HIV-Associated Lipodystrophy Syndrome, HIV Infections
Conditions
Keywords
HIV-Associated Lipodystrophy Syndrome, pioglitazone, HIV infections, Treatment Experienced
Brief summary
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.
Detailed description
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.
Interventions
DRUGPioglitazone
Sponsors
Takeda
French National Agency for Research on AIDS and Viral Hepatitis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evolution from inclusion to week 48 of limb fat using DEXA Scan (Dual Energy X-ray Absorptiometry) | — |
Secondary
| Measure | Time frame |
|---|---|
| Lipid profile and the glucidic metabolism | — |
| SAT/TAT and VAT/TAT ratios evaluated with scanner | — |
| Changes from inclusion to week 48: | — |
| Anthropometric measurements and the quality of life (WHO-QOL-HIV BREF) | — |
| Evaluation of clinical and biological safety | — |
| X ray of L4 | — |
Countries
France
Outcome results
None listed