drugset / Trial / NCT00759070
Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism
Phase 4
Unknown
50 enrolled
Juan A. Arnaiz
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · collabGermans Trias i Pujol Hospital · collabHospital Universitari Joan XXIII de Tarragona. · collabHospitales Universitarios Virgen del Rocío · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is an open-label, randomized, pilot comparison of the effects of either lopinavir/ritonavir or efavirenz in combination with tenofovir plus emtricitabine on cholesterol metabolism, mitochondrial functioning and immune response in 50 naive HIV patients after 48 weeks.
Timeline
- Start
- 2008-09
- Primary completion
- 2013-07
- Completion
- 2013-07
Publications
- Leyes P, Cofan M, Gonzalez-Cordon A, de Lazzari E, Trabal J, Domingo P, Negredo E, Vidal F, Forga MT, Gatell JM, Ros E, Martinez E. Increased cholesterol absorption rather than synthesis is involved in boosted protease inhibitor-associated hypercholesterolaemia. AIDS. 2018 Jun 19;32(10):1309-1316. doi: 10.1097/QAD.0000000000001837.
- Egana-Gorrono L, Martinez E, Domingo P, Lonca M, Escriba T, Fontdevila J, Vidal F, Negredo E, Gatell JM, Arnedo M. Differential subcutaneous adipose tissue gene expression patterns in a randomized clinical trial of efavirenz or lopinavir-ritonavir in antiretroviral-naive patients. Antimicrob Agents Chemother. 2014 Nov;58(11):6717-23. doi: 10.1128/AAC.03481-14. Epub 2014 Aug 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Efavirenz | Other / unclassified | 600 mg | — |
| Comparator | Lopinavir | Other / unclassified | 400 mg | — |
| Comparator | Ritonavir | Other / unclassified | 100 mg | — |
| Comparator | Tenofovir | Small molecule | 300 mg | — |
| Comparator | emtricitabine | Other / unclassified | 200 mg | — |