MedTrace Logo

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

NCT00160849 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2005-10-21

No results posted yet for this study

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

DRUG

Lopinavir/r

Sponsors & Collaborators

  • Universidade Federal do Rio de Janeiro

    lead OTHER

Principal Investigators

  • Estevão P Nunes, M.Sc · Projeto Praça Onze

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Completion
2007-03-31

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00160849 on ClinicalTrials.gov