265. Lipodystrophy Clinical trials / Disease details
Clinical trials : 116 / Drugs : 170 - (DrugBank : 61) / Drug target genes : 26 - Drug target pathways : 97
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2005-004021-26-GB (EUCTR) | 06/10/2005 | 05/09/2005 | Longitudinal relationship between lipodystrophy and adipocyte mitochondria DNA in HIV Patients: comparison between Efavirenz (Sustiva) plus AZT/3TC (Combivir) and a less mitochrondial DNA-toxic regimen - Tenefovir/Emtricitabine (Truvada) plus Efavirenz. - Mitochondrial DNA Study | Longitudinal relationship between lipodystrophy and adipocyte mitochondria DNA in HIV Patients: comparison between Efavirenz (Sustiva) plus AZT/3TC (Combivir) and a less mitochrondial DNA-toxic regimen - Tenefovir/Emtricitabine (Truvada) plus Efavirenz. - Mitochondrial DNA Study | HIV | Trade Name: SUSTIVA Product Name: Efavirenz Trade Name: COMBIVIR Product Name: AZT/3TC Trade Name: TRUVADA Product Name: emtricitabine/tenofovir | University Hospital Birmingham | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): yes | United Kingdom | ||
| 2 | NCT00192660 (ClinicalTrials.gov) | February 2003 | 12/9/2005 | HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001) | Analysis of Lipodystrophy in HIV-Infected Individuals A Prospective, Non-randomised, 48 Week Study of the Effect of PI Containing and Non-PI Containing Antiretroviral Regimens on the Expression of Adipocyte Specific Genes, Protein Levels and Cellular Structure in HIV-infected Individuals, Naive to Therapy, Who Are Starting Therapy for the First Time | HIV-Associated Lipodystrophy Syndrome;Cardiovascular Disease | Drug: Lamivudine;Drug: Stavudine;Drug: Didanosine;Drug: Zidovudine;Drug: Tenofovir;Drug: Abacavir;Drug: Efavirenz (EFV);Drug: Nevirapine;Drug: Indinavir;Drug: Saquinavir;Drug: Amprenavir;Drug: Ritonavir;Drug: Nelfinavir;Drug: Tipranavir;Drug: enfuvirtide (T20) | Kirby Institute | St Vincent's Hospital, Sydney;National Heart, Lung, and Blood Institute (NHLBI) | Completed | 18 Years | N/A | Both | 80 | Phase 4 | Australia |
| 3 | NCT00457665 (ClinicalTrials.gov) | February 2002 | 4/4/2007 | Mechanisms of Lipodystrophy in HIV-Infected Pateints | Mecahnisms of Lipodystrophy in HIV-Infected Patients | HIV Infections | Drug: Nelfinavir;Drug: Efavirenz | University of Texas Southwestern Medical Center | Bristol-Myers Squibb;GlaxoSmithKline | Completed | 18 Years | 70 Years | All | 56 | Phase 4 | United States |
| 4 | NCT00017758 (ClinicalTrials.gov) | June 2001 | 11/6/2001 | The Effect of Efavirenz and Nelfinavir on the Blood Levels of Certain Lipid-Lowering Drugs | The Effect of Efavirenz and Nelfinavir on the Pharmacokinetics of Hydroxymethylglutaryl Coenzyme A Reductase Inhibitors | HIV Infections;HIV Seronegativity;Lipodystrophy | Drug: Pravastatin sodium;Drug: Simvastatin;Drug: Atorvastatin calcium;Drug: Nelfinavir mesylate;Drug: Efavirenz | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 18 Years | 60 Years | Both | 56 | Phase 1 | United States |
| 5 | NCT00021463 (ClinicalTrials.gov) | April 2001 | 14/7/2001 | Changing to Nonprotease Inhibitor Treatment to Improve Side Effects | Phase II, Randomized, Open-Label Study of Switching to Protease Inhibitor-Sparing Regimens for Improvement of Metabolic Abnormalities | HIV Infections;Lipodystrophy | Drug: Abacavir sulfate, Lamivudine and Zidovudine;Drug: Abacavir sulfate;Drug: Efavirenz;Drug: Nevirapine | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 13 Years | N/A | Both | 342 | Phase 2 | United States |
| 6 | NCT00006190 (ClinicalTrials.gov) | November 2000 | 25/8/2000 | A Study to Determine How and Why HIV-Infected Subjects on Anti-viral Treatment Develop Lipodystrophy | The Study of Mechanisms of Lipodystrophy in HIV-Infected Patients | HIV Infections;Lipodystrophy | Drug: Nelfinavir mesylate;Drug: Stavudine;Drug: Lamivudine;Drug: Efavirenz | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Completed | 18 Years | 70 Years | Both | Phase 4 | United States |