Biomedical subjects

W Sukeepaisarncharoen

Publications and source records attributed to W Sukeepaisarncharoen.

6 recordsLinked to original sources

PubMed2004

Delayed progression to AIDS in volunteers treated with long-term HIV-1 Immunogen (REMUNE) therapy in Thailand.

OBJECTIVES: To observe the long-term effects of an immune-based therapy HIV-1 Immunogen (REMUNE; Immune Response Corp., Carlsbad, CA, USA) as a first course of treatment designed to sustain the immune system and thus delay the initiation of therapy with antiretroviral drugs and/or delay disease progression. METHODS: In this open-label, multi-institute extended phase II P2101B study, disease progression, CD4 and CD8 T-cell counts, HIV-1 RNA levels, and genotypic antiretroviral drug resistance were examined in 223 asymptomatic HIV-1-infected Thai volunteers receiving REMUNE every 12 weeks over 132 weeks. A subset of subjects was randomly selected by the physicians to receive antiretroviral drugs for 10 months. RESULTS: Patients treated with REMUNE demonstrated a low rate of clinical disease progression (0.72 per 100 person-years), higher CD4 and CD8 T-cell counts, higher body weight before and after treatment in the same patient, and stable viral load with no serious adverse events. We found no genotypic evidence of drug resistance in subgroups of patients on REMUNE monotherapy or REMUNE plus antiretrovirals (ARTs). CONCLUSIONS: This Thai study, like previous US and European studies, confirms that therapeutic immunization of HIV-infected volunteers modifies disease progression, as evidenced by stabilization of CD4 and CD8 T-cell counts, body weight, and viral load. As the majority of asymptomatic patients demonstrated an objective response to immunization, this study suggests that REMUNE may be utilized prior to initiation of antiviral drug therapy when CD4 cell counts are still above the current ART guidelines. Further work should be carried out to examine its potential use in combination with ART in order to reduce the increasingly common occurrence of drug resistance.

AIDS Vaccines↗

PubMed2000

A double-blind, adjuvant-controlled trial of human immunodeficiency virus type 1 (HIV-1) immunogen (Remune) monotherapy in asymptomatic, HIV-1-infected thai subjects with CD4-cell counts of >300.

We examined the effect of a human immunodeficiency virus (HIV)-specific immune-based therapy in Thailand, where access to antiviral drug therapy is limited. A 40-week trial was conducted with 297 asymptomatic, HIV-infected Thai subjects with CD4-cell counts greater than 300 microl/mm(3). Subjects were randomized to receive either HIV type 1 (HIV-1) immunogen (Remune; inactivated HIV-1 from which gp120 is depleted in incomplete Freund's adjuvant or adjuvant control at 0, 12, 24, and 36 weeks at five different clinical sites in Thailand. Neither group received antiviral drug therapy. The a priori primary endpoint for the trial was changes in CD4-cell counts with secondary parameters of percent changes in CD8-cell counts (percent CD4, CD8, and CD4/CD8) and body weight. Subsets of subjects were also examined for changes in plasma HIV-1 RNA levels, Western blot immunoreactivity, and HIV-1 delayed-type hypersensitivity (DTH) skin test reactivity. There was a significant difference in changes in CD4-cell counts that favored the HIV-1 immunogen-treated group compared to those for the adjuvant-treated control group (P<0.05). On average, for HIV-1 immunogen-treated subjects CD4-cell counts increased by 84 cells by week 40, whereas the increase for the control group was 38 cells by week 40. This increase in CD4-cell count was associated with increased HIV-specific immunogenicity, as shown by Western blotting and enhanced HIV-1 DTH skin reactivity. No significant differences in adverse events were observed between the groups. The results of this trial suggest that HIV-1 immunogen is safe and significantly increases CD4-cell counts and HIV-specific immunity compared to those achieved with the adjuvant control in asymptomatic HIV-1-infected subjects not taking antiviral drugs.

AIDS Vaccines↗

PubMed1997

Comparison of amphotericin B, flucytosine and itraconazole with amphotericin B and flucytosine in the treatment of cryptococcal meningitis in AIDS.

We compared amphotericin B (0.3 mg/kg/d) plus flucytosine (150 mg/kg/d) plus itraconazole (400 mg/d) (study group) with amphotericin B plus flucytosine (control group) by an open-randomized trial. In the study group, after CSF mycological cultures disclosed nothing, itraconazole was administrated alone through six weeks of treatment. Treatment was considered successful if the patient had two consecutive negative CSF cultures by the end of the 6-week treatment period. Fifty patients were enrolled in each group. There were significant differences between the study group and the control group in the successful treatment (100% vs 90%; P = 0.03), the mean length of time until normal body temperature after treatment (5.9 +/- 3.7 days vs 8.8 +/- 5.1 days; P = 0.02) and the adverse effects. The mean length of time to the first negative CSF culture was 13.9 +/- 6.1 days in the study group and 13.3 +/- 6.5 days in the control group (P = 0.66). Relapse rate with itraconazole 200 mg/day was higher in the study group.

AIDS-Related Opportunistic Infections↗

PubMed1997

Maintenance therapy with itraconazole after treatment of cryptococcal meningitis in the acquired immunodeficiency syndrome.

We conducted a prospective, open trial to establish the efficacy of itraconazole 400 mg/d as maintenance treatment for cryptococcal meningitis in AIDS patients. Between February 1996 and May 1997, 50 patients were included for analysis. After a mean follow-up of 326 days, 2 of 38 patients (5.3 per cent) had relapses of symptomatic cryptococcal meningitis. Hepatotoxicity occurred in 2 cases. In conclusion, maintenance therapy with itraconazole 400 mg/d is effective in preventing recurrent cryptococcal meningitis.

AIDS-Related Opportunistic Infections↗

PubMed1996

Burkholder meningitis.

We report two cases of Burkholder meningitis. Case 1 presented with subacute lymphocytic meningitis, low sugar profile in CSF and positive culture for Burkholder. Case 2 presented with purulent meningitis that emerged during treatment of cryptococcal meningitis which, to our knowledge, has not been reported. Thus, Burkholder should be considered as one of the etiologic agents in this clinical setting.

Adult↗

PubMedDate not supplied

Long-term follow-up of HIV-1-infected Thai patients immunized with Remune monotherapy.

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/microL. CD8+ T-cell counts showed an increase from baseline during the follow-up period (415.21 cells/microL). 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/microL in order to limit the cost and toxicity.

AIDS Vaccines↗