Lopinavir/r Monotherapy as Maintenance Therapy After Long Term Viral Suppression
- To investigate the possibility of maintaining virological suppression of HIV in infected patients, switching them to LPV/r as the only antiretroviral agent
- To assess the immunological response in patients who switched to LPV/r as single agent, based on the observation of changes in the serum levels of CD4+ cells.
- To investigate the rate of clinical and laboratorial adverse events in the two treatment groups.
- To investigate the rate of emergence of antiretroviral resistance mutations in the two treatment groups, in case of virological failure of the current regimen.
- To describe the adherence to the prescribed regimen in the two treatment groups
- To describe changes in body fat distribution (abdominal, arms and thigh circumference) and in the lipid profile, in patients from the two treatment groups
- To describe the rate of clinical failure of the antiretroviral therapy in the two treatment groups.
The 60 patients were selected by the investigators according to the study’s inclusion and exclusion criteria, and were divided into 2 groups with 30 patients each.
The study is multicentric, open-label, randomized. Virological, immunological and clinical failures will be analyzed in both groups. In addition, data on clinical or laboratorial toxicity and compliance are being recorded.
- Group 1 maintenance of the currently used antiretroviral therapy
- Group 2 switch to LPV/r antiretroviral monotherapy in the dose of 400/100 mg 12/12 hs with food. Patients in group 2 who were being treated previously with non-nucleoside reverse transcriptase inhibitors (Efavirenz or Nevirapine) were instructed to take 4 capsules of Lopinavir/r each 12 hs, during the first 14 days of therapy (up to Week 2 visit).
96 weeks of treatment
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study on the Feasibility of Antiretroviral Therapy With a Single Agent - Lopinavir/r - in Patients Treated With HAART and With Viral Load Below 80 Copies/Ml|
- • Rate of suppression of viral load to less than 80 copies/ml on weeks 4, 12, 24, 36, 48, 60, 72, 84, 96.
- • Average change of CD4 count on weeks 4, 12, 24, 36, 48, 60, 72, 84, 96
- • Two-year incidence rate of immunodeficiency related clinical conditions.
- • Toxicity rate (clinical and laboratorial adverse events).
|Study Start Date:||August 2004|
|Estimated Study Completion Date:||March 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00160849
|Hospital Geral de Nova Iguaçu|
|Nova Iguaçu, Rio de Janeiro, Brazil, 01620.020|
|Projeto Praça Onze|
|Rio de Janeiro, Brazil, 20210.030|
|Principal Investigator:||Estevão P Nunes, M.Sc||Projeto Praça Onze|