RiSolubles™, the Soluble Fraction of Rice Bran for HIV-Infected Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00480350
Recruitment Status : Unknown
Verified March 2007 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : May 30, 2007
Last Update Posted : September 5, 2007
Information provided by:
Hadassah Medical Organization

Brief 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. 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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: rice based food supplement Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : September 2007
Estimated Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The proportion with virologic response defined as a plasma HIV-1 reduction of 1 log at week 24 [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00480350

Contact: Allon E Moses, MD 972507874364
Contact: Shlomo Maayan, MD 972-50-7874327

Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD    00 972 26776095   
Contact: Hadas Lemberg, PhD    00 972 2 6777572   
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Allon E Moses, MD Hadassah.Medical Center Identifier: NCT00480350     History of Changes
Other Study ID Numbers: shah1HMO-CTIL
First Posted: May 30, 2007    Key Record Dates
Last Update Posted: September 5, 2007
Last Verified: March 2007

Keywords provided by Hadassah Medical Organization:
virological response
food supplement
Human Immunodeficiency Virus
Complementary Therapies

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases