Effect of Pioglitazone on HIV-1 Related Lipoatrophy: a Randomized, Double Blind, Placebo-Controlled Trial in 130 Patients
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Purpose
The aim of this randomized study is to compare the effect of pioglitazone versus placebo on change in limb fat in HIV 1-infected patients treated with antiretroviral therapy for at least 6 months and with clinical lipoatrophy.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV-Associated Lipodystrophy Syndrome HIV Infections |
Drug: Pioglitazone |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized, Phase 3, Double Blind, Multicentre Trial, Evaluating the Effect of Pioglitazone Versus Placebo on Change in Lipoatrophy in HIV- 1 Infected Patients Treated With Stable Antiretroviral Therapy for at Least 6 Months.ANRS 113 LIPIOT Study |
- Evolution from inclusion to week 48 of limb fat using DEXA Scan (Dual Energy X-ray Absorptiometry)
- Changes from inclusion to week 48:
- Lipid profile and the glucidic metabolism
- SAT/TAT and VAT/TAT ratios evaluated with scanner
- X ray of L4
- Anthropometric measurements and the quality of life (WHO-QOL-HIV BREF)
- Evaluation of clinical and biological safety
| Estimated Enrollment: | 130 |
| Study Start Date: | February 2003 |
| Estimated Study Completion Date: | October 2004 |
Lipodystrophy is one of the most frequent treatment side effect in HIV-1 infected patients. This complication can be stigmatizing in some affected patients and lead to reduced adherence to treatment, increased risk of cardiovascular complications and induce insulinoresistance. The pathophysiology of lipodystrophy remains poorly understood. Some antiretroviral drugs could be involved. Therefore, using PPAR G as a therapeutic target with the objective to reverse drug induced lipoatrophy appeared as a promising objective Thiazolidinediones are a new class of insulin sensitizing drugs for the treatment of type 2 diabetes. These PPARG agonist which mainly promote the differentiation of adipocytes, decrease circulating plasma free fatty acids. In non-HIV infected patients this class of drugs decreases intraabdominal fat accumulation and increases subcutaneous fat depot.
Different previous studies were performed with that aim, most of them using rosiglitazone.
We designed a prospective randomized, double blind placebo controlled multicentre study aiming to test the hypothesis that pioglitazone would improve lipoatrophy without deleterious effect on lipid profile in adult subjects receiving antiretroviral therapy.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 years of ages and older
Confirmed laboratory diagnosis of HIV-1-infection
– Karnofsky equal or over 70%
- Patients treated with stable antiretroviral therapy for at least 6 months
- Plasma viral load below 400 copies/ ml and CD4 count over 200/mm3 for at least 6 months
- Patients with a clinical peripheral lipoatrophy self reported by the patient and confirmed by physical examination
Exclusion Criteria:
- Cachexia
- Cardiac failure class3 or 4 at NYHA classification
- Acute opportunistic infection
- Pregnancy or breast-feeding
- Polynuclear neutrophils below 1000/mm3
- Hemoglobin below 9 g/dl
Platelets below 50 000/mm3
– Creatinine level over 2 UN
- ASAT, ALAT over 2.5UN
- Bilirubin, amylase, lipase level over 2 UN
- CD4 count below 200/mm3
- Patients treated by any antidiabetic or lipid lowering drugs, anabolic or corticosteroid hormone
Contacts and Locations| France | |
| Service des Maladies Infectieuses et Tropicales, Hopital Tenon | |
| Paris, France, 75020 | |
| Principal Investigator: | Willy Rozenbaum, MD | Hopital Tenon Paris |
| Study Chair: | Dominique Costagliola | INSERM U 720 |
More Information
No publications provided by French National Agency for Research on AIDS and Viral Hepatitis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00148850 History of Changes |
| Other Study ID Numbers: | ANRS 113 LIPIOT |
| Study First Received: | September 7, 2005 |
| Last Updated: | October 19, 2005 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
|
HIV-Associated Lipodystrophy Syndrome pioglitazone HIV infections Treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lipodystrophy HIV-Associated Lipodystrophy Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Slow Virus Diseases Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders Metabolic Diseases Pioglitazone Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 07, 2013
