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

NCT ID: NCT00480350

Last Updated: 2007-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-01-31

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

rice based food supplement

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Principal Investigators

Allon E Moses, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Hadassah Medical Organization

Jerusalem, , Israel

Countries

Israel

Central Contacts

Allon E Moses, MD

Role: CONTACT

AllonM@hadassah.org.il

972507874364

Shlomo Maayan, MD

Role: CONTACT

shlomo_m@hadassah.org.il

972-50-7874327

Facility Contacts

Arik Tzukert, DMD

Role: primary

arik@hadassah.org.il

00 972 26776095

Hadas Lemberg, PhD

Role: backup

Lhadas@hadassah.org.il

00 972 2 6777572

Other Identifiers

shah1HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id