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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00493506
Other study ID # H-0002-01
Secondary ID 087/2006
Status Completed
Phase N/A
First received June 26, 2007
Last updated June 27, 2007
Start date May 2006
Est. completion date September 2006

Study information

Verified date June 2007
Source Health Enhancement Products, Inc.
Contact n/a
Is FDA regulated No
Health authority Cameroon: Ministry of Public Health
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 59
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 45 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Drug:
ProAlgaZyme


Locations

Country Name City State
Cameroon Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I Yaounde

Sponsors (2)

Lead Sponsor Collaborator
Health Enhancement Products, Inc. University of Yaounde

Country where clinical trial is conducted

Cameroon, 

Outcome

Type Measure Description Time frame Safety issue
Primary CD4+ T-lymphocytes 12 weeks
Primary HIV Viral Load 12 weeks
Primary hsCRP (C-reactive protein) 12 weeks
Primary Total cholesterol 12 weeks
Primary Liver enzymes (ALT, ALP, GGT) 12 weeks
Primary MDA (malonaldehyde) and thiol proteins 12 weeks
Secondary RBC and WBC counts 12 weeks
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