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 | 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 | |
| 2 | EUCTR2004-002740-10-DE (EUCTR) | 07/11/2005 | 04/10/2005 | A PHASE IV, OPEN-LABEL, RANDOMIZED, MULTICENTER TRIAL ASSESSING A REYATAZ-BASED SUBSTITUTION APPROACH IN THE MANAGEMENT OF LIPODYSTROPHY SYNDROME. Pharmacogenetics Blood Sample Amendment 01, version 2.0 dated 13-Feb-05Revised Protocol 03, version v8.0, incorporating Protocol Amendments 03, 04 and 05 - THE REAL STUDY - RESEARCH INTO ATAZANAVIR IN LIPODYSTROPHY | A PHASE IV, OPEN-LABEL, RANDOMIZED, MULTICENTER TRIAL ASSESSING A REYATAZ-BASED SUBSTITUTION APPROACH IN THE MANAGEMENT OF LIPODYSTROPHY SYNDROME. Pharmacogenetics Blood Sample Amendment 01, version 2.0 dated 13-Feb-05Revised Protocol 03, version v8.0, incorporating Protocol Amendments 03, 04 and 05 - THE REAL STUDY - RESEARCH INTO ATAZANAVIR IN LIPODYSTROPHY | HIV-infected individuals with lipodystrophy | Trade Name: Reyataz Product Name: Reyataz Product Code: BMS-232632 INN or Proposed INN: Atazanavir Other descriptive name: ATV Trade Name: Norvir Product Name: Norvir INN or Proposed INN: Ritonavir Other descriptive name: RTV | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | United Kingdom;Germany;Spain;Italy | ||
| 3 | EUCTR2004-002740-10-IT (EUCTR) | 04/07/2005 | 24/01/2006 | A phase IV, open-label, randomized, multicenter trial assessing a reyataz-based substitution approach in the management of lipodystrophy syndrome. | A phase IV, open-label, randomized, multicenter trial assessing a reyataz-based substitution approach in the management of lipodystrophy syndrome. | HIV MedDRA version: 6.1;Level: PT;Classification code 10049287 | Trade Name: REYATAZ 150MG 60 CPS BL INN or Proposed INN: atazanavir | BRISTOL-M.SQUIBB | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Germany;United Kingdom;Spain;Italy | ||
| 4 | NCT00135356 (ClinicalTrials.gov) | July 2005 | 25/8/2005 | Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome | A Phase IV, Open-Label, Randomized, Multicenter Trial Assessing a Reyataz-Based Substitution Approach in the Management of Lipodystrophy Syndrome. Research Into Atazanavir in Lipodystrophy (The REAL Study) | HIV-Associated Lipodystrophy Syndrome | Drug: Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs);Drug: continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs) | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | All | 219 | Phase 4 | United States;Canada;France;Germany;Italy;Mexico;Poland;Spain;United Kingdom;Netherlands |
| 5 | EUCTR2004-002740-10-ES (EUCTR) | 16/05/2005 | 17/05/2006 | A PHASE IV, OPEN-LABEL, RANDOMIZED, MULTICENTER TRIAL ASSESSING A REYATAZ-BASED SUBSTITUTION APPROACH IN THE MANAGEMENT OF LIPODYSTROPHY SYNDROME. Pharmacogenetics Blood Sample Amendment 01, version 2.0 dated 13-Feb-05Revised protocol 02 version 6.0, incorporating Amendment 03 and 04 dated 27-Oct-05. - THE REAL STUDY - RESEARCH INTO ATAZANAVIR IN LIPODYSTROPHY | A PHASE IV, OPEN-LABEL, RANDOMIZED, MULTICENTER TRIAL ASSESSING A REYATAZ-BASED SUBSTITUTION APPROACH IN THE MANAGEMENT OF LIPODYSTROPHY SYNDROME. Pharmacogenetics Blood Sample Amendment 01, version 2.0 dated 13-Feb-05Revised protocol 02 version 6.0, incorporating Amendment 03 and 04 dated 27-Oct-05. - THE REAL STUDY - RESEARCH INTO ATAZANAVIR IN LIPODYSTROPHY | HIV-infected individuals with lipodystrophy | Trade Name: Reyataz Product Name: Reyataz Product Code: BMS-232632 INN or Proposed INN: Atazanavir Other descriptive name: ATV Trade Name: Norvir Product Name: Norvir INN or Proposed INN: Ritonavir Other descriptive name: RTV | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Germany;United Kingdom;Spain;Italy | ||
| 6 | EUCTR2004-002740-10-GB (EUCTR) | 12/05/2005 | 19/04/2005 | A PHASE IV, OPEN-LABEL, RANDOMIZED, MULTICENTER TRIAL ASSESSING A REYATAZ-BASED SUBSTITUTION APPROACH IN THE MANAGEMENT OF LIPODYSTROPHY SYNDROME. Pharmacogenetics Blood Sample Amendment 01, version 2.0 dated 13-Feb-05, andRevised Protocol 02 version 6.0, incorporating Amendment 03 and 04 dated 27-Oct-05 - THE REAL STUDY - RESEARCH INTO ATAZANAVIR IN LIPODYSTROPHY | A PHASE IV, OPEN-LABEL, RANDOMIZED, MULTICENTER TRIAL ASSESSING A REYATAZ-BASED SUBSTITUTION APPROACH IN THE MANAGEMENT OF LIPODYSTROPHY SYNDROME. Pharmacogenetics Blood Sample Amendment 01, version 2.0 dated 13-Feb-05, andRevised Protocol 02 version 6.0, incorporating Amendment 03 and 04 dated 27-Oct-05 - THE REAL STUDY - RESEARCH INTO ATAZANAVIR IN LIPODYSTROPHY | HIV-infected individuals with lipodystrophy | Trade Name: Reyataz Product Name: Reyataz Product Code: BMS-232632 INN or Proposed INN: Atazanavir Other descriptive name: ATV Trade Name: Norvir Product Name: Norvir INN or Proposed INN: Ritonavir Other descriptive name: RTV | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Spain;Germany;Italy;United Kingdom |