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Sponsors and Collaborators: |
Health Enhancement Products, Inc. University of Yaounde |
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Information provided by: | Health Enhancement Products, Inc. |
ClinicalTrials.gov Identifier: | NCT00493506 |
The purpose of this study is to determine the safety and effects in HIV patients of supplementation (4-20 fl. oz. daily) with ProAlgaZyme, a novel fermentation product of a freshwater algae ecosystem, on markers of immune status, dyslipidemia, inflammation and oxidative stress alone or in combination with HAART (highly-active antiretroviral therapy).
Condition | Intervention |
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HIV Infections Hepatitis B Dyslipidemia |
Drug: ProAlgaZyme |
Study Type: | Interventional |
Study Design: | Supportive Care, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Effects of ProAlgaZyme Novel Algae Infusion Alone or in Combination With HAART on Markers of Immune Status, Dyslipidemia, Inflammation and Oxidative Stress in HIV or HIV/HBV Patients |
Enrollment: | 59 |
Study Start Date: | May 2006 |
Study Completion Date: | September 2006 |
HIV infection and interventions such as HAART (highly-active antiretroviral therapy) are associated with dyslipidemia and increased markers of inflammatory and oxidative stress. These effects can hasten the progression towards AIDS and present serious cardiovascular complications. Therapeutic agents that can provide immune support with minimal side effects and/or reduce the adverse effects of HAART are in high demand worldwide. Such agents may help HIV patients to live a better quality of life, and may potentially improve the compliance with traditional therapies including HAART. This study is a single-center open-label design to evaluate the safety of ProAlgaZyme novel algae infusion and its effects in varying dosages on markers of immune status, dyslipidemia, inflammation and oxidative stress in patients with HIV or HIV/HBV co-infection, who may also be taking HAART.
Ages Eligible for Study: | 19 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Either/or:
Exclusion Criteria:
Cameroon | |
Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I | |
Yaounde, Cameroon |
Principal Investigator: | Julius Oben, Ph.D. | Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I, Yaounde, Cameroon |
Study ID Numbers: | H-0002-01, 087/2006 |
Study First Received: | June 26, 2007 |
Last Updated: | June 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00493506 |
Health Authority: | Cameroon: Ministry of Public Health |
ProAlgaZyme HIV HAART hsCRP Oxidative stress |
CD4+ lymphocytes Algae HAART adverse effects HBV Oxidative stress |
Sexually Transmitted Diseases, Viral Liver Diseases Metabolic Diseases Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human Stress Immunologic Deficiency Syndromes Inflammation Hepatitis Virus Diseases |
Digestive System Diseases HIV Infections Sexually Transmitted Diseases Hepatitis B DNA Virus Infections Metabolic disorder Retroviridae Infections Dyslipidemias Lipid Metabolism Disorders |
RNA Virus Infections Slow Virus Diseases Immune System Diseases |
Lentivirus Infections Infection Hepadnaviridae Infections |