ProAlgaZyme Novel Algae Infusion: Applications in Immunodeficiency

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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HIV Infections, Hepatitis B, Dyslipidemia

Intervention / Treatment
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* Drug: ProAlgaZyme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed as HIV +ve or HIV/HBV +ve Either/or: had not taken antiretroviral drugs before (pre-HAART patients) were treated with triple drug therapy for at least 3-6 months Exclusion Criteria: Obese Taking any cholesterol-lowering medications 30 days prior to the start of enrollment and during the course of the study. Enrolled in another clinical study in the past 6 months.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ProAlgaZyme|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RBC and WBC counts |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ProAlgaZyme, HIV, HAART, hsCRP, Oxidative stress, CD4+ lymphocytes, Algae, HAART adverse effects, HBV