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 (QoLKAMON)

Sociedad Andaluza de Enfermedades Infecciosas

Status and phase: Completed; Phase 4

Conditions: HIV Infection

Treatments: Drug: Triple therapy with ritonavir; Drug: Lopinavir and ritonavir

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01166477

SAI-CDV-2009-01

Details and patient eligibility

About

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

Full description

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.

Enrollment: 228 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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228 participants in 2 patient groups

Triple therapy

Active Comparator group

Description:

The patients who would be allocated to this arm will continue with their triple therapy treatment, based on any protease inhibitor boosted with ritonavir

Treatment:

Drug: Triple therapy with ritonavir

Monotherapy

Experimental group

Description:

Those patients allocated to this arm will start to take Kaletra (lopinavir200mg/ritonavir50mg)two tablets bid

Treatment:

Drug: Lopinavir and ritonavir