Overview
Clinical Trial, Open-label, Randomised, in Order to Compare the Quality of Life for Those VIH+ Patients That Start With Monotherapy on LPV/r Tablets Vs. Triple Therapy With a Boosted Protease Inhibitor
Status:
Completed
Completed
Trial end date:
2011-12-01
2011-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The Study will help to compare the Quality of Life for those HIV patients that are on monotherapy with LPV/r Vs. triple therapy with a boosted protease inhibitorPhase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Sociedad Andaluza de Enfermedades InfecciosasTreatments:
HIV Protease Inhibitors
Lopinavir
Protease Inhibitors
Ritonavir
Criteria
Inclusion Criteria:- Patients infected with HIV-1, documented with a positive HIV-1 antibodies test and/or
positive PCR confirmed for HIV-1 RNA.
- Patients on triple antiretroviral therapy with any boosted protease inhibitor.
- Patients with an undetectable viral load, which will be defined as <50 viral RNA
copies/mL within the last six months.
- Men or women agedā„18.
- For women with childbearing potential, negative urine pregnancy test during the
Screening visit.
- Patients who would have granted a written informed consent prior to any Study-specific
screening procedure.
Exclusion Criteria:
- Patients with a written proof of resistance in the accumulated genotype, which would
lead to a sensibility loss to lopinavir/ritonavir, or, in case of genotype absence, a
documented failure to a protease inhibitor therapy.
- Patients with a CD4 cells nadir CD4 <100 cell/microL.
- Patients who, for any reason, could not be treated with lopinavir/ritonavir.
- Prior medical history of psychiatric disorders, such as depressive syndrome,
schizophrenia or psychotic disease.
- Known previous medical history of drug abuse/addiction or alcohol chronic consumption,
which in the Investigator's opinion, would be incompatible with his/her Study
participation.
- Pregnant or breastfeeding women, or women of childbearing potential who do not use an
appropriate contraceptive method, according to the Investigator's opinion.
- Documented past(within four weeks prior to screening) or active current opportunistic
infection.
- Patients who, due to severe toxicities related to any of their current HAART
compounds, there is a planned discontinuation or modification concerning any of the
drugs from their triple therapy.
- Patients for which, according to the Investigator, will have to change their HAART,
regardless of the reason, within the next six months.
- Renal disease with creatinine clearance <60 mL/min.
- Concomitant use of Lopinavir/ritonavir contraindicated drugs, such as rifampicin,
dihydroergotamine, ergotamine, methylergonovine, cisapride, hypericum perforatum,
lovastatin, simvastatin, pimozide, midazolam and triazolam.
- Concomitant use of nephrotoxic or immunosuppressor drugs.
- Patients currently treated with systemic corticosteroids, interleukine-2 or
chemotherapy.
- Patients treated with other Investigative Medical Product.
- Patients with acute hepatitis.
- Any disease or condition that, according to the Investigator, would be incompatible
with the patient's participation in the Study.