Rosiglitazone Effect on Mitochondria and Lipoatrophy
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Rosiglitazone (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Grace McComsey, Principal Investigator, Affiliation: Case Western Reserve University
Overall contact:
Grace McComsey, MD, Phone: 2168443645, Email: mccomsey.grace@clevelandactu.org
Summary
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).
Clinical Details
Official title: Placebo Controlled Study of Rosiglitazone in HIV Lipoatrophy
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Limb fat and mitochondrial indices
Secondary outcome: Carotid IMT and cardiovascular markers
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Grace McComsey, MD, Phone: 2168443645, Email: mccomsey.grace@clevelandactu.org
University Hospitals of Cleveland/Case Western Reserve University, Cleveland, Ohio 44141, United States; Recruiting
Grace McComsey, MD, Phone: 216-844-3645, Email: mccomsey.grace@clevelandactu.org
Norma Storer, RN, Phone: 2168442752, Email: storer.norma@clevelandactu.org
Grace McComsey, MD, Principal Investigator
Cleveland Clinc Foundation, Cleveland, Ohio 44106, United States; Recruiting
Marisa Tungsiripat, MD, Phone: 216-444-2037, Email: TUNGSIM@ccf.org
Marisa Tungsiripat, MD, Phone: 2164442037, Email: TUNGSIM@ccf.org
Additional Information
Starting date: July 2006
Ending date: April 2009
Last updated: May 28, 2008
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