Clinical Trials Directory

Trials / Completed

CompletedNCT00493506

ProAlgaZyme Novel Algae Infusion: Applications in Immunodeficiency

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
59 (actual)
Sponsor
Health Enhancement Products, Inc. · Industry
Sex
All
Age
19 Years – 45 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
DRUGProAlgaZyme

Timeline

Start date
2006-05-01
Completion
2006-09-01
First posted
2007-06-28
Last updated
2007-06-28

Locations

1 site across 1 country: Cameroon

Source: ClinicalTrials.gov record NCT00493506. Inclusion in this directory is not an endorsement.