Clinical trial NCT00493506: ProAlgaZyme Novel Algae Infusion: Applications in Immunodeficiency
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Hepatitis B
Dyslipidemia
Keywords: ProAlgaZyme
HIV
HAART
hsCRP
Oxidative stress
CD4+ lymphocytes
Algae
HAART adverse effects
HBV
Lead sponsor: Health Enhancement Products, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Yaounde
First posted: 2007-06-28
Enrollment: 59
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).

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 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.

Primary outcomes:
measure: CD4+ T-lymphocytes
timeFrame: 12 weeks
measure: HIV Viral Load
timeFrame: 12 weeks
measure: hsCRP (C-reactive protein)
timeFrame: 12 weeks
measure: Total cholesterol
timeFrame: 12 weeks
measure: Liver enzymes (ALT, ALP, GGT)
timeFrame: 12 weeks
measure: MDA (malonaldehyde) and thiol proteins
timeFrame: 12 weeks
Secondary outcomes:
measure: RBC and WBC counts
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Yaounde
country: Cameroon
facility: Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I
Study officials:
affiliation: Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I, Yaounde, Cameroon
name: Julius Oben, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: