Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy

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Brief Title

Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy

Official Title

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

Brief Summary

      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.
    

Detailed 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.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Change in Limb Fat (g) From Baseline

Secondary Outcome

 Time to Safety Events (Signs/Symptoms or Laboratory Abnormalities)

Condition

HIV Infections

Intervention

NucleomaxX

Study Arms / Comparison Groups

 NucleomaxX
Description:  Participants received NucleomaxX for 48 weeks

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

167

Start Date

September 2006

Completion Date

December 2008

Primary Completion Date

December 2008

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Grace A. McComsey, MD, , 

Location Countries

Puerto Rico

Location Countries

Puerto Rico

Administrative Informations


NCT ID

NCT00307164

Organization ID

A5229

Secondary IDs

10136

Responsible Party

Sponsor

Study Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)


Study Sponsor

Grace A. McComsey, MD, Study Chair, Division of Infectious Diseases, Case Western Reserve University


Verification Date

January 2019