Status:
COMPLETED
Lopinavir/r Monotherapy as Maintenance Therapy After Long Term Viral Suppression
Lead Sponsor:
Universidade Federal do Rio de Janeiro
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 t...
Eligibility Criteria
Inclusion
- 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.
- 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).
- The patient must be in treatment with at least three antiretroviral drugs, for at least 6 months without changes.
- The patient should have no history of documented virological failure to previously used antiretroviral therapies.
- 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).
- CD4 count \> 200 cels/ml at screening
- Patient agrees not to use concomitant medication that might have unacceptable drug interactions with the study drug.
- 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
- Pregnant or lactating female patient. If the patient becomes pregnant during the study, she will be discontinued from the study.
- Patients with allergic reaction or hypersensitivity to Lopinavir or Ritonavir .
- A patient with previous history of opportunistic disease ( appendix 1) or CD4 count below 100 cels/mm3.
- A patient who presents any HIV viral load test result above 400 copies/mL over the past 6 months.
- Patient who is receiving or has received systemic chemotherapy during the past 6 months.
- 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
- Patient is taking any drug known to be contraindicated concomitantly with lopinavir/r. Please refer to the product's package insert.
- According to the investigator's opinion, the patient has little probability of complying with the study protocol or is unsuitable for any other reason.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00160849
Start Date
August 1 2004
End Date
March 1 2007
Last Update
October 21 2005
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Geral de Nova Iguaçu
Nova Iguaçu, Rio de Janeiro, Brazil, 01620.020
2
Projeto Praça Onze
Rio de Janeiro, Rio de Janeiro, Brazil, 20210.030