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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
History of Changes
  Purpose

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).


Condition Intervention
HIV Infections
Hepatitis B
Dyslipidemia
 Drug: ProAlgaZyme

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Health Enhancement Products, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • RBC and WBC counts [ Time Frame: 12 weeks ]

Enrollment: 59
Study Start Date: May 2006
Study Completion Date: September 2006
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.

  Eligibility

Ages Eligible for Study:   19 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00493506

Locations
Cameroon
Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I
Yaounde, Cameroon
Sponsors and Collaborators
Health Enhancement Products, Inc.
University of Yaounde
Investigators
Principal Investigator: Julius Oben, Ph.D. Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I, Yaounde, Cameroon
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00493506     History of Changes
Other Study ID Numbers: H-0002-01, 087/2006
Study First Received: June 26, 2007
Last Updated: June 27, 2007
Health Authority: Cameroon: Ministry of Public Health

Keywords provided by Health Enhancement Products, Inc.:
ProAlgaZyme
HIV
HAART
hsCRP
Oxidative stress
 CD4+ lymphocytes
Algae
HAART adverse effects
HBV

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis
Hepatitis A
Hepatitis B
Dyslipidemias
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Hepadnaviridae Infections
DNA Virus Infections
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 18, 2013