Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy

NCT00307164 | Completed Phase 2 Results

• 3 other identifiers: A522910136ACTG A5229
• Study Type: interventional
• Target: 167
• Locations: 2 countries
• Sites: 30

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.

Conditions

HIV Infections; Lipoatrophy

Keywords

Treatment Experienced; Uridine

Outcome Measures

Primary Outcomes (1)

• Change in Limb Fat (g) From Baseline

  Limb fat was measured at baseline and visit week 48 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.

  Baseline and Week 48

Secondary Outcomes (15)

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

  Through Week 48

• Number of Subjects Discontinuing Study Medication

  Through Week 48

• Change in Limb Fat From Baseline (Week 24 - Baseline)

  Baseline and Week 24

• HIV-1 RNA Level

  At Week 48

• Change in CD4+ Count From Baseline (Week 48 - Baseline)

  Baseline and Week 48

Study Arms (2)

NucleomaxX

ACTIVE COMPARATOR

Participants received NucleomaxX for 48 weeks

Drug: NucleomaxX

Placebo

PLACEBO COMPARATOR

Participants received NucleomaxX placebo for 48 weeks

Drug: NucleomaxX placebo

Interventions

NucleomaxX DRUG

36 g sachet taken orally three times daily

NucleomaxX

NucleomaxX placebo DRUG

36 g placebo sachet taken orally three times daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (30)

Alabama Therapeutics CRS

Birmingham, Alabama, 35924-2050, United States

Location

USC CRS

Los Angeles, California, 90033, United States

Location

UCLA CARE Center CRS

Los Angeles, California, United States

Location

Stanford CRS

Palo Alto, California, 94305-5107, United States

Location

Ucsd, Avrc Crs

San Diego, California, 92103, United States

Location

Harbor-UCLA Med. Ctr. CRS

Torrance, California, 90502-2052, United States

Location

University of Colorado Hospital CRS

Aurora, Colorado, 80262-3706, United States

Location

The Ponce de Leon Ctr. CRS

Atlanta, Georgia, 30308, United States

Location

Univ. of Hawaii at Manoa, Leahi Hosp.

Honolulu, Hawaii, 96816, United States

Location

Rush Univ. Med. Ctr. ACTG CRS

Chicago, Illinois, 60612, United States

Location

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, 46202-5250, United States

Location

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, 21287-8106, United States

Location

University of Minnesota, ACTU

Minneapolis, Minnesota, 55455, United States

Location

Beth Israel Med. Ctr., ACTU

New York, New York, 10003, United States

Location

NY Univ. HIV/AIDS CRS

New York, New York, 10016-6481, United States

Location

Cornell CRS

New York, New York, 10021, United States

Location

HIV Prevention & Treatment CRS

New York, New York, 10032, United States

Location

Trillium Health ACTG CRS

Rochester, New York, 14607, United States

Location

Univ. of Rochester ACTG CRS

Rochester, New York, 14642-0001, United States

Location

Unc Aids Crs

Chapel Hill, North Carolina, 27514, United States

Location

Duke Univ. Med. Ctr. Adult CRS

Durham, North Carolina, 27710, United States

Location

Univ. of Cincinnati CRS

Cincinnati, Ohio, 45267-0405, United States

Location

Case CRS

Cleveland, Ohio, 44106-5083, United States

Location

MetroHealth CRS

Cleveland, Ohio, 44109, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Pitt CRS

Pittsburgh, Pennsylvania, 15213-2582, United States

Location

The Miriam Hosp. ACTG CRS

Providence, Rhode Island, 02906, United States

Location

Vanderbilt Therapeutics CRS

Nashville, Tennessee, 37203, United States

Location

University of Washington AIDS CRS

Seattle, Washington, 98104, United States

Location

Puerto Rico-AIDS CRS

San Juan, 00936-5067, Puerto Rico

Location

Related Publications (5)

• 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.

  PMID: 14640397 BACKGROUND

• 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.

  PMID: 16120376 BACKGROUND

• 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.

  PMID: 12799554 BACKGROUND

• Walker UA, Venhoff N. Uridine in the prevention and treatment of NRTI-related mitochondrial toxicity. Antivir Ther. 2005;10 Suppl 2:M117-23.

  PMID: 16152713 BACKGROUND

• 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.

  PMID: 20827170 RESULT

MeSH Terms

Conditions

HIV Infections; Lipodystrophy

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: ACTG ClinicalTrials.gov Coordinator
• Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.

ACTGCT.Gov@s-3.com

(301) 628-3313

Study Officials

• Grace A. McComsey, MD

  Division of Infectious Diseases, Case Western Reserve University

  STUDY CHAIR

• Judith A. Aberg, MD

  New York University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2006
• First Posted: March 27, 2006
• Study Start: September 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 4, 2021
• Results First Posted: October 4, 2011

Record last verified: 2019-01

Locations

US (29); PR (1)