HIVPhase 4NCT01225705
Safety Study of Raltegravir in HIV/HCV Co-infected Patients
A Phase 4 study testing raltegravir and Atazanavir/ritonavir in people with HIV and Hepatitis C, run by University Hospital, Bonn at 8 sites in Germany.
Trial summary
Current European AIDS Clinical Society (EACS) guidelines for the treatment of HIV infection recommend a combination antiretroviral regimen composed of two nucleoside reverse transcriptase inhibitors plus a ritonavir boosted protease inhibitor or a non-nucleoside reverse transcriptase inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Hepatitis C
- What is being tested?
- raltegravir and Atazanavir/ritonavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 8 sitesGermany
- Study dates
- Oct 2010to Aug 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV and Hepatitis C co-infected patients
- indication for HAART according to current German-Austrian guidelines
- HAART naive
- no primary NRTI / Integrase / PI associated resistance mutation according to the Stanford algorithm at screening; every patient MUST have a genotypic resistance assay prior baseline available (< 6 months prior to baseline)
- women of childbearing age: negative pregnancy test
- ability to sign written informed consent
Who cannot join
- advanced liver cirrhosis Child-Pugh B or C or decompensated liver disease
- Pegylated interferon / ribavirin or other anti-HCV therapy; planned anti-HCV therapy for duration of the study (48 weeks).
- acute or chronic hepatitis B infection
- acute hepatitis A or other hepatotropic virus infections
- any other chronic liver disease such as alcohol abuse or hemosiderosis
- use or planned use (for the duration of the study, 48 weeks) of rifampicin, St. John´s wort and drugs that are metabolized via the cytochrome P450 system with a narrow therapeutic PK-range such as astemizole, terfenadine, cisapride, pimozide, chinidin, bepridil, triazolam, midazolam, ergotamine, dihydroergotamin, ergometrine, methyl-ergometrine. FOR OTHER COMEDICATIONS please consult with the SPC of Raltegravir (Isentress®), Atazanavir (Reyataz®), Ritonavir (Norvir®), your hospital pharmacist, www.hiv-drug-interactions.org or the principal investigator in case of uncertainty.
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- new AIDS defining event, except for Kaposi sarcoma, < 1 months prior to screening
- malignancy, except for Kaposi sarcoma, with current radio- or chemotherapy
- history of organ transplantation
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Auguste Viktoria Hospital (AVK)
Berlin
Praxiszentrum Kaiserdamm
Berlin
Private Practice Dupke, Carganico, Baumgarten
Berlin
Department of Internal Medicine I, Bonn University
Bonn
University of Essen
Essen
Infektiologikum Frankfurt
Frankfurt am Main
University of Frankfurt
Frankfurt am Main
Infektionsmedizinisches Centrum Hamburg (ICH)
Hamburg
About this study
Official title: An Open, Prospective Study to Compare the Safety and Efficacy of Raltegravir vs. Atazanavir / Ritonavir, Both in Combination With Tenofovir DF and Emtricitabine, in the Treatment of HIV-infection in ART Naive Subjects With HCV Co-infection.
Current European AIDS Clinical Society (EACS) guidelines for the treatment of HIV infection recommend a combination antiretroviral regimen composed of two nucleoside reverse transcriptase inhibitors plus a ritonavir boosted protease inhibitor or a non-nucleoside reverse transcriptase inhibitor.
The non-nucleoside reverse transcriptase inhibitors licensed for naïve patients - nevirapine and efavirenz - have both been asociated with increased rates of hepatotoxicity (nevirapine) and CNS toxicity (efavirenz) in HIV/HCV co-infected patients. Although PI-based therapy has dramatically reduced morbidity and mortality, it has been limited by complex dosing regimens and toxicities, leading to adherence challenges. Varying degree of liver insufficiency may necessitate pharmacokinetic monitoring of the protease inhibitor and may necessitate dose adjustments. In HIV/HCV co-infected patients HAART based on another class of antiretrovirals than NNRTI or PI may thus offer advantages with regard to adverse events and thus long-term efficacy.
Read more
The overall intention of this trial is to examine in a non-inferiority design the safety and efficacy of a raltegravir based HAART with a standard-of-care HAART in HIV-/HCV co-infected patients. The standard of care used in this study will be atazanavir/ritonavir. All patients will in addition receive a fixed combination of tenofovir and emtricitabine.
The primary end-point is the rate of hepatotoxic events, defined by ALT elevations.
