Efficacy of Pegylated Interferon Plus Ribavirin Plus Nitazoxanide in HCV Genotype 4 and HIV Coinfection

NCT01529073 | Unknown Phase 2 DMC

• 2 other identifiers: NTZSPA0012010-024336-42
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: 1. Primary objective: To Evaluate the rate of sustained virological response (SVR) of pegylated interferon alfa-2b (Peg-IFN) plus ribavirin (RBV) plus nitazoxanide (NTZ) in patients coinfected by HIV and HCV genotype 4 (HCV-4), never treated before (naïve) and with a treatment failure to a standard therapy with Peg-IFN plus RBV (experienced), and to compare it with the rate of SVR of these patients with Peg-IFN plus RBV is a historical cohort. 2. Secondary objectives: In naive, as well as in experienced patients: a) To evaluate the virological activity at weeks 4 and 12 after starting