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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Germans Trias i Pujol Hospital
• Collaborators: Fundacio Lluita Contra la SIDA; Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• Treatments: Abacavir; Dideoxynucleosides; Efavirenz; Lamivudine

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.