ProAlgaZyme Novel Algae Infusion: Applications in Immunodeficiency

This study has been completed.
Sponsor:
Collaborator:
University of Yaounde
Information provided by:
Health Enhancement Products, Inc.
ClinicalTrials.gov Identifier:
NCT00493506
First received: June 26, 2007
Last updated: June 27, 2007
Last verified: June 2007

June 26, 2007
June 27, 2007
May 2006
Not Provided
  • CD4+ T-lymphocytes [ Time Frame: 12 weeks ]
  • HIV Viral Load [ Time Frame: 12 weeks ]
  • hsCRP (C-reactive protein) [ Time Frame: 12 weeks ]
  • Total cholesterol [ Time Frame: 12 weeks ]
  • Liver enzymes (ALT, ALP, GGT) [ Time Frame: 12 weeks ]
  • MDA (malonaldehyde) and thiol proteins [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT00493506 on ClinicalTrials.gov Archive Site
RBC and WBC counts [ Time Frame: 12 weeks ]
Same as current
Not Provided
Not Provided
 
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

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).

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • HIV Infections
  • Hepatitis B
  • Dyslipidemia
Drug: ProAlgaZyme
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
September 2006
Not Provided

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.
Both
19 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Cameroon
 
NCT00493506
H-0002-01, 087/2006
No
Not Provided
Health Enhancement Products, Inc.
University of Yaounde
Principal Investigator: Julius Oben, Ph.D. Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I, Yaounde, Cameroon
Health Enhancement Products, Inc.
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP