Rice Bran Supplementation in Treated HIV Infection (BRM4)

This is an interventional treatment trial for Inflammation in HIV Infection Read More

Inclusion Criteria:

• Documented HIV-1 infection
• Currently on a combination antiretroviral regimen for ≥24 weeks prior to study entry with no interruption longer than 7 consecutive days during that period.
• Plasma HIV-1 RNA levels below 50 copies/mL for at least 24 weeks prior to study entry.
• CD4+ cell count 100-350 cells/mm3 obtained within 90 days prior to study entry.

• The following laboratory values obtained within 90 days prior to entry by any US laboratory that has a CLIA certification or its equivalent.

  • Absolute neutrophil count (ANC) ≥750/mm3
  • Hemoglobin ≥8.0 g/dL
  • Platelet count ≥50,000/mm3
  • Calculated creatinine clearance (CrCl) ≥50 mL/min as estimated by the Cockroft-Gault formula
  • Aspartate aminotransferase (AST) (SGOT) ≤5 x upper limit of normal (ULN).
  • alanine aminotransferase (ALT) (SGPT) ≤5 x ULN.
  • alkaline phosphatase ≤5 x ULN.
  • Total bilirubin ≤2.5 x ULN (if the participant is receiving atazanavir, a total bilirubin of ≤5 x ULN is acceptable)
• For females of reproductive potential (women who have not been post-menopausal for at least 24 consecutive months, i.e. who have had menses within 24 months prior to study entry), or women who have not undergone surgical sterilization (specifically hysterectomy or bilateral oophorectomy or tubal ligation), will require a negative serum or urine pregnancy test (latter with a sensitivity of 15-25 mIU/mL) within 2 days prior to entry.
• If participating in sexual activity that could lead to pregnancy, the female study volunteer must be willing to use a contraceptive while receiving protocol-specified medication
• Men and women age 18 years or greater.
• Ability and willingness of participant or legal guardian/representative to provide informed consent.
• Participants on statin therapy must be stable on the same dose for at least the prior 12 weeks with no anticipated change in statin or dose during the intervention

Exclusion Criteria:

• Change in the ART regimen within the 12 weeks prior to study entry, or anticipated/intended modification of ART during the study period.
• Two or more HIV-1 RNA determinations >200 copies/mL within the 48 week period prior to study entry.
• Use of any immunomodulator, HIV vaccine, investigational therapy, or anti-TNF therapies within 90 days prior to study entry.
• Active malignancy with expected need for systemic chemotherapy or radiation therapy during the study period.
• Pregnant or breastfeeding.
• Known allergy/sensitivity to rice, rice bran, mushrooms, or related food products.
• Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
• Acute or serious illness requiring systemic treatment and/or hospitalization within 90 days prior to entry.