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Mahidol University Annual Research Abstracts

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Flight Booking ¹Dept. of Pathobiology and Dept. of Biochemistry, Faculty of Science, Mahidol University, Bangkok, Thailand; ²Dept. of Medicine, Faculty of Medicine, Khon Kaen University Hospital, Khon Kaen, Thailand; ³Dept. of Medicine, BMA Medical College and Vajira Hospital, Bangkok, Thailand; ⁴Obstetrics and Gynaecology Dept., Pramongkut College of Medicine, Pramonkutklao Hospital, Bangkok, Thailand; ⁵Dept. of Obstetrics and Gynecology, Prince of Songkla University, Songkla, Thailand; ⁶Dept. of Obstetrics and Gynecology, Chiang Mai University, Chiang Mai, Thailand; ⁷Dept. of Biostatistics, Mahidol University, Bangkok, Thailand; ⁸The Immune Response Corporation, California, USA

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Travel Agent Key words : immune-based therapy

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Hotel Chicago                     The second clinical trial to examine the effect of HIV-1 Immunogen (Remune^TM) in Thailand started in 1997. A 40-week trial was conducted in 297 symptomatic HIV-infected volunteers with CD4 cell count at screening greater than 300cells/mm³. Subjects were divided equally into 9 cohorts and randomized at 2:1 ratio to receive either Remune or Incomplete Freunds Adjuvant (IFA) as placebo control at 0,12,24 and 36 weeks in 5 university hospitals. The primary endpoint for the trial was changes in CD4 cell counts with secondary parameters of changes in CD8 cell count, %CD4, %CD8, %CD4/%CD8 and body weight. A subset of subjects were examined for changes in plasma HIV-1 RNA, humoral antibodies by Western blot analysis and HIV-1 delayed-type hypersensitivity (DTH) skin reactivity. At Week 40, CD4 cells of Remune-treated subjects showed a significant increase by an average of 84 cells while IFA group increased by 38 cells, AUCMB (p< .05). Significant increases were found in both humoral immunity (p=.001) and cellular immunity by DTH skin test (p= .042) while the other endpoint remained stable at Week 40. At Week 88, 68 subjects on Remune only (total maximum of 8 doses) remained healthy with no opportunistic infection observed. Twenty subjects (29.5%) showed a significant decrease in viral load with an average decline of 0.99 log with increasing body weight, increasing ratio of CD4+ to CD8 percent. Thirty-nine subjects (57.3%) had viral load at stable level (between -.5 to +.5 log_n), and only 9 subjects showed increased viral load by more than 0.5 log_n. From these results, we propose the treatment of asymptomatic HIV+ subjects with HIV-1 Immunogen alone and add antiretroviral drugs only in the case of non-responders.

Online Booking (An International Conference on HIV Vaccines An Annual Update 2000 March 20-24 2000, Siam City Hotel, Bangkok, Thailand.)

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London Hotel Booking   CLINICAL INVESTIGATIONS OF SUBJECTS TREATED WITH REMUNE^TM
  (NO. 664)

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Orlando Hotel Sukeepaisarncharoen, Wisut¹, Churdboonchart, Vina², Sakondhavat, Chuanchom¹, Kulpradist, Sang-a-roon³, Isarangkura Na Ayudthya, Boonsri⁴, Boonshuyar, Chaweewon⁵, Sirawaraporn, Worachart¹, Carlo, Dennis J.⁶, and Ronald B. Moss⁶

Booking Agency 1Dept. of Medicine, Faculty of Medicine, Khon Kaen University Hospital, Khon Kaen, Thailand; 2Dept. of Pathobiology and Dept. of Biochemistry, Faculty of Science, Mahidol University, Bangkok, Thailand; 3Dept. of Medicine, BMA Medical College and Vajira Hospital, Bangkok, Thailand; 4Obstetrics and Gynaecology Dept., Pramongkut College of Medicine, Pramonkutklao Hospital, Bangkok, Thailand; 5Dept. of Biostatistics, Mahidol University, Bangkok, Thailand; 6Dept. of Obstetrics and Gynecology, Prince of Songkla University, Songkla, Thailand; 7Dept. of Obstetrics and Gynecology, Chiang Mai University, Chiang Mai, Thailand; 8The Immune Response Corporation, California, USA

International Travel Medical Key words : immune-based therapy

New York Hotel                     Examining volunteers at Week 88 after about 2 years seeing each volunteer on the Remune trial, a promising evidence is found. The data also obtained before unblinding. The physical scores using Karnofsky is still 100%. At Week 40, no significant difference in the physical examination results between the two groups was observed. Out of 99 subjects in three cohorts of 33 subjects each, there were 5 dropouts by Week 40 and another 8 no-shows or discontinued by Week 88. Eighteen (18) subjects were selected to receive antiretroviral drugs. Ten subjects were put on a 3-drug regimen (HAART) + Remune and 8 were given a 2-drug regimen + Remune. The remaining 68 subjects were treated with Remune alone. The Wilcoxon Signed Rank test revealed significant differences on absolute CD4 cells (Wk 40 p=.027 and Wk 88 p=.006), body weight (Wk40 p=.007 and Wk88 p=.005), and viral load (log_n Wk40 p=.023; Wk88 p=.054). Blood chemistries especially for liver and kidney functions were within normal acceptable range at Week 40 and at Week 88. Pap test for female subjects was normal. There was no difference in the rates of new diagnoses between the two groups (p =0.474). At Week 40, adverse events noted were only mild local reactions in the injection site (redness, pain and swelling) unrelated to the vaccine and regularly found with vaccine immunizations.

Online Travel Booking (An International Conference on HIV Vaccines An Annual Update 2000 March 20-24, 2000, Siam City Hotel, Bangkok, Thailand.)

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Air Deccan Booking   DATA FROM A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY IN
  THAILAND EXAMI-NING THE EFFECT OF REMUNE AS A MONO-THERAPY
  (NO. 665)

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Las Vegas Nv Hotel Churdboonchart, Vina¹ and Ronald B. Moss²

Hotel Florence Booking Online ¹Dept. of Pathobiology, Faculty of Science, Mahidol University, Bangkok, Thailand; ²The Immune Response Corporation, California, USA

Orlando Travel Key words : immune based monotherapy

Hilton Hotel                     This study was conducted at five leading university hospitals with 297 HIV+ asymptomatic volunteers with CD4+ cell count > 300 cells/mm³. Subjects were divided into nine cohorts and randomized to receive Remune or IFA at 2:1 ratio at 12-week intervals. The two groups, Remune and IFA, were balanced in terms of baseline characteristics. Four weeks after the fourth dose (at Week 40), complete analysis of data was done. All subjects were then followed for one year and given Remune every 12 weeks beginning at Week 48. Subjects were given the option to continue receiving the same Remune regimen for up to two years.

Booking Delta Com                     The primary endpoint for this study is the average change in CD4 cell count.Overall, the Remune group increased by 84 cells while the IFA group increased by 38 cells. We believe that IFA may have had a non-specific immune stimulation besides the psychological effects and benefit from counseling. The Area Under the Curve analysis favored the Remune over the IFA group (p < 0.05). Another im-

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