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ProAlgaZyme Novel Algae Infusion: Applications in Immunodeficiency

Primary Purpose

HIV Infections, Hepatitis B, Dyslipidemia

Status
Completed
Phase
Not Applicable
Locations
Cameroon
Study Type
Interventional
Intervention
ProAlgaZyme
Sponsored by
Health Enhancement Products, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV Infections focused on measuring ProAlgaZyme, HIV, HAART, hsCRP, Oxidative stress, CD4+ lymphocytes, Algae, HAART adverse effects, HBV

Eligibility Criteria

19 Years - 45 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I

Outcomes

Primary Outcome Measures

CD4+ T-lymphocytes
HIV Viral Load
hsCRP (C-reactive protein)
Total cholesterol
Liver enzymes (ALT, ALP, GGT)
MDA (malonaldehyde) and thiol proteins

Secondary Outcome Measures

RBC and WBC counts

Full Information

First Posted
June 26, 2007
Last Updated
June 27, 2007
Sponsor
Health Enhancement Products, Inc.
Collaborators
University of Yaounde
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1. Study Identification

Unique Protocol Identification Number
NCT00493506
Brief Title
ProAlgaZyme Novel Algae Infusion: Applications in Immunodeficiency
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 Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Health Enhancement Products, Inc.
Collaborators
University of Yaounde

4. Oversight

Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Hepatitis B, Dyslipidemia
Keywords
ProAlgaZyme, HIV, HAART, hsCRP, Oxidative stress, CD4+ lymphocytes, Algae, HAART adverse effects, HBV

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ProAlgaZyme
Primary Outcome Measure Information:
Title
CD4+ T-lymphocytes
Time Frame
12 weeks
Title
HIV Viral Load
Time Frame
12 weeks
Title
hsCRP (C-reactive protein)
Time Frame
12 weeks
Title
Total cholesterol
Time Frame
12 weeks
Title
Liver enzymes (ALT, ALP, GGT)
Time Frame
12 weeks
Title
MDA (malonaldehyde) and thiol proteins
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
RBC and WBC counts
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julius Oben, Ph.D.
Organizational Affiliation
Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I, Yaounde, Cameroon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I
City
Yaounde
Country
Cameroon

12. IPD Sharing Statement

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ProAlgaZyme Novel Algae Infusion: Applications in Immunodeficiency

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