Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Genotype 1 and/or 4
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| ClinicalTrials.gov Identifier: NCT00612755 |
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Recruitment Status
:
Completed
First Posted
: February 12, 2008
Last Update Posted
: February 12, 2008
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections Hepatitis C | Drug: Peginterferon alfa-2a + ribavirin | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 43 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 Start Date : | October 2005 |
| Actual Primary Completion Date : | January 2007 |
| Actual Study Completion Date : | January 2008 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Peginterferon alfa-2a 180 mcg/week + 1000-1200 mg/day ribavirin during 24 weeks
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Drug: Peginterferon alfa-2a + ribavirin
Peginterferon alfa-2a 180 mcg/week ribavirin 1000-1200 mg/day during 24 weeks
Other Name: Pegasys
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| No Intervention: 2 |
- % of patients with RNA-HCV undetectable [ Time Frame: at 48 week of study (24 weeks after the end of treatment period of trial). ]
- % of percentage of patients with RNA-HCV undetectable [ Time Frame: 24 weeks of trial period ]
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00612755
| Spain | |
| Hospital de Txagorritxu | |
| Vitoria, Alava, Spain, 01009 | |
| Hospital de Bellvitge | |
| Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
| Hospital de Jerez | |
| Jerez de la Frontera, Cádiz, Spain, 11407 | |
| Hospital Insular | |
| Las Palmas, Gran Canaria, Spain, 35016 | |
| Hospital de Donostia | |
| San Sebastián, Guipúzcoa, Spain, 20014 | |
| Complejo Hospitalario Universitario | |
| Santiago, La Coruña, Spain, 15705 | |
| Fundación Hospital de Alcorcón | |
| Alcorcón, Madrid, Spain, 28922 | |
| Hospital Son Dureta | |
| Palma de Mallorca, Mallorca, Spain, 07014 | |
| Hospital Santa Creu i Sant Pau | |
| Barcelona, Spain, 08025 | |
| Hospital Puerta del Mar | |
| Cádiz, Spain, 11009 | |
| Hospital Clínico Universitario San Cecilio | |
| Granada, Spain, 18013 | |
| Hospital Clínico San Carlos | |
| Madrid, Spain, 28040 | |
| Hospital 12 de Octubre | |
| Madrid, Spain, 28041 | |
| Hospital La Paz | |
| Madrid, Spain, 28046 | |
| Hospital Virgen Macarena | |
| Sevilla, Spain, 41008 | |
| Hospital Virgen del Rocío | |
| Sevilla, Spain, 41013 | |
| Hospital de Valme | |
| Sevilla, Spain, 41014 | |
| Consorcio Hospital General | |
| Valencia, Spain, 46014 | |
| Hospital Clínico de Valladolid | |
| Valladolid, Spain, 47011 | |
| Study Chair: | José Hernández-Quero, Dr | Hospital Clínico Universitario San Cecilio |
| Responsible Party: | José Hernández-Quero, Hospital Clinico Universitario San Cecilio |
| ClinicalTrials.gov Identifier: | NCT00612755 History of Changes |
| Other Study ID Numbers: |
Extrados 2004-004948-45 |
| First Posted: | February 12, 2008 Key Record Dates |
| Last Update Posted: | February 12, 2008 |
| Last Verified: | January 2008 |
Keywords provided by Hospital Clinico Universitario San Cecilio:
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chronic hepatitis C co-infection extend treatment co-infected HIV-HCV |
Additional relevant MeSH terms:
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Hepatitis Hepatitis C HIV Infections Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Lentivirus Infections Retroviridae Infections Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ribavirin Peginterferon alfa-2a Interferon-alpha Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs |