HIV InfectionsNCT00493506
ProAlgaZyme Novel Algae Infusion: Applications in Immunodeficiency
A study testing ProAlgaZyme in people with HIV Infections and Hepatitis B, run by Health Enhancement Products, Inc. at 1 site in Cameroon.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 45 years
- Conditions the study is for
- HIV Infections, Hepatitis B, Dyslipidemia
- What is being tested?
- ProAlgaZyme
- How many people
- 59 participants
- Where
- 1 siteCameroon
- Study dates
- May 2006to Sep 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Cameroon1 site
Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I
Yaoundé
About this study
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
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).
Read the 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.
- Conditions
- HIV Infections, Hepatitis B, Dyslipidemia
- Being tested
- ProAlgaZyme
- Keywords
- ProAlgaZyme, HIV, HAART, hsCRP, Oxidative stress, CD4+ lymphocytes, Algae, HAART adverse effects, HBV
- Medical subject headings
- HIV Infections, Hepatitis B, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProAlgaZymeDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
CD4+ T-lymphocytes
Measured: 12 weeks
HIV Viral Load
Measured: 12 weeks
hsCRP (C-reactive protein)
Measured: 12 weeks
Total cholesterol
Measured: 12 weeks
Liver enzymes (ALT, ALP, GGT)
Measured: 12 weeks
MDA (malonaldehyde) and thiol proteins
Measured: 12 weeks
Secondary outcomes (1)
RBC and WBC counts
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startMay 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Enhancement Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Yaounde
- Investigators
- Julius Oben, Ph.D., Principal investigator, Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I, Yaounde, Cameroon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493506
- Sponsor's protocol ID
- H-0002-01
- Other IDs
- 087/2006
- Status last verified
- Jun 2007
- First submitted
- 26 Jun 2007
- Last updated
- 28 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00493506
- Acronym / sponsor ID
- H-0002-01
- Conditions
- HIV Infections, Hepatitis B, Dyslipidemia
- Keywords
- ProAlgaZyme, HIV, HAART, hsCRP, Oxidative stress, CD4+ lymphocytes, Algae, HAART adverse effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Health Enhancement Products, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Yaounde
- Study start
- May 2006
- Study completion
- Sep 2006 (actual)
- First posted
- 28 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosed as HIV +ve or HIV/HBV +ve
- Either/or:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProAlgaZyme | Drug | – |
Primary outcome
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
1 secondary outcome
RBC and WBC counts
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julius Oben, Ph.D. principal investigator
Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I, Yaounde, Cameroon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProAlgaZyme in people with HIV Infections and Hepatitis B, run by Health Enhancement Products, Inc. at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD4+ T-lymphocytes (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2007.