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| ID | Type | Description | Link |
|---|---|---|---|
| 087/2006 |
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| Name | Class |
|---|---|
| University of Yaounde | OTHER |
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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).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProAlgaZyme | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| CD4+ T-lymphocytes | 12 weeks | |
| HIV Viral Load | 12 weeks | |
| hsCRP (C-reactive protein) | 12 weeks | |
| Total cholesterol | 12 weeks | |
| Liver enzymes (ALT, ALP, GGT) | 12 weeks | |
| MDA (malonaldehyde) and thiol proteins | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| RBC and WBC counts | 12 weeks |
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Inclusion Criteria:
Diagnosed as HIV +ve or HIV/HBV +ve
Either/or:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julius Oben, Ph.D. | Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I, Yaounde, Cameroon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I | Yaoundé | Cameroon |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006509 | Hepatitis B |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |