Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy
NCT ID: NCT00307164
Last Updated: 2021-11-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
167 participants
INTERVENTIONAL
2006-09-30
2008-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
NucleomaxX
Participants received NucleomaxX for 48 weeks
NucleomaxX
36 g sachet taken orally three times daily
Placebo
Participants received NucleomaxX placebo for 48 weeks
NucleomaxX placebo
36 g placebo sachet taken orally three times daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NucleomaxX
36 g sachet taken orally three times daily
NucleomaxX placebo
36 g placebo sachet taken orally three times daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Grace A. McComsey, MD
Role: STUDY_CHAIR
Division of Infectious Diseases, Case Western Reserve University
Judith A. Aberg, MD
Role: STUDY_CHAIR
New York University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alabama Therapeutics CRS
Birmingham, Alabama, United States
USC CRS
Los Angeles, California, United States
UCLA CARE Center CRS
Los Angeles, California, United States
Stanford CRS
Palo Alto, California, United States
Ucsd, Avrc Crs
San Diego, California, United States
Harbor-UCLA Med. Ctr. CRS
Torrance, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
The Ponce de Leon Ctr. CRS
Atlanta, Georgia, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, United States
Beth Israel Med. Ctr., ACTU
New York, New York, United States
NY Univ. HIV/AIDS CRS
New York, New York, United States
Cornell CRS
New York, New York, United States
HIV Prevention & Treatment CRS
New York, New York, United States
Trillium Health ACTG CRS
Rochester, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States
Unc Aids Crs
Chapel Hill, North Carolina, United States
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States
Case CRS
Cleveland, Ohio, United States
MetroHealth CRS
Cleveland, Ohio, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Pitt CRS
Pittsburgh, Pennsylvania, United States
The Miriam Hosp. ACTG CRS
Providence, Rhode Island, United States
Vanderbilt Therapeutics CRS
Nashville, Tennessee, United States
University of Washington AIDS CRS
Seattle, Washington, United States
Puerto Rico-AIDS CRS
San Juan, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Koch EC, Schneider J, Weis R, Penning B, Walker UA. Uridine excess does not interfere with the antiretroviral efficacy of nucleoside analogue reverse transcriptase inhibitors. Antivir Ther. 2003 Oct;8(5):485-7. No abstract available.
McComsey GA, Walker UA. Role of mitochondria in HIV lipoatrophy: insight into pathogenesis and potential therapies. Mitochondrion. 2004 Jul;4(2-3):111-8. doi: 10.1016/j.mito.2004.05.008.
Nolan D, Hammond E, Martin A, Taylor L, Herrmann S, McKinnon E, Metcalf C, Latham B, Mallal S. Mitochondrial DNA depletion and morphologic changes in adipocytes associated with nucleoside reverse transcriptase inhibitor therapy. AIDS. 2003 Jun 13;17(9):1329-38. doi: 10.1097/00002030-200306130-00007.
Walker UA, Venhoff N. Uridine in the prevention and treatment of NRTI-related mitochondrial toxicity. Antivir Ther. 2005;10 Suppl 2:M117-23.
McComsey GA, Walker UA, Budhathoki CB, Su Z, Currier JS, Kosmiski L, Naini LG, Charles S, Medvik K, Aberg JA; AIDS Clinical Trials Group A5229 Team. Uridine supplementation in the treatment of HIV lipoatrophy: results of ACTG 5229. AIDS. 2010 Oct 23;24(16):2507-15. doi: 10.1097/QAD.0b013e32833ea9bc.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10136
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG A5229
Identifier Type: -
Identifier Source: secondary_id
A5229
Identifier Type: -
Identifier Source: org_study_id