Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase

Completed

Phase 3

Phase 2

Conditions

Lipoatrophy

HIV Infections

Treatments

Drug: NucleomaxX placebo

Drug: NucleomaxX

Study type

Interventional

Funder types

NIH

Identifiers

NCT00307164

A5229

10136 (Registry Identifier)

ACTG A5229

Details and patient eligibility

About

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.

Full description

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.

Enrollment

167 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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