hiv info source nyu medical center bellevue hospital center

A5229 - A Phase II/III, Randomized, Double-Blind, Placebo-Controlled Trial of Uridine Supplementation in HIV Lipoatrophy

Eligible candidates:

  • have an HIV viral load less than 5,000 copies.
  • are currently taking and plan to continue antiretroviral drugs containing stavudine (d4T) or zidovudine (ZDV.)
  • have a clinical diagnosis of fat loss in two of the following areas: face, arms, legs, or buttocks.
  • Additional requirements will be discussed by the study nurse or doctor.

Study Objective:
This study will test to see if taking uridine supplementation (NucleomaxX) is safe in HIV-infected persons who are currently taking antiretroviral medications, and if it will reverse fat loss (lipoatrophy) in the face, arms, legs or buttocks. The study will also test to see how well NucleomaxX is tolerated.
NucleomaxX is a nutritional supplement in the form of powder that elevates the body's levels of a substance called uridine. It comes in a sachet (packet) and is mixed in with juice, milk or water. NucleomaxX is used in Europe as a food supplement but is not approved by the Food and Drug Administration (FDA) and is considered an experimental drug.

Study Scheme:
There will be 164 persons enrolled into the study. Arm A (82 patients) will receive 1 sachet of NucleomaxX (36 grams each) three times per day, every other day for 48 weeks. Arm B (82 patients) will receive 1 sachet of the placebo for NucleomaxX (36 grams each) three times per day, every other day for 48 weeks. Participants and study staff will not know who is in Arm A or Arm B.

Study Drugs:

  • NucleomaxX

Study Status: Closed to enrollment.

Study Staff:

Study Sponsors:

  • AIDS Clinical Trials Group (NIH)

Study Volunteers Receive:

  • Cost-free lab work
  • Transportation reimbursement