HIV InfectionsPhase 4NCT00612755
Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Genotype 1 and/or 4
A Phase 4 study testing Peginterferon alfa-2a + ribavirin in people with HIV Infections and Hepatitis C, run by Hospital Clinico Universitario San Cecilio at 19 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Hepatitis C
- What is being tested?
- Peginterferon alfa-2a + ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 19 sitesSpain
- Study dates
- Oct 2005to Jan 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Spain19 sites
Fundación Hospital de Alcorcón
Alcorcón, Madrid, 28922
Hospital Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
Hospital Puerta del Mar
Cadiz, Cádiz, 11009
Hospital Clínico Universitario San Cecilio
Granada, Granada, 18013
Hospital de Jerez
Jerez de la Frontera, Cádiz, 11407
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Insular
Las Palmas, Gran Canaria, 35016
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Hospital 12 de Octubre
Madrid, Madrid, 28041
Hospital La Paz
Madrid, Madrid, 28046
Hospital Son Dureta
Palma de Mallorca, Mallorca, 07014
Hospital de Donostia
San Sebastián, Guipúzcoa, 20014
Complejo Hospitalario Universitario
Santiago, La Coruña, 15705
Hospital Virgen Macarena
Seville, Sevilla, 41008
Hospital Virgen del Rocío
Seville, Sevilla, 41013
Hospital de Valme
Seville, Sevilla, 41014
Consorcio Hospital General
Valencia, Valencia, 46014
Hospital Clínico de Valladolid
Valladolid, Valladolid, 47011
Hospital de Txagorritxu
Vitoria-Gasteiz, Alava, 01009
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- HIV Infections, Hepatitis C
- Being tested
- Peginterferon alfa-2a + ribavirin
- Keywords
- chronic hepatitis C, co-infection, extend treatment, co-infected HIV-HCV
- Medical subject headings
- HIV Infections, Hepatitis C, Hepatitis C, Chronic, Coinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa-2a + ribavirinDrug
Also called Pegasys
Peginterferon alfa-2a 180 mcg/week ribavirin 1000-1200 mg/day during 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Peginterferon alfa-2a 180 mcg/week + 1000-1200 mg/day ribavirin during 24 weeks Receives: Drug: Peginterferon alfa-2a + ribavirin |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patients with RNA-HCV undetectable
Measured: 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
Measured: 24 weeks of trial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2008 (estimated)
- Study startOct 2005
- Primary completionJan 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinico Universitario San Cecilio
- Sponsor type
- University, hospital or other
- Investigators
- José Hernández-Quero, Dr, Study chair, Hospital Clínico Universitario San Cecilio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612755
- Sponsor's protocol ID
- Extrados
- Other IDs
- 2004-004948-45, 2004
- Status last verified
- Jan 2008
- First submitted
- 29 Jan 2008
- Last updated
- 12 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00612755
- Acronym / sponsor ID
- Extrados
- Conditions
- HIV Infections, Hepatitis C
- Keywords
- chronic hepatitis C, co-infection, extend treatment, co-infected HIV-HCV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hospital Clinico Universitario San CecilioUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 12 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Peginterferon alfa-2a + ribavirinPeginterferon alfa-2a 180 mcg/week + 1000-1200 mg/day ribavirin during 24 weeks |
| 2 | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peginterferon alfa-2a + ribavirinAlso: PegasysPeginterferon alfa-2a 180 mcg/week ribavirin 1000-1200 mg/day during 24 weeks | Drug | 1 |
Primary outcome
% of patients with RNA-HCV undetectable
Time frame: at 48 week of study (24 weeks after the end of treatment period of trial).
1 secondary outcome
% of percentage of patients with RNA-HCV undetectable
Time frame: 24 weeks of trial period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Hernández-Quero, Dr study chair
Hospital Clínico Universitario San Cecilio
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Peginterferon alfa-2a + ribavirin in people with HIV Infections and Hepatitis C, run by Hospital Clinico Universitario San Cecilio at 19 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of patients with RNA-HCV undetectable (time frame: at 48 week of study (24 weeks after the end of treatment period of trial).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2008.