HIV-1 and Hepatitis C Co-InfectionPhase 2NCT00665353
Pioglitazone Before Peginterferon and Ribavirin for Hepatitis C Infection in HIV/HCV-Coinfected Patients With Insulin Resistance
A Phase 2 study testing pioglitazone, peginterferon and ribavirin in people with HIV-1 and Hepatitis C Co-Infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 8 sites in United States.
Trial summary
Insulin resistance is common in people coinfected with HIV and Hepatitis C virus (HCV) and is associated with poor responses to treatment for HCV. Pioglitazone is an FDA-approved medication for the treatment of type 2 diabetes. It works by increasing the body's sensitivity to insulin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1 and Hepatitis C Co-Infection
- What is being tested?
- pioglitazone, peginterferon and ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 8 sitesUnited States
- Study dates
- Mar 2009to Dec 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- For Step 1:
- HIV infected
- Exhibited no response to previous treatment with PEG-IFN alfa-2a 180 mcg/week or alfa-2b 1.5 mcg/kg/week and at least 1000 mg/day ribavirin given for at least 12 consecutive weeks. More information on this criterion can be found in the protocol.
- HOMA-IR valued greater than 2.5 within 42 days prior to study entry. More information on this criterion can be found in the protocol.
- CD4 count of at least 200 cells/mm3 within 42 days prior to study entry
- HCV RNA of at least 60 IU/ml by quantitative RT-PCR assay with or without reactive anti-HCV antibodies within 42 days prior to study entry
Show all 24Show fewer
- Documentation of infection with HCV genotype 1, within 42 days prior to study entry
- On stable or no antiretroviral therapy for 12 weeks prior to study entry. Interruptions in treatment lasting 14 days or less are allowed if the participant reinitiated the same regimen prior to study entry. Dose modifications or changes in drug formulations during the 12 weeks prior to study entry are permissible.
- Participants on antiretroviral therapy should plan to remain on the same therapy for at least 24 weeks after study entry. Participants not on antiretroviral therapy should have no plans to initiate therapy during the first 24 weeks following study entry.
- Participants with documented or suspected hepatic cirrhosis must have a modified Child-Pugh-Turcotte (CPT) within 42 days prior to study entry.
- Participants with documented or suspected hepatic cirrhosis must have either serum alpha-fetoprotein level of 50 ng/ml or less within 24 weeks prior to study entry; OR serum alpha-fetoprotein greater than 50 ng/ml but no greater than 400 ng/ml with an imaging procedure that shows no evidence of a hepatic tumor, both obtained within 24 weeks prior to study entry.
- Certain laboratory values obtained within 42 days prior to study entry. More information on this criterion can be found in the protocol.
- Willing to use effective forms of contraception throughout the study. More information on this criterion can be found in the protocol.
- Ability and willingness of participant to give written informed consent.
- For Step 2:
- No more than 28 days have passed since the Step 1, Week 24 visit
- Participants who were treated in Step 1 who meet the following criteria:
- Detectable HCV RNA (> 60 IU/mL) at the Step 1, Week 24 evaluation
- CD4 cell count of at least 200 cells/mm3 at Week 24. If the CD4 count is less than 200 cells/mm3 at Week 24, then it must not have decreased by more than 20 cells/mm3 from the Step 1 entry value.
- Taking pioglitazone at the time of Step 2 entry
- Certain laboratory values obtained within 28 days prior to Step 2 entry. More information on this criterion can be found in the protocol.
- Willing to use an effective form of contraception throughout the study
- Female participants of reproductive potential are required to have a negative serum or urine β-HCG pregnancy test within 14 days prior to Step 2 entry
- Participants without a pregnant partner.
Who cannot join
- Presence of known causes of significant liver disease. More information on this criterion can be found in the protocol.
- Evidence of decompensated liver disease manifested by presence or history of ascites, variceal bleeding, or hepatic encephalopathy
- History of HCV treatment within 28 days prior to study entry
- Evidence that nonresponse to prior HCV treatment may have been due to nonadherence or certain dose reductions. More information on this criterion can be found in the protocol.
- Use of interferon gamma, TNF-alpha inhibitors, rifampin, rifabutin, pyrazinamide, isoniazid, ganciclovir, or hydroxyurea within 14 days prior to study entry
- Current use of didanosine or zidovudine or plans to initiate use of either during the study
Show all 29Show fewer
- Active drug or alcohol abuse or dependence that, in the opinion of the study investigator, could interfere with adherence to study requirements
- History of uncontrolled seizure disorder
- Uncontrolled depression or other psychiatric disorder, such as untreated Grade 3 psychiatric disorder, Grade 3 disorder not amenable to medical intervention, or any hospitalization within the past 52 weeks that may affect tolerability of study requirements
- History of autoimmune disorders, including but not limited to Crohn's disease, ulcerative colitis, severe psoriasis, and rheumatoid arthritis, that have been exacerbated by previous interferon use
- Any systematic antineoplastic or immunomodulatory treatment or radiation within 24 weeks prior to study entry
- Serious illness including malignancy, active symptomatic coronary artery disease within 24 weeks prior to study entry, or other chronic medical condition that could interfere with safe study completion
- Presence of AIDS-defining opportunistic infections within 12 weeks prior to study entry
- Hemoglobinopathy (e.g., thalassemia major) or any other cause of or tendency to hemolysis. Subjects with thalassemia minor may be enrolled at the discretion of the investigator.
- History of major organ transplantation with an existing functional graft
- Use of antidiabetic medications for any reason within 12 weeks prior to study entry
- Fasting plasma glucose level of at least 126 mg/dl within 42 days prior to study entry or current or previous treatment at any time for diabetes with measures other than diet. Women with a history of gestational diabetes, patients with diabetes or hyperglycemia occurring in the context of short term use of corticosteroids, growth hormone, or other diabetogenic medication, and patients with diabetes or hyperglycemia following an episode of pancreatitis who no longer require treatment for diabetes are not excluded.
- Known osteoporosis or receipt of treatment of osteopenia or osteoporosis within 12 weeks prior to study entry with the following medications: risedronate (Actonel®), ibandronate (Boniva®), etidronate (Didronel®), raloxifene (Evista®), teriparatide (Forteo®), aledronate (Fosamax®), calcitonin (Miacalcin®).
- Known initiation or change in dose of any statins, fibrates, omega-3 fatty acids, bile acid sequestrants, ezetimibe, and niacin derivatives within 12 weeks prior to study entry
- Known allergy, sensitivity, or hypersensitivity to components of the study drugs or their formulation
- Regular and excessive use of alcohol within the 12 weeks prior to study entry. More information on this criterion can be found in the protocol.
- Unwilling to restrict alcohol use during the study to 120 g of alcohol per week or less for men and 60 g of alcohol per week or less for women
- Known glucocorticoid use in supraphysiologic doses (e.g., more than 10 mg per day of prednisone or equivalent doses of other glucocorticoids) within 12 weeks prior to study entry
- Known glucocorticoid use in physiologic replacement doses (e.g., 10 mg or less per day of prednisone or equivalent doses of other glucocorticoids) initiated within 28 days prior to study entry
- History of congestive heart failure corresponding to New York Heart Association Class II or greater
- Current use of prohibited concomitant medications. More information on this criterion is available in the protocol.
