Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy



Status:Completed
Conditions:HIV / AIDS, Endocrine
Therapuetic Areas:Endocrinology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:2/9/2019
Start Date:September 2006
End Date:December 2008

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

Lipoatrophy, the loss of body fat from particular areas of the body, is a common side effect
of antiretroviral therapy (ART). The purpose of this study was to determine the effectiveness
of uridine supplementation in treating HIV infected individuals on stable ART with
lipoatrophy.

Lipoatrophy is a distressing long-term complication of ART and is associated with decreased
quality of life, an increased risk of cardiovascular disease, and nonadherence to ART. The
cause of lipoatrophy in HIV-infected individuals receiving ART is not completely understood.
However, past research suggests that mitochondrial toxicity in subcutaneous adipose tissue
caused by thymidine analogue nucleoside analogues may be responsible for the development of
lipoatrophy.

Uridine is a nucleoside that has been shown to be an effective supplement in treating
individuals with mitochondrial toxicity. NucleomaxX is a food supplement that consists of
mitocnol, a sugar cane extract that has a high content of nucleosides, including uridine. The
purpose of this study was to evaluate the effects of uridine supplementation in the form of
NucleomaxX on limb fat in HIV-infected individuals receiving stable ART containing stavudine
(d4T) or zidovudine (ZDV). In addition, this study evaluated the safety and tolerability of
NucleomaxX.

This study lasted for 48 weeks. Participants were randomly assigned to one of two treatment
arms, stratified by d4T or ZDV use. Arm A participants received NucleomaxX for uridine, while
Arm B participants received a placebo for NucleomaxX. Participants in both arms received
their assigned intervention three times per day, every other day, for the duration of the
study. There were 8 study visits over the 48-week study duration. Blood collection and a
physical exam occurred at all study visits, and participants completed an adherence
assessment at most visits. Participants underwent dual energy X-ray absorptiometry scans
(DEXA) within 14 days prior to or following the screening visit and at other selected visits.
Specific fasting tests for glucose and lipid levels occurred at selected visits. ART was not
provided by this study.

Inclusion Criteria:

- HIV-1 infected

- Stable ART containing zidovudine or stavudine for at least 12 consecutive weeks prior
to study entry

- Cumulative ART with zidovudine or stavudine for at least 24 weeks prior to study entry

- Viral load of 5,000 copies/ml or less within 45 days prior to study entry

- Lipoatrophy in at least two of the following areas: face, arms, legs, OR buttocks

- Not planning to add to or change current vitamin supplementation

- Willing to use acceptable forms of contraception

Exclusion Criteria:

- Life expectancy of less than 12 months

- Currently enrolled in or planning to enroll in an ART interruption study

- Plans to change current ART regimen

- Liver failure at anytime prior to study entry

- Greater than Grade 2 diarrhea or vomiting within 7 days prior to study entry

- Current AIDS-defining opportunistic infection or illness. Individuals with cutaneous
Kaposi's sarcoma not requiring chemotherapy are not excluded.

- Currently receiving insulin or oral hypoglycemic products for diabetes mellitus

- Systemic cancer chemotherapy or immunomodulating agents within 30 days prior to study
entry

- Systemic steroids for a cumulative duration of longer than 4 weeks within the 6 months
prior to study entry

- Known allergy or sensitivity to study drug or any of its components

- Severe lactose intolerance

- Current drug or alcohol abuse or dependence

- Clinically significant illness requiring systemic treatment or hospitalization

- Chronic disability or serious illness that may affect body composition

- Received an investigational drug other than NucleomaxX or uridine for lipoatrophy
within 30 days prior to study entry

- Certain abnormal laboratory values

- Pregnancy or breastfeeding
We found this trial at
30
sites
Rochester, New York 14642
2242
mi
from 91732
Rochester, NY
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Atlanta, Georgia 30308
1919
mi
from 91732
Atlanta, GA
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Aurora, Colorado 80045
825
mi
from 91732
Aurora, CO
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Baltimore, Maryland 21287
2302
mi
from 91732
Baltimore, MD
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Birmingham, Alabama 35294
1777
mi
from 91732
Birmingham, AL
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Chapel Hill, North Carolina 27514
2195
mi
from 91732
Chapel Hill, NC
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Chicago, Illinois 60612
1726
mi
from 91732
Chicago, IL
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Cincinnati, Ohio 45267
1878
mi
from 91732
Cincinnati, OH
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Cleveland, Ohio 44106
2036
mi
from 91732
Cleveland, OH
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Cleveland, Ohio 44109
2031
mi
from 91732
Cleveland, OH
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1959
mi
from 91732
Columbus, OH
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Durham, North Carolina 27710
2203
mi
from 91732
Durham, NC
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Honolulu, Hawaii 96816
2573
mi
from 91732
Honolulu, HI
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1792
mi
from 91732
Indianapolis, IN
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Los Angeles, California 90033
11
mi
from 91732
Los Angeles, CA
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Los Angeles, California 90035
21
mi
from 91732
Los Angeles, CA
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Minneapolis, Minnesota 55455
1511
mi
from 91732
Minneapolis, MN
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Nashville, Tennessee 37203
1762
mi
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Nashville, TN
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New York, New York 10003
2351
mi
from 91732
New York, NY
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New York, New York 10016
2434
mi
from 91732
New York, NY
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New York, New York 10011
2433
mi
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New York, NY
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New York, New York 10032
2435
mi
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New York, NY
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Palo Alto, California 94304
327
mi
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Palo Alto, CA
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Pittsburgh, Pennsylvania 15213
2121
mi
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Pittsburgh, PA
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Providence, Rhode Island 02906
2562
mi
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Providence, RI
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Rochester, New York 14607
2246
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Rochester, NY
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San Diego, California 92103
103
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San Diego, CA
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San Juan, 00935
3356
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San Juan,
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Seattle, Washington 98104
961
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Seattle, WA
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Torrance, California 90502
22
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from 91732
Torrance, CA
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