Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Genotype 1 and/or 4

HIV Infections Clinical Trial

Official title:

Open, Randomized, Multicenter Phase IV Study to Evaluate Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Patients Genotype 1 and/or 4

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612755
• Other study ID #: Extrados
• Secondary ID: 2004-004948-45
• Status: Completed
• Phase: Phase 4
• First received: January 29, 2008
• Last updated: January 29, 2008
• Start date: October 2005
• Est. completion date: January 2008

Study information

• Verified date: January 2008
• Source: Hospital Clinico Universitario San Cecilio
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

A study concerning viral kinetic with 10 co-infected HIV-HCV patients on treatment with peginterferon alfa-2a + ribavirin o IFN + ribavirin was reported in Conference on Retroviruses and Opportunistic Infections 2002 by Dr. Torriani shown half-life of HCV virions and the viral clearance was larger than mono-infected patients.

The doubt is if this difference in viral kinetic of HIV-HCV co-infected patients versus mono-infected is related with the loss of profited on treatment.

In the APRICOT trial patients genotype 2/3 were treated for 48 weeks and the relapse rates was only 2%.

The present study want to evaluate is the treatment extent for 24 weeks more in patients genotype 1 and/or 4 will be improve the percentage of patients with viral clearance at the end of the follow-up period, to prevent relapsed in patients with response at the end of treatment.

Patients will be randomized to received 180 µg/week of peginterferon alfa-2a + 1000-1200 mg/day of ribavirin during 24 weeks more or control.

Description:

To evaluate efficacy of extend treatment during 24 weeks more in co-infected HIV-HCV patients with genotype 1 and/or 4 who at 44 week of treatment with peginterferón alfa-2a in combination with ribavirin have RNA-HCV undetectable.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: January 2008
• Est. primary completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients on treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day) who are RNA-HCV undetectable at 44 week

• RNA-HCV positive at 48 week before study and genotype 1 or 4.

• HIV-1 positive: ELISA y Western-blot.

• Stable status of HIV-1 infection in the opinion of the investigator, (patients who are not expected to progress during the study).

• Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 6 months after treatment end. This may include, but is not limited to, using birth control pills, IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state.

• Willingness to give written informed consent and willingness to participate to and comply with the study.

Exclusion Criteria:

• Patients with RNA-HCV detectable after 44 weeks of treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day).

• Patients with other treatment for chronic hepatitis, different which of inclusion criteria is described.

• More of tree weeks from the end of treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day) to the inclusion in "EXTRADOS" trial.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C
• HIV Infections

Intervention

Drug:
• Peginterferon alfa-2a + ribavirin
Peginterferon alfa-2a 180 mcg/week ribavirin 1000-1200 mg/day during 24 weeks

Locations

Country	Name	City	State
Spain	Fundación Hospital de Alcorcón	Alcorcón	Madrid
Spain	Hospital Santa Creu i Sant Pau	Barcelona
Spain	Hospital Puerta del Mar	Cádiz
Spain	Hospital Clínico Universitario San Cecilio	Granada
Spain	Hospital de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Hospital de Jerez	Jerez de la Frontera	Cádiz
Spain	Hospital Insular	Las Palmas	Gran Canaria
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Son Dureta	Palma de Mallorca	Mallorca
Spain	Hospital de Donostia	San Sebastián	Guipúzcoa
Spain	Complejo Hospitalario Universitario	Santiago	La Coruña
Spain	Hospital de Valme	Sevilla
Spain	Hospital Virgen del Rocío	Sevilla
Spain	Hospital Virgen Macarena	Sevilla
Spain	Consorcio Hospital General	Valencia
Spain	Hospital Clínico de Valladolid	Valladolid
Spain	Hospital de Txagorritxu	Vitoria	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinico Universitario San Cecilio

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of patients with RNA-HCV undetectable		at 48 week of study (24 weeks after the end of treatment period of trial).	Yes
Secondary	% of percentage of patients with RNA-HCV undetectable		24 weeks of trial period	Yes