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QoLKAMON: 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

Sponsor
Sociedad Andaluza de Enfermedades Infecciosas (Other)
Overall Status
Completed
CT.gov ID
NCT01166477
Collaborator
(none)
228
Enrollment
31
Locations
2
Arms
23
Duration (Months)
7.4
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Drug: Lopinavir and ritonavir
  • Drug: Triple therapy with ritonavir
 Phase 4

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
228 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Ensayo clínico, Abierto, Aleatorizado Para Comparar la Calidad de Vida de Los Pacientes VIH+ Que Inician Monoterapia Con Comprimidos de LPV/r vs Triple Terapia Que Contenga un IP Potenciado
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Triple therapy

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

Drug: Triple therapy with ritonavir
The patients will continue to take their usual triple therapy, as established in the summary of product characteristics
Experimental: Monotherapy

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

Drug: Lopinavir and ritonavir
The patients will take Kaletra (lopinavir200mg/ritonavir50mg)two tablets bid

Outcome Measures

Primary Outcome Measures

  1. Quality of Life comparison for HIV patients that start monotherapy with lopinavir/ritonavir (LPV/r) tablets vs patients with triple therapy which would include any boosted protease inhibitor (PI). [24 weeks per patients]

Secondary Outcome Measures

  1. Virologic efficacy assessment for HIV patients on monotherapy based on LPV/r tablet vs triple therapy which would include any protease inhibitor [24 weeks per patient]

  2. Immune response changes assessment for those HIV patients who start monotherapy with LPV/r tablets vs HIV patients on triple therapy which would include any protease inhibitor [24 weeks per patients]

  3. Patient satisfaction assessment for HIV patients that start monotherapy with LPV/r tablets vs triple therapy which would include any protease inhibitor [24 weeks per patient]

  4. Treatment adherence assessment for HIV patients who start on LPV/r monotherapy tablets vs triple therapy which include any protease inhibitor [24 weeks per patient]

  5. Tolerability and safety assessment for the HIV patients who start monotherapy treatment with LPV/r tablets vs triple therapy which would include any protease inhibitor [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital de San Juan San Juan Alicante Spain 03550
2 Hospital de Torrevieja Torrevieja Alicante Spain 03186
3 Hospital de Villajoyosa Villajoyosa Alicante Spain 03570
4 Hospital Universitario de Bellvitge Hospitalet de Llobregat Barcelona Spain 08907
5 Hospital General de l'Hospitalet L'Hospitalet de Llobregat Barcelona Spain 08906
6 Hospital Universitario Marqués de Valdecilla Santander Cantabria Spain 39008
7 Hospital Clínico Santiago de Compostela Santiago de Compostela La Coruña Spain 15706
8 Hospital Dr. Negrín Las Palmas de Gran Canaria Las Palmas Spain 35010
9 Hospital Severo Ochoa Leganés Madrid Spain 28911
10 Hospital Virgen de la Cinta Tortosa Tarragona Spain 43500
11 Hospital de Cruces Barakaldo Vizcaya Spain 48904
12 Hospital de Basurto Basurto Vizcaya Spain 48013
13 Hospital de Torrecárdenas Almería Spain 04009
14 Hospital General Yagüe Burgos Spain 09005
15 Hospital Puerta del Mar Cádiz Spain 11009
16 Hospital Puerto Real Cádiz Spain 11510
17 Hospital Clínico San Cecilio Granada Spain 18012
18 Hospital Virgen de las Nieves Granada Spain 18014
19 Pilar Vázquez Rodríguez La Coruña Spain 15006
20 Hospital Universitario de La Princesa Madrid Spain 28006
21 Hospital Gregorio Marañón Madrid Spain 28007
22 Hospital Clínico San Carlos Madrid Spain 28040
23 Hospital Universitario La Paz Madrid Spain 28046
24 Hospital Carlos Haya Málaga Spain 29010
25 Hospital Clínico de Málaga Málaga Spain 29010
26 Hospital Universitario de Canarias Santa Cruz de Tenerife Spain 38320
27 Hospital de Valme Sevilla Spain 41014
28 Hospital Universitario Virgen Macarena Sevilla Spain 41071
29 Hospital Clínico de Valencia Valencia Spain 46010
30 Hospital Arnau de Vilanova Valencia Spain 46015
31 Hospital Clínico Lozano Blesa Zaragoza Spain 50009

Sponsors and Collaborators

  • Sociedad Andaluza de Enfermedades Infecciosas

Investigators

  • Principal Investigator: Juan Pasquau, MD, Sociedad Andaluza de Enfermedades Infecciosas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sociedad Andaluza de Enfermedades Infecciosas
ClinicalTrials.gov Identifier:
NCT01166477
Other Study ID Numbers:
  • SAI-CDV-2009-01
First Posted:
Jul 21, 2010
Last Update Posted:
Mar 20, 2013
Last Verified:
Oct 1, 2009
Additional relevant MeSH terms:
HIV Infections
Ritonavir
Lopinavir

Study Results

No Results Posted as of Mar 20, 2013