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Lipodystrophy clinical trials

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NCT ID: NCT00192621 Completed - HIV Infections Clinical Trials

Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir® in HIV-Negative Healthy Subjects

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

This is a randomised study of the effect of treatment with Combivir (zidovudine [AZT] and lamivudine [3TC]) and Kaletra (lopinavir [LPVr]), alone and in combination, on the development of abnormalities in lipid and glucose metabolism in HIV negative healthy subjects.

NCT ID: NCT00172315 Recruiting - Clinical trials for Acquired Immunodeficiency Syndrome

Proton Magnetic Resonance Spectroscopy (1H MRS) in Evaluating the Bone Marrow, Muscle and Adipose Tissue on Normal and Human Immunodeficiency Virus Infected Subjects

Start date: December 2003
Phase: Phase 3
Study type: Observational

Magnetic resonance spectroscopy (MRS) is commonly applied in medicine with 1H proton or 31-phosphorus spectra. The proton MRS is often used in evaluating the central nervous system and 31P MRS is used in muscular diseases or neoplasms. However, the proton MRS is also considered to be applied to the musculoskeletal system because of its profound amount of protons. Ballon used the STEAM technique, and Schick used the PRESS technique, to investigate the lipid and water spectra of the bone marrow and also correlated those with hematological diseases and post-treatment effects. Schellinger et al. used the STEAM sequence to calculate the lipid content of the vertebral bone marrow and found that it was influenced according to age and sex. The investigator had used the proton MRS to evaluate the lipid and water spectra of the femoral head and revealed its significance in predicting avascular necrosis of the femoral head. According to the above research literature, the investigators considered further investigation of the proton MRS in evaluating the musculoskeletal system.

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: NCT00148850 Terminated - HIV Infections Clinical Trials

Effect of Pioglitazone on HIV-1 Related Lipoatrophy: a Randomized, Double Blind, Placebo-Controlled Trial in 130 Patients

Start date: February 2003
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT00140244 Active, not recruiting - Clinical trials for HAART-induced Lipodystrophy and Metabolic Syndrome

Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome

Start date: December 2001
Phase: Phase 2
Study type: Interventional

The purpose of this study is to examine whether replacing leptin to normal levels can reverse the changes in fat distribution, lipid profile, and other metabolic problems associated with highly active antiretroviral therapy (HAART)-induced lipodystrophy and metabolic syndrome in HIV patients.

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: NCT00135460 Active, not recruiting - Clinical trials for HIV-Associated Lipodystrophy Syndrome

Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected Patients

Start date: June 2003
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. There is limited knowledge about lipodystrophic adverse events in nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimens. The hypothesis is that nucleoside analogues are responsible for development of lipoatrophy, and, patients receiving an NRTI-sparing regimen will have little risk of peripheral lipoatrophy. The researchers plan to perform a randomized study recruiting 100 antiretroviral naive patients that will be randomized to receive a nucleoside analogue sparing HAART regimen or a protease-inhibitor sparing regimen. The main endpoint is changes in peripheral fat mass as determined by dual energy X-ray absortiometry (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: NCT00126308 Terminated - HIV Infections Clinical Trials

Facial Lipoatrophy Trial: Immediate Versus Deferred Injections of Poly-L-Lactic Acid for HIV Facial Lipoatrophy

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

This is a multi-centre, open-label, 96 week study to evaluate the safety, tolerability and extent and duration of improvement in HIV-1 infected subjects with antiretroviral induced facial lipoatrophy, randomised in a 1:1 ratio to receive immediate or deferred deep subcutaneous injections of poly-L-lactic acid (PLA). Subjects will receive 4 treatments of PLA approximately every 2nd week, either at trial entry or following a delay period of 24 weeks.