Study to Evaluate the Effectiveness of ABC+3TC +EFV in Once-Daily Regimens Versus KLT in Twice-Daily Regimens in Naive HIV Patients
This study has been completed.
Sponsor:
Germans Trias i Pujol Hospital
Collaborator:
Fundacio Lluita Contra la SIDA
Information provided by:
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT00318123
First received: April 25, 2006
Last updated: January 25, 2008
Last verified: January 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Kivexa |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Germans Trias i Pujol Hospital:
Primary Outcome Measures:
- To evaluate the virological response over the 48 weeks of the study. [ Time Frame: At 12, 24, 36 and 48 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
- To evaluate the impact of treatment on the lipid profile. [ Time Frame: At 12, 24, 36 and 48 weeks ] [ Designated as safety issue: Yes ]
- 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. ] [ Designated as safety issue: Yes ]
- 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. ] [ Designated as safety issue: No ]
- To analyse the mutations that appear in patients that present virological failure. [ Time Frame: When there is a virological failure. ] [ Designated as safety issue: No ]
| Enrollment: | 126 |
| Study Start Date: | April 2004 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Abacavir 600mg + lamivudine 300mg in on table QD + efavirenz 600mg QD
|
Drug: Kivexa
abacavir 600mg + lamivudine 300mg in one tablet QD
|
|
Experimental: B
Abacavir 600mg + lamivudine 300mg in ine tablet QD * lopinavir/ritonavir 400/100 mg BID
|
Drug: Kivexa
abacavir 600mg + lamivudine 300mg in one tablet QD
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318123
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318123
Locations
| Italy | |
| Institute of Infections and Tropical Diseases University of Brescia | |
| Brescia, Italy, 25125 | |
| Spain | |
| Hospital Arquitecto Marcide | |
| Ferrol, A Coruña, Spain, 15405 | |
| Hospital Generall de Alicante | |
| Alicante, Alacant, Spain, 03010 | |
| Hospital Universitari Germans Trias i Pujol | |
| Badalona, Barcelona, Spain, 08916 | |
| Hospital de Granollers | |
| Granollers, Barcelona, Spain, 08400 | |
| Hospital Universitario de Canarias | |
| Santa Cruz de Tenerife, Canarias, Spain, 38320 | |
| Hospital Clínico Universitario de Santiago | |
| Santiago de Compostela, Galicia, Spain, 15706 | |
| Hopsital Costa del Sol | |
| Marbella, Malaga, Spain, 29600 | |
| Hospital Nuestra Sra del Rosell | |
| Cartagena, Murcia, Spain, 30203 | |
| Hospital Central de Asturias | |
| Asturias, Oviedo, Spain, 33006 | |
| Hospital Xeral de Vigo | |
| Vigo, Pontevedra, Spain, 36204 | |
| Hospital Virgen de las Nieves | |
| Granada, Spain, 18014 | |
| Hopsital Gregorio Marañón | |
| Madrid, Spain, 28007 | |
| Hospital 12 de Octubre | |
| Madrid, Spain, 28041 | |
| Hospital General de Murcia | |
| Murcia, Spain, 30003 | |
| Hospital Virgen del Rocío | |
| Sevilla, Spain, 41013 | |
| Hospital Virgen Macarena | |
| Sevilla, Spain, 41009 | |
| Hospital de Tarragona | |
| Tarragona, Spain, 43007 | |
| Hospital Universitari Dr. Peset | |
| Valencia, Spain, 46017 | |
| Hospital Miguel Servet | |
| Zaragoza, Spain, 50009 | |
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Fundacio Lluita Contra la SIDA
Investigators
| Principal Investigator: | Bonaventura Clotet, MD, PhD | LLuita contra la Sida Foundation-HIV Unit |
More Information
No publications provided
| Responsible Party: | Lluita Sida Foundation |
| ClinicalTrials.gov Identifier: | NCT00318123 History of Changes |
| Other Study ID Numbers: | LAKE, 2004-001282-18 |
| Study First Received: | April 25, 2006 |
| Last Updated: | January 25, 2008 |
| Health Authority: | Spain: Ministry of Health |
Keywords provided by Germans Trias i Pujol Hospital:
|
Simplification therapy Efficacy Safety |
Virological effectiveness Immunological effectiveness HIV |
ClinicalTrials.gov processed this record on March 03, 2015