Study to Evaluate the Effectiveness of ABC+3TC +EFV in Once-Daily Regimens Versus KLT in Twice-Daily Regimens in Naive HIV Patients
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ClinicalTrials.gov Identifier: NCT00318123 |
Recruitment Status
:
Completed
First Posted
: April 26, 2006
Last Update Posted
: January 29, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Kivexa | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 126 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | April 2004 |
Actual Primary Completion Date : | April 2007 |
Actual Study Completion Date : | April 2007 |

Arm | Intervention/treatment |
---|---|
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
|
- To evaluate the virological response over the 48 weeks of the study. [ Time Frame: At 12, 24, 36 and 48 weeks ]
- 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. ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00318123
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 Macarena | |
Sevilla, Spain, 41009 | |
Hospital Virgen del Rocío | |
Sevilla, Spain, 41013 | |
Hospital de Tarragona | |
Tarragona, Spain, 43007 | |
Hospital Universitari Dr. Peset | |
Valencia, Spain, 46017 | |
Hospital Miguel Servet | |
Zaragoza, Spain, 50009 |
Principal Investigator: | Bonaventura Clotet, MD, PhD | LLuita contra la Sida Foundation-HIV Unit |
Responsible Party: | Lluita Sida Foundation |
ClinicalTrials.gov Identifier: | NCT00318123 History of Changes |
Other Study ID Numbers: |
LAKE 2004-001282-18 |
First Posted: | April 26, 2006 Key Record Dates |
Last Update Posted: | January 29, 2008 |
Last Verified: | January 2008 |
Keywords provided by Germans Trias i Pujol Hospital:
Simplification therapy Efficacy Safety |
Virological effectiveness Immunological effectiveness HIV |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lamivudine Efavirenz Abacavir Dideoxynucleosides Reverse Transcriptase Inhibitors |
Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers Antimetabolites |