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Phase 2 N=50 Randomized Treatment

Effectiveness of Nucleoside Supplementation or Switch to Tenofovir in Reversing Fat Loss in HIV Infected Adults

HIV Infections · Lipodystrophy · Metabolic Diseases · Nutrition Disorders

Enrolled (actual)
50
Serious AEs
28.0%
Results posted
May 2017
Primary outcome: Primary: Change in Fat mtDNA Content — -169; 321 copies/cell

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
NucleomaxX (Drug); Tenofovir Disoproxil Fumarate (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion
Oct 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Fat mtDNA Content
-169; 321
PRIMARY
Change in PBMC mtDNA
-24; -52
SECONDARY
Change in Limb Fat
0.1; 0.4
SECONDARY
Change in Trunk Fat
0.2; 0.7
SECONDARY
Change in Lumbar Spine Bone Mineral Density (BMD)
0.39; 0.0
SECONDARY
Change in Hip Bone Mineral Density (BMD)
0.45; -3.3

Summary

HIV lipoatrophy is a condition marked by fat loss; it occurs in many patients taking antiretroviral (ARV) therapy that includes nucleoside reverse transcriptase inhibitors (NRTIs). Lipoatrophy may be related to mitochondrial toxicity, a condition that can damage the heart, nerves, muscles, kidneys, and liver, and can affect the body's ability to produce energy. NucleomaxX is a food supplement consisting of a sugar cane extract high in nucleosides, which are building blocks that may counteract the negative effects of NRTIs. Tenofovir disoproxil fumarate (TDF) is an NRTI that may cause less lipoatrophy than other drugs in its class, such as zidovudine (ZDV) or stavudine (d4T). The purpose of this study is to determine whether nucleoside supplementation with NucleomaxX and substitution of TDF for ZDV or d4T in an ARV regimen can reverse fat loss caused by mitochondrial toxicity in HIV infected adults. Study hypotheses: 1) The substitution of TDF for d4T or ZDV in patients with HIV lipoatrophy will result in an increase in mitochondrial DNA content in fat, skeletal muscle, and peripheral blood mononuclear cells (PBMCs), which in turn will lead to an improvement in mitochondrial function as assessed by electron transport chain (ETC) and oxidative phosphorylation pathway (OXPHOS) activity. The latter should lead to a decrease in fat apoptosis and in mitochondrial and lipid oxidative damage biomarkers. 2) Supplementation with uridine (via NucleomaxX) will increase mtDNA content in adipose tissue and increase body fat content.

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of HIV lipoatrophy
  • Receiving a stable stavudine- or zidovudine-containing ARV regimen
  • HIV-1 RNA viral load less than 50 copies/ml

Exclusion Criteria

  • Coagulopathies or other bleeding disorders
  • Diabetes requiring medication
  • Creatinine clearance less than 50 ml/min
  • Pregnancy or breastfeeding
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00119379). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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