NCT00493506

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Timeline
Completed

Started May 2006

Shorter than P25 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2007

Completed
Last Updated

June 28, 2007

Status Verified

June 1, 2007

First QC Date

June 26, 2007

Last Update Submit

June 27, 2007

Conditions

HIV InfectionsHepatitis BDyslipidemia

Keywords

ProAlgaZymeHIVHAARThsCRPOxidative stressCD4+ lymphocytesAlgaeHAART adverse effectsHBV

Outcome Measures

Primary Outcomes (6)

  • CD4+ T-lymphocytes

    12 weeks

  • HIV Viral Load

    12 weeks

  • hsCRP (C-reactive protein)

    12 weeks

  • Total cholesterol

    12 weeks

  • Liver enzymes (ALT, ALP, GGT)

    12 weeks

  • MDA (malonaldehyde) and thiol proteins

    12 weeks

Secondary Outcomes (1)

  • RBC and WBC counts

    12 weeks

Interventions

ProAlgaZymeDRUG

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Yaoundé, Cameroon

Location

MeSH Terms

Conditions

HIV InfectionsHepatitis BDyslipidemias

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepadnaviridae InfectionsDNA Virus InfectionsHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Julius Oben, Ph.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 26, 2007

First Posted

June 28, 2007

Study Start

May 1, 2006

Study Completion

September 1, 2006

Last Updated

June 28, 2007

Record last verified: 2007-06

Locations

CA(1)