ProAlgaZyme Novel Algae Infusion: Applications in Immunodeficiency

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2006-09-30

Brief Summary

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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

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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.

Conditions

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HIV Infections Hepatitis B Dyslipidemia

Keywords

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ProAlgaZyme HIV HAART hsCRP Oxidative stress CD4+ lymphocytes Algae HAART adverse effects HBV

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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ProAlgaZyme

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Julius Oben, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Yaoundé, , Cameroon

Site Status

Countries

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Cameroon

Other Identifiers

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087/2006

Identifier Type: -

Identifier Source: secondary_id

H-0002-01