ProAlgaZyme Novel Algae Infusion: Applications in Immunodeficiency

Health Enhancement Products

Status

Completed

Conditions

Dyslipidemia

Hepatitis B

HIV Infections

Treatments

Drug: ProAlgaZyme

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00493506

H-0002-01

087/2006

Details and patient eligibility

About

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).

Full 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.

Enrollment

59 patients

Sex

All

Ages

19 to 45 years old

Volunteers

No 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.