Antiretroviral Treatment Simplification Study With Efavirenz + Abacavir + 3TC Once Daily

Multicentre, Open Label, Prospective, Randomised Clinical Trial of an Antiretroviral Simplification Treatment With Efavirenz + Abacavir + 3TC Once Daily

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00314626

Enrollment

Registered

2006-04-14

Start date

2004-11-30

Completion date

2007-03-31

Last updated

2008-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Antiviral efficacy, Tolerability, Immunologic response, Virologic response, HIV

Brief 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.

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.

Interventions

DRUGefavirenz

Efavirenz

DRUGAbacavir+lamivudine

Abacavir+lamivudine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Age \> 18 years. 2. HIV-1 infected patients. 3. Patients on HAART therapy including efavirenz and two NRTIs in a twice-daily regimen for 6 months at least. 4. Patients with an undetectable HIV-1 viral load over the last 6 months (at least 2 determinations separated by 3 months). 5. Subject able to follow the treatment period. 6. Signature of the informed consent. 7. 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.

Exclusion criteria

1. Hepatic tests \> 5 times above normality. 2. Pregnancy or breastfeeding 3. Presence of opportunistic infections and/or recent tumours (\< 6 months). 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.

Design outcomes

Primary

Measure	Time frame
Viral load of HIV-1 at each visit with regard to the baseline visit.	At 12, 24, 36 and 48 weeks

Secondary

Measure	Time frame
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.	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).	At 12, 24, 36 and 48 weeks
To evaluate immunological efficacy (changes in the CD4 and CD8 counts) of the combination studied over the follow-up period.	At 12, 24, 36 and 48 weeks

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026