Antiretroviral Treatment Simplification Study With Efavirenz + Abacavir + 3TC Once Daily
Information source: Germans Trias i Pujol Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: efavirenz (Drug); Abacavir+lamivudine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Germans Trias i Pujol Hospital Official(s) and/or principal investigator(s):
Bonaventura Clotet, MD, PhD, Principal Investigator, Affiliation: Lluita contra la Sida Foundation-HIV Unit
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.
Clinical Details
Official title: Multicentre, Open Label, Prospective, Randomised Clinical Trial of an Antiretroviral Simplification Treatment With Efavirenz + Abacavir + 3TC Once Daily
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Viral load of HIV-1 at each visit with regard to the baseline visit.
Secondary outcome: To evaluate immunological efficacy (changes in the CD4 and CD8 counts) of the combination studied over the follow-up period.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. 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).
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Hospital de la Vall d'Hebron, Barcelona 08035, Spain
Hospital Virgen de las Nieves, Granada 18014, Spain
Hospital Arnau de Vilanova de Lleida, Lleida 25198, Spain
Hospital Severo Ochoa Leganés, Madrid 28911, Spain
Hospital Santa María Nai, Ourense 32005, Spain
Hospital Cristal-Piñor, Ourense 32005, Spain
Hospital de Navarra, Pamplona 31008, Spain
Hospital General de Valencia, Valencia 46014, Spain
Germans Trias i Pujol Hospital, Badalona, Barcelona 08916, Spain
Hospital de Mataró, Mataro, Barcelona 08304, Spain
Hospital de Aranzazu, San Sebastian, Guipuzcoa 20014, Spain
Hospital San Millan de Logroño, Logroño, La Rioja 26001, Spain
Hospital Principe de Asturias, Alcala de Henares, Madrid 28005, Spain
Hospital de Móstoles, Mostoles, Madrid 28935, Spain
Hospital Costa del Sol, Marbella, Málaga 29600, Spain
Hospital Universitario de Canarias, La Laguna, Santa Cruz de Tenerife 38320, Spain
Additional Information
Starting date: November 2004
Ending date: March 2007
Last updated: January 25, 2008
|
