Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Arribas, Jose R., M.D. Pulido, Federico, M.D. Abbott |
---|---|
Information provided by: | Arribas, Jose R., M.D. |
ClinicalTrials.gov Identifier: | NCT00114933 |
Lopinavir/ritonavir monotherapy may maintain virologic suppression in patients who have been undetectable for six months while on triple drug antiretroviral therapy. Lopinavir/ritonavir pharmacokinetics might prevent resistance development in patients who experience virological rebound after single-drug simplification.
Condition | Intervention | Phase |
---|---|---|
HIV Infection |
Drug: Stopping nucleosides and continuing lopinavir/ritonavir monotherapy |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Phase III-IV, Comparative, Randomized, Open-Label, Study to Evaluate Safety and Efficacy of Suspending Nucleosides From a Triple-Drug Therapy Based on Lopinavir/Ritonavir Versus Continuing Triple-Drug Therapy in HIV-Infected Subjects With Undetectable Plasma HIV Viremia for Six Months |
Estimated Enrollment: | 200 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | May 2007 |
Primary Study Objective: Efficacy and durability of switching to lopinavir/ritonavir single-drug HAART compared to maintaining therapy based on lopinavir/ritonavir and two nucleosides
Secondary Study Objective(s):
Subject Population: 200 patients
Study Design:
RANDOMIZATION:
Patients are randomized (1:1) either to continue under the same treatment or stop nucleosides as follows:
STUDY PROCEDURES: A baseline HIV-RNA, CD4 and routine labs will be collected if the most recent results are not collected within the 4 weeks prior entering the study. Patients will be followed for HIV-RNA (and CD4) at w1, w4, w8, w16, w24, w 36 and w48. After w48, durability of response to lopinavir/r single-drug therapy will be studied long-term (up to w96). Routine hematology and clinical chemistry (including fasting triglycerides and cholesterol, total and HDL/LDL ratio) will be measured at w4, w16, w24, w 36 and w48. A central laboratory will be used for HIV-RNA determinations and to archive plasma/cell samples for further genotype test in case of rebound.
Treatment adherence will be followed with a self-patient report questionnaire (GEEMA study)
All AEs will be collected if suspected relation (possible or probable) to any concomitant ARV drug, and SAEs, related or not, reported within 24h.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Spain | |
Hospital General de Alicante | |
Alicante, Spain, 03010 | |
Hospital del Mar | |
Barcelona, Spain, 08003 | |
Hospital Sant Creu i Sant Pau | |
Barcelona, Spain, 08025 | |
Hospital Germans Trias i Pujol | |
Barcelona, Spain, 08916 | |
Hospital Clinic i Provincial | |
Barcelona, Spain, 08036 | |
Hospital Virgen de las Nieves | |
Granada, Spain, 18014 | |
Hospital 12 de Octubre | |
Madrid, Spain, 28041 | |
Hospital Nuestra Señora de Valme (Sevilla) | |
Sevilla, Spain, 41014 | |
Hospital Gregorio Marañón | |
Madrid, Spain, 28007 | |
Hospital Ramón y Cajal | |
Madrid, Spain, 28034 | |
Hospital La Princesa | |
Madrid, Spain, 28006 | |
Hospital Clínico San Carlos | |
Madrid, Spain, 28040 | |
Fundación Jiménez Díaz | |
Madrid, Spain, 28040 | |
Hospital La Paz | |
Madrid, Spain, 28 046 | |
Hospital Virgen Macarena | |
Sevilla, Spain, 41009 | |
Hospital La Fe | |
Valencia, Spain, 46009 | |
Hospital Clínico de Valencia | |
Valencia, Spain, 46010 | |
Hospital General de Valencia | |
Valencia, Spain, 46014 | |
Hospital Dr. Peset | |
Valencia, Spain, 46017 | |
Hospital Miguel Servet | |
Zaragoza, Spain, 50010 | |
Spain, Alicante | |
Hospital General de Elche | |
Elche, Alicante, Spain, 03202 | |
Spain, Barcelona | |
Hospital de Bellvitge | |
Hospitalet de LLobregat, Barcelona, Spain, 08907 | |
Spain, Gran Canaria | |
Hospital Insular | |
Las Palmas de Gran Canaria, Gran Canaria, Spain, 35500 | |
Spain, Guipuzcoa | |
Hospital de Donostia | |
San Sebastián, Guipuzcoa, Spain, 20014 | |
Spain, Madrid | |
Hospital U. Príncipe de Asturias | |
Alcalá de Henares, Madrid, Spain, 28880 | |
Spain, Pontevedra | |
Hospital Xeral Cies | |
Vigo, Pontevedra, Spain, 362004 | |
Spain, Tenerife | |
Hospital Universitario de Canarias | |
Santa Cruz de Tenerife, Tenerife, Spain, 38010 | |
Spain, Vizcaya | |
Hospital de Basurto | |
Bilbao, Vizcaya, Spain, 48013 |
Study Chair: | José R. Arribas, MD | Hospital La Paz |
Study Chair: | Federico Pulido, MD | Hospital 12 de Octubre |
Study ID Numbers: | SPA-378-05-40, EudraCT 2004-001323-37 |
Study First Received: | June 20, 2005 |
Last Updated: | March 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00114933 |
Health Authority: | Spain: Spanish Agency of Medicines |
HIV AIDS Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral Lopinavir Ritonavir HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Viremia Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections HIV Protease Inhibitors Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections |