ProAlgaZyme Novel Algae Infusion: Applications in Immunodeficiency

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00493506
• Other study ID #: H-0002-01
• Secondary ID: 087/2006
• Status: Completed
• Phase: N/A
• First received: June 26, 2007
• Last updated: June 27, 2007
• Start date: May 2006
• Est. completion date: September 2006

Study information

• Verified date: June 2007
• Source: Health Enhancement Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cameroon: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hepatitis B
• HIV Infections

Intervention

Drug:
• ProAlgaZyme

Locations

Country	Name	City	State
Cameroon	Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I	Yaounde

Sponsors (2)

Lead Sponsor	Collaborator
Health Enhancement Products, Inc.	University of Yaounde

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD4+ T-lymphocytes		12 weeks
Primary	HIV Viral Load		12 weeks
Primary	hsCRP (C-reactive protein)		12 weeks
Primary	Total cholesterol		12 weeks
Primary	Liver enzymes (ALT, ALP, GGT)		12 weeks
Primary	MDA (malonaldehyde) and thiol proteins		12 weeks
Secondary	RBC and WBC counts		12 weeks