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Lipodystrophy clinical trials

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NCT ID: NCT01077765 Completed - HIV Infection Clinical Trials

Polyacrylamide Hydrogel Injection in HIV-related Lipoatrophy

LIPOPHILL
Start date: November 2005
Phase: Phase 3
Study type: Interventional

Combined antiretroviral therapy (cART) is associated with facial lipoatrophy, which is potentially stigmatizing for HIV-positive patients. Eutrophill is a 2.5% polyacrylamide hydrogel obtained by polymerization of acrylamide monomers with an official half-life of 5 years. Preliminary encouraging results with the use of polyacrylamide hydrogel for reconstruction of facial lipoatrophy in HIV-infected patients have been previously reported. The primary objective of the study was to evaluate the long-term efficacy and safety of subcutaneous facial injections of Eutrophill in HIV-infected patients with severe facial lipoatrophy as assessed by facial ultrasonography at screening , after 6, 12 and 24 months

NCT ID: NCT01023620 Completed - HIV Infections Clinical Trials

HIV Acquired Lipodystrophy (HAL) Classification, Measurement and Fat Response to Thiazolidinedione (TZD) (Pioglitazone)

HAL
Start date: October 2009
Phase: N/A
Study type: Interventional

This study is being done to better understand why people with HIV who have taken drugs for HIV begin to show abnormal changes in fat loss or fat gain in their bodies. This condition is called lipodystrophy. Patients who take medicine for HIV and who have lipodystrophy report loss of subcutaneous (sc) fat from the arms, legs, and face and excess fat gain in the neck and truncal region. They also more likely to have problems with insulin in the body, high fat levels in the blood and diabetes. The reason that lipodystrophy develops is not fully understood although some HIV drugs have are very likely the cause. The complications pose an increased risk of fat blockage forming in the arteries making you more at risk for heart problems in the future. Changes in body fat can cause physical discomfort and psychological distress. Management of these problems can be a challenge for the patient's doctor. The investigators propose data collection to determine if there is more than one reason why this might happen in some people and not in others. Laboratory samples being collected: 1) special imaging of the liver; 2) fat collected by needle from the mid thigh and mid-shoulder areas; 3) blood samples to measure the virus, t-cells, fats, and other markers of how the patient's body is handling the virus. This study is being done because science does not fully understand why some patients with HIV who take medicines for the virus have abnormal fat loss or gain and some do not. This research study is intended to help us better understand why and how this happens.

NCT ID: NCT00978237 Completed - HIV Infections Clinical Trials

Clinical Trial to Assess the Effect of the Change of Efavirenz (EFV) for Lopinavir/Ritonavir (LPV/r) in Lipoatrophy in HIV-infected Patients

LIPOKAL
Start date: October 2009
Phase: Phase 4
Study type: Interventional

Eligible HIV-infected patients with clinically evident lipoatrophy despite treatment with efavirenz and fixed-dose combination of thymidine nucleoside analogues will be informed and asked to enroll in the study; will be randomized (1:1) into two branches, A: EFV + Fixed combinations of analogue tenofovir + emtricitabine.B (experimental): LPV/r + combination of correspondent analogues. The main variable is the evaluation of the absolute change in limb fat mass at 24 months from baseline in both groups.

NCT ID: NCT00931268 Completed - Atrophy Clinical Trials

Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane

Start date: August 2009
Phase: N/A
Study type: Interventional

The study is being undertaken to establish the effectiveness and safety of Macrolane volume restoration factor 30 (VRF30) when used for treatment of HIV-infected subjects with buttocks lipoatrophy.

NCT ID: NCT00910936 Recruiting - HIV Infections Clinical Trials

Exercise for Patients With HIV Infections

Start date: May 2009
Phase: Phase 2/Phase 3
Study type: Interventional

The investigators will evaluate the effects of an endurance exercise program on the physical performance, the well being, and indicators of metabolic function in patients with an HIV infection.

NCT ID: NCT00896298 Completed - Insulin Resistance Clinical Trials

Trial of Leptin Replacement Therapy in Patients With Lipodystrophy

Start date: April 2006
Phase: Phase 2/Phase 3
Study type: Interventional

Lipodystrophies represent a therapeutic challenge with regards to insulin resistance, hypertriglyceridemia and fatty liver which often is coupled with significant adipose tissue loss. The purpose of the study is to examine the safety and efficacy of Leptin on subjects with lipodystrophy.

NCT ID: NCT00865007 Completed - HIV Infections Clinical Trials

Lopinavir/r Monotherapy Versus Abacavir/Lamivudine and Lopinavir/r for Limb Fat Recovery in Persons With Lipoatrophy

KRETA
Start date: December 2008
Phase: Phase 4
Study type: Interventional

The aim of this study is to evaluate the efficacy for the recovery of peripheral fat of lopinavir/ritonavir in monotherapy versus abacavir/lamivudine and lopinavir/ritonavir in subjects who developed lipoatrophy while receiving zidovudine plus lamivudine plus abacavir.

NCT ID: NCT00822042 Completed - Lipodystrophy Clinical Trials

Corticosteroid-induced Lipodystrophy and Adipokines

ADIPOKINES
Start date: August 2006
Phase: N/A
Study type: Observational

Hypothesis: systemic therapy with corticosteroid induces morphological changes (e.g., moon face, buffalo neck) called lipodystrophy (LD). We hypothesize that this LD is associated with variation of adipocytokines (e.g., adiponectin, leptine, IL6) levels Primary objective: To show a 50% decrease in adipocytes adiponectin's expression in patients who developed LD versus those who did not developed LD during the first 3 months of a systemic therapy with corticosteroids Secondary objectives: To look for differences in the mRNA expression of 11bHSD1, SREBP1c and PPARg in fat samples of patients before and after treatment with systemic corticosteroids and between LD+ and LD-patients To compare the fat morphology before and after treatment with glucosteroids

NCT ID: NCT00795210 Completed - HIV Lipodystrophy Clinical Trials

Effects of Short-term Growth Hormone in HIV-infected Patients

Start date: February 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the short-term effects of two different doses of growth hormone, compared to treatment with growth hormone releasing hormone, on the brain's secretion of growth hormone and the body's glucose metabolism. We hypothesize that growth hormone administration will alter the body's endogenous pulsatile growth hormone secretion and that higher dose growth hormone may decrease insulin sensitivity. We hypothesize that growth hormone releasing hormone will augment endogenous GH pulsatility and be neutral to insulin sensitivity.

NCT ID: NCT00715546 Active, not recruiting - Lipodystrophy Clinical Trials

Autologous Adipose-Derived Stem Cell Transplantation in Patients With Lipodystrophy

AADSCTPL
Start date: October 2007
Phase: Phase 1
Study type: Interventional

The aim of this study is to determine the safety of the autologous transplantation of adipose-derived stem cells in the treatment of lipodystrophies.