- Current participation in experimental studies that include treatments not approved by the FDA or any blinded treatments, with the exception of investigational antiretrovirals available through expanded access programs
- Body mass index (BMI) greater than 35 kg/m2
- Participant or participant's partner is pregnant or breastfeeding
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Northwestern University CRS (2701)
Chicago, Illinois, 60611
Metro Health CRS (2503)
Cleveland, Ohio, 44109
Cornell CRS (7804)
New York, New York, 10011
NY Univ. HIV/AIDS CRS (401)
New York, New York, 10016
New Jersey Medical School-Adult Clinical Research Ctr. CRS (31477)
Newark, New Jersey, 07103
Virginia Commonwealth Univ. Medical Ctr. CRS (31475)
Richmond, Virginia, 23219
AIDS Care CRS (1108)
Rochester, New York, 14642
Ucsf Aids Crs (801)
San Francisco, California, 94110
About this study
Official title: A Pilot Study of Therapy With Pioglitazone Prior to HCV Treatment in HIV-1 and HCV Genotype 1-Infected Subjects With Insulin Resistance Who Are Prior Nonresponders to Peginterferon and Ribavirin Therapy
Insulin resistance is common in people coinfected with HIV and Hepatitis C virus (HCV) and is associated with poor responses to treatment for HCV. Pioglitazone is an FDA-approved medication for the treatment of type 2 diabetes. It works by increasing the body's sensitivity to insulin. The purpose of this study is to determine whether treatment with pioglitazone prior to HCV treatment with peginterferon and ribavirin is safe and effective in improving the treatment outcome in insulin-resistant, HIV/HCV-coinfected people for whom previous treatment with peginterferon and ribavirin was unsuccessful.
Read the detailed description
New and better strategies for the treatment of HCV in HIV/HCV-coinfected people are urgently needed. Standard therapy for HCV includes treatment with peginterferon plus ribavirin. Peginterferon is a modified form of the drug interferon and is used either alone or in combination with ribavirin for the treatment of HCV. Ribavirin works by stopping HCV from multiplying inside the body. Sustained virologic response rates in past large studies of peginterferon plus ribavirin used for treating HCV types 1 or 4 ranged from 11% to 29%. Studies have shown that insulin resistance in HCV-infected people who are HIV uninfected leads to poorer HCV treatment response. Improving the body's response to insulin may also improve the outcome of treatment for HCV.
Participants in this study will take pioglitazone alone for up to 28 weeks. At Entry and Weeks 2, 4, 8, 12,18, and 24 participants will receive clinical assessments. At Week 24, participants will undergo additional tests to ensure that they can enter Step 2 of the study. Participants who are able to continue will then take peginterferon and ribavirin in addition to the pioglitazone for up to 48 additional weeks. Clinical assessments will take place at the time of entry and Weeks 2, 4, 8, 12, 16, and 24 of Step 2. Participants who do not exhibit a response to the treatment at Weeks 12 or 24 will not continue Step 2, as it is unlikely that further treatment will elicit a response. Participants who continue in the study will return to the study site for clinical assessments at Weeks 32, 40, and 48 of Step 2. Follow-up visits will be held at Weeks 60 and 72. The assessments done at clinic visits may include any or all of the following tests: thyroid function, hematology and chemistry, fasting plasma glucose, liver function, gamma-glutamyl transferase, pregnancy, CD4/CD8, HIV-1 RNA, qualitative HCV RNA, and quantitative HCV RNA.
On November 18, 2011 the study was closed to accrual due to not meeting targeted accrual goals.
- Conditions
- HIV-1 and Hepatitis C Co-Infection
- Being tested
- pioglitazone, peginterferon, ribavirin
- Keywords
- HIV, HCV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pioglitazoneDrug
Traditionally used in the treatment of type 2 diabetes to increase insulin sensitivity. Participants will take 30 mg daily in tablet form.
peginterferonDrug
Used in the treatment of HCV. Participants will receive 180 mcg subcutaneously once a week.
ribavirinDrug
Used in the treatment of HCV. Participants will receive 1000 to 1200 mg orally per day depending on weight.
| Study group | Role | What they receive |
|---|---|---|
| PIO (step 1) then PIO+PEG-INF+RBV (step 2) | Experimental | All participants in this study will receive pioglitazone therapy for 24 to 28 weeks. Participants will continue pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks. Receives: Drug: pioglitazone; Drug: peginterferon; Drug: ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of All Subjects With HCV Viral Load < 60 IU/mL at Week 24 of Step 2.
Measured: Week 24 of Step 2
Secondary outcomes (6)
Safety and Tolerability
Summary of the number of subjects with at least one grade 3 or higher sign/symptom or laboratory abnormality.
Measured: Step 1 (Up to 24 to 28 weeks)
Safety and Tolerability
Summary of the number of subjects with at least one grade 3 or higher sign/symptom or laboratory abnormality.
Measured: Step 2 (Up to 72 weeks)
The Proportion of All Subjects With HCV Viral Load < 60 IU/mL at Week 72of Step 2.
Measured: Week 72 of Step 2
Absolute Change From Entry to Week 24 of Step 1 in AST and ALT.
Measured: From Entry to Week 24 of Step 1
Absolute Change From Entry to Week 24 of Step 1 in Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR)
Measured: From Entry to Week 24 of Step 1
Absolute Change From Entry to Week 24 of Step 1 in Fasting Total Cholesterol and Triglycerides.
Measured: From Entry to Week 24 of Step 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startMar 2009
- Primary completionMay 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV-1 and Hepatitis C Co-InfectionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Marshall Glesby, MD, PhD, Study chair, Cornell Clinical Trials Unit, Weill Medical College of Cornell UniversityKristen Marks, MD, MS, Principal investigator, New York Presbyterian Hospital-Cornell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665353
- Sponsor's protocol ID
- ACTG A5239
- Other IDs
- 1U01AI068636
- Status last verified
- Sep 2018
- First submitted
- 22 Apr 2008
- Last updated
- 12 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
de Larranaga GF, Wingeyer SD, Puga LM, Alonso BS, Benetucci JA. Relationship between hepatitis C virus (HCV) and insulin resistance, endothelial perturbation, and platelet activation in HIV-HCV-coinfected patients under highly active antiretroviral treatment. Eur J Clin Microbiol Infect Dis. 2006 Feb;25(2):98-103. doi: 10.1007/s10096-006-0090-6.
PubMed 16477441Patel MR, Mullen MP, Dieterich DT. Sustained virologic response with short-course ribavirin and peginterferon treatment in 2 patients coinfected with HIV and HCV genotype 1. AIDS Read. 2006 Mar;16(3):164, 168-9; discussion 168-9.
PubMed 16538956Romero-Gomez M, Del Mar Viloria M, Andrade RJ, Salmeron J, Diago M, Fernandez-Rodriguez CM, Corpas R, Cruz M, Grande L, Vazquez L, Munoz-De-Rueda P, Lopez-Serrano P, Gila A, Gutierrez ML, Perez C, Ruiz-Extremera A, Suarez E, Castillo J. Insulin resistance impairs sustained response rate to peginterferon plus ribavirin in chronic hepatitis C patients. Gastroenterology. 2005 Mar;128(3):636-41. doi: 10.1053/j.gastro.2004.12.049.
PubMed 15765399Torriani FJ, Rodriguez-Torres M, Rockstroh JK, Lissen E, Gonzalez-Garcia J, Lazzarin A, Carosi G, Sasadeusz J, Katlama C, Montaner J, Sette H Jr, Passe S, De Pamphilis J, Duff F, Schrenk UM, Dieterich DT; APRICOT Study Group. Peginterferon Alfa-2a plus ribavirin for chronic hepatitis C virus infection in HIV-infected patients. N Engl J Med. 2004 Jul 29;351(5):438-50. doi: 10.1056/NEJMoa040842.
PubMed 15282351
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Therapy With Pioglitazone Prior to HCV Treatment in HIV-1 and HCV Genotype 1-Infected Subjects With Insulin Resistance Who Are Prior Nonresponders to Peginterferon and Ribavirin Therapy
- ClinicalTrials.gov ID
- NCT00665353
- Acronym / sponsor ID
- ACTG A5239
- Conditions
- HIV-1 and Hepatitis C Co-Infection
- Keywords
- HIV, HCV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Mar 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 Apr 2008 (estimated)
- Results
- Posted 13 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Insulin resistance is common in people coinfected with HIV and Hepatitis C virus (HCV) and is associated with poor responses to treatment for HCV. Pioglitazone is an FDA-approved medication for the treatment of type 2 diabetes. It works by increasing the body's sensitivity to insulin. The purpose of this study is to determine whether treatment with pioglitazone prior to HCV treatment with peginterferon and ribavirin is safe and effective in improving the treatment outcome in insulin-resistant, HIV/HCV-coinfected people for whom previous treatment with peginterferon and ribavirin was unsuccessful.
Detailed description
New and better strategies for the treatment of HCV in HIV/HCV-coinfected people are urgently needed. Standard therapy for HCV includes treatment with peginterferon plus ribavirin. Peginterferon is a modified form of the drug interferon and is used either alone or in combination with ribavirin for the treatment of HCV. Ribavirin works by stopping HCV from multiplying inside the body. Sustained virologic response rates in past large studies of peginterferon plus ribavirin used for treating HCV types 1 or 4 ranged from 11% to 29%. Studies have shown that insulin resistance in HCV-infected people who are HIV uninfected leads to poorer HCV treatment response. Improving the body's response to insulin may also improve the outcome of treatment for HCV.
Participants in this study will take pioglitazone alone for up to 28 weeks. At Entry and Weeks 2, 4, 8, 12,18, and 24 participants will receive clinical assessments. At Week 24, participants will undergo additional tests to ensure that they can enter Step 2 of the study. Participants who are able to continue will then take peginterferon and ribavirin in addition to the pioglitazone for up to 48 additional weeks. Clinical assessments will take place at the time of entry and Weeks 2, 4, 8, 12, 16, and 24 of Step 2. Participants who do not exhibit a response to the treatment at Weeks 12 or 24 will not continue Step 2, as it is unlikely that further treatment will elicit a response. Participants who continue in the study will return to the study site for clinical assessments at Weeks 32, 40, and 48 of Step 2. Follow-up visits will be held at Weeks 60 and 72. The assessments done at clinic visits may include any or all of the following tests: thyroid function, hematology and chemistry, fasting plasma glucose, liver function, gamma-glutamyl transferase, pregnancy, CD4/CD8, HIV-1 RNA, qualitative HCV RNA, and quantitative HCV RNA.
On November 18, 2011 the study was closed to accrual due to not meeting targeted accrual goals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PIO (step 1) then PIO+PEG-INF+RBV (step 2) | Experimental | Drug: pioglitazone, Drug: peginterferon, Drug: ribavirinAll participants in this study will receive pioglitazone therapy for 24 to 28 weeks. Participants will continue pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- HIV infected
- Exhibited no response to previous treatment with PEG-IFN alfa-2a 180 mcg/week or alfa-2b 1.5 mcg/kg/week and at least 1000 mg/day ribavirin given for at least 12 consecutive weeks. More information on this criterion can be found in the protocol.
- HOMA-IR valued greater than 2.5 within 42 days prior to study entry. More information on this criterion can be found in the protocol.
- CD4 count of at least 200 cells/mm3 within 42 days prior to study entry
- HCV RNA of at least 60 IU/ml by quantitative RT-PCR assay with or without reactive anti-HCV antibodies within 42 days prior to study entry
Key exclusion criteria (29 listed)
- Presence of known causes of significant liver disease. More information on this criterion can be found in the protocol.
- Evidence of decompensated liver disease manifested by presence or history of ascites, variceal bleeding, or hepatic encephalopathy
- History of HCV treatment within 28 days prior to study entry
- Evidence that nonresponse to prior HCV treatment may have been due to nonadherence or certain dose reductions. More information on this criterion can be found in the protocol.
