ProAlgaZyme Novel Algae Infusion: Applications in Immunodeficiency - Full Text View

Sponsors and Collaborators:	Health Enhancement Products, Inc. University of Yaounde
Information provided by:	Health Enhancement Products, Inc.
ClinicalTrials.gov Identifier:	NCT00493506

Purpose

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
HIV Infections Hepatitis B Dyslipidemia	Drug: ProAlgaZyme

MedlinePlus related topics: AIDS Hepatitis Hepatitis B

U.S. FDA Resources

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

Further study details as provided by Health Enhancement Products, Inc.:

Primary Outcome Measures:

CD4+ T-lymphocytes [ Time Frame: 12 weeks ]
HIV Viral Load [ Time Frame: 12 weeks ]
hsCRP (C-reactive protein) [ Time Frame: 12 weeks ]
Total cholesterol [ Time Frame: 12 weeks ]
Liver enzymes (ALT, ALP, GGT) [ Time Frame: 12 weeks ]
MDA (malonaldehyde) and thiol proteins [ Time Frame: 12 weeks ]

Secondary Outcome Measures:

RBC and WBC counts [ Time Frame: 12 weeks ]

Enrollment:	59
Study Start Date:	May 2006
Study Completion Date:	September 2006

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.

Eligibility

Ages Eligible for Study:	19 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493506

Locations

Cameroon
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

More Information

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

Keywords provided by Health Enhancement Products, Inc.:

ProAlgaZyme
HIV
HAART
hsCRP
Oxidative stress

CD4+ lymphocytes
Algae
HAART adverse effects
HBV
Oxidative stress

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases

Lentivirus Infections
Infection
Hepadnaviridae Infections

ClinicalTrials.gov processed this record on January 16, 2009