ProAlgaZyme Novel Algae Infusion: Applications in Immunodeficiency

Not Applicable

Completed

• Conditions: HIV Infections; Hepatitis B; Dyslipidemia

• Registration Number: NCT00493506
• Lead Sponsor: Health Enhancement Products, Inc.

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).

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 Timeline

• Study Start: 2006-05
• Study Completion: 2006-09
• Status Verified: 2007-06
• Study First Submitted: 2007-06-26
• Study First Submitted QC: 2007-06-27
• Last Update Submitted: 2007-06-27
• Study First Posted: 2007-06-28
• Last Update Posted: 2007-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
RBC and WBC counts	12 weeks

Trial Locations

Locations (1)

Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I; 🇨🇲 Yaounde, Cameroon