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Completed

NCT Number: NCT00493506

ProAlgaZyme Novel Algae Infusion: Applications in Immunodeficiency

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).

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Dyslipidemia Dyslipidemias Genital Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lipid Metabolism Disorders Liver Diseases Metabolic Diseases Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I

Yaoundé, Cameroon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ProAlgaZyme

Drug

Primary outcomes

  1. CD4+ T-lymphocytes

    Time frame: 12 weeks

  2. HIV Viral Load

    Time frame: 12 weeks

  3. hsCRP (C-reactive protein)

    Time frame: 12 weeks

  4. Total cholesterol

    Time frame: 12 weeks

  5. Liver enzymes (ALT, ALP, GGT)

    Time frame: 12 weeks

  6. MDA (malonaldehyde) and thiol proteins

    Time frame: 12 weeks

Secondary outcomes

  1. RBC and WBC counts

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Health Enhancement Products, Inc.

Industry

Collaborators

  • University of Yaounde

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2006
First posted
Jun 28, 2007
Registry last updated
Jun 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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