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Completed

NCT Number: NCT00367744

Rosiglitazone Effect on Mitochondria and Lipoatrophy

The purpose of this study is to examine the effect of rosiglitazone on limb fat and mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that does not contain stavudine (d4T) or zidovudine (AZT).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cleveland Clinc Foundation, Cleveland, Ohio, United States

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About this study

This is a phase II, randomized, double-blind, placebo-controlled study of rosiglitazone for the treatment of HIV-associated lipoatrophy. Subjects will receive blinded study treatment for 48 weeks. This study will examine the effect of rosiglitazone on limb fat and mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that does not contain d4T or AZT. The study also will assess the safety and tolerability of rosiglitazone in this population, and its effect on carotid IMT, prevalence of metabolic syndrome, lipid parameters and glucose metabolism.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Lipoatrophy
  • Thymidine sparing ARV for at least 24 weeks
  • Prior thymidine NRTIs for at least 12 months

Exclusion criteria

  • Diabetes
  • Heart failure
  • Liver disease
  • Hormonal therapies

Treatment and study plan

rosiglitazone

Drug

Rosiglitazone 4mg BID

Other names: Glitazones, avandia

Placebo

Drug

Placebo for rosiglitazone

Primary outcomes

  1. Change in Limb Fat at 48 Weeks

    Time frame: 48 weeks

    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.

Secondary outcomes

  1. the Change in the Carotid IMT of the Common Carotid Artery

    Time frame: 48 weeks

    Carotid IMT of the Common carotid artery (CCA) was measured at baseline and week 48, and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Placebo Controlled Study of Rosiglitazone in HIV Lipoatrophy

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 23, 2006
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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