Clinical trial NCT00612755: Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Genotype 1 and/or 4
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Hepatitis C
Keywords: chronic hepatitis C
co-infection
extend treatment
co-infected HIV-HCV
Lead sponsor: Hospital Clinico Universitario San Cecilio
Sponsor class: OTHER
First posted: 2008-02-12
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: % of patients with RNA-HCV undetectable
timeFrame: at 48 week of study (24 weeks after the end of treatment period of trial).
Secondary outcomes:
measure: % of percentage of patients with RNA-HCV undetectable
timeFrame: 24 weeks of trial period
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Hospital de Txagorritxu
state: Alava
city: Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
state: Barcelona
city: Jerez de la Frontera
country: Spain
facility: Hospital de Jerez
state: Cádiz
city: Las Palmas
country: Spain
facility: Hospital Insular
state: Gran Canaria
city: San Sebastián
country: Spain
facility: Hospital de Donostia
state: Guipúzcoa
city: Santiago
country: Spain
facility: Complejo Hospitalario Universitario
state: La Coruña
city: Alcorcón
country: Spain
facility: Fundación Hospital de Alcorcón
state: Madrid
city: Palma de Mallorca
country: Spain
facility: Hospital Son Dureta
state: Mallorca
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Cádiz
country: Spain
facility: Hospital Puerta del Mar
city: Granada
country: Spain
facility: Hospital Clínico Universitario San Cecilio
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital La Paz
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Sevilla
country: Spain
facility: Hospital de Valme
city: Valencia
country: Spain
facility: Consorcio Hospital General
city: Valladolid
country: Spain
facility: Hospital Clínico de Valladolid
Study officials:
affiliation: Hospital Clínico Universitario San Cecilio
name: José Hernández-Quero, Dr
role: STUDY_CHAIR
References: