Full Text View
Tabular View
No Study Results Posted
Related Studies
The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections
This study has been completed.
Study NCT00001035   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)
First Received: November 2, 1999   Last Updated: August 22, 2008   History of Changes

November 2, 1999
August 22, 2008
 
 
 
 
Complete list of historical versions of study NCT00001035 on ClinicalTrials.gov Archive Site
 
 
 
The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections
A Phase I Pilot Study of the Safety and Efficacy of Interferon Alfa-2b (IFN Alfa-2b) in Combination With Nucleoside Analog Therapy in Patients With Combined Hepatitis C (HCV) and Advanced Human Immunodeficiency Virus (HIV) Infections

To investigate the toxicity of interferon alfa-2b ( IFN alfa-2b ) in combination with nucleoside analog therapy in HIV-positive patients with chronic hepatitis C. To determine the efficacy of treatment with IFN alfa-2b for chronic hepatitis C in patients with advanced HIV infections treated with nucleoside analog therapy.

IFN alfa-2b has HIV inhibitory properties and has also been approved for treatment of chronic hepatitis C. Studies have shown that IFN alfa-2b is effective in asymptomatic HIV-positive patients with chronic hepatitis C, but the drug's benefit against hepatitis C in patients with advanced HIV infection has not been determined.

IFN alfa-2b has HIV inhibitory properties and has also been approved for treatment of chronic hepatitis C. Studies have shown that IFN alfa-2b is effective in asymptomatic HIV-positive patients with chronic hepatitis C, but the drug's benefit against hepatitis C in patients with advanced HIV infection has not been determined.

Patients receive interferon alpha-2b subcutaneously 3 times weekly for 6 months. If no response is seen after 18 weeks of therapy or if an initial response is followed by relapse while on therapy, dose is increased. Patients who require a dose escalation should continue on IFN alfa-2b for an additional 6 months. All patients will also receive available nucleoside analog therapy ( zidovudine, didanosine, zalcitabine ) at currently accepted doses as clinically appropriate.

Phase I
Interventional
Treatment
  • HIV Infections
  • Hepatitis C
  • Drug: Interferon alfa-2b
  • Drug: Zidovudine
  • Drug: Zalcitabine
  • Drug: Didanosine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
10
 
 

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Treatment or suppression of opportunistic infections with standard drugs.
  • Pneumovax, HIB, tetanus, influenza, and hepatitis B vaccines.
  • Clinically indicated antibiotics.
  • Short courses of steroids (< 21 days) for acute problems not related to hepatitis C.
  • Other regularly prescribed medications such as analgesics, nonsteroidal anti-inflammatory agents, antipyretics, allergy medications, and oral contraceptives.

Patients must have:

  • HIV positivity.
  • Documented hepatitis C virus.
  • CD4 count <= 200 cells/mm3.
  • No severe liver disease (Grade C Childs-Pugh classification) or chronic liver disease not caused by hepatitis C.
  • Willingness to be followed for the duration of treatment and follow-up period.

Prior Medication:

Allowed:

  • Prior AZT, ddI, and ddC.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Hepatitis B (HBsAg positive).
  • Autoimmune hepatitis (FANA titer >= 1:160 and anti-smooth muscle antibody titer >= 1:160).
  • Wilson's disease.
  • alpha-1 antitrypsin deficiency.
  • Hemochromatosis.
  • Malignancy requiring systemic chemotherapy.

Concurrent Medication:

Excluded:

  • Nonnucleoside analog therapy for HIV.
  • Biologic response modifiers.
  • Systemic cytotoxic chemotherapy.
  • Chronic systemic steroid use.

Concurrent Treatment:

Excluded:

  • Radiation therapy other than local irradiation to the skin.

Prior Medication:

Excluded:

  • Prednisone within 12 weeks prior to study entry (if patient has received prior daily doses for 1 month or longer duration).
  • Acute therapy for an infection within 2 weeks prior to study entry.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001035
 
ACTG 203P
National Institute of Allergy and Infectious Diseases (NIAID)
Schering-Plough
Study Chair: Gill JC
Study Chair: Eyster ME
National Institute of Allergy and Infectious Diseases (NIAID)
October 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP