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| Sponsor: | Fundacion SEIMC-GESIDA |
|---|---|
| Information provided by: | Fundacion SEIMC-GESIDA |
| ClinicalTrials.gov Identifier: | NCT00865007 |
Purpose
The aim of this study is to evaluate the efficacy for the recovery of peripheral fat of lopinavir/ritonavir in monotherapy versus abacavir/lamivudine and lopinavir/ritonavir in subjects who developed lipoatrophy while receiving zidovudine plus lamivudine plus abacavir.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection Lipodystrophy HIV Infections |
Drug: Monotherapy (Lopinavir/ritonavir) Drug: Monotherapy (Lopinavir/ritonavir) + ABC/3TC |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Monotherapy group: Experimental
Lopinavir/ritonavir (LPV/r).
|
Drug: Monotherapy (Lopinavir/ritonavir)
NRTI sparing
|
|
Triple arm: Active Comparator
Lopinavir/ritonavir (LPV/r)+ ABC/3TC
|
Drug: Monotherapy (Lopinavir/ritonavir)
NRTI sparing
Drug: Monotherapy (Lopinavir/ritonavir) + ABC/3TC
NRTI sparing regimen
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Elena Barquilla | 0034 91 556 80 25 | ebarquilla@f-sg.org |
| Contact: Herminia Esteban | 0034 91 556 80 25 | hesteban@f-sg.org |
| Spain | |
| Hospital General Universitario de Alicante | Recruiting |
| Alicante, Spain, 03010 | |
| Contact: Joaquin Portilla 0034 965 93 89 79 | |
| Principal Investigator: Joaquin Portilla, Dr. | |
| Hospital Clinico y Provincial | Recruiting |
| Barcelona, Spain, 08036 | |
| Contact: Esteban Martinez, Dr. 0034 932 27 54 00 | |
| Principal Investigator: Esteban Martinez, Dr. | |
| Hospital Sant Creu i Sant Pau | Recruiting |
| Barcelona, Spain, 08025 | |
| Contact: Pere Domingo, Dr. 0034 932 91 90 00 | |
| Principal Investigator: Pere Domingo, Dr. | |
| Hospital Universitario Reina Sofia | Recruiting |
| Cordoba, Spain, 14004 | |
| Contact: Antonio Rivero, Dr. 0034 957 01 16 13 | |
| Principal Investigator: Antonio Rivero, Dr. | |
| Hospital La Paz | Recruiting |
| Madrid, Spain, 28046 | |
| Contact: Jose Ignacio Bernardino, Dr. 0034 91 358 20 66 | |
| Principal Investigator: Jose Ignacio Bernardino, Dr. | |
| Hospital La Paz | Recruiting |
| Madrid, Spain, 28006 | |
| Contact: José Ramon Arribas, Dr. 0034 91 358 20 66 | |
| Contact: , Dr. | |
| Principal Investigator: Jose Ramon Arribas, Dr | |
| Hospital Doce de Octubre | Recruiting |
| Madrid, Spain, 28041 | |
| Contact: Federico Pulido, Dr. 34 91 390 82 02 | |
| Principal Investigator: Federico Pulido, Dr. | |
| Spain, Madrid | |
| Hospital Severo Ochoa | Recruiting |
| Leganes, Madrid, Spain, 28911 | |
| Contact: Rafael Torres, Dr. 0034 91481 80 00 | |
| Principal Investigator: Rafael Torres, Dr. | |
| Spain, Pontevedra | |
| Hospital Xeral Cies | Recruiting |
| Vigo, Pontevedra, Spain, 36204 | |
| Contact: Antonio Ocampo, Dr. 0034 986 81 60 00 | |
| Principal Investigator: Antonio Ocampo, Dr. | |
| Spain, San Sebastian | |
| Hospital de Donostia | Recruiting |
| Donostia, San Sebastian, Spain, 20014 | |
| Contact: Julio Arrizabalaga, Dr. 0034 943 44 70 00 | |
| Principal Investigator: Julio Arrizabalaga, Dr. | |
| Spain, Vizcaya | |
| Hospital de Basurto | Recruiting |
| Bilbao, Vizcaya, Spain, 48013 | |
| Contact: Josefa Muñoz, Dra. 0034 944 00 60 75 | |
| Principal Investigator: Josefa Muñoz, Dra. | |
| Study Chair: | Jose Ignacio Bernardino | Hospital La Paz |
| Study Chair: | Jose Ramon Arribas | Hospital La Paz |
More Information
| Responsible Party: | SEIMC-GESIDA Foundation ( Jose Ignacio Bernardino ) |
| Study ID Numbers: | GESIDA-6008 |
| Study First Received: | March 18, 2009 |
| Last Updated: | April 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00865007 History of Changes |
| Health Authority: | Spain: Spanish Agency of Medicines |
|
Lipodystrophy treatment experienced |
|
Anti-Infective Agents Communicable Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Lopinavir Therapeutic Uses Lipodystrophy Retroviridae Infections Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors |
RNA Virus Infections Anti-HIV Agents Metabolic Diseases Immune System Diseases Skin Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Protease Inhibitors Virus Diseases HIV Infections Skin Diseases, Metabolic Ritonavir |