- Conditions
- HIV, Hepatitis C
- Being tested
- raltegravir, Atazanavir/ritonavir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
raltegravirDrug
Patients will be randomized 1:1 to either the experimental or the active control arm
Atazanavir/ritonavirDrug
Patients will be randomized 1:1 to either the experimental or the active control arm
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir | Experimental | 45 patients will receive open label raltegravir, in addition to the common backbone tenofovir and emtricitabine Receives: Drug: raltegravir |
| Atazanavir/ritonavir | Active comparator | 45 patients will receive open label atazanavir/ritonavir Receives: Drug: Atazanavir/ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective
- there is no difference in the rate of grade 1/2, or 3/4 ALT elevations
- there is a higher incidence of grade 1 - 4 hyperbilirubinemias in the ATV/r arm
Secondary outcomes (1)
Secondary objectives
Other parameters of safety and efficacy will be compared between both arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: no pts recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Axel Baumgarten, Berlin, Dr. Christoph Stephan, Frankfurt/M, Dr. Stefan Esser, Essen, Dr. Keikawus Arastéh, Berlin, Prof. Dr. Hans-Jürgen Stellbrink, Hamburg, Dr. Thomas Lutz, Frankfurt/M, Dr. Jörg Gölz , Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225705
- Sponsor's protocol ID
- UKB-2009-MED-I-JKR-01
- Other IDs
- 2009-015904-24, 2009
- Status last verified
- Oct 2010
- First submitted
- 20 Oct 2010
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Prospective Study to Compare the Safety and Efficacy of Raltegravir vs. Atazanavir / Ritonavir, Both in Combination With Tenofovir DF and Emtricitabine, in the Treatment of HIV-infection in ART Naive Subjects With HCV Co-infection.
- ClinicalTrials.gov ID
- NCT01225705
- Acronym / sponsor ID
- UKB-2009-MED-I-JKR-01
- Conditions
- HIV, Hepatitis C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no pts recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- Dr. Axel Baumgarten, Berlin, Dr. Christoph Stephan, Frankfurt/M, Dr. Stefan Esser, Essen, Dr. Keikawus Arastéh, Berlin, Prof. Dr. Hans-Jürgen Stellbrink, Hamburg, Dr. Thomas Lutz, Frankfurt/M, Dr. Jörg Gölz , Berlin
- Study start
- Oct 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 21 Oct 2010 (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.
Current European AIDS Clinical Society (EACS) guidelines for the treatment of HIV infection recommend a combination antiretroviral regimen composed of two nucleoside reverse transcriptase inhibitors plus a ritonavir boosted protease inhibitor or a non-nucleoside reverse transcriptase inhibitor.
The non-nucleoside reverse transcriptase inhibitors licensed for naïve patients - nevirapine and efavirenz - have both been asociated with increased rates of hepatotoxicity (nevirapine) and CNS toxicity (efavirenz) in HIV/HCV co-infected patients. Although PI-based therapy has dramatically reduced morbidity and mortality, it has been limited by complex dosing regimens and toxicities, leading to adherence challenges. Varying degree of liver insufficiency may necessitate pharmacokinetic monitoring of the protease inhibitor and may necessitate dose adjustments. In HIV/HCV co-infected patients HAART based on another class of antiretrovirals than NNRTI or PI may thus offer advantages with regard to adverse events and thus long-term efficacy.
The overall intention of this trial is to examine in a non-inferiority design the safety and efficacy of a raltegravir based HAART with a standard-of-care HAART in HIV-/HCV co-infected patients. The standard of care used in this study will be atazanavir/ritonavir. All patients will in addition receive a fixed combination of tenofovir and emtricitabine.
The primary end-point is the rate of hepatotoxic events, defined by ALT elevations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raltegravir | Experimental | Drug: raltegravir45 patients will receive open label raltegravir, in addition to the common backbone tenofovir and emtricitabine |
| Atazanavir/ritonavir | Active comparator | Drug: Atazanavir/ritonavir45 patients will receive open label atazanavir/ritonavir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV and Hepatitis C co-infected patients
- indication for HAART according to current German-Austrian guidelines
- HAART naive
- no primary NRTI / Integrase / PI associated resistance mutation according to the Stanford algorithm at screening; every patient MUST have a genotypic resistance assay prior baseline available (< 6 months prior to baseline)
- women of childbearing age: negative pregnancy test
Key exclusion criteria (9 listed)
- advanced liver cirrhosis Child-Pugh B or C or decompensated liver disease
- Pegylated interferon / ribavirin or other anti-HCV therapy; planned anti-HCV therapy for duration of the study (48 weeks).
- acute or chronic hepatitis B infection
- acute hepatitis A or other hepatotropic virus infections
- any other chronic liver disease such as alcohol abuse or hemosiderosis
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 |
|---|---|---|
| raltegravirPatients will be randomized 1:1 to either the experimental or the active control arm | Drug | Raltegravir |
| Atazanavir/ritonavirPatients will be randomized 1:1 to either the experimental or the active control arm | Drug | Atazanavir/ritonavir |
Primary outcome
Primary objective
1. there is no difference in the rate of grade 1/2, or 3/4 ALT elevations 2. there is a higher incidence of grade 1 - 4 hyperbilirubinemias in the ATV/r arm
1 secondary outcome
Secondary objectives
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 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 raltegravir and Atazanavir/ritonavir in people with HIV and Hepatitis C, run by University Hospital, Bonn at 8 sites in Germany.
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 9 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: withdrawn, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. 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 was withdrawn before enrolling participants, so there are no results.
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?
Primary objective. 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 3 Jun 2015.