Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480350
Status:
UNKNOWN
Last Update Posted:
2007-09-05
First Post:
2007-05-28
Brief Title:
RiSolubles the Soluble Fraction of Rice Bran for HIV-Infected Patients
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2007-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 cellsmm3 or HIV plasma RNA level is 5000 copiesml 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None