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
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: 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 inhibitor

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sociedad Andaluza de Enfermedades Infecciosas
• Treatments: 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 aged≥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.