Status:
TERMINATED
Trial About Hepatic Security of Antiretroviral Treatment Based on Kaletra Versus Nevirapine in Co-infected HIV/HCV Patients
Lead Sponsor:
Germans Trias i Pujol Hospital
Collaborating Sponsors:
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Conditions:
HIV Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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 Hum...
Detailed Description
The prevalence of the HIV-HCV co-infection in Spain is one of the highest because both infections are strongly related to parenteral drugs use; so, from 61 to 69 % of HIV infected patients are also HC...
Eligibility Criteria
Inclusion
- 18 years old or elder.
- HCV and HIV co-infected patients.
- 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.
- If women and of childbearing age, negative pregnancy test. Furthermore, barrier contraceptive method must be undertaken during the study.
- Date and signature of the informed consent.
Exclusion
- Concomitant treatment with drugs that can significantly interact with the study drugs.
- Opportunistic infections in the last 6 months.
- Patients who can be candidates for an HCV infection treatment in the next 3 years.
- 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.
- Active alcohol consumption (over 50 g per day) or other substance abuse.
- Pregnant or breastfeeding women.
- 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.
- Any formal contraindication for being treated with the study drugs.
- Patients who, basing in their antiretroviral treatment history, could be considered as being infected with a virus that has no sensibility to LPV.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00661349
Start Date
February 1 2008
End Date
December 1 2008
Last Update
December 5 2019
Active Locations (9)
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1
Hospital Son Dureta
Palma de Mallorca, Balearic Islands, Spain, 07014
2
H.U. Germans Trias i Pujol - Unitat VIH, Fundació Lluita contra la Sida
Badalona, Barcelona, Spain, 08916
3
Hospital General Universitario de Alicante
Alicante, Spain, 03010
4
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain, 08036