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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00480350
First received: May 28, 2007
Last updated: September 4, 2007
Last verified: March 2007
  Purpose

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 Intervention Phase
HIV Infections
Behavioral: rice based food supplement
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

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

Estimated Enrollment: 140
Study Start Date: September 2007
Estimated Study Completion Date: January 2009
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480350

Contacts
Contact: Allon E Moses, MD 972507874364 AllonM@hadassah.org.il
Contact: Shlomo Maayan, MD 972-50-7874327 shlomo_m@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD    00 972 26776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    00 972 2 6777572    Lhadas@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Allon E Moses, MD Hadassah.Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00480350     History of Changes
Other Study ID Numbers: shah1HMO-CTIL
Study First Received: May 28, 2007
Last Updated: September 4, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
HIV
virological response
CD4
food supplement
Human Immunodeficiency Virus
Complementary Therapies

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

ClinicalTrials.gov processed this record on September 22, 2014