Clinical trial NCT00001035: The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Hepatitis C
Keywords: AIDS-Related Opportunistic Infections
Interferon Alfa-2b
Zalcitabine
Didanosine
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Zidovudine
Hepatitis C
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Schering-Plough
First posted: 2001-08-31
Enrollment: 10
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC CRS
state: California
city: Indianapolis
country: United States
facility: Indiana Univ. School of Medicine, Infectious Disease Research Clinic
state: Indiana
city: New York
country: United States
facility: NY Univ. HIV/AIDS CRS
state: New York
Study officials:
name: Gill JC
role: STUDY_CHAIR
name: Eyster ME
role: STUDY_CHAIR
References: