HIV InfectionsPhase 3NCT00314626
Antiretroviral Treatment Simplification Study With Efavirenz + Abacavir + 3TC Once Daily
A Phase 3 study testing efavirenz and Abacavir+lamivudine in people with HIV Infections, run by Germans Trias i Pujol Hospital at 16 sites in Spain.
Trial summary
To evaluate the proportion of patients with virological failure after 48 weeks of treatment with the combination of efavirenz 600 mg + lamivudine (3TC) 300 mg + abacavir 600 mg once daily as an antiretroviral simplification regimen. 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?
- efavirenz and Abacavir+lamivudine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 16 sitesSpain
- Study dates
- Nov 2004to Mar 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.
- Patients on HAART therapy including efavirenz and two NRTIs in a twice-daily regimen for 6 months at least.
- Patients with an undetectable HIV-1 viral load over the last 6 months (at least 2 determinations separated by 3 months).
- Subject able to follow the treatment period.
- Signature of the informed consent.
- Women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use a barrier contraceptive method during the study.
Who cannot join
- Hepatic tests > 5 times above normality.
- Pregnancy or breastfeeding
- Presence of opportunistic infections and/or recent tumours (< 6 months).
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Spain16 sites
Hospital Principe de Asturias
Alcalá de Henares, Madrid, 28005
Germans Trias i Pujol Hospital
Badalona, Barcelona, 08916
Hospital de la Vall d'Hebron
Barcelona, Barcelona, 08035
Hospital de Aranzazu
Donostia / San Sebastian, Guipuzcoa, 20014
Hospital Virgen de las Nieves
Granada, Granada, 18014
Hospital Arnau de Vilanova de Lleida
Lleida, Lleida, 25198
Hospital San Millan de Logroño
Logroño, La Rioja, 26001
Hospital Severo Ochoa Leganés
Madrid, Madrid, 28911
Hospital Costa del Sol
Marbella, Málaga, 29600
Hospital de Mataró
Mataró, Barcelona, 08304
Hospital de Móstoles
Móstoles, Madrid, 28935
Hospital Cristal-Piñor
Ourense, Ourense, 32005
Hospital Santa María Nai
Ourense, Ourense, 32005
Hospital de Navarra
Pamplona, Pamplona, 31008
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320
Hospital General de Valencia
Valencia, Valencia, 46014
About this study
Official title: Multicentre, Open Label, Prospective, Randomised Clinical Trial of an Antiretroviral Simplification Treatment With Efavirenz + Abacavir + 3TC Once Daily
To evaluate the proportion of patients with virological failure after 48 weeks of treatment with the combination of efavirenz 600 mg + lamivudine (3TC) 300 mg + abacavir 600 mg once daily as an antiretroviral simplification regimen.
Read the detailed description
Treatment simplification is a therapeutic strategy that allows patients with controlled viral replication to switch to an easier-to-take antiretroviral system to promote long-term adherence and thus maintain controlled viral load for longer, delaying the evolution of the HIV infection.
The combination of ABC+3TC+EFV is a potent and easy-to-take regimen (2 tablets once a day) that could be suitable for the simplification of antiretroviral treatment in patients with controlled viral load with a regimen that includes 2 NRTI taken twice daily.
- Conditions
- HIV Infections
- Being tested
- efavirenz, Abacavir+lamivudine
- Keywords
- Antiviral efficacy, Tolerability, Immunologic response, Virologic response, 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.
efavirenzDrug
Also called sustiva
Efavirenz
Abacavir+lamivudineDrug
Also called Kivexa
Abacavir+lamivudine
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | abacavir 600 mg + lamivudine (3TC) 300 mg in 1 tablet + efavirenz 600 mg 1/24h Receives: Drug: efavirenz; Drug: Abacavir+lamivudine |
| B | No intervention | efavirenz + 2 NUCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral load of HIV-1 at each visit with regard to the baseline visit.
Measured: At 12, 24, 36 and 48 weeks
Secondary outcomes (3)
To evaluate immunological efficacy (changes in the CD4 and CD8 counts) of the combination studied over the follow-up period.
Measured: At 12, 24, 36 and 48 weeks
To evaluate the tolerance and safety of the combination of abacavir+ lamivudine (in a single tablet) + efavirenz given once daily over 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2006 (estimated)
- Study startNov 2004
- Primary completionFeb 2007
- Study completionMar 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
- 99 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
- NCT00314626
- Sponsor's protocol ID
- ELA
- Other IDs
- 2004-001198-25, 2004
- Status last verified
- Nov 2007
- First submitted
- 12 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 of an Antiretroviral Simplification Treatment With Efavirenz + Abacavir + 3TC Once Daily
- ClinicalTrials.gov ID
- NCT00314626
- Acronym / sponsor ID
- ELA
- Conditions
- HIV Infections
- Keywords
- Antiviral efficacy, Tolerability, Immunologic response, Virologic response, HIV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 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
- Nov 2004
- Primary completion
- Feb 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 14 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 proportion of patients with virological failure after 48 weeks of treatment with the combination of efavirenz 600 mg + lamivudine (3TC) 300 mg + abacavir 600 mg once daily as an antiretroviral simplification regimen.
Detailed description
Treatment simplification is a therapeutic strategy that allows patients with controlled viral replication to switch to an easier-to-take antiretroviral system to promote long-term adherence and thus maintain controlled viral load for longer, delaying the evolution of the HIV infection.
The combination of ABC+3TC+EFV is a potent and easy-to-take regimen (2 tablets once a day) that could be suitable for the simplification of antiretroviral treatment in patients with controlled viral load with a regimen that includes 2 NRTI taken twice daily.
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: efavirenz, Drug: Abacavir+lamivudineabacavir 600 mg + lamivudine (3TC) 300 mg in 1 tablet + efavirenz 600 mg 1/24h |
| B | No intervention | –efavirenz + 2 NUCS |
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.
- Patients on HAART therapy including efavirenz and two NRTIs in a twice-daily regimen for 6 months at least.
- Patients with an undetectable HIV-1 viral load over the last 6 months (at least 2 determinations separated by 3 months).
- Subject able to follow the treatment period.
Key exclusion criteria (7 listed)
- Hepatic tests > 5 times above normality.
- Pregnancy or breastfeeding
- Presence of opportunistic infections and/or recent tumours (< 6 months).
- 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 |
|---|---|---|
| efavirenzAlso: sustivaEfavirenz | Drug | A |
| Abacavir+lamivudineAlso: KivexaAbacavir+lamivudine | Drug | A |
Primary outcome
Viral load of HIV-1 at each visit with regard to the baseline visit.
Time frame: At 12, 24, 36 and 48 weeks
3 secondary outcomes
To evaluate immunological efficacy (changes in the 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 tolerance and safety of the combination of abacavir+ lamivudine (in a single tablet) + efavirenz given once daily over 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
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
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing efavirenz and Abacavir+lamivudine in people with HIV Infections, run by Germans Trias i Pujol Hospital at 16 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 7 inclusion and 7 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 16 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 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?
Viral load of HIV-1 at each visit with regard to the baseline visit. (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.