ProAlgaZyme Novel Algae Infusion: Applications in Immunodeficiency

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00493506

Enrollment

Registered

2007-06-28

Start date

2006-05-31

Completion date

2006-09-30

Last updated

2007-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Hepatitis B, HIV Infections

Keywords

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

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.

Interventions

DRUGProAlgaZyme

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 45 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
RBC and WBC counts	12 weeks

Countries

Cameroon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026