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HIV InfectionsPhase 3NCT01482767

Evaluating the Effectiveness of Boceprevir, Pegylated-Interferon Alfa 2b and Ribavirin in Treating Hepatitis C Virus (HCV) Infection in Adults With HIV and HCV Infection

A Phase 3 study testing Pegylated-Interferon Alfa 2b (PEG-IFN), Ribavirin (RBV) and Boceprevir (BOC) in people with HIV Infections and Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) at 43 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

Hepatitis C virus (HCV) infection is a leading cause of death and illness in people with HIV-1. At the time the study was designed, the standard treatment for people with HIV-1 and HCV coinfection included two drugs: pegylated-interferon alfa 2b (PEG-IFN) and ribavirin (RBV). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections, Hepatitis C
What is being tested?
Pegylated-Interferon Alfa 2b (PEG-IFN), Ribavirin (RBV) and Boceprevir (BOC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
262 participants
Where
43 sitesin 2 countries
Study dates
Apr 2012to Apr 2015
Phase
Phase 3
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

  • Men and women 18 years of age or older
  • Presence of chronic HCV infection, defined by presence of plasma or serum HCV RNA in a participant with HCV antibody for at least 180 days, two documented HCV RNA positive results greater than 180 days apart, or positive HCV RNA with biopsy demonstrating chronic hepatitis. More information on this criterion can be found in the protocol.
  • Serum or plasma HCV RNA level 10,000 IU/mL or greater obtained within 42 days prior to study entry.
  • Screening HCV genotype 1 performed within 6 months prior to study entry.
  • Liver biopsy or HCV FibroSURE™ test within 104 weeks prior to study entry with interpretation consistent with chronic HCV infection. If a liver biopsy HCV FibroSURE™ test had not been performed within 104 weeks prior to study entry, then either a biopsy or HCV FibroSURE™ test must have been obtained prior to enrollment. The cut-off value for the FibroSURE™ test was 0.74, where greater than 0.74 was interpreted as cirrhosis. More information on this criterion can be found in the protocol.
  • Alpha feto protein (AFP) levels less than 50. If 50 or greater, they must have had a liver imaging study (e.g., ultrasound, computed tomography [CT] scan, magnetic resonance imaging [MRI] showing no evidence of hepatocellular carcinoma.
Show all 30Show fewer
  • HIV-1 infection. More information on this criterion can be found in the protocol.
  • Currently not on any antiretroviral therapy (ART) for at least 4 weeks immediately prior to entry or on stable ART for at least 8 weeks prior to study entry using a dual NRTI backbone PLUS one of the following: EFV, RAL, LPV/RTV 400/100 mg twice daily, ATV/RTV, DRV/RTV 600/100 mg twice daily. Breaks in therapy for a maximum of 14 days were allowed. Dose modifications or changes in drugs during the 8 weeks prior to study entry were permitted unless the change in drug was due to treatment failure. More information on this criterion can be found in the protocol.
  • CD4+ T-cell count greater than 200 cells/mm^3 obtained within 42 days prior to study entry.
  • For participants on ART, screening plasma HIV-1 RNA less than 50 copies/mL obtained within 42 days prior to study entry. For participants not on ART, plasma HIV-1 RNA less than 50,000 copies/mL obtained within 42 days prior to study entry.
  • The following laboratory values within 42 days prior to entry:
  • Absolute neutrophil count (ANC) 1000/mm^3 or greater,
  • Hemoglobin greater than 12 g/dL for men and greater than 11 g/dL for women,
  • Platelet count greater than 80,000 per mm^3,
  • Creatinine less than 1.5 mg/dL,
  • Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT), alkaline phosphatase (ALT)/serum glutamic pyruvic transaminaseless (SGPT) less than or equal to 10 x the upper limit of normal (ULN),
  • Direct bilirubin less than 1.5 mg/dL,
  • International normalized ratio (INR) less than 1.5,
  • Serum lipase less than or equal to 1.5 x ULN,
  • Thyroid stimulating hormone (TSH) within normal range, unless accompanied by thyroid profile consistent with normal thyroid function.
  • For female participants of reproductive potential, a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL performed within 42 days prior to study entry. More information on this criterion can be found in the protocol.
  • All participants must have agreed not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization).
  • When participating in sexual activity that could lead to pregnancy, participants must have agreed to use at least two reliable methods of contraception simultaneously while receiving protocol-specified medications, and for 6 months after stopping the medications. Such methods include:
  • Condoms (male or female) with a spermicidal agent,
  • Diaphragm or cervical cap with spermicide,
  • Intrauterine device (IUD),
  • Tubal ligation.
  • More information on this criterion can be found in the protocol.
  • Participants not of reproductive potential were eligible without requiring the use of contraceptives. More information on this criterion can be found in the protocol.
  • Ability and willingness of participant to provide written informed consent.

Who cannot join

  • Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.
  • Evidence of decompensated liver disease manifested by the presence of or history of ascites, variceal bleeding, or hepatic encephalopathy. If hepatic cirrhosis was determined by liver biopsy (Stage 4 Metavir or Stage 5, 6 Ishak) or by imaging, then participants had to be no more than Child-Pugh Class A and have a Child-Pugh-Turcotte (CPT) score of 6 or less. More information on this criterion can be found in the protocol.
  • Other known causes of significant liver disease including chronic or acute hepatitis B, acute hepatitis A, hemochromatosis, or homozygote alpha-1 antitrypsin deficiency.
  • Infection with any HCV genotype other than genotype 1, or mixed genotype infection.
  • Uncontrolled or active depression or other psychiatric disorder such as untreated. Grade 3 psychiatric disorder or Grade 3 disorder not amenable to medical intervention that in the opinion of the site investigator might have precluded tolerability or safety of study requirements. Individuals with suicidal ideation or history of a suicidal attempt in the last 5 years prior to enrollment were excluded.
  • History of uncontrolled seizure disorders.
Show all 18Show fewer
  • Serious illness including malignancy, active coronary artery disease within 24 weeks prior to study entry, or other chronic medical conditions that in the opinion of the site investigator may have precluded completion of the protocol.
  • Presence of active or acute AIDS-defining opportunistic infections within 12 weeks prior to study entry. More information on this criterion can be found in the protocol.
  • History of hemoglobinopathy (e.g., thalassemia) or any other cause of or tendency to hemolysis.
  • History of major organ transplantation with an existing functional graft.
  • History of autoimmune processes including Crohn's disease, ulcerative colitis, severe psoriasis, or rheumatoid arthritis that may be exacerbated by IFN use.
  • Breastfeeding.
  • Male participants with pregnant sexual partner.
  • Use of granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days prior to study entry.
  • Use of systemic corticosteroids, lovastatin, simvastatin, interferon gamma, tumor necrosis factor(TNF)-alpha inhibitors, rifampin, rifabutin, pyrazinamide, isoniazid, ganciclovir or hydroxyurea within 14 days prior to study entry.
  • Previous use of any HCV protease or polymerase inhibitor.
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would have interfered with adherence to study requirements.
  • Serious illness requiring systemic treatment and/or hospitalization within 42 days prior to entry.

Trial locations and contacts

43 sites in 2 countries.

43 sites in 2 countries

United States42 sites

  • The Ponce de Leon Center CRS

    Atlanta, Georgia, 30308-2012

  • University of Colorado Hospital CRS

    Aurora, Colorado, 80045

  • IHV Baltimore Treatment CRS

    Baltimore, Maryland, 21201

  • Johns Hopkins University CRS

    Baltimore, Maryland, 21205

  • Alabama CRS

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital CRS (MGH CRS)

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS

    Boston, Massachusetts, 02115

  • Bmc Actg Crs

    Boston, Massachusetts, 02118

  • Cooper Univ. Hosp. CRS

    Camden, New Jersey, 08103

  • Chapel Hill CRS

    Chapel Hill, North Carolina, 27599

  • Northwestern University CRS

    Chicago, Illinois, 60611

  • Rush University CRS

    Chicago, Illinois, 60612

  • Cincinnati Clinical Research Site

    Cincinnati, Ohio, 45219

  • Case Clinical Research Site

    Cleveland, Ohio, 44106

  • MetroHealth CRS

    Cleveland, Ohio, 44109

  • Ohio State University CRS

    Columbus, Ohio, 43210

  • Trinity Health and Wellness Center CRS

    Dallas, Texas, 75208

  • Denver Public Health CRS

    Denver, Colorado, 80204

  • Wayne State Univ. CRS

    Detroit, Michigan, 48201

  • Henry Ford Hosp. CRS

    Detroit, Michigan, 48202

  • Duke Univ. Med. Ctr. Adult CRS

    Durham, North Carolina, 27710

  • Houston AIDS Research Team CRS

    Houston, Texas, 77030

  • 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

  • Weill Cornell Chelsea CRS

    New York, New York, 10011

  • Columbia P&S CRS

    New York, New York, 10032-3732

  • Weill Cornell Uptown CRS

    New York, New York, 10065

  • New Jersey Medical School Clinical Research Center CRS

    Newark, New Jersey, 07103

  • Stanford AIDS Clinical Trials Unit CRS

    Palo Alto, California, 94304-5350

  • Penn Therapeutics, CRS

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh CRS

    Pittsburgh, Pennsylvania, 15213

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

    Providence, Rhode Island, 02906

  • Virginia Commonwealth University CRS

    Richmond, Virginia, 23298

  • University of Rochester Adult HIV Therapeutic Strategies Network CRS

    Rochester, New York, 14642

  • UCSD Antiviral Research Center CRS

    San Diego, California, 92103

  • Ucsf Hiv/Aids Crs

    San Francisco, California, 94110

  • University of Washington AIDS CRS

    Seattle, Washington, 98104-9929

  • Washington University Therapeutics (WT) CRS

    St Louis, Missouri, 63110-1010

  • Bronx-Lebanon Hosp. Ctr. CRS

    The Bronx, New York, 10457

  • Harbor-UCLA CRS

    Torrance, California, 90502

  • 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: A Prospective, Phase III, Open-Label Study of Boceprevir, Pegylated-Interferon Alfa 2b and Ribavirin in HCV/HIV Coinfected Subjects

Hepatitis C virus (HCV) infection is a leading cause of death and illness in people with HIV-1. At the time the study was designed, the standard treatment for people with HIV-1 and HCV coinfection included two drugs: pegylated-interferon alfa 2b (PEG-IFN) and ribavirin (RBV). The purpose of this study was to evaluate the effectiveness of giving boceprevir (BOC) together with standard treatment in treating HCV infection in people with HIV-1 and HCV coinfection.

Read the detailed description

For HIV-1-infected individuals, HCV infection is a leading cause of morbidity and mortality, and the prevalence of HCV infection is higher among those infected with HIV-1. At the time the study was designed, the standard-of-care (SOC) therapy for HCV infection was treatment with both PEG-IFN and RBV. This therapy is 40%-45% effective in patients with HCV infection but is significantly less effective in patients with both HCV and HIV-1 (Shire et al. J Viral Hepat., 2007). The purpose of this study was to evaluate the effectiveness of adding BOC (Kwo et al. Lancet, 2010), an HCV protease inhibitor, to SOC therapy in treating HCV infection (genotype 1) in HCV/HIV-1-coinfected adults.

Participants were enrolled into one of two groups based on previous HCV treatment experience.

  1. Group A: HCV treatment-naive participants who had never received treatment with PEG-IFN or experimental agents used to treat HCV, with or without RBV (N=170, refer to the note below).
  2. Group B: HCV treatment-experienced participants who had received any treatment with standard interferon or with PEG-IFN with or without RBV, provided the last dose of treatment was 90 days or more before study entry (N=140, refer to the note below).

Note: The team correspondence with the FDA led to an amendment to close enrollment in December 2013, prior to the target sample sizes of 170 in Group A and 140 in Group B, as the study power could be lowered while still meeting the key study objectives.

All participants had to be on stable antiretroviral therapy (ART) for at least 8 weeks prior to study entry using a dual nucleos(t)ide reverse transcriptase inhibitor (NRTI) backbone plus one of the following: efavirenz (EFV), raltegravir (RAL), lopinavir (LPV)/ritonavir (RTV) 400/100 mg twice daily, atazanavir (ATV)/RTV, darunavir (DRV)/RTV 600/100 mg twice daily OR must not have received any ART for at least 4 weeks immediately prior to entry. Participation in this study lasted approximately 72 weeks.

HCV treatment-naive participants (Group A) were treated with PEG-IFN and RBV for 4 weeks (lead-in). Then BOC was added to the treatment regimen (triple therapy). Cirrhotic participants received 44 weeks of triple therapy. Among non-cirrhotics, the Week 8 HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of double-drug therapy with PEG-IFN/RBV. HCV treatment-experienced participants (Group B) also had a lead-in followed by 32 weeks of triple therapy and 12 weeks of PEG-IFN/RBV double therapy if non-cirrhotic, or by 44 weeks of triple therapy if cirrhotic.

Treatment was to be discontinued due to HCV virologic failure if:

  1. HCV RNA ≥100 IU/mL at Week 12,
  2. detectable HCV RNA at Week 24, or
  3. confirmed HCV RNA >1000 IU/mL any time after Week 12.

Undetectable HCV RNA was defined as below the lower limit of quantification (LLOQ) and target not detected (TND) by Roche COBAS® TaqMan® HCV Test v2.0.

Study visits were scheduled at screening and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24 and 28 for both study groups. Group A participants who completed treatment at Week 28 had further study visits at Weeks 40, 52, 60, and 72. Participants who were prescribed 48-weeks of therapy (Group A and Group B) had further study visits at Weeks 32, 36, 40, 44, 48, 60, and 72. At each visit, a physical examination and blood collection were conducted. Participants also completed an HCV treatment adherence questionnaire. Select visits included urine collection and pregnancy testing (for women of reproductive potential). Plasma, serum, and peripheral blood mononuclear cells (PBMCs) were be stored for use in future studies. After experiencing HCV virologic failure as defined above or premature treatment discontinuation due to safety or other reasons, participants were followed on a separate schedule of events with visits every 12 weeks from Week 24 to 72. The evaluations at these follow-up visits were limited to safety evaluations and stored plasma/serum sample collection.

The A5294 study consisted of single-arm evaluations to assess the efficacy of BOC added to PEG-IFN/RBV in the two study populations:

  1. HCV treatment-naive participants (Group A)
  2. HCV treatment-experienced participants (Group B).

The two study populations were addressed together in this single trial - rather than in two separate trials - mainly for administrative efficiency. The analyses were conducted separately for each Study Group. The study was not designed for comparison. The pooled summaries for Baseline Characteristics provided in the Results Section in this record were prepared solely for the ClinicalTrials.gov results submission.

Being tested
Pegylated-Interferon Alfa 2b (PEG-IFN), Ribavirin (RBV), Boceprevir (BOC)
Medical subject headings
HIV Infections, Hepatitis C

What participants receive

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

  • Pegylated-Interferon Alfa 2b (PEG-IFN)Drug

    1.5 mcg/kg subcutaneously (SC) once a week (based on participant's weight at entry) for up to 48 weeks depending on cirrhosis status and, in Group A, Week 8 HCV viral response.

  • Ribavirin (RBV)Drug

    800-1400 mg orally per day with food (based on participant's weight at entry) for up to 48 weeks depending on cirrhosis status and, in Group A, Week 8 HCV viral response.

  • Boceprevir (BOC)Drug

    800 mg orally every 8 hours with food from Week 5 to up to Week 48 depending on cirrhosis status and, in Group A, Week 8 HCV viral response

Study groups in NCT01482767
Study groupRoleWhat they receive
HCV Treatment-Naive (Group A)ExperimentalParticipants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the Week 8 HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Receives: Drug: Pegylated-Interferon Alfa 2b (PEG-IFN); Drug: Ribavirin (RBV); Drug: Boceprevir (BOC)
HCV Treatment-Experienced (Group B)ExperimentalParticipants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Receives: Drug: Pegylated-Interferon Alfa 2b (PEG-IFN); Drug: Ribavirin (RBV); Drug: Boceprevir (BOC)

What is being measured

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

  1. Percentage of Participants With Sustained Virologic Response at 24 Weeks After Treatment Discontinuation (SVR24)

    SVR24 was defined as undetectable HCV RNA (below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0) at 24 weeks after treatment discontinuation. Participants without HCV RNA for SVR24 determination were considered not to have achieved SVR24.

    Measured: 24 weeks after treatment discontinuation

Secondary outcomes (7)

  1. Percentage of Participants With Grade 3 or Higher Adverse Events (AEs)

    Number of participants who experienced an AE (sign or symptom or laboratory abnormality) of Grade 3 or higher at any time after baseline while on study. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening.

