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 | NCT04904406 (ClinicalTrials.gov) | October 22, 2020 | 9/10/2020 | Changes in Weight, Body Composition and Cardiac Risk After Discontinuing Abacavir Treatment in HIV-infected Individuals | Changes in Weight and Body Composition After Switch to Dolutegravir/Lamivudine Compared to Continued Dolutegravir/Abacavir/Lamivudine for Virologically Suppressed HIV Infection: A Randomized Open-label Superiority Trial: AVERTAS-1 | Hiv;HIV Infections;HIV Cardiomyopathy;Weight Change, Body;HIV Lipodystrophy;Cardiovascular Diseases | Drug: Dolutegravir / Lamivudine Oral Tablet | Thomas Benfield | NULL | Recruiting | 18 Years | N/A | All | 95 | Phase 4 | Denmark |
| 2 | NCT00865007 (ClinicalTrials.gov) | December 2008 | 18/3/2009 | Lopinavir/r Monotherapy Versus Abacavir/Lamivudine and Lopinavir/r for Limb Fat Recovery in Persons With Lipoatrophy | A Phase IV-III Comparative, Randomized, Open-label Study to Evaluate the Efficacy for the Recovery of Peripheral Fat (or of the Extremities) of Lopinavir/Ritonavir in Monotherapy Versus Abacavir/Lamivudine and Lopinavir/Ritonavir | HIV Infection;Lipodystrophy;HIV Infections | Drug: Monotherapy (Lopinavir/ritonavir);Drug: Monotherapy (Lopinavir/ritonavir) + ABC/3TC | Fundacion SEIMC-GESIDA | Abbott | Completed | 18 Years | N/A | Both | 88 | Phase 4 | Spain |
| 3 | NCT00426296 (ClinicalTrials.gov) | August 2006 | 23/1/2007 | SHARE: Simple HAART With Abacavir, Reyataz, and Epivir | An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of a Fixed-Dose Combination of Abacavir 600 mg/Lamivudine 300 mg Once-Daily in Combination With Atazanavir 300 mg + Ritonavir 100 mg Once-Daily in Antiretroviral-Naïve HIV-1 Infected Subjects With Continuing Evaluation of Abacavir/Lamivudine Plus Atazanavir 400 mg for Maintenance Over an Additional 48 Weeks | HIV Infections;Lipodystrophy | Drug: atazanavir (Reyataz);Drug: ritonavir (Norvir) | Clinical Alliance for Research & Education - Infectious Diseases, LLC. | GlaxoSmithKline | Recruiting | 18 Years | N/A | Both | Phase 4 | United States | |
| 4 | 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 |
| 5 | NCT00647946 (ClinicalTrials.gov) | February 2003 | 27/3/2008 | Study to Evaluate Changes in Limb Fat When Switching From a Thymidine Analogue | A Phase II, Open-Label, Multicentre, Randomised, Comparator Study of Substitution With Tenofovir or Abacavir in HIV-1 Infected Individuals, With a Viral Load < 50 Copies/mL, Receiving a Thymidine Analogue (Zidovudine or Stavudine) as Part of Their Highly Active Antiretroviral Therapy (HAART) | Lipodystrophy | Drug: tenofovir DF;Drug: abacavir 300mg twice daily | Gilead Sciences | NULL | Completed | 18 Years | N/A | Both | 100 | Phase 2 | United Kingdom |
| 6 | NCT00028314 (ClinicalTrials.gov) | March 2002 | 20/12/2001 | Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients | A Restrictively Randomized, Open-Label, Controlled, Pilot Study of the Effect of a Thymidine Analogue Substitution or Change to a Nucleoside-Sparing Regimen on Peripheral Fat Wasting | HIV Infections;Lipodystrophy;Wasting Disease | Drug: Abacavir sulfate;Drug: Atazanavir/Ritonavir;Drug: Lopinavir/Ritonavir;Drug: Nevirapine | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 13 Years | N/A | Both | 150 | N/A | United States |
| 7 | 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 |
| 8 | NCT00005764 (ClinicalTrials.gov) | May 2000 | 30/5/2000 | A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients | Glaxo Wellcome Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects (TARHEEL) | HIV Infections;Lipodystrophy | Drug: Lamivudine/Zidovudine;Drug: Abacavir sulfate;Drug: Lamivudine | Glaxo Wellcome | NULL | Completed | 18 Years | N/A | Both | 100 | Phase 4 | United States |