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HIV InfectionsNCT00100581

Effects of Anti-HIV Therapy on Treatment for Hepatitis C in HCV/HIV Infected Adults

A study testing Efavirenz, Lamivudine and Lopinavir/ritonavir in people with HIV Infections and Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.

Completed

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

Official record
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Trial summary

A significant proportion of HIV infected people in the U.S. are also infected with hepatitis C virus (HCV). The purpose of this study is to determine the effects of anti-HIV therapy on treatment of HCV with pegylated interferon alfa-2a and ribavirin (PEG/RBV). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
HIV Infections, Hepatitis C
What is being tested?
Efavirenz, Lamivudine and Lopinavir/ritonavir
How many people
2 participants
Where
2 sitesUnited States
Study dates
Start not givento Jan 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HIV infected
  • HIV viral load of greater than 1000 copies/ml within 45 days of study entry
  • HCV genotype 1 infected
  • CD4 count of 300 cells/mm3 or greater within 45 days prior to study entry
  • ART-naive or off ART for at least 6 months
  • Willing to accept randomly assigned study treatment
  • Willing to use acceptable forms of contraception during the study and for 6 months after stopping all study medications
  • Chronic liver disease consistent with chronic viral hepatitis as indicated by either liver biopsy within 2 years prior to study entry or a physician's report of hepatitis C infection for more than 6 months. Participants with cirrhosis or without a liver biopsy result within 2 years of study entry must have a serum alpha-fetoprotein of 100 ng/ml or less and a Child-Pugh score of 6 or higher within 45 days prior to study entry to be eligible for this study.

Who cannot join

  • Hepatitis B surface antigen positive within 45 days prior to study entry
  • HCV genotype other than genotype 1 at any time prior to study entry
  • Any medical conditions associated with chronic liver disease other than HCV (e.g., genetic hemochromatosis, autoimmune hepatitis)
  • Prior use of intravenous or subcutaneous interferon for more than 2 weeks total at any time prior to study entry
  • Known allergy/sensitivity to pegylated interferon alpha-2a, ribavirin, or their formulations
  • Current drug or alcohol abuse that, in the opinion of the investigator, may interfere with the study. Participants in methadone programs are not excluded, but may require methadone dose changes during the study.
Show all 22Show fewer
  • Need to start ART at the time of study entry
  • Uncontrolled diabetes mellitus within 30 days prior to study entry
  • Previous suicide attempt or hospitalization for a psychiatric illness within 6 months prior to study entry. Participants with psychiatric disease, especially depression, uncontrolled with medication are not eligible for the study.
  • Prior or current evidence of immunologically mediated disease (e.g., inflammatory bowel disease, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis)
  • Chronic pulmonary disease associated with functional limitation
  • Severe cardiac disease within 24 weeks prior to study entry
  • History of severe retinopathy due to diabetes, hypertension, cytomegalovirus, or macular degeneration
  • History of major organ transplantation
  • Severe illness, cancer, or other conditions that would interfere with the study
  • Any systemic antineoplastic or immunomodulatory treatment (except epoetin alfa or granulocyte colony-stimulating factor [G-CSF]) or radiation within 24 weeks of study entry. Participants who anticipate the need to begin such treatment during the study are not eligible.
  • History of hemoglobinopathy (e.g., thalassemia, sickle cell anemia)
  • Require certain medications
  • Evidence of decompensated liver disease, such as history or presence of ascites, jaundice, bleeding varices, or hepatic encephalopathy
  • Prior opportunistic infection or lowest ever CD4 count less than 200 cells/mm3
  • Has a pregnant partner
  • Pregnancy or breastfeeding

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

    Dallas, Texas, 75235-9173

  • Columbia Univ., HIV Prevention and Treatment Medical Ctr.

    New York, New York, 10032-3784

Other trials in United States

About this study

Official title: An Open-Label, Randomized Study to Determine the Impact of Antiretroviral Treatment in HCV/HIV-Coinfected Subjects With High CD4+ Cell Count on the Efficacy of Hepatitis C Treatment With Pegylated Interferon Alfa-2A and Ribavirin

A significant proportion of HIV infected people in the U.S. are also infected with hepatitis C virus (HCV). The purpose of this study is to determine the effects of anti-HIV therapy on treatment of HCV with pegylated interferon alfa-2a and ribavirin (PEG/RBV).

Read the detailed description

An estimated 15% to 30% of HIV infected people in the U.S. are also infected with HCV. Since the introduction of antiretroviral therapy (ART) for the treatment of HIV, HCV infection has emerged as a major cause of morbidity and mortality in HCV/HIV coinfected patients. One infection often accelerates the progression of the other, and effective management strategies for both infections need to be developed for HCV/HIV coinfected patients. This study will determine whether HIV ART followed by HCV therapy taken concurrently with ART results in better treatment outcomes compared to HCV therapy alone.

This study will last up to 102 weeks. Participants will be randomly assigned to one of two arms. Arm A participants will receive 24 to 30 weeks of ART consisting of tenofovir disoproxil fumarate (TDF) and lamivudine (3TC) and either efavirenz (EFV) or lopinavir/ritonavir (LPV/r). If deemed eligible, Arm A participants will continue their ART regimen and begin a concurrent PEG/RBV regimen for up to 48 weeks. At Week 48, participants in Arm A will stop PEG/RBV and will be followed for an additional 24 weeks on ART alone.

Arm B participants will receive PEG/RBV alone for up to 48 weeks. At Week 48, participants in Arm B will be followed for an additional 48 weeks with no treatment.

There will be 20 study visits over 102 weeks for Arm A participants and 18 study visits over 96 weeks for Arm B participants. Blood collection and clinical assessment will occur at all visits, and urine collection will occur at selected visits. Participants will also be asked to complete adherence questionnaires. Participants in this study are encouraged to also enroll in ACTG A5128.

Being tested
Efavirenz, Lamivudine, Lopinavir/ritonavir, Pegylated interferon alfa-2a, Ribavirin
Keywords
Treatment Naive
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.

  • EfavirenzDrug

  • LamivudineDrug

  • Lopinavir/ritonavirDrug

  • Pegylated interferon alfa-2aDrug

  • RibavirinDrug

  • Tenofovir disoproxil fumarateDrug

What is being measured

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

  1. HCV viral load at least 2 log10 less than baseline or below the limit of detection by quantitative assay at 12 weeks after the start of HCV treatment (early virologic response)

  2. HIV and/or HCV treatment-limiting or Grade 4 or higher signs and symptoms and laboratory values

Timeline

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

  1. First posted4 Jan 2005 (estimated)
  2. Study completionJan 2007

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00100581
Sponsor's protocol ID
A5184
Other IDs
10133, ACTG A5184
Status last verified
Oct 2021
First submitted
3 Jan 2005
Last updated
1 Nov 2021
Results posted
No

Publications

  • Mehta SH, Thomas DL, Torbenson M, Brinkley S, Mirel L, Chaisson RE, Moore RD, Sulkowski MS. The effect of antiretroviral therapy on liver disease among adults with HIV and hepatitis C coinfection. Hepatology. 2005 Jan;41(1):123-31. doi: 10.1002/hep.20541.

    PubMed 15619237

  • Plosker GL, Keating GM. Peginterferon-alpha-2a (40kD) plus ribavirin: a review of its use in hepatitis C Virus And HIV co-infection. Drugs. 2004;64(24):2823-43. doi: 10.2165/00003495-200464240-00009.

    PubMed 15563253

  • Sterling RK, Sulkowski MS. Hepatitis C virus in the setting of HIV or hepatitis B virus coinfection. Semin Liver Dis. 2004;24 Suppl 2:61-8. doi: 10.1055/s-2004-832930.

    PubMed 15346248

  • Sulkowski MS, Moore RD, Mehta SH, Chaisson RE, Thomas DL. Hepatitis C and progression of HIV disease. JAMA. 2002 Jul 10;288(2):199-206. doi: 10.1001/jama.288.2.199.

    PubMed 12095384

  • Sulkowski MS, Thomas DL. Hepatitis C in the HIV-infected patient. Clin Liver Dis. 2003 Feb;7(1):179-94. doi: 10.1016/s1089-3261(02)00074-0.

    PubMed 12691466

Questions about this trial

What is this clinical trial studying?

A study testing Efavirenz, Lamivudine and Lopinavir/ritonavir in people with HIV Infections and Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 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 1 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 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

HCV viral load at least 2 log10 less than baseline or below the limit of detection by quantitative assay at 12 weeks after the start of HCV treatment (early virologic response). The study lists 2 primary outcomes in all. 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 NCT00100581, which also lists 5 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 1 Nov 2021.

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