Antiretroviral Treatment Simplification Study With Efavirenz + Abacavir + 3TC Once Daily
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Antiviral efficacy, Tolerability, Immunologic response, Virologic response, HIV
Eligibility Criteria
Inclusion Criteria: Age > 18 years. HIV-1 infected patients. Patients on HAART therapy including efavirenz and two NRTIs in a twice-daily regimen for 6 months at least. Patients with an undetectable HIV-1 viral load over the last 6 months (at least 2 determinations separated by 3 months). Subject able to follow the treatment period. Signature of the informed consent. 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: Hepatic tests > 5 times above normality. Pregnancy or breastfeeding Presence of opportunistic infections and/or recent tumours (< 6 months). 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.
Sites / Locations
- Germans Trias i Pujol Hospital
- Hospital de Mataró
- Hospital de Aranzazu
- Hospital San Millan de Logroño
- Hospital Principe de Asturias
- Hospital de Móstoles
- Hospital Costa del Sol
- Hospital Universitario de Canarias
- Hospital de la Vall d'Hebron
- Hospital Virgen de las Nieves
- Hospital Arnau de Vilanova de Lleida
- Hospital Severo Ochoa Leganés
- Hospital Cristal-Piñor
- Hospital Santa María Nai
- Hospital de Navarra
- Hospital General de Valencia
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
A
B
abacavir 600 mg + lamivudine (3TC) 300 mg in 1 tablet + efavirenz 600 mg 1/24h
efavirenz + 2 NUCS