Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Genotype 1 and/or 4
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
2 other identifiers
interventional
43
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 hiv-infections
Started Oct 2005
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 29, 2008
CompletedFirst Posted
Study publicly available on registry
February 12, 2008
CompletedFebruary 12, 2008
January 1, 2008
1.3 years
January 29, 2008
January 29, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
% of patients with RNA-HCV undetectable
at 48 week of study (24 weeks after the end of treatment period of trial).
Secondary Outcomes (1)
% of percentage of patients with RNA-HCV undetectable
24 weeks of trial period
Study Arms (2)
1
EXPERIMENTALPeginterferon alfa-2a 180 mcg/week + 1000-1200 mg/day ribavirin during 24 weeks
2
NO INTERVENTIONInterventions
Peginterferon alfa-2a 180 mcg/week ribavirin 1000-1200 mg/day during 24 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Hospital de Txagorritxu
Vitoria-Gasteiz, Alava, 01009, Spain
Hospital Santa Creu i Sant Pau
Barcelona, Barcelona, 08025, Spain
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Puerta del Mar
Cadiz, Cádiz, 11009, Spain
Hospital de Jerez
Jerez de la Frontera, Cádiz, 11407, Spain
Hospital Insular
Las Palmas, Gran Canaria, 35016, Spain
Hospital Clínico Universitario San Cecilio
Granada, Granada, 18013, Spain
Hospital de Donostia
San Sebastián, Guipúzcoa, 20014, Spain
Complejo Hospitalario Universitario
Santiago, La Coruña, 15705, Spain
Fundación Hospital de Alcorcón
Alcorcón, Madrid, 28922, Spain
Hospital Clínico San Carlos
Madrid, Madrid, 28040, Spain
Hospital 12 de Octubre
Madrid, Madrid, 28041, Spain
Hospital La Paz
Madrid, Madrid, 28046, Spain
Hospital Son Dureta
Palma de Mallorca, Mallorca, 07014, Spain
Hospital Virgen Macarena
Seville, Sevilla, 41008, Spain
Hospital Virgen del Rocío
Seville, Sevilla, 41013, Spain
Hospital de Valme
Seville, Sevilla, 41014, Spain
Consorcio Hospital General
Valencia, Valencia, 46014, Spain
Hospital Clínico de Valladolid
Valladolid, Valladolid, 47011, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
José Hernández-Quero, Dr
Hospital Clínico Universitario San Cecilio
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 29, 2008
First Posted
February 12, 2008
Study Start
October 1, 2005
Primary Completion
January 1, 2007
Study Completion
January 1, 2008
Last Updated
February 12, 2008
Record last verified: 2008-01