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CompletedNCT00078403Updated Nov 8, 2021Results posted

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

A Phase 2 interventional study of Peginterferon alfa-2a and Ribavirin in HIV Infections, Hepatitis C and Liver Disease, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 37 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-08.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
333
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • HIV Infections
  • Hepatitis C
  • Liver Disease

Keywords

  • Treatment Experienced
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 333 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria for Step 1:

  • 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
  • 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

Inclusion Criteria for Step 2:

  • 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

Inclusion Criteria for Step 3:

  • 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

Exclusion Criteria for Steps 1 and 3:

  • 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
  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
333 participants (actual)

Study arms

  • Experimental
    Arm A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)

    At 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.

    Drug: Peginterferon alfa-2a · Drug: Ribavirin

  • Experimental
    Arm B: OL (PEG-IFN, RBV) then OL Randomized (Observation)

    At 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).

    Drug: Peginterferon alfa-2a · Drug: Ribavirin

  • Experimental
    Arm C: OL (PEG-IFN, RBV) then OL (PEG-IFN, RBV)

    At 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.

    Drug: Peginterferon alfa-2a · Drug: Ribavirin

Interventions

  • DrugPeginterferon alfa-2a

    180 mcg PEG-IFN subcutaneously

  • DrugRibavirin

    One tablet or capsule containing ribavirin 200 mg

06

What researchers measure

Primary outcomes

  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).

    Time frame: Baseline and at week 72 or premature discontinuation

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: At any time after pre-assignment

  17. Weight

    Participant weight in kilograms.

    Time frame: 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.

07

Results

Posted Apr 27, 2011

Participant flow

People with hepatitis C virus (HCV)/HIV coinfection were recruited for participation in this study.

Participant flow — Overall Study
MilestoneOpen Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)OL (PEG-IFN, RBV) Then OL Randomized (Observation)OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)
Started4442169
Completed2626141
Not completed181628

Outcome measures

PrimaryTime-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).

Time frame:
Baseline and at week 72 or premature discontinuation
Reported as:
Median · Metavir units per one year (52 weeks)
Time-scaled Change in Metavir Liver Fibrosis Score (SCMFS)
Metavir units per one year (52 weeks)A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)
Time-scaled Change in Metavir Liver Fibrosis Score (SCMFS)0 (0 to 1.37)0 (0 to 2)—
Statistical analysis
  • A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) vs B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) · Exact Wilcoxon rank sum test · p = 0.58 (P-value is pre-specified 1-sided test that PEG slows liver fibrosis progression. Accrual and follow-up on Arms A and B were halted at interim review for lack of fibrosis progression in Arm B (control arm). P-value is unadjusted for interim analysis.)
SecondaryNumber 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.

Time frame:
Arms A and B: Weeks 0, 12, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 60, 72, 84
Reported as:
Number · Participant
Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL)
ParticipantA: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)
Week 0--Number of participants with HCV RNA data4442164
Week 0--Number of participants with detectable HCV424253
Week 12--Number of participants with HCV RNA data4234158
Week 12-Number of participants with detectable HCV403431
Week 24--Number of participants with HCV RNA data3635163
Week 24-Number of participants with detectable HCV353539
Week 36--Number of participants with HCV RNA data00158
Week 36-Number of participants with detectable HCVNANA41
Week 48--Number of participants with HCV RNA data31280
Week 48-Number of participants with detectable HCV3128NA
Week 60--Number of participants with HCV RNA data00137
Week 60-Number of participants with detectable HCVNANA34
Week 72--Number of participants with HCV RNA data2722135
Week 72-Number of participants with detectable HCV272251
Week 84--Number of participants with HCV RNA data00137
Week 84-Number of participants with detectable HCVNANA50
SecondaryTime-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.

Time frame:
Baseline and at week 72 or premature discontinuation
Reported as:
Median · Ishak units per one year (52 weeks)
Time-scaled Change in Ishak Liver Inflammation Score (SCIIS)
Ishak units per one year (52 weeks)A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)
Time-scaled Change in Ishak Liver Inflammation Score (SCIIS)0 (-0.75 to 1.79)1.31 (0 to 2.10)—
SecondaryNumber 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.

Time frame:
Up to 96 weeks
Reported as:
Number · Participant
Number of Participants With Anemia
ParticipantA: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)
Anemia >= Grade 2106
Grade 2003
Grade 3001
Grade 4102
SecondaryNumber 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.

Time frame:
Up to 96 weeks
Reported as:
Number · Participant
Number of Participants With Neutropenia
ParticipantA: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)
Neutropenia >= Grade 2201096
Grade 27438
Grade 310537
Grade 43121
SecondaryNumber 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.

Time frame:
Up to 96 weeks
Reported as:
Number · Participant
Number of Participants With Thrombocytopenia
ParticipantA: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)
Thrombocytopenia >= Grade 214431
Grade 210325
Grade 3415
Grade 4001
SecondaryNumber 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.

Time frame:
Up to 96 weeks
Reported as:
Number · Participant
Number of Participants With Depression and/or Other Psychological Events
ParticipantA: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)
Any psychological3119
Grade 32118
Grade 4101
SecondaryNumber 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.

Time frame:
Up to 96 Weeks
Reported as:
Number · Participant
Number of Participants With High-grade Signs and Symptoms or Laboratory Values
ParticipantA: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)
Any Grade 3 or higher222084
Grade 3151573
Grade 47511
SecondaryNumber 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.

Time frame:
Up to 96 Weeks
Reported as:
Number · Participant
Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations
ParticipantA: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)
Premature treatment discontinuation16—57
Temporarily off treatment7—29
Reduced dose2—33
SecondaryNumber 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.

Time frame:
Arm A: at weeks 12, 24, 48 and 72. Arm C: at entry and weeks 12, 24, 48, 60.
Reported as:
Number · Participant
Number of Participants Adherent to Study Medications
ParticipantA: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)
Week 0: Number of participants with adherence data0—158
Week 0: Number of participants adherent to medsNA—132
Week 12:Number of participants with adherence data37—150
Week 12:Number of participants adherent to meds32—125
Week 24:Number of participants with adherence data32—145
Week 24:Number of participants adherent to meds28—118
Week 48:Number of participants with adherence data22—120
Week 48:Number of participants adherent to meds19—95
Week 60:Number of participants with adherence data0—91
Week 60:Number of participants adherent to medsNA—79
Week 72:Number of participants with adherence data8—0
Week 72:Number of participants adherent to meds7—NA
SecondaryHCV Polymorphisms

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

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

No measurements were reported for this outcome.

SecondaryHCV-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.

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

No measurements were reported for this outcome.

SecondaryNumber 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.

Time frame:
Arms A and B: Weeks 0, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 48, 60, 72, 84
Reported as:
Number · Participant
Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL)
ParticipantA: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)
Week 0: Number of participants with HIV RNA data4442169
Week 0: No. of participants with undetectable VL3234146
Week 12: Number of participants with HIV RNA data00164
Week 12: No. of participants with undetectable VLNANA138
Week 24: Number of participants with HIV RNA data3939165
Week 24: No. of participants with undetectable VL2525141
Week 36: Number of participants with HIV RNA data00160
Week 36: No. of participants with undetectable VLNANA134
Week 48: Number of participants with HIV RNA data3533150
Week 48: No. of participants with undetectable VL2425125
Week 60: Number of participants with HIV RNA data00140
Week 60: No. of participants with undetectable VLNANA113
Week 72: Number of participants with HIV RNA data2727140
Week 72: No. of participants with undetectable VL1920107
Week 84: Number of participants with HIV RNA data00136
Week 84: No. of participants with undetectable VLNANA108
SecondaryHomeostasis 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.

Time frame:
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.
Reported as:
Median · mg/dL x uIU/mL
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
mg/dL x uIU/mLA: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)
Week 0: HOMA-IR (N=32 in A, 32 in B, 72 in C)3.84 (2.77 to 9.03)2.49 (1.83 to 4.48)2.37 (1.50 to 5.36)
Week 12: HOMA-IR (N=72 in C)NA (NA to NA)NA (NA to NA)2.47 (1.63 to 4.22)
Week 24: HOMA-IR (N=34 in A, 30 in B, 73 in C)3.08 (1.68 to 5.59)4.78 (1.78 to 6.13)2.58 (1.35 to 4.44)
Week 36: HOMA-IR (N=66 in C)NA (NA to NA)NA (NA to NA)2.41 (1.44 to 4.58)
Week 48: HOMA-IR (N=30 in A, 24 in B, 74 in C)3.53 (1.72 to 6.65)2.84 (1.78 to 6.38)3.25 (1.73 to 5.01)
Week 72: HOMA-IR (N=67 in C)4.79 (3.41 to 7.83)4.82 (2.46 to 9.12)2.69 (1.66 to 5.47)
Week 84: HOMA-IR (N=63 in C)NA (NA to NA)NA (NA to NA)2.99 (1.66 to 4.98)
Week 96: HOMA-IR (N=65 in C)NA (NA to NA)NA (NA to NA)2.30 (1.63 to 4.15)
SecondarySustained Virologic Response

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

Time frame:
24 weeks after end of treatment
Reported as:
Number · Participant
Sustained Virologic Response
ParticipantA: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)
Yes0088
No444281
SecondaryNumber 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.

Time frame:
Up to 96 weeks
Reported as:
Number · Participant
Number of Participants Who Used Antianorexia Agents, Such as Megestrol and Dronabinol
ParticipantA: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)
Number of participants who used megestrol216
Number of participants who used dronabinol4422
SecondaryNumber 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

Time frame:
At any time after pre-assignment
Reported as:
Number · Participant
Number of Participants With Prescription as Needed of Erythropoietin (EPO), Granulocyte Colony-stimulating Factor (GCSF), and Granulocyte-monocyte Colony-stimulating Factor (GM-CSF)
ParticipantA: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)
Number of participants who used EPO141370
Number of participants who used GCSF17860
Number of participants who used GM-CSF000
SecondaryWeight

Participant weight in kilograms.

Time frame:
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.
Reported as:
Median · kilograms
Weight
kilogramsA: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)
Week 0: Weight (N=43 in A, 42 in B, 169 in C)74.9 (67.6 to 86.8)79.8 (69.7 to 88.3)75.8 (68.6 to 84.4)
Week 4: Weight (N=43 in A, 35 in B, 161 in C)74.7 (68.6 to 87.4)80.4 (70.5 to 88.5)75.8 (68.3 to 83.5)
Week 8: Weight (N=39 in A, 34 in B, 162 in C)74.9 (66.7 to 87.3)80.8 (71.8 to 90.9)75.8 (67.6 to 84.9)
Week 12: Weight (N=42 in A, 30 in B, 157 in C)76.3 (67.2 to 87.9)81.1 (69.9 to 89.9)76.3 (67.4 to 83.0)
Week 16: Weight (N=39 in A, 35 in B, 164 in C)77.4 (67.9 to 89.5)79.9 (70.0 to 90.4)76.3 (66.3 to 83.2)
Week 24: Weight (N=39 in A, 36 in B, 165 in C)75.5 (66.3 to 89.0)79.4 (72.5 to 91.0)75.8 (65.9 to 82.6)
Week 32: Weight (N=37 in A, 35 in B)76.5 (69.0 to 88.1)80.4 (70.8 to 87.7)NA (NA to NA)
Week 36: Weight (N=162 in C)NA (NA to NA)NA (NA to NA)75.0 (65.9 to 84.0)
Week 40: Weight (N=32 in A, 29 in B)75.7 (67.7 to 86.4)83.1 (70.9 to 91.0)NA (NA to NA)
Week 48: Weight (N=33 in A, 31 in B, 153 in C)78.2 (68.8 to 88.7)80.4 (68.1 to 93.3)75.1 (66.3 to 84.4)
Week 56: Weight (N=31 in A, 24 in B)79.7 (69.4 to 92.7)81.6 (68.8 to 90.9)NA (NA to NA)
Week 64: Weight (N=26 in A, 24 in B)78.5 (69.3 to 87.7)84.0 (72.8 to 91.9)NA (NA to NA)
Week 72: Weight (N=26 in A, 27 in B, 141 in C)81.6 (68.6 to 89.6)85.4 (71.7 to 94.0)75.6 (65.5 to 84.6)
Week 84: Weight (N=140 in C)NA (NA to NA)NA (NA to NA)77.0 (67.6 to 87.6)
Week 96: Weight (N=138)NA (NA to NA)NA (NA to NA)78.4 (69.6 to 88.0)

Adverse events

Collected over From entry (Step 2 for Arms A and B, Step 3 for Arm C) to study completion (at Week 72 for Step 2; at week 78-84 for Step 3, depending on participants' time in Step 1).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)—6/44 (13.6%)43/44 (97.7%)
OL (PEG-IFN, RBV) Then OL Randomized (Observation)—2/42 (4.8%)41/42 (97.6%)
OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)—37/169 (21.9%)166/169 (98.2%)
Most frequent serious events
Showing 10 of 31
Most frequent serious events
EventOpen Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)OL (PEG-IFN, RBV) Then OL Randomized (Observation)OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)
NeutropeniaBlood and lymphatic system disorders2/440/4213/169
Basedow's diseaseEndocrine disorders0/441/420/169
Neutrophil countInvestigations1/441/420/169
Neutrophil count decreasedInvestigations1/441/423/169
AnaemiaBlood and lymphatic system disorders1/440/422/169
LymphomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/440/420/169
DyspnoeaRespiratory, thoracic and mediastinal disorders1/440/420/169
PancreatitisGastrointestinal disorders0/440/422/169
Bone marrow failureBlood and lymphatic system disorders0/440/421/169
ThrombocytopeniaBlood and lymphatic system disorders0/440/421/169
Most frequent other events
Showing 10 of 23
Most frequent other events
EventOpen Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)OL (PEG-IFN, RBV) Then OL Randomized (Observation)OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)
Neutrophil count decreasedInvestigations37/4425/42144/169
Alanine aminotransferase increasedInvestigations30/4432/4264/169
Platelet count decreasedInvestigations21/449/4258/169
Blood glucose abnormalInvestigations14/448/4255/169
Blood glucose increasedInvestigations11/447/4216/169
Activated partial thromboplastin time prolongedInvestigations8/448/421/169
Gamma-glutamyltransferase increasedInvestigations8/442/426/169
Aspartate aminotransferase increasedInvestigations7/446/4212/169
Lipase increasedInvestigations5/446/4213/169
Blood triglycerides abnormalInvestigations6/440/4222/169

Baseline characteristics

All Arm A, B and C participants.

Age, Categorical
Age, Categorical(Participants)Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)OL (PEG-IFN, RBV) Then OL Randomized (Observation)OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)Total
<=18 years0000
Between 18 and 65 years4442169255
>=65 years0000
Age, Continuous
Age, Continuous(years)Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)OL (PEG-IFN, RBV) Then OL Randomized (Observation)OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)Total
Mean48.8 ± 6.748.1 ± 5.847.2 ± 7.147.6 ± 6.8
Sex: Female, Male
Sex: Female, Male(Participants)Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)OL (PEG-IFN, RBV) Then OL Randomized (Observation)OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)Total
Female12121943
Male3230150212
Region of Enrollment
Region of Enrollment(participants)Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)OL (PEG-IFN, RBV) Then OL Randomized (Observation)OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)Total
United States4140168249
Puerto Rico3216
08

