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

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ClinicalTrials.gov Identifier: NCT00160849
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : October 21, 2005
Information provided by:
Universidade Federal do Rio de Janeiro

Brief 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.


    • 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 or disease Intervention/treatment Phase
HIV Infections Drug: Lopinavir/r Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2004
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Lopinavir

Primary Outcome Measures :
  1. • Rate of suppression of viral load to less than 80 copies/ml on weeks 4, 12, 24, 36, 48, 60, 72, 84, 96.
  2. • Average change of CD4 count on weeks 4, 12, 24, 36, 48, 60, 72, 84, 96
  3. • Two-year incidence rate of immunodeficiency related clinical conditions.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00160849

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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
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Principal Investigator: Estevão P Nunes, M.Sc Projeto Praça Onze
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ClinicalTrials.gov Identifier: NCT00160849    
Other Study ID Numbers: KalMo
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: October 21, 2005
Last Verified: July 2005
Keywords provided by Universidade Federal do Rio de Janeiro:
Treatment Experienced
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors