HIV InfectionsPhase 2NCT00480350
RiSolubles™, the Soluble Fraction of Rice Bran for HIV-Infected Patients
A Phase 2 study testing rice based food supplement in people with HIV Infections, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
HIV infection is a growing problem in Israel with over 4000 known patients who are either infected with the virus or have developed AIDS. Patients are usually followed for years until they develop an increase in their viral load (HIV-1 RNA) or their CD4 + cells decline. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- rice based food supplement
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 140 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2007to Jan 2009
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with documented HIV-1 infection
- Male and female ages > 18 years old
- Subjects who have given informed consent
- Subjects may either receive or not receive antiretroviral therapy at the time of enrollment
- Plasma HIV-1 RNA higher than 5000 copies/ml
- OR
- Patient CD4+ cell count less than 500 cells/mm3
- Patients who can comply with protocol requirements
Who cannot join
- Patients incapable of oral intake
- Patients who are allergic to rice
- Pregnant or breast-feeding women
- Active drug abuse which, in the opinion of the investigator, is expected to interfere with the subject's ability to adhere to the study procedures
- Active, clinically-significant disease or life-threatening disease that would compromise the subject's safety or outcome of the study
- Any medical or psychiatric condition which, in the opinion of the investigator, could compromise the subject's safety or adherence to the trial protocol
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- Patients who have started their anti-HIV treatment within less than 3 months from inclusion in the study. However, patients who have changed anti-HIV medication but have initiated therapy more than 3 months before inclusion will be eligible for the study.
- Patients known to suffer from diabetes mellitus
- Participation in any other clinical trial
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization
Jerusalem, 91120
Arik Tzukert, DMD, 00 972 26776095, arik@hadassah.org.il
Hadas Lemberg, PhD, 00 972 2 6777572, Lhadas@hadassah.org.il
About this study
HIV infection is a growing problem in Israel with over 4000 known patients who are either infected with the virus or have developed AIDS. Patients are usually followed for years until they develop an increase in their viral load (HIV-1 RNA) or their CD4 + cells decline. At this point, patients are usually treated with Highly Active, Anti-Retroviral Therapy (HAART). The mainstay of response to such treatment is the lowering of viral load and increase in CD4+ cells. Food supplements for HIV patients have been given in several studies, with controversial results. A meta-analysis published recently [1] assessed whether micronutrient supplements are effective in reducing morbidity and mortality in adults and children with HIV infection. They recommended supporting the current WHO recommendations to promote and support adequate dietary intake of micronutrients wherever possible. We expect to enroll 140 subjects in this randomized, double blind, placebo controlled study. Seventy subjects will be enrolled in the rice-supplement arm and 70 subjects in the control group, which will receive supplemental, flavored dextrose to their current medical treatment. The treatment duration is 24 weeks with follow-up at 36 weeks from enrollment. The target population is HIV-1 infected individuals who may be either on anti-retroviral therapy or not on therapy. Subjects must be with either CD4+ cells are <500 cells/mm3, or HIV plasma RNA level is > 5000 copies/ml. The primary objective is to demonstrate the efficacy of food supplementation versus a flavored-dextrose supplement with respect to increment of patient CD4+ cell count from baseline at 24 weeks, or virological response defined as lowering of plasma HIV-1 RNA and immunologic response.
- Conditions
- HIV Infections
- Being tested
- rice based food supplement
- Keywords
- HIV, virological response, CD4, food supplement, Human Immunodeficiency Virus, Complementary Therapies
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rice based food supplementBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be an increment of CD4+ cells by a mean of 25% or increase of 100 cells/ mm3 at week 24 in the treatment group
Measured: 24 weeks
Secondary outcomes (1)
The proportion with virologic response defined as a plasma HIV-1 reduction of 1 log at week 24
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2007 (estimated)
- Study startSep 2007
- Study completionJan 2009 (estimated)
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.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Allon E Moses, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480350
- Sponsor's protocol ID
- shah1HMO-CTIL
- Status last verified
- Mar 2007
- First submitted
- 28 May 2007
- Last updated
- 5 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RiSolubles™, the Soluble Fraction of Rice Bran for HIV-Infected Patients
- ClinicalTrials.gov ID
- NCT00480350
- Acronym / sponsor ID
- shah1HMO-CTIL
- Conditions
- HIV Infections
- Keywords
- HIV, virological response, CD4, food supplement, Human Immunodeficiency Virus, Complementary Therapies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Sep 2007
- Study completion
- Jan 2009 (estimated)
- First posted
- 30 May 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.
HIV infection is a growing problem in Israel with over 4000 known patients who are either infected with the virus or have developed AIDS. Patients are usually followed for years until they develop an increase in their viral load (HIV-1 RNA) or their CD4 + cells decline. At this point, patients are usually treated with Highly Active, Anti-Retroviral Therapy (HAART). The mainstay of response to such treatment is the lowering of viral load and increase in CD4+ cells. Food supplements for HIV patients have been given in several studies, with controversial results. A meta-analysis published recently [1] assessed whether micronutrient supplements are effective in reducing morbidity and mortality in adults and children with HIV infection. They recommended supporting the current WHO recommendations to promote and support adequate dietary intake of micronutrients wherever possible. We expect to enroll 140 subjects in this randomized, double blind, placebo controlled study. Seventy subjects will be enrolled in the rice-supplement arm and 70 subjects in the control group, which will receive supplemental, flavored dextrose to their current medical treatment. The treatment duration is 24 weeks with follow-up at 36 weeks from enrollment. The target population is HIV-1 infected individuals who may be either on anti-retroviral therapy or not on therapy. Subjects must be with either CD4+ cells are <500 cells/mm3, or HIV plasma RNA level is > 5000 copies/ml. The primary objective is to demonstrate the efficacy of food supplementation versus a flavored-dextrose supplement with respect to increment of patient CD4+ cell count from baseline at 24 weeks, or virological response defined as lowering of plasma HIV-1 RNA and immunologic response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects with documented HIV-1 infection
- Male and female ages > 18 years old
- Subjects who have given informed consent
- Subjects may either receive or not receive antiretroviral therapy at the time of enrollment
- Plasma HIV-1 RNA higher than 5000 copies/ml
Key exclusion criteria (9 listed)
- Patients incapable of oral intake
- Patients who are allergic to rice
- Pregnant or breast-feeding women
- Active drug abuse which, in the opinion of the investigator, is expected to interfere with the subject's ability to adhere to the study procedures
- Active, clinically-significant disease or life-threatening disease that would compromise the subject's safety or outcome of the study
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 |
|---|---|---|
| rice based food supplement | Behavioural | – |
Primary outcome
The primary endpoint will be an increment of CD4+ cells by a mean of 25% or increase of 100 cells/ mm3 at week 24 in the treatment group
Time frame: 24 weeks
1 secondary outcome
The proportion with virologic response defined as a plasma HIV-1 reduction of 1 log at week 24
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 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.
Allon E Moses, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rice based food supplement in people with HIV Infections, run by Hadassah Medical Organization at 1 site in Israel.
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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 5 Sep 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 Israel. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Allon E Moses, MD (972507874364, AllonM@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint will be an increment of CD4+ cells by a mean of 25% or increase of 100 cells/ mm3 at week 24 in the treatment group (time frame: 24 weeks). 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 5 Sep 2007.