Study locations

37 sites
  • Alabama Therapeutics CRS
    Birmingham, Alabama 35924-2050, United States
  • University of Southern California CRS
    Los Angeles, California 90033-1079, United States
  • UCLA CARE Center CRS
    Los Angeles, California 90035, United States
  • Stanford AIDS Clinical Trials Unit CRS
    Palo Alto, California 94304-5350, United States
  • UCSD Antiviral Research Center CRS
    San Diego, California 92103, United States
  • Ucsf Hiv/Aids Crs
    San Francisco, California 94110, United States
  • Santa Clara Valley Med. Ctr.
    San Jose, California 95128, United States
  • University of Colorado Hospital CRS
    Aurora, Colorado 80045, United States
  • Georgetown University CRS (GU CRS)
    Washington, District of Columbia 20007, United States
  • Univ. of Hawaii at Manoa, Leahi Hosp.
    Honolulu, Hawaii 96816, United States
  • Northwestern University CRS
    Chicago, Illinois 60611, United States
  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic
    Indianapolis, Indiana 46202-5250, United States
  • Indiana Univ. School of Medicine, Wishard Memorial
    Indianapolis, Indiana 46202-5250, United States
  • Johns Hopkins University CRS
    Baltimore, Maryland 21205, United States
  • Massachusetts General Hospital CRS (MGH CRS)
    Boston, Massachusetts 02114, United States
  • Brigham and Women's Hosp. ACTG CRS
    Boston, Massachusetts 02115, United States
  • Beth Israel Deaconess Med. Ctr., ACTG CRS
    Boston, Massachusetts 02215, United States
  • Washington University Therapeutics (WT) CRS
    Saint Louis, Missouri 63110-1010, United States
  • Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
    Omaha, Nebraska 68198-9500, United States
  • Beth Israel Med. Ctr., ACTU
    New York, New York 10003, United States
  • Weill Cornell Chelsea CRS
    New York, New York 10011, United States
  • NY Univ. HIV/AIDS CRS
    New York, New York 10016, United States
  • Weill Cornell Uptown CRS
    New York, New York 10021, United States
  • Columbia P&S CRS
    New York, New York 10032-3732, United States
  • Trillium Health ACTG CRS
    Rochester, New York 14607, United States
  • McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit
    Rochester, New York 14642, United States
  • Univ. of Rochester ACTG CRS
    Rochester, New York 14642, United States
  • Chapel Hill CRS
    Chapel Hill, North Carolina 27599, United States
  • Cincinnati CRS
    Cincinnati, Ohio 45267-0405, United States
  • MetroHealth CRS
    Cleveland, Ohio 44109, United States
  • Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.
    Philadelphia, Pennsylvania 19104, United States
  • University of Pittsburgh CRS
    Pittsburgh, Pennsylvania 15213, United States
  • The Miriam Hospital Clinical Research Site (TMH CRS) CRS
    Providence, Rhode Island 02906, United States
  • Vanderbilt Therapeutics (VT) CRS
    Nashville, Tennessee 37204, United States
  • Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic
    Dallas, Texas 75235-9173, United States
  • Univ. of Texas Medical Branch, ACTU
    Galveston, Texas 77555-0435, United States
  • Puerto Rico AIDS Clinical Trials Unit CRS
    San Juan, 00935, Puerto Rico
09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00078403
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
Feb 25, 2004
Start date
Jul 2004
Primary completion
May 2007
Completion
Feb 2009
Results posted
Apr 27, 2011
Last update
Nov 8, 2021

Study contacts

Kenneth E. Sherman, MD, PhD
study chair · University of Cincinnati
Raymond Chung, MD
study chair · Harvard/Massachusetts General Hospital
View the source record on ClinicalTrials.gov ↗

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