HIV InfectionsPhase 3NCT00318123
Study to Evaluate the Effectiveness of ABC+3TC +EFV in Once-Daily Regimens Versus KLT in Twice-Daily Regimens in Naive HIV Patients
A Phase 3 study testing Kivexa in people with HIV Infections, run by Germans Trias i Pujol Hospital at 20 sites in 2 countries.
Trial summary
To evaluate the therapeutic equivalence between the two arms of treatment in virological and immunological response after 48 weeks and to evaluate the presence of side effects during the follow-up period. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Kivexa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Apr 2004to Apr 2007
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> 18 years.
- HIV-1 infected patients.
- Naive to antiretroviral treatment.
- Candidate patient for initiating antiretroviral treatment*.
- Subject able to follow the treatment period.
- Signature of the informed consent.
- Women may not be fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use two contraceptive methods during the study, one of them at least being a barrier method.
Who cannot join
- Hepatic tests > 5 times above normality.
- Pregnancy or breastfeeding.
- Treatment for opportunistic infections or neoplasms associated with the stable HIV over the last 6 weeks.
- Suspected or documented resistance to any of the investigational drugs.
- Known allergic hypersensitivity to any of the investigational drugs or any similar drug.
- Subjects with abusive consumption of alcohol or illegal drugs.
- Patients participating in another clinical trial.
- Terminal renal disease.
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
Spain19 sites
Hospital Generall de Alicante
Alicante, Alacant, 03010
Hospital Central de Asturias
Asturias, Oviedo, 33006
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Nuestra Sra del Rosell
Cartagena, Murcia, 30203
Hospital Arquitecto Marcide
Ferrol, A Coruña, 15405
Hospital Virgen de las Nieves
Granada, Granada, 18014
Hospital de Granollers
Granollers, Barcelona, 08400
Hopsital Gregorio Marañón
Madrid, Madrid, 28007
Hospital 12 de Octubre
Madrid, Madrid, 28041
Hopsital Costa del Sol
Marbella, Malaga, 29600
Hospital General de Murcia
Murcia, Murcia, 30003
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, 38320
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Galicia, 15706
Hospital Virgen Macarena
Seville, Sevilla, 41009
Hospital Virgen del Rocío
Seville, Sevilla, 41013
Hospital de Tarragona
Tarragona, Tarragona, 43007
Hospital Universitari Dr. Peset
Valencia, Valencia, 46017
Hospital Xeral de Vigo
Vigo, Pontevedra, 36204
Hospital Miguel Servet
Zaragoza, Zaragoza, 50009
Italy1 site
Institute of Infections and Tropical Diseases University of Brescia
Brescia, 25125
About this study
Official title: Multicentre, Open Label, Prospective, Randomised Clinical Trial to Evaluate the Effectiveness of Abacavir 600 mg+ Lamivudine 300 mg as QD+ Efavirenz 600 mg QD Versus Kaletra 400/100 mg BID as Initial Antiretroviral Treatment
To evaluate the therapeutic equivalence between the two arms of treatment in virological and immunological response after 48 weeks and to evaluate the presence of side effects during the follow-up period.
Read the detailed description
The efficacy of the highly active antiretroviral treatment (HAART) has been demonstrated in several clinical trials. Even so, a substantial proportion of patients do not manage to maintain correct viral suppression in daily clinical practice.
Adherence to HAART treatment is critical to obtain lasting viral suppression. Thus, factors that are related to adherence such as high pill load or takes, the complexity of the antiretroviral system, tolerability and food restrictions may have an effect on viral replication.
It has been demonstrated that simpler regimens with a scant number of tablets, without food restrictions and with a single take a day are safe, efficacious and that adherence improves.
The combination of abacavir 600 mg + lamivudine 300 mg QD in a single tablet is a novel dosage that may help increase treatment adherence.
- Conditions
- HIV Infections
- Being tested
- Kivexa
- Keywords
- Simplification therapy, Efficacy, Safety, Virological effectiveness, Immunological effectiveness, HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KivexaDrug
abacavir 600mg + lamivudine 300mg in one tablet QD
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Abacavir 600mg + lamivudine 300mg in on table QD + efavirenz 600mg QD Receives: Drug: Kivexa |
| B | Experimental | Abacavir 600mg + lamivudine 300mg in ine tablet QD * lopinavir/ritonavir 400/100 mg BID Receives: Drug: Kivexa |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the virological response over the 48 weeks of the study.
Measured: At 12, 24, 36 and 48 weeks
Secondary outcomes (5)
To evaluate the immunological efficacy (changes in CD4 and CD8 counts) of the combination studied over the follow-up period.
Measured: At 12, 24, 36 and 48 weeks.
To evaluate the impact of treatment on the lipid profile.
Measured: At 12, 24, 36 and 48 weeks
To evaluate the tolerance and safety of the combination of Efavirenz + lamivudine + abacavir given once daily over the 48-week treatment period.
Measured: At 12, 24, 36 and 48 weeks.
To evaluate treatment adherence (assessed by a self-reported questionnaire and with graduated satisfaction scales) and patient quality of life (assessed by means of the MOS-HIV questionnaire).
Measured: At 12, 24, 36 and 48 weeks.
To analyse the mutations that appear in patients that present virological failure.
Measured: When there is a virological failure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2006 (estimated)
- Study startApr 2004
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Investigators
- Bonaventura Clotet, MD, PhD, Principal investigator, LLuita contra la Sida Foundation-HIV Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318123
- Sponsor's protocol ID
- LAKE
- Other IDs
- 2004-001282-18, 2004
- Status last verified
- Jan 2008
- First submitted
- 25 Apr 2006
- Last updated
- 29 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Open Label, Prospective, Randomised Clinical Trial to Evaluate the Effectiveness of Abacavir 600 mg+ Lamivudine 300 mg as QD+ Efavirenz 600 mg QD Versus Kaletra 400/100 mg BID as Initial Antiretroviral Treatment
- ClinicalTrials.gov ID
- NCT00318123
- Acronym / sponsor ID
- LAKE
- Conditions
- HIV Infections
- Keywords
- Simplification therapy, Efficacy, Safety, Virological effectiveness, Immunological effectiveness, HIV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Collaborators
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Study start
- Apr 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 26 Apr 2006 (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.
To evaluate the therapeutic equivalence between the two arms of treatment in virological and immunological response after 48 weeks and to evaluate the presence of side effects during the follow-up period.
Detailed description
The efficacy of the highly active antiretroviral treatment (HAART) has been demonstrated in several clinical trials. Even so, a substantial proportion of patients do not manage to maintain correct viral suppression in daily clinical practice.
Adherence to HAART treatment is critical to obtain lasting viral suppression. Thus, factors that are related to adherence such as high pill load or takes, the complexity of the antiretroviral system, tolerability and food restrictions may have an effect on viral replication.
It has been demonstrated that simpler regimens with a scant number of tablets, without food restrictions and with a single take a day are safe, efficacious and that adherence improves.
The combination of abacavir 600 mg + lamivudine 300 mg QD in a single tablet is a novel dosage that may help increase treatment adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: KivexaAbacavir 600mg + lamivudine 300mg in on table QD + efavirenz 600mg QD |
| B | Experimental | Drug: KivexaAbacavir 600mg + lamivudine 300mg in ine tablet QD * lopinavir/ritonavir 400/100 mg BID |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age> 18 years.
- HIV-1 infected patients.
- Naive to antiretroviral treatment.
- Candidate patient for initiating antiretroviral treatment*.
- Subject able to follow the treatment period.
Key exclusion criteria (8 listed)
- Hepatic tests > 5 times above normality.
- Pregnancy or breastfeeding.
- Treatment for opportunistic infections or neoplasms associated with the stable HIV over the last 6 weeks.
- Suspected or documented resistance to any of the investigational drugs.
- Known allergic hypersensitivity to any of the investigational drugs or any similar drug.
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 |
|---|---|---|
| Kivexaabacavir 600mg + lamivudine 300mg in one tablet QD | Drug | A, B |
Primary outcome
To evaluate the virological response over the 48 weeks of the study.
Time frame: At 12, 24, 36 and 48 weeks
5 secondary outcomes
To evaluate the immunological efficacy (changes in CD4 and CD8 counts) of the combination studied over the follow-up period.
Time frame: At 12, 24, 36 and 48 weeks.
To evaluate the impact of treatment on the lipid profile.
Time frame: At 12, 24, 36 and 48 weeks
To evaluate the tolerance and safety of the combination of Efavirenz + lamivudine + abacavir given once daily over the 48-week treatment period.
Time frame: At 12, 24, 36 and 48 weeks.
To evaluate treatment adherence (assessed by a self-reported questionnaire and with graduated satisfaction scales) and patient quality of life (assessed by means of the MOS-HIV questionnaire).
Time frame: At 12, 24, 36 and 48 weeks.
To analyse the mutations that appear in patients that present virological failure.
Time frame: When there is a virological failure.
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 29 Jan 2008.
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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.
Bonaventura Clotet, MD, PhD principal investigator
LLuita contra la Sida Foundation-HIV Unit
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Kivexa in people with HIV Infections, run by Germans Trias i Pujol Hospital at 20 sites in 2 countries.
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 7 inclusion and 8 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 29 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain, Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To evaluate the virological response over the 48 weeks of the study. (time frame: At 12, 24, 36 and 48 weeks). 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 29 Jan 2008.