    Measured: From study treatment dispensation to Week 72

  2. Percentage of Participants With Sustained Virologic Response at 12 Weeks After Treatment Discontinuation (SVR12)

    SVR12 was defined as undetectable HCV RNA (below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0) at 12 weeks after treatment discontinuation. Participants without HCV RNA for SVR12 determination were considered not to have achieved SVR12.

    Measured: 12 weeks after treatment discontinuation

  3. Percentage of Participants With HIV-1 Viral Load <50 Copies/mL

    HIV-1 RNA testing was performed with Abbott RealTime HIV-1 assay (LLOQ=40 copies/mL) or with Roche COBAS AmpliPrep/Taqman HIV-1 assay (LLOQ=20 copies/mL).

    Measured: Entry and weeks (W) 4, 8, 12, 24, 28, 40, 48, 52, 60, 72

  4. CD4+ T-Cell Count (CD4) Change From Baseline

    Change in CD4 T-cell count was calculated as value at the post entry visit minus the value at entry.

    Measured: Entry and weeks (W) 8, 12, 24, 28, 40, 48, 52, 60, 72

  5. Number of Participants With Undetectable HCV RNA at Week 4, 8 and 12 Study Visits

    Undetectable HCV RNA was defined as below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0.

    Measured: Weeks (W) 4, 8, 12

  6. Number of Participants With Undetectable HCV RNA at Week 16, 20, 24 and 28 Study Visits

    Undetectable HCV RNA was defined as below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0. This outcome measure was intended for a potential interim analysis when study data up to Week 28 were complete. However, this interim analysis was not conducted.

    Measured: Weeks (W) 16, 20, 24, and 28

  7. Number of Participants With Grade 2 or Higher Signs and Symptoms and Laboratory Abnormalities and Other Serious AEs

    This outcome measure was intended for a potential interim analysis when study data up to Week 28 were complete. However, this interim analysis was not conducted. Refer to Outcome Measure 2 above for the safety outcome that includes the whole study duration from entry to week 72.

    Measured: From study treatment dispensation to Week 28

Timeline

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

  1. First posted1 Dec 2011 (estimated)
  2. Study startApr 2012
  3. Primary completionApr 2015
  4. Study completionApr 2015

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
262 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01482767
Sponsor's protocol ID
A5294 (BIRTH)
Other IDs
11774, ACTG 5294, BIRTH
Status last verified
Jun 2016
First submitted
28 Nov 2011
Last updated
4 Nov 2021
Data monitoring committee
Yes

Publications

  • Shire NJ, Welge JA, Sherman KE. Response rates to pegylated interferon and ribavirin in HCV/HIV coinfection: a research synthesis. J Viral Hepat. 2007 Apr;14(4):239-48. doi: 10.1111/j.1365-2893.2006.00824.x.

    PubMed 17381715

  • Kwo PY, Lawitz EJ, McCone J, Schiff ER, Vierling JM, Pound D, Davis MN, Galati JS, Gordon SC, Ravendhran N, Rossaro L, Anderson FH, Jacobson IM, Rubin R, Koury K, Pedicone LD, Brass CA, Chaudhri E, Albrecht JK; SPRINT-1 investigators. Efficacy of boceprevir, an NS3 protease inhibitor, in combination with peginterferon alfa-2b and ribavirin in treatment-naive patients with genotype 1 hepatitis C infection (SPRINT-1): an open-label, randomised, multicentre phase 2 trial. Lancet. 2010 Aug 28;376(9742):705-16. doi: 10.1016/S0140-6736(10)60934-8. Epub 2010 Aug 6.

    PubMed 20692693

  • The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009).

  • Sherman KE, Kang M, Sterling R, Umbleja T, Marks K, Alston-Smith B, Greaves W, Butt A. BIRTH: A Phase 3 Trial of Boceprevir/Pegylated Interferon/Ribavirin in HCV/HIV. IDWeek. San Diego, CA. October, 2015. [Abstract 903]

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pegylated-Interferon Alfa 2b (PEG-IFN), Ribavirin (RBV) and Boceprevir (BOC) in people with HIV Infections and Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) at 43 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 30 inclusion and 18 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 4 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 43 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 10 May 2016). 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?

Percentage of Participants With Sustained Virologic Response at 24 Weeks After Treatment Discontinuation (SVR24) (time frame: 24 weeks after treatment 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 NCT01482767, 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 4 Nov 2021.

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