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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:
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
History of Changes

April 25, 2006
January 25, 2008
April 2004
April 2007   (final data collection date for primary outcome measure)
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 ]
To evaluate the virological response over the 48 weeks of the study.
Complete list of historical versions of study NCT00318123 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To evaluate the immunological efficacy (changes in CD4 and CD8 counts) of the combination studied over the follow-up period.
  • To evaluate the impact of treatment on the lipid profile.
  • To evaluate the tolerance and safety of the combination of Efavirenz + lamivudine + abacavir given once daily over the 48-week treatment period.
  • 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).
  • To analyse the mutations that appear in patients that present virological failure.
Not Provided
Not Provided
 
Study to Evaluate the Effectiveness of ABC+3TC +EFV in Once-Daily Regimens Versus KLT in Twice-Daily Regimens in Naive HIV Patients
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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Kivexa
abacavir 600mg + lamivudine 300mg in one tablet QD
  • Experimental: A
    Abacavir 600mg + lamivudine 300mg in on table QD + efavirenz 600mg QD
    Intervention: Drug: Kivexa
  • Experimental: B
    Abacavir 600mg + lamivudine 300mg in ine tablet QD * lopinavir/ritonavir 400/100 mg BID
    Intervention: Drug: Kivexa
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
April 2007
April 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age> 18 years.
  2. HIV-1 infected patients.
  3. Naive to antiretroviral treatment.
  4. Candidate patient for initiating antiretroviral treatment*.
  5. Subject able to follow the treatment period.
  6. Signature of the informed consent.
  7. 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:

  1. Hepatic tests > 5 times above normality.
  2. Pregnancy or breastfeeding.
  3. Treatment for opportunistic infections or neoplasms associated with the stable HIV over the last 6 weeks.
  4. Suspected or documented resistance to any of the investigational drugs.
  5. Known allergic hypersensitivity to any of the investigational drugs or any similar drug.
  6. Subjects with abusive consumption of alcohol or illegal drugs.
  7. Patients participating in another clinical trial.
  8. Terminal renal disease.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy,   Spain
 
NCT00318123
LAKE, 2004-001282-18
No
Lluita Sida Foundation
Germans Trias i Pujol Hospital
Fundacio Lluita Contra la SIDA
Principal Investigator: Bonaventura Clotet, MD, PhD LLuita contra la Sida Foundation-HIV Unit
Germans Trias i Pujol Hospital
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP