HIV InfectionPhase 4QoLKAMONNCT01166477
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
A Phase 4 study testing Lopinavir and ritonavir and Triple therapy with ritonavir in people with HIV Infection, run by Sociedad Andaluza de Enfermedades Infecciosas at 31 sites in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- Lopinavir and ritonavir and Triple therapy with ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 31 sitesSpain
- Study dates
- Jan 2010to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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 locations and contacts
31 sites in 1 country.
31 sites in 1 country
Spain31 sites
Pilar Vázquez Rodríguez
A Coruña, La Coruña, 15006
Hospital de Torrecárdenas
Almería, Almería, 04009
Hospital de Cruces
Barakaldo, Vizcaya, 48904
Hospital de Basurto
Basurto, Vizcaya, 48013
Hospital General Yagüe
Burgos, Burgos, 09005
Hospital Puerta del Mar
Cadiz, Cádiz, 11009
Hospital Puerto Real
Cadiz, Cádiz, 11510
Hospital Clínico San Cecilio
Granada, Granada, 18012
Hospital Virgen de las Nieves
Granada, Granada, 18014
Hospital General de l'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08906
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas, 35010
Hospital Severo Ochoa
Leganés, Madrid, 28911
Hospital Universitario de La Princesa
Madrid, Madrid, 28006
Hospital Gregorio Marañón
Madrid, Madrid, 28007
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Hospital Universitario La Paz
Madrid, Madrid, 28046
Hospital Carlos Haya
Málaga, Málaga, 29010
Hospital Clínico de Málaga
Málaga, Málaga, 29010
Hospital de San Juan
San Juan, Alicante, 03550
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38320
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital Clínico Santiago de Compostela
Santiago de Compostela, La Coruña, 15706
Hospital de Valme
Seville, Sevilla, 41014
Hospital Universitario Virgen Macarena
Seville, Sevilla, 41071
Hospital de Torrevieja
Torrevieja, Alicante, 03186
Hospital Virgen de la Cinta
Tortosa, Tarragona, 43500
Hospital Clínico de Valencia
Valencia, Valencia, 46010
Hospital Arnau de Vilanova
Valencia, Valencia, 46015
Hospital de Villajoyosa
Villajoyosa, Alicante, 03570
Hospital Clínico Lozano Blesa
Zaragoza, Zaragoza, 50009
About this study
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
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
Read the 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.
- Conditions
- HIV Infection
- Being tested
- Lopinavir and ritonavir, Triple therapy with ritonavir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lopinavir and ritonavirDrug
The patients will take Kaletra (lopinavir200mg/ritonavir50mg)two tablets bid
Triple therapy with ritonavirDrug
The patients will continue to take their usual triple therapy, as established in the summary of product characteristics
| Study group | Role | What they receive |
|---|---|---|
| Triple therapy | Active comparator | The patients who would be allocated to this arm will continue with their triple therapy treatment, based on any protease inhibitor boosted with ritonavir Receives: Drug: Triple therapy with ritonavir |
| Monotherapy | Experimental | Those patients allocated to this arm will start to take Kaletra (lopinavir200mg/ritonavir50mg)two tablets bid Receives: Drug: Lopinavir and ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 weeks per patients
Secondary outcomes (5)
Virologic efficacy assessment for HIV patients on monotherapy based on LPV/r tablet vs triple therapy which would include any protease inhibitor
Measured: 24 weeks per patient
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
Measured: 24 weeks per patients
Patient satisfaction assessment for HIV patients that start monotherapy with LPV/r tablets vs triple therapy which would include any protease inhibitor
Measured: 24 weeks per patient
Treatment adherence assessment for HIV patients who start on LPV/r monotherapy tablets vs triple therapy which include any protease inhibitor
Measured: 24 weeks per patient
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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Andaluza de Enfermedades Infecciosas
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Juan Pasquau, MD, Principal investigator, Sociedad Andaluza de Enfermedades Infecciosas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166477
- Sponsor's protocol ID
- SAI-CDV-2009-01
- Acronym
- QoLKAMON
- Status last verified
- Oct 2009
- First submitted
- 19 Jul 2010
- Last updated
- 20 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01166477
- Acronym / sponsor ID
- QoLKAMON / SAI-CDV-2009-01
- Conditions
- HIV Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Sociedad Andaluza de Enfermedades InfecciosasResearch network
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triple therapy | Active comparator | Drug: Triple therapy with ritonavirThe patients who would be allocated to this arm will continue with their triple therapy treatment, based on any protease inhibitor boosted with ritonavir |
| Monotherapy | Experimental | Drug: Lopinavir and ritonavirThose patients allocated to this arm will start to take Kaletra (lopinavir200mg/ritonavir50mg)two tablets bid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lopinavir and ritonavirThe patients will take Kaletra (lopinavir200mg/ritonavir50mg)two tablets bid | Drug | Monotherapy |
| Triple therapy with ritonavirThe patients will continue to take their usual triple therapy, as established in the summary of product characteristics | Drug | Triple therapy |
Primary outcome
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).
Time frame: 24 weeks per patients
5 secondary outcomes
Virologic efficacy assessment for HIV patients on monotherapy based on LPV/r tablet vs triple therapy which would include any protease inhibitor
Time frame: 24 weeks per patient
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
Time frame: 24 weeks per patients
Patient satisfaction assessment for HIV patients that start monotherapy with LPV/r tablets vs triple therapy which would include any protease inhibitor
Time frame: 24 weeks per patient
Treatment adherence assessment for HIV patients who start on LPV/r monotherapy tablets vs triple therapy which include any protease inhibitor
Time frame: 24 weeks per patient
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
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Pasquau, MD principal investigator
Sociedad Andaluza de Enfermedades Infecciosas
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lopinavir and ritonavir and Triple therapy with ritonavir in people with HIV Infection, run by Sociedad Andaluza de Enfermedades Infecciosas at 31 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 24 weeks per patients). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2013.