ProAlgaZyme Novel Algae Infusion: Applications in Immunodeficiency

Sponsor

Health Enhancement Products, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00493506

Collaborator

University of Yaounde (Other)

Enrollment

Location

Duration (Months)

14.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Hepatitis B Dyslipidemia	Drug: ProAlgaZyme	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Study Start Date :

May 1, 2006

Actual Study Completion Date :

Sep 1, 2006

Outcome Measures

Primary Outcome Measures

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

RBC and WBC counts [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I	Yaounde		Cameroon

Sponsors and Collaborators

Health Enhancement Products, Inc.
University of Yaounde

Investigators

Principal Investigator: Julius Oben, Ph.D., Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I, Yaounde, Cameroon