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Lipodystrophy clinical trials

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NCT ID: NCT00149097 Completed - HIV Infections Clinical Trials

Role of the Autonomic Nervous System in HIV-Lipodystrophy

Start date: March 2005
Phase: N/A
Study type: Observational

The study aims to characterise the influence of the autonomic nervous system activity on the development of the lipodystrophy syndrome in HIV-infected patients by measuring heart rate variability and various metabolic pathways in HIV patients receiving highly active antiretroviral therapy.

NCT ID: NCT00139178 Completed - HIV Clinical Trials

Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir.

Start date: March 2004
Phase: Phase 4
Study type: Interventional

Highly active antiretroviral therapy (HAART) has improved the long time survival of HIV infected individuals. However an increasing number of HIV-patients have developed metabolic and morphological alterations including peripheral lipoatrophy. The main hypothesis of the study is that switching from thymidine-analogue based HAART will reverse lipoatrophy. We plan to perform an observational study recruiting up to 100 HIV-infected patients receiving Trizivir (zidovudine/lamivudine/abacavir). The patients will be offered an NRTI or lopinavir/ritonavir instead of zidovudine or they can choose to continue with Trizivir. The main endpoint is changes in peripheral fat mass as determined by DEXA-scanning.

NCT ID: NCT00135356 Completed - Clinical trials for HIV-Associated Lipodystrophy Syndrome

Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome

Start date: July 2005
Phase: Phase 4
Study type: Interventional

The purpose of this clinical research study is to learn if human immunodeficiency virus (HIV)-infected subjects with abdominal fat accumulation on their highly active antiretroviral treatment (HAART) regimen have better changes in fat distribution after switching to atazanavir-ritonavir than those remaining on their current protease inhibitor boosted HAART regimen.

NCT ID: NCT00130286 Completed - HIV Infections Clinical Trials

Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance

Start date: March 2005
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to determine if the combination of recombinant human growth hormone plus rosiglitazone (an insulin-sensitizing drug) is safe and more effective than either drug alone (or no active therapy) for the treatment of fat accumulation in people with HIV infection and insulin resistance.

NCT ID: NCT00123253 Completed - HIV Infections Clinical Trials

TH9507 in Patients With HIV-Associated Lipodystrophy

Start date: June 2005
Phase: Phase 3
Study type: Interventional

HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation and loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Data from a previous randomized, placebo-controlled trial demonstrated that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV patients with an excess of abdominal fat accumulation for 12 weeks resulted in decreases in visceral adipose tissue (VAT) and trunk fat, with no significant changes in limb fat and subcutaneous adipose tissue (SAT). This study is aimed at further assessing the efficacy and safety of 2 mg TH9507 in a larger population of HIV patients treated with ART and experiencing an excess of abdominal fat accumulation.

NCT ID: NCT00119769 Completed - HIV Infections Clinical Trials

The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients

Start date: February 2005
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate the effect of low-dose human growth hormone therapy on immune status and fat morphology.

NCT ID: NCT00119379 Completed - HIV Infections Clinical Trials

Effectiveness of Nucleoside Supplementation and Substituting Tenofovir Disoproxil Fumarate for Other Drugs in Anti-HIV Regimens in Reversing Fat Loss in HIV Infected Adults

Start date: April 2005
Phase: Phase 2
Study type: Interventional

HIV lipoatrophy is a condition marked by fat loss; it occurs in many patients taking antiretroviral (ARV) therapy that includes nucleoside reverse transcriptase inhibitors (NRTIs). Lipoatrophy may be related to mitochondrial toxicity, a condition that can damage the heart, nerves, muscles, kidneys, and liver, and can affect the body's ability to produce energy. NucleomaxX is a food supplement consisting of a sugar cane extract high in nucleosides, which are building blocks that may counteract the negative effects of NRTIs. Tenofovir disoproxil fumarate (TDF) is an NRTI that may cause less lipoatrophy than other drugs in its class, such as zidovudine (ZDV) or stavudine (d4T). The purpose of this study is to determine whether nucleoside supplementation with NucleomaxX and substitution of TDF for ZDV or d4T in an ARV regimen can reverse fat loss caused by mitochondrial toxicity in HIV infected adults. Study hypotheses: 1) The substitution of TDF for d4T or ZDV in patients with HIV lipoatrophy will result in an increase in mitochondrial DNA content in fat, skeletal muscle, and peripheral blood mononuclear cells (PBMCs), which in turn will lead to an improvement in mitochondrial function as assessed by electron transport chain (ETC) and oxidative phosphorylation pathway (OXPHOS) activity. The latter should lead to a decrease in fat apoptosis and in mitochondrial and lipid oxidative damage biomarkers. 2) Supplementation with uridine (via NucleomaxX) will increase mtDNA content in adipose tissue and increase body fat content.

NCT ID: NCT00100698 Completed - HIV Infections Clinical Trials

Physiologic Growth Hormone Effects in HIV Lipodystrophy

Start date: January 2004
Phase: N/A
Study type: Interventional

This study will investigate long-term, low-dose growth hormone administration in HIV-infected patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We hypothesize that low-dose growth hormone will reduce visceral fat. Secondary endpoints will include measures of insulin-like growth factor-1 (IGF-1), glucose homeostasis, lipids, blood pressure,bone density, cardiovascular risk and safety parameters.

NCT ID: NCT00082628 Completed - HIV Infections Clinical Trials

Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients

Start date: May 28, 2004
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to determine if Serostim® 4 mg administered daily for 12 weeks as treatment for the abnormal fat accumulation and distribution associated with HIV-associated Adipose Redistribution Syndrome (HARS) reduces Visceral Adipose Tissue (VAT, measured by CT scan) more effectively than placebo.

NCT ID: NCT00069004 Completed - HIV Infections Clinical Trials

A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth

Start date: October 2003
Phase: N/A
Study type: Observational

The purpose of this study is to assess the prevalence of metabolic and physical abnormalities in HIV infected (via mother-to-child transmission) and uninfected children and youth. Metabolism, body composition, bone density, and other factors will be assessed in relationship to participants' exposure to highly active antiretroviral therapy (HAART).