NCT00160849

Lopinavir/r Monotherapy as Maintenance Therapy After Long Term Viral Suppression

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: Universidade Federal do Rio de Janeiro · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

1. Objectives Primary * 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. Secondary * 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. 2. Patient population: 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. 3. Study design: 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. 4. Regime: * 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). 5. Duration: 96 weeks of treatment

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Lopinavir/r

Timeline

• Start date: 2004-08-01
• Completion: 2007-03-01
• First posted: 2005-09-12
• Last updated: 2005-10-21

Locations

2 sites across 1 country: Brazil