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HIV InfectionsPhase 2NCT00078403

Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV)

A Phase 2 study testing Peginterferon alfa-2a and Ribavirin in people with HIV Infections and Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) at 37 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Infection with both HIV and hepatitis C virus (HCV) may result in serious and sometimes fatal liver disease. The purpose of this study was to test the effectiveness of long-term pegylated interferon alfa-2a (PEG-IFN) and ribavirin treatment in slowing liver disease progression in people infected with both HIV and HCV. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections, Hepatitis C, Liver Disease
What is being tested?
Peginterferon alfa-2a and Ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
333 participants
Where
37 sitesin 2 countries
Study dates
Jul 2004to Feb 2009
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

  • HIV infected
  • Stable antiretroviral therapy for at least 8 weeks prior to study entry OR have not received any antiretroviral therapy for at least 4 weeks prior to entry
  • HIV viral load less than 50,000 copies/ml within 6 weeks prior to study entry
  • CD4 count greater than 200 cells/mm^3 within 6 weeks prior to study entry
  • Hepatitis C virus (HCV) infected
  • Either HCV treatment naive OR previously treated with interferon (IFN), PEG-IFN, IFN and ribavirin, or PEG-IFN and ribavirin for at least 12 weeks and HCV RNA positive following their last course of HCV treatment
Show all 17Show fewer
  • Chronic liver disease consistent with chronic viral hepatitis
  • At least stage I fibrosis on a liver biopsy obtained within 104 weeks of study entry
  • If at stage VI fibrosis, Child-Pugh-Turcotte (CPT) score of 5 or less and no more than Child-Pugh Class A
  • Liver enzyme (alanine aminotransferase [ALT], aspartate aminotransferase [AST], and alkaline phosphatase) levels 10 times or less than upper limit of normal
  • Agree to use acceptable methods of contraception
  • Currently enrolled in Step 1 or received 12 weeks of PEG-IFN plus ribavirin outside this study
  • Detectable HCV viral load and <2 log10 decrease from baseline in plasma/serum HCV viral load at Week 12.
  • On Step 1 study treatment for no longer than 18 weeks
  • Currently enrolled in Step 1
  • Undetectable HCV RNA or a 2-log or greater decrease in plasma/serum HCV viral load.
  • On Step 1 study treatment for no longer than 18 weeks

Who cannot join

  • Have received HCV treatment within 4 weeks of study entry. Participants currently receiving treatment for HCV, if non-EVRs, were considered for direct entry into Step 2, without the run-in period in Step 1.
  • Could not tolerate treatment with PEG-IFN, defined as missing 3 or more consecutive PEG-IFN doses during the first 12 weeks or a total of 5 doses prior to Step 3 entry. Participants who have missed doses of ribavirin will not be excluded from Step 3 entry.
  • Use of granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days prior to study entry
  • Alpha feto protein level 400 ng/ml or greater within 24 weeks prior to study entry, or alpha feto protein level greater than 50 ng/ml and less than 400 ng/ml (unless computed tomography [CT] scan or magnetic resonance imaging [MRI] shows no evidence of hepatic tumor) within 24 weeks prior to study entry
  • Decompensated liver disease, including presence or history of ascites, variceal bleeding, and brain or nervous system damage as a result of liver damage
  • Other causes of significant liver disease, including hepatitis A or B, excess iron deposits in the liver (hemochromatosis), or homozygote alpha-1 antitrypsin deficiency
Show all 21Show fewer
  • Use of systemic corticosteroids, interferon gamma, TNF-alpha inhibitors, rifampin, rifabutin, pyrazinamide, isoniazid, ganciclovir, or hydroxyurea within 2 weeks prior to study entry
  • Known allergy/sensitivity to PEG-IFN alfa-2a or ribavirin or their formulations
  • History of uncontrolled seizure disorders
  • Clinically active thyroid disease. Thyroid hormone replacement therapy is permitted, but thyroid-stimulating hormone (TSH) and free thyroxine index (FTI) must be in normal range.
  • History of autoimmune processes, including Crohn's disease, ulcerative colitis, severe psoriasis, and rheumatoid arthritis, that may be made worse by interferon use
  • Any systemic antineoplastic or immunomodulatory treatment or radiation within 24 weeks prior to study entry
  • Malignancy
  • Active coronary artery disease within 24 weeks prior to study entry
  • Acute or active AIDS-defining opportunistic infections within 12 weeks of study entry
  • Hemoglobin abnormalities (e.g., thalassemia) or any other cause of or tendency to break down red blood cells (hemolysis)
  • History of major organ transplantation with an existing functional graft
  • Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with study adherence
  • Uncontrolled or active depression or other psychiatric disorder, such as untreated Grade 3 psychiatric disorder, medically untreatable Grade 3 disorder, or any hospitalization within 52 weeks of study entry that, in the opinion of the investigator, may interfere with study requirements
  • Other serious illness or chronic medical condition that, in the opinion of the investigator, may have prevented participant's completion of the study
  • Pregnant or breastfeeding

Trial locations and contacts

37 sites in 2 countries.

37 sites in 2 countries

United States36 sites

  • University of Colorado Hospital CRS

    Aurora, Colorado, 80045

  • Johns Hopkins University CRS

    Baltimore, Maryland, 21205

  • Alabama Therapeutics CRS

    Birmingham, Alabama, 35924-2050

  • Massachusetts General Hospital CRS (MGH CRS)

    Boston, Massachusetts, 02114

  • Brigham and Women's Hosp. ACTG CRS

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Med. Ctr., ACTG CRS

    Boston, Massachusetts, 02215

  • Chapel Hill CRS

    Chapel Hill, North Carolina, 27599

  • Northwestern University CRS

    Chicago, Illinois, 60611

  • Cincinnati CRS

    Cincinnati, Ohio, 45267-0405

  • MetroHealth CRS

    Cleveland, Ohio, 44109

  • Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic

    Dallas, Texas, 75235-9173

  • Univ. of Texas Medical Branch, ACTU

    Galveston, Texas, 77555-0435

  • Univ. of Hawaii at Manoa, Leahi Hosp.

    Honolulu, Hawaii, 96816

  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic

    Indianapolis, Indiana, 46202-5250

  • Indiana Univ. School of Medicine, Wishard Memorial

    Indianapolis, Indiana, 46202-5250

  • University of Southern California CRS

    Los Angeles, California, 90033-1079

  • UCLA CARE Center CRS

    Los Angeles, California, 90035

  • Vanderbilt Therapeutics (VT) CRS

    Nashville, Tennessee, 37204

  • Beth Israel Med. Ctr., ACTU

    New York, New York, 10003

  • Weill Cornell Chelsea CRS

    New York, New York, 10011

  • NY Univ. HIV/AIDS CRS

    New York, New York, 10016

  • Weill Cornell Uptown CRS

    New York, New York, 10021

  • Columbia P&S CRS

    New York, New York, 10032-3732

  • Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.

    Omaha, Nebraska, 68198-9500

  • Stanford AIDS Clinical Trials Unit CRS

    Palo Alto, California, 94304-5350

  • Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh CRS

    Pittsburgh, Pennsylvania, 15213

  • The Miriam Hospital Clinical Research Site (TMH CRS) CRS

    Providence, Rhode Island, 02906

  • Trillium Health ACTG CRS

    Rochester, New York, 14607

  • McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit

    Rochester, New York, 14642

  • Univ. of Rochester ACTG CRS

    Rochester, New York, 14642

  • UCSD Antiviral Research Center CRS

    San Diego, California, 92103

  • Ucsf Hiv/Aids Crs

    San Francisco, California, 94110

  • Santa Clara Valley Med. Ctr.

    San Jose, California, 95128

  • Washington University Therapeutics (WT) CRS

    St Louis, Missouri, 63110-1010

  • Georgetown University CRS (GU CRS)

    Washington D.C., District of Columbia, 20007

Other trials in United States

Puerto Rico1 site

  • Puerto Rico AIDS Clinical Trials Unit CRS

    San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: Suppressive Long-Term Antiviral Management of Hepatitis C Virus (HCV) and HIV-1 Coinfected Subjects (SLAM-C)

Infection with both HIV and hepatitis C virus (HCV) may result in serious and sometimes fatal liver disease. The purpose of this study was to test the effectiveness of long-term pegylated interferon alfa-2a (PEG-IFN) and ribavirin treatment in slowing liver disease progression in people infected with both HIV and HCV.

Read the detailed description

Rapid progression of liver disease to liver failure has been observed in people coinfected with HIV and HCV. This observation appears to be directly related to an increase in the rate of fibrotic progression in the liver compared to people infected with HCV alone. PEG-IFN and ribavirin are used in standard treatment of HCV. This study tested the effectiveness of using PEG-IFN in reducing the rate of liver fibrosis progression in participants coinfected with HIV and HCV who could not lower their HCV viral load to undetectable or who could not maintain their HCV viral load at undetectable on PEG-IFN and ribavirin treatment.

Participants entered Step 1 (initial run-in period) to receive 12 weeks of 180 mcg PEG-IFN subcutaneously once weekly plus 1 to 1.2 g/day ribavirin based on body weight. At week 12, HCV RNA testing was performed.

Participants with early virologic response (EVR), defined as >=2 log10 drop in HCV RNA from baseline or undetectable HCV RNA (<600 IU/ml with quantitative assay used in Step 1) at Week 12, who had tolerated Step 1 treatment, entered into Step 3 to continue receiving the Step 1 treatment for a total of 72 weeks (Arm C). Participants who did not meet the criteria for entry into Step 3 were discontinued from the study. In Step 3, participants were followed for an additional 24 weeks after treatment discontinuation to determine sustained virologic response (SVR). Initially, Step 3 participants who had a detectable HCV viral load (>=60 IU/ml with the qualitative assay used in Step 3) at Week 36 were eligible to enroll in Step 2. After early closure of Step 2, such participants remained in Step 3 until study completion.

Participants with <2 log10 drop in HCV RNA from baseline and detectable HCV RNA at Week 12 (non-EVR) discontinued Step 1 treatment. Non-EVRs who met the Step 2 eligibility criteria, were enrolled in Step 2 and randomized to receive 180 mcg PEG-IFN subcutaneously weekly for 72 weeks (Arm A) or observation for 72 weeks (Arm B). Participants who did not meet the criteria for entry into Step 2 were discontinued from the study. Step 2 of the study was closed prematurely in May 2007 due to lower than expected progression rates among the participants in the observation arm such that the primary objective could not be reached. There were no safety concerns.

Liver biopsies were conducted at study screening, and at Step 2 entry and exit until the early closure of Step 2. Medical history assessment, physical exams, and blood collection were conducted every 4-12 weeks for participants in Steps 1, 2, and 3. Participants were followed for up to 18 weeks in Step 1, followed by a total of 72 in Step 2 or by up to a total of 84 weeks in Step 3.

Being tested
Peginterferon alfa-2a, Ribavirin
Keywords
Treatment Experienced
Medical subject headings
HIV Infections, Hepatitis C, Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peginterferon alfa-2aDrug

    180 mcg PEG-IFN subcutaneously

  • RibavirinDrug

    One tablet or capsule containing ribavirin 200 mg

Study groups in NCT00078403
Study groupRoleWhat they receive
Arm A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)ExperimentalAt week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin
Arm B: OL (PEG-IFN, RBV) then OL Randomized (Observation)ExperimentalAt week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin
Arm C: OL (PEG-IFN, RBV) then OL (PEG-IFN, RBV)ExperimentalAt week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time-scaled Change in Metavir Liver Fibrosis Score (SCMFS)

    SCMFS is the difference between the Metavir fibrosis scores of the study exit and study entry liver biopsies where the difference is scaled to one year. The SCMFS assesses the annualized change in the severity of liver fibrosis on a continuous scale from -4.0 Metavir units per year (reduced fibrosis over time, a positive study outcome) to +4.0 Metavir units per year (increased fibrosis over time).

    Measured: Baseline and at week 72 or premature discontinuation

Secondary outcomes (17)

  1. Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL)

    Qualitative plasma HCV viral load was categorized as less than 60 IU/mL vs greater than or equal to 60 IU/mL where 60 IU/mL is the lower limit of qualitative assay used in Steps 2 and 3.

    Measured: Arms A and B: Weeks 0, 12, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 60, 72, 84

  2. Time-scaled Change in Ishak Liver Inflammation Score (SCIIS)

    Liver biopsies were performed within 42 days prior to randomization between Arms A and B while the participant remained on PEG-IFN plus RBV (=entry biopsy) and again at week 72 or premature study discontinuation (=exit biopsy). SCIIS was defined as the difference between the Ishak inflammation score of the exit biopsy and the Ishak inflammation score of the entry biopsy, where the difference is scaled to one year.

    Measured: Baseline and at week 72 or premature discontinuation

  3. Number of Participants With Anemia

    Number of participants with anemia by grade (defined by hemoglobin level in grams per deciliter; g/dL). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = hemoglobin of 8 to 9.4 g/dl; Grade 2 = 7 to 7.9 g/dl; Grade 3 = 6.5 to 6.9 g/dl; Grade 4 = below 6.5 g/dl.

    Measured: Up to 96 weeks

  4. Number of Participants With Neutropenia

    Number of participants with neutropenia by grade (defined by absolute neutrophil count [ANC] per cubic millimeter; mm^3). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = ANC of 1000 to 1500 /mm^3; Grade 2 = 750 to 999 /mm^3; Grade 3 = 500 to 749 /mm^3; Grade 4 = below 500 /mm^3.

    Measured: Up to 96 weeks

  5. Number of Participants With Thrombocytopenia

    Number of participants with thrombocytopenia by grade (defined by platelet count per cubic millimeter; mm^3). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = platelets of 75,000 to 99,000 /mm^3; Grade 2 = 50,000 to 74,999 /mm^3; Grade 3 = 20,000 to 49,999 /mm^3; Grade 4 = below 20,000 /mm^3.

    Measured: Up to 96 weeks

  6. Number of Participants With Depression and/or Other Psychological Events

    Depression and other psychological events. DAIDS Toxicity Grading Table (1992) was used for grading. The protocol required reporting of depression and other psychological events of Grade 3 or higher or if led to a change in treatment, regardless of grade.

    Measured: Up to 96 weeks

  7. Number of Participants With High-grade Signs and Symptoms or Laboratory Values

    Number of participants with high-grade (Grade 3 or higher) signs and symptoms or laboratory values. DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = transient/mild discomfort, no limitation in activity, no medical intervention; Grade 2 = mild/moderate limitation in activity, some assistance, no/minimal medical intervention; Grade 3 = marked limitation in activity, some assistance, medical intervention required); Grade 4 = extreme limitation in activity, significant medical intervention, assistance, hospitalization.

    Measured: Up to 96 Weeks

  8. Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations

    3-level categorical of the worst of 1) premature treatment discontinuation, 2) temporary stop or 3) dose reduction. For Arm C, the worst for either PEG-IFN or RBV is summarized.

    Measured: Up to 96 Weeks

  9. Number of Participants Adherent to Study Medications

    A categorical variable with levels adherent and non-adherent based on participants' self report. For Arm A, adherence was defined as not missing PEG within 2 weeks of visit. For Arm C, adherence was defined as not missing any PEG within 2 weeks of visit and not missing RBV within 4 days of visit.

    Measured: Arm A: at weeks 12, 24, 48 and 72. Arm C: at entry and weeks 12, 24, 48, 60.

  10. HCV Polymorphisms

    Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued.

    Measured: Entry and week 72 (Arms A and B only).

  11. HCV-specific Immune Response in Intrahepatic Lymphocytes

    Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued.

    Measured: Entry and week 72 (Arms A and B only).

  12. Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL)

    A blood sample was drawn to determine the HIV-1 viral load. HIV-1 viral load was categorized as <50 copies/mL (undetectable) or >=50 copies/mL (detectable). 50 is the lower limit of detection of the assay.

    Measured: Arms A and B: Weeks 0, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 48, 60, 72, 84

  13. Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    Insulin resistance was evaluated by HOMA-IR, calculated as [fasting glucose (mg/dL) x fasting insulin (uIU/mL)]/405. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin and fasting glucose testing.

    Measured: Arms A and B: at entry and weeks 24, 48 and 72; Arm C: at entry and at weeks 12, 24, 36, 48, 72, 84 and 96.

  14. Sustained Virologic Response

    Sustained Virologic Response (SVR) was defined as undetectable HCV viral load (<60 IU/ml) 24 weeks after treatment discontinuation.

    Measured: 24 weeks after end of treatment

  15. Number of Participants Who Used Antianorexia Agents, Such as Megestrol and Dronabinol

    Use of antianorexia agents, such as megestrol and dronabinol at any time after pre-assignment.

    Measured: Up to 96 weeks

  16. Number of Participants With Prescription as Needed of Erythropoietin (EPO), Granulocyte Colony-stimulating Factor (GCSF), and Granulocyte-monocyte Colony-stimulating Factor (GM-CSF)

    Prescription as needed of hematologic adjuvant therapies: erythropoietin (EPO), granulocyte colony-stimulating factor (GCSF), and granulocyte-monocyte colony-stimulating factor (GM-CSF) any time after pre-assignment

    Measured: At any time after pre-assignment

  17. Weight

    Participant weight in kilograms.

    Measured: Arms A and B: at entry and weeks 4, 8, 12, 16, 24, 32, 40, 48, 56, 64 and 72; Arm C: at entry and weeks 4, 8, 12, 16, 24, 36, 48, 72, 84 and 96.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2004 (estimated)
  2. Study startJul 2004
  3. Primary completionMay 2007
  4. Study completionFeb 2009

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
333 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00078403
Sponsor's protocol ID
A5178
Other IDs
10008
Status last verified
Nov 2016
First submitted
24 Feb 2004
Last updated
8 Nov 2021

Publications

  • Brau N. Treatment of chronic hepatitis C in human immunodeficiency virus/hepatitis C virus-coinfected patients in the era of pegylated interferon and ribavirin. Semin Liver Dis. 2005 Feb;25(1):33-51. doi: 10.1055/s-2005-864780.

    PubMed 15731996

  • Borgia G, Reynaud L, Gentile I, Piazza M. HIV and hepatitis C virus: facts and controversies. Infection. 2003 Aug;31(4):232-40. doi: 10.1007/s15010-003-3131-4.

    PubMed 14562947

  • Khalili M, Bernstein D, Lentz E, Barylski C, Hoffman-Terry M. Pegylated interferon alpha-2a with or without ribavirin in HCV/HIV coinfection: partially blinded, randomized multicenter trial. Dig Dis Sci. 2005 Jun;50(6):1148-55. doi: 10.1007/s10620-005-2723-5.

    PubMed 15986873

  • Neau D, Trimoulet P, Winnock M, Rullier A, Le Bail B, Lacoste D, Ragnaud JM, Bioulac-Sage P, Lafon ME, Chene G, Dupon M; ROCO Study Group. Comparison of 2 regimens that include interferon-alpha-2a plus ribavirin for treatment of chronic hepatitis C in human immunodeficiency virus-coinfected patients. Clin Infect Dis. 2003 Jun 15;36(12):1564-71. doi: 10.1086/375067. Epub 2003 Jun 3.

    PubMed 12802757

  • Torriani FJ, Ribeiro RM, Gilbert TL, Schrenk UM, Clauson M, Pacheco DM, Perelson AS. Hepatitis C virus (HCV) and human immunodeficiency virus (HIV) dynamics during HCV treatment in HCV/HIV coinfection. J Infect Dis. 2003 Nov 15;188(10):1498-507. doi: 10.1086/379255. Epub 2003 Nov 13.

    PubMed 14624375

  • Torriani 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

  • The Division of AIDS Table for Grading the Severity of Adult Adverse Events (DAIDS AE Grading Table), August 1992.

  • Manual for Expedited Reporting of Adverse Events to Division of AIDS (DAIDS EAE Manual), May 2004.

  • Butt AA, Umbleja T, Andersen JW, Chung RT, Sherman KE; ACTG A5178 Study Team. The incidence, predictors and management of anaemia and its association with virological response in HCV / HIV coinfected persons treated with long-term pegylated interferon alfa 2a and ribavirin. Aliment Pharmacol Ther. 2011 Jun;33(11):1234-44. doi: 10.1111/j.1365-2036.2011.04648.x. Epub 2011 Mar 29.

    PubMed 21535051

  • Sherman KE, Andersen JW, Butt AA, Umbleja T, Alston B, Koziel MJ, Peters MG, Sulkowski M, Goodman ZD, Chung RT; AIDS Clinical Trials Group A5178 Study Team. Sustained long-term antiviral maintenance therapy in HCV/HIV-coinfected patients (SLAM-C). J Acquir Immune Defic Syndr. 2010 Dec 15;55(5):597-605. doi: 10.1097/QAI.0b013e3181f6d916.

    PubMed 20921898

  • Chung RT, Umbleja T, Chen JY, Andersen JW, Butt AA, Sherman KE; Actg A5178 Study Team. Extended therapy with pegylated interferon and weight-based ribavirin for HCV-HIV coinfected patients. HIV Clin Trials. 2012 Mar-Apr;13(2):70-82. doi: 10.1310/hct1302-70.

    PubMed 22510354

  • Butt AA, Umbleja T, Andersen JW, Sherman KE, Chung RT; ACTG A5178 Study Team. Impact of peginterferon alpha and ribavirin treatment on lipid profiles and insulin resistance in Hepatitis C virus/HIV-coinfected persons: the AIDS Clinical Trials Group A5178 Study. Clin Infect Dis. 2012 Sep;55(5):631-8. doi: 10.1093/cid/cis463. Epub 2012 May 4.

    PubMed 22563020

  • Branch AD, Kang M, Hollabaugh K, Wyatt CM, Chung RT, Glesby MJ. In HIV/hepatitis C virus co-infected patients, higher 25-hydroxyvitamin D concentrations were not related to hepatitis C virus treatment responses but were associated with ritonavir use. Am J Clin Nutr. 2013 Aug;98(2):423-9. doi: 10.3945/ajcn.112.048785. Epub 2013 Jun 5.

    PubMed 23739141

  • Shire NJ, Rao MB, Succop P, Buncher CR, Andersen JA, Butt AA, Chung RT, Sherman KE; AIDS Clinical Trials Group 5178 Study Group. Improving noninvasive methods of assessing liver fibrosis in patients with hepatitis C virus/human immunodeficiency virus co-infection. Clin Gastroenterol Hepatol. 2009 Apr;7(4):471-80, 480.e1-2. doi: 10.1016/j.cgh.2008.12.016. Epub 2008 Dec 25.

    PubMed 19268724

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Peginterferon alfa-2a and Ribavirin in people with HIV Infections and Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) at 37 sites in 2 countries.

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 17 inclusion and 21 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 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Puerto Rico. 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 27 Apr 2011). 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?

Time-scaled Change in Metavir Liver Fibrosis Score (SCMFS) (time frame: Baseline and at week 72 or premature discontinuation). 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 NCT00078403, which also lists 14 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 8 Nov 2021.

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