Trial About Hepatic Security of Antiretroviral Treatment Based on Kaletra Versus Nevirapine in Co-infected HIV/HCV Patients

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In retrospective studies, acceleration of hepatic fibrosis has been seen in Nevirapine (NVP) treatment when compared with Protease Inhibitors (PI) boosted with ritonavir treatment in patients with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) infection. The high incidence in our country of HIV-HCV co-infection, the availability of a new Kaletra (LPV/r) formulation (more convenient and better tolerated than soft capsules) as well as the possibility of analyzing hepatic fibrosis evolution in a fast and bloodless way, make attractive a study that, in a prospective way, could check the benefits of substituting NVP by LPV/r on hepatic fibrosis in this community.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Germans Trias i Pujol Hospital
• Collaborator: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• Treatments: Lopinavir; Nevirapine; Ritonavir

Criteria

Inclusion Criteria:

1. 18 years old or elder.

2. HCV and HIV co-infected patients.

3. Patients with antiretroviral treatment based in NVP plus 2 NRTIs (or 1 NRTI and Tenofovir), with undetectable viral load (under 50 copies/mL) during at least the last 24 weeks.

4. If women and of childbearing age, negative pregnancy test. Furthermore, barrier contraceptive method must be undertaken during the study.

5. Date and signature of the informed consent.

Exclusion Criteria:

1. Concomitant treatment with drugs that can significantly interact with the study drugs.

2. Opportunistic infections in the last 6 months.

3. Patients who can be candidates for an HCV infection treatment in the next 3 years.

4. Patients in who efficacy of previous NRTIs can not be ensured. For example, patients with mono or dual therapy history or with previous blips in whom NRTI-related mutations were identified that could reduce the sensibility to the used backbone.

5. Active alcohol consumption (over 50 g per day) or other substance abuse.

6. Pregnant or breastfeeding women.

7. Patients with transaminase level over 5 times the Upper Limit of Normality (ULN) or Creatinin over 2 mg/dL or Total Bilirubin over 3 times the ULN.

8. Any formal contraindication for being treated with the study drugs.

9. Patients who, basing in their antiretroviral treatment history, could be considered as being infected with a virus that has no sensibility to LPV.