing countries where access to antiviral drugs is limited and also in early chronic HIV-1 infection when CD4+ cells are still over 300 cells/μL in order to limit the cost and toxicity.