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

NCT00661349 | Terminated Phase 4

• 1 other identifier: A10-174 (KANELA)
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 9

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 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.

Conditions

HIV Infections

Keywords

Kaletra; Nevirapina; HCV chronic infection; Fibroscan; hepatic fibrosis; treatment experienced

Outcome Measures

Primary Outcomes (1)

• The average of hepatic rigidity increase in each group. Hepatic rigidity will be measured in kilopascals through elastography (Fibroscan). Distribution of hepatic rigidity will be normalized by a logarithmic transformat

  From Basal to 144 week (last visit) every 3 months

Secondary Outcomes (6)

• Virological and immunologic efficacy will be assessed through the proportion of patients with virological failure during the follow-up and the CD4 lymphocytes count of both treatment regimens.

  From Basal to 144 week (last visit) every 3 months

• The effect of both treatments in lipidic and glucidic metabolism will be assessed through the following variables: Total Cholesterol, HDL and LDL Cholesterol, Triglycerides and Glucose.

  From Basal to 144 week (last visit) every 3 months

• Higher than log 7.2 Kpa in patients with non-significant basal fibrosis (less than log 7.2 Kpa)

  From Basal to 144 week (last visit) every 3 months

• The security of each regimen will be studied through the proportion of patients who give up treatment because of adverse events and hepatic-related adverse events presence.

  From Basal to 144 week (last visit) every 3 months

• Toxicity will be determined depending on: Clinical History and Physical Examination; Coagulation, hemogram and chemistry tests, which will include: transaminase levels, GGT, alkaline phosphatase, bilirrubin, albumin, urea and creatinin

  From Basal to 144 week (last visit) every 3 months

Study Arms (2)

1

ACTIVE COMPARATOR

Nevirapine

Drug: Nevirapine

2

EXPERIMENTAL

Lopinavir/ritonavir

Drug: Lopinavir/ritonavir

Interventions

Lopinavir/ritonavir DRUG

2 ITIAN (o 1 ITIAN+TDF)+ lopinavir/ritonavir, 2 tablet 200/50 mg to 12 hours

2

Nevirapine DRUG

2 ITIAN (o 1 ITIAN+TDF)+ nevirapine, 2 tablet 200/50 mg to 12 hours

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead
• Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia: collaborator

Study Sites (9)

Hospital Son Dureta

Palma de Mallorca, Balearic Islands, 07014, Spain

Location

H.U. Germans Trias i Pujol - Unitat VIH, Fundació Lluita contra la Sida

Badalona, Barcelona, 08916, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Clínic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Príncipe de Asturias

Madrid, 28005, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario la Paz

Madrid, 28046, Spain

Location

Hospital Clínico de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario de Valme

Seville, 41014, Spain

Location

MeSH Terms

Conditions

HIV Infections; Liver Cirrhosis

Interventions

Lopinavir; Nevirapine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2008
• First Posted: April 18, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 5, 2019

Record last verified: 2019-12

Locations

ES (9)