- Use of interferon gamma, TNF-alpha inhibitors, rifampin, rifabutin, pyrazinamide, isoniazid, ganciclovir, or hydroxyurea within 14 days prior to study entry
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 |
|---|---|---|
| pioglitazoneTraditionally used in the treatment of type 2 diabetes to increase insulin sensitivity. Participants will take 30 mg daily in tablet form. | Drug | PIO (step 1) then PIO+PEG-INF+RBV (step 2) |
| peginterferonUsed in the treatment of HCV. Participants will receive 180 mcg subcutaneously once a week. | Drug | PIO (step 1) then PIO+PEG-INF+RBV (step 2) |
| ribavirinUsed in the treatment of HCV. Participants will receive 1000 to 1200 mg orally per day depending on weight. | Drug | PIO (step 1) then PIO+PEG-INF+RBV (step 2) |
Primary outcome
The Proportion of All Subjects With HCV Viral Load < 60 IU/mL at Week 24 of Step 2.
Time frame: Week 24 of Step 2
6 secondary outcomes
Safety and Tolerability
Time frame: Step 1 (Up to 24 to 28 weeks)
Safety and Tolerability
Time frame: Step 2 (Up to 72 weeks)
The Proportion of All Subjects With HCV Viral Load < 60 IU/mL at Week 72of Step 2.
Time frame: Week 72 of Step 2
Absolute Change From Entry to Week 24 of Step 1 in AST and ALT.
Time frame: From Entry to Week 24 of Step 1
Absolute Change From Entry to Week 24 of Step 1 in Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR)
Time frame: From Entry to Week 24 of Step 1
Absolute Change From Entry to Week 24 of Step 1 in Fasting Total Cholesterol and Triglycerides.
Time frame: From Entry to Week 24 of Step 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16477441de Larranaga GF, Wingeyer SD, Puga LM, Alonso BS, Benetucci JA. Relationship between hepatitis C virus (HCV) and insulin resistance, endothelial perturbation, and platelet activation in HIV-HCV-coinfected patients under highly active antiretroviral treatment. Eur J Clin Microbiol Infect Dis. 2006 Feb;25(2):98-103. doi: 10.1007/s10096-006-0090-6.
- Background: PubMed 16538956Patel MR, Mullen MP, Dieterich DT. Sustained virologic response with short-course ribavirin and peginterferon treatment in 2 patients coinfected with HIV and HCV genotype 1. AIDS Read. 2006 Mar;16(3):164, 168-9; discussion 168-9.
- Background: PubMed 15765399Romero-Gomez M, Del Mar Viloria M, Andrade RJ, Salmeron J, Diago M, Fernandez-Rodriguez CM, Corpas R, Cruz M, Grande L, Vazquez L, Munoz-De-Rueda P, Lopez-Serrano P, Gila A, Gutierrez ML, Perez C, Ruiz-Extremera A, Suarez E, Castillo J. Insulin resistance impairs sustained response rate to peginterferon plus ribavirin in chronic hepatitis C patients. Gastroenterology. 2005 Mar;128(3):636-41. doi: 10.1053/j.gastro.2004.12.049.
- Background: PubMed 15282351Torriani FJ, Rodriguez-Torres M, Rockstroh JK, Lissen E, Gonzalez-Garcia J, Lazzarin A, Carosi G, Sasadeusz J, Katlama C, Montaner J, Sette H Jr, Passe S, De Pamphilis J, Duff F, Schrenk UM, Dieterich DT; APRICOT Study Group. Peginterferon Alfa-2a plus ribavirin for chronic hepatitis C virus infection in HIV-infected patients. N Engl J Med. 2004 Jul 29;351(5):438-50. doi: 10.1056/NEJMoa040842.
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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.
Marshall Glesby, MD, PhD study chair
Cornell Clinical Trials Unit, Weill Medical College of Cornell University
Kristen Marks, MD, MS principal investigator
New York Presbyterian Hospital-Cornell
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pioglitazone, peginterferon and ribavirin in people with HIV-1 and Hepatitis C Co-Infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 8 sites in United States.
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 24 inclusion and 29 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 Oct 2018. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Proportion of All Subjects With HCV Viral Load < 60 IU/mL at Week 24 of Step 2. (time frame: Week 24 of Step 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00665353, which also lists 4 linked publications.
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 Oct 2018.