HIV & AIDS
UJI KLINIS IMMUNOCAL UNTUK HIV/AIDS
Canadian Trial Network meneliti efek Immunocal pada 14 anak penderita AIDS dan wasting syndrome [penyakit AIDS yang lanjut disertai gejala penurunan berat badan]. Hasilnya menunjukkan adanya kenaikan berat badan bagi anak penderita AIDS sampai 18% dari berat badan semula. Hasil lain, Efek dari Immunocal pada penderita HIV selama 3 bulan menunjukkan peningkatan berat badan mereka antara 2-7 kg.
Penelitian lain melaporkan dua kasus seorang ibu dan anak yang terkena HIV diberikan Immunocal [20g/2 sachet per hari] selama 7 bulan, menunjukkan hasil adanya penurunan terhadap Viral Load dari 140.000 copies m/l menjadi 5.000, DNA Bload Lymphocyte meningkat dari 2.5 k/c mm menjadi 3.33, Neutrophils dari 1.6 menjadi 3.65 dan CD4 dari 1.025 jadi 1.450.
Pada kasus satu keluarga ketika seorang ayah [46 th] pada April 1995 terdiagnosa positif HIV-1 yang tertular dari hubungan heterosex, setelah diberikan Immunocal 25 g perhari, 2 minggu kemudian pasien tsb merasa lebih baik dan dapat bekerja lagi seperti biasa. Begitu juga istrinya [35 th] yang positif HIV-1, telah minum obat AZT selama sebulan tapi malah muntah dan sakit kepala. Setelah minum Immunocal 20 g per hari, kekuatan dan energinya bertambah. Anaknya [2 th juga positif HIV-1, dengan Immunocal 10g per hari, ditemukan perbaikan dan peningkatan energi si anak. Tes darah menunjukkan peningkatan Viral Load, Lymphocyte [sel darah putih] dan CD4 Lymphocyte.
Produsen produk Immunocal yaitu Immunotec Research Ltd. di Kanada merupakan perusahaan yang mengkhususkan diri dalam penelitian produk kesehatan. Produk Immunocal sudah diteliti selama lebih dari 20 tahun oleh para ahli di negara Kanada, Amerika, Jerman dan Arab Saudi, juga telah melalui uji klinis pada lembaga-lembaga yang ternama di seluruh dunia dan diterbitkan dalam majalah-majalah ilmiah kedokteran dan biologi internasional antara lain Lancet, Anti Cancer Research, British Medical Journal dan European Journal of Clinical Pharmacology.
Immunocal mendapatkan patent dari United State’s Patent untuk penyakit AIDS dalam Method of Treatment of HIV-Seropositive Individual with Dietary Whey Proteins pada tanggal 9 Oktober 1995 dengan nomor 5.456.924 serta memperoleh hak patent dalam Undernatured Whey Protein Concentrat to Improve Active Systemic Humoral Immune Response dengan nomor 5.230.902 pada tanggal 27 Juli 1993. Di Australia Immunocal mendapatkan hak patent dengan nomor 8812-93 : Method of Treatment of HIV-Seropositive Individual with Dietary Whey Proteins.
Immunocal merupakan satu-satunya produk OTC (Over the Counter) yang dimasukkan ke dalam daftar edisi tahun 2000 dari US Phisician Desk Reference (PDR). Selain itu terdaftar juga ke dalam the Pharmacist’s Red Book, yakni sebuah buku yang memuat semua jenis obat-obatan yang harus dikeluarkan dengan resep dokter.
Jadi, bisa kita simpulkan keandalan Immunocal melawan HIV ini diakui dunia, dengan bukti :
- Hak patent dari United States Patent mengenai AIDS dalam Method of Treatment of HIV-Seropositive Individuals with Dietary Whey Protein pada tanggal 9 Oktober 1995 dengan nomor 5.456.924.
- Hak patent dalam Undenatured Whey Protein Concentrate to Improve Active Systemic Humoral Immune Respone dengan nomor 5.230.902 pada tanggal 27 Juli1993.
- Hak patent dari Australia nomor 8812-93 : Method of Treatment of HIV-seropositive Individuals with Dietary Whey Protein.
- Diuji klinis lembaga ternama dunia dan diterbitkan majalah ilmiah kedokteran dan biologi internasional, antara lain : Lancet, Anti Cancer Research, British Medical Journal, dan European Journal of Clinical Pharmacology.
Anda kini bertemu dengan produk kesehatan yang sangat unik dan luar biasa, yang melewati riset luar biasa!
Berikut ini percobaan yang dilakukan pada penyakit HIV/AIDS menggunakan terapi Gluthation dengan text asli berbahasa Inggris.
► Clinical trials of Glutathione and Whey protein in HIV-AIDS
Clinical Trials with Glutathione, Whey Protein in HIV-AIDS
Bioactive, Cysteine-Rich Dietary Supplement Alleviates Gastrointestinal Side-Effects with Associated Weight Gain and Marked Improvement in HAART Adherence in AIDS Patients
A recent open label trial was conducted by Louisa Pacheco, M.D. and her collegues on the therapeutic use of un-denatured whey protein with HIV/AIDS patients at the Tidewater AIDS Crisis Task Force in Norfolk, Virginia. Patients taking the nutraceutical achieved significant reduction in gastrointestinal side effects (diarrhea, nausea, vomiting, impaired appetite), as well as improved energy levels. Additionally, they were able to adhere to their HAART medications as prescribed, which they had previously been unable to do. In fact, patients using the nutraceutical became 100% adherent to HAART by the end of the 8- week trial. Non-participating patients experienced an average weight loss of 8.5 lbs and remained non-adherent with anti-retroviral therapy. Summary & Conclusions: This immune-enhancing GRAS nutraceutical can be used beneficially in AIDS patients to promote weight gain, improve their health status and tolerance for taking HAART. Thus, including it as part of an AIDS patient’s therapeutic regimen may improve three major conditions - immune deficiency, weight loss, and adherence to HAART.
Oral supplementation with whey proteins increases plasma glutathione levels of HIV-infected patients
Micke P, Beeh KM, Schlaak JF, Buhl R. [Eur J Clin Invest. 2001 Feb;31(2):171-8.] Ddifferent strategies to supplement cysteine supply have been suggested to increase glutathione levels in HIV-infected individuals. The aim of this study was to evaluate the effect of oral supplementation with two different cysteine-rich whey protein formulas on plasma GSH levels and parameters of oxidative stress and immune status in HIV-infected patients. In glutathione-deficient patients with advanced HIV-infection, short-term oral supplementation with whey proteins increases plasma glutathione levels. A long-term clinical trial is clearly warranted to see if this "biochemical efficacy" of whey proteins translates into a more favourable course of the disease.
Effects of long-term supplementation with whey proteins on plasma glutathione levels of HIV-infected patients
Micke P, Beeh KM, Buhl R. [Eur J Nutr 2002 Feb;41(1):12-8] HIV infection is characterized by an enhanced oxidant burden and a systemic deficiency of the tripeptide glutathione (GSH), a major antioxidant. Whey proteins are rich in cysteine as well as in GSH precursor peptides. In order to evaluate the effects of whey supplementation on plasma GSH levels, HIV-infected patients were treated with whey proteins for a period of six months. Supplementation with whey proteins persistently increased plasma glutathione levels in patients with advanced HIV-infection. The treatment was well tolerated. A larger long-term trial is clearly warranted to evaluate whether this positive influence on the glutathione metabolism translates into a more favorable course of the disease.
CTN (Canadian HIV Trials Network) Trial Results - Whey protein supplementation CTN043: Whey Protein Supplementation in HIV-Infected Children: A Pilot Study
This study assessed the value of whey protein, a milk supplement, to prevent severe weight loss in children with AIDS. This was an open label, pilot study (both investigators and volunteers knew which treatment was being given), with only one study group. Participants received daily oral supplementation of whey protein, given as a powder at a starting dose based on 20% of the total daily protein requirement, and increased by increments of five percent every month during four months to reach 35% of the total protein intake at the end of the six-month study. Study Population: Fourteen children were enrolled in four centres. Essential requirements for study entry included wasting syndrome (severe weight loss) within the six months preceding entry into the study. Of 14 participants enrolled, 11 were evaluated. The age of the participants ranged from eight months to 15 years. None of the children experienced any toxicity (side effects) such as diarrhea, vomiting or milk intolerance. All of them gained weight, between 3.2% and 18% from their starting weight. Eight demonstrated improvements in growth parameters, such as in tricep skinfolds, with mid-arm muscle circumference increasing from +1.2% to +25% independently of energy intake. No changes were found in CD4 cell count, but two children experienced a significant increase in CD8 cell count. Whey protein is very well-tolerated in children with AIDS, and it was shown to improve nutrition and growth in a subgroup of patients.
Whey Protein for Wasting: CTN079: Multicentre, Double-blind, Randomized Control Study of Whey Protein Concentrate HMS-90 vs Casein in Patients with AIDS and Wasting Syndrome
One study of this all-natural product concluded that this "whey protein concentrate" a derivative of cows milk, is completely safe for people who have been diagnosed as lactose-intolerant. This analysis has lead to the funding of phase 3, clinical trial on adult AIDS patients with wasting syndrome. About the study: Treating AIDS-related wasting syndrome with a whey protein concentrate (WPC) may combat the negative effect of oxidative stress, improve T-cell function and T-cell survival, as well as aid in the control of HIV replication. The study's primary objectives are to determine the effect of WPC on nutrition in patients with AIDS-related wasting syndrome, and to determine the glutathione-changing activity of WPC in people with AIDS-related wasting syndrome.
Whey proteins as a food supplement in HIV-seropositive individuals
Bounous G, Baruchel S, Falutz J, Gold P. Department of Surgery, Montreal General Hospital, Quebec. [Clin Invest Med 1993 Jun;16(3):204-9] On the basis of numerous animal experiments, a pilot study was undertaken to evaluate the effect of undenatured, biologically active, dietary whey protein in 3 HIV-seropositive individuals over a period of 3 months. Whey protein concentrate was prepared so that the most thermosensitive proteins, such as serum albumin which contains 6 glutamylcysteine groups, would be in undenatured form. Whey protein powder dissolved in a drink of the patient's choice was drunk cold in quantities that were increased progressively from 8.4 to 39.2 g per day. Patients took whey proteins without adverse side effects. In the 3 patients whose body weight had been stable in the preceding 2 months, weight gain increased
progressively between 2 and 7 kg, with 2 of the patients reaching ideal body weight. Serum proteins, including albumin, remained unchanged and within normal range, indicating that protein replenishment per se was not likely the cause of increased body weight. The glutathione content of the blood mononuclear cells was, as expected, below normal values in all patients at the beginning of the study. Over the 3-month period, glutathione levels increased in all 3 cases. In conclusion, these preliminary data indicate that, in patients who maintain an adequate total caloric intake, the addition of "bioactive" whey protein concentrate as a significant portion of total protein intake increases body weight and shows elevation of glutathione (GSH) content of mononuclear cells toward normal levels. This pilot study will serve as a basis for a much larger clinical trial.
Glutathione deficiency is associated with impaired survival in HIV disease
Herzenberg LA, De Rosa SC, Dubs JG, Roederer M, Anderson MT, Ela SW, Deresinski SC, Herzenberg LA. Department of Genetics, Stanford University Medical School, CA 94305-5125, USA. In vitro studies showing that low GSH levels both promote HIV expression and impair T cell function suggested a link between GSH depletion and HIV disease progression. Clinical studies presented here directly demonstrate that low GSH levels predict poor survival in otherwise indistinguishable HIV-infected subjects. Specifically, we show that GSH deficiency in CD4 T cells from such subjects is associated with markedly decreased survival 2-3 years after baseline data collection. This finding, supported by evidence demonstrating that oral administration of the GSH prodrug N-acetylcysteine replenishes GSH in these subjects and suggesting that N-acetylcysteine administration can improve their survival, establishes GSH deficiency as a key determinant of survival in HIV disease. Further, it argues strongly that the unnecessary or excessive use of acetaminophen, alcohol, or other drugs known to deplete GSH should be avoided by HIV-infected individuals.
Stanford NAC Study: Glutathione Level Predicts Survival
Author: John S. James [AIDS Treatment News; Issue: 266 03/07/97] A small randomized controlled trial of oral N-acetylcysteine(NAC) was run in San Francisco in 1993 and 1994. A report from this study was published in the PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES, USA; it was also presented at a major immunology conference in San Francisco on February 22, receiving television and newspaper coverage. The basic findings were: (1) For persons with a CD4 count under 200, an abnormally low level of glutathione -- inside CD4 T-cells in the blood --was remarkably predictive of poor survival. (Glutathione is the major defense of those cells against oxidative stress.) Persons with a CD4 count under 200, who also had very low glutathione levels, had an estimated three-year survival a slow as 20 percent -- compared to 60 to 80 percent survival for those with CD4 below 200 but with adequate glutathione levels. (2) Oral NAC helped to replenish low glutathione in blood cells. Followup studies two to three years later showed that persons who were given or chose to take NAC during the trial had considerably better survival than similar subjects who did not take NAC.
N- acetylcysteine replenishes glutathione in HIV infection
De Rosa SC, Zaretsky MD, Dubs JG, and others. [Eur J Clin Invest 2000 Oct;30(10):915-29.] Glutathione (GSH) deficiency is common in HIV-infected individuals and is associated with impaired T cell function and impaired survival. N-acetylcysteine (NAC) is used to replenish GSH that has been depleted by acetaminophen overdose. Studies here test oral administration of NAC for safe and effective GSH replenishment in HIV infection. Whole blood GSH levels in NAC arm subjects significantly increased, bringing GSH levels in NAC-treated subjects to 89% of uninfected controls. NAC treatment for 8 weeks safely replenishes whole blood GSH and T cell GSH in HIV-infected individuals. Thus, NAC offers useful adjunct therapy to increase protection against oxidative stress, improve immune system function and increase detoxification of acetaminophen and other drugs. These findings suggest that NAC therapy could be valuable in other clinical situations in which GSH deficiency or oxidative stress plays a role in disease pathology.