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

This study has been completed.
Sponsor:
Information provided by:
Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT00160849
First received: September 8, 2005
Last updated: October 19, 2005
Last verified: July 2005
  Purpose
  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


Condition Intervention Phase
HIV Infections
Drug: Lopinavir/r
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Universidade Federal do Rio de Janeiro:

Primary Outcome Measures:
  • • 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.

Secondary Outcome Measures:
  • • Toxicity rate (clinical and laboratorial adverse events).

Estimated Enrollment: 60
Study Start Date: August 2004
Estimated Study Completion Date: March 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patients must fulfill all of the following criteria: The patient has confirmed his/her willingness to participate in the study, after being informed about all the aspects of the study that might be relevant for his/her decision to participate, and has signed and dated the informed consent form, as approved by the Institutional Review Board/ Ethics Committee (IRB/EC). And he/she can withdraw the study participation at any moment, if he/she wants to do so.
  2. The patient has laboratorial confirmation of an HIV infection through a positive ELISA test for anti-HIV antibodies and an additional test (Western-blot, indirect immunofluorescence or PCR).
  3. The patient must be in treatment with at least three antiretroviral drugs, for at least 6 months without changes.
  4. The patient should have no history of documented virological failure to previously used antiretroviral therapies.
  5. Undetectable viral load (test result < 400 copies/ml) for more than 6 months measured on a sample collected during treatment with the current regimen and at screening (test result < 80 copies).
  6. CD4 count > 200 cels/ml at screening
  7. Patient agrees not to use concomitant medication that might have unacceptable drug interactions with the study drug.
  8. If the patient is a female, she must have a negative pregnancy test and must agree to use at least 14 days before the study drug administration and for the whole study duration and up to 6 months after, a barrier contraceptive method with a proven reliability track record, as judged by the investigator

Exclusion Criteria:

  1. Pregnant or lactating female patient. If the patient becomes pregnant during the study, she will be discontinued from the study.
  2. Patients with allergic reaction or hypersensitivity to Lopinavir or Ritonavir .
  3. A patient with previous history of opportunistic disease ( appendix 1) or CD4 count below 100 cels/mm3.
  4. A patient who presents any HIV viral load test result above 400 copies/mL over the past 6 months.
  5. Patient who is receiving or has received systemic chemotherapy during the past 6 months.
  6. Laboratory test results Hemoglobin < 8 g/dl Absolute neutrophil count < 750 cels/mL Platelet count < 20,000/mL Bilirubin > 1.5 x UNL or > 6 x UNL if patient is using Indinavir or Atazanavir ALT and AST > 2 x UNL Creatinine > 2 x UNL
  7. Patient is taking any drug known to be contraindicated concomitantly with lopinavir/r. Please refer to the product’s package insert.
  8. According to the investigator’s opinion, the patient has little probability of complying with the study protocol or is unsuitable for any other reason.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00160849

Locations
Brazil
Hospital Geral de Nova Iguaçu
Nova Iguaçu, Rio de Janeiro, Brazil, 01620.020
Projeto Praça Onze
Rio de Janeiro, Brazil, 20210.030
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Investigators
Principal Investigator: Estevão P Nunes, M.Sc Projeto Praça Onze
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00160849     History of Changes
Other Study ID Numbers: KalMo
Study First Received: September 8, 2005
Last Updated: October 19, 2005
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Federal do Rio de Janeiro:
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014