Study to Evaluate the Effectiveness of ABC+3TC +EFV in Once-Daily Regimens Versus KLT in Twice-Daily Regimens in Naive HIV Patients

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• 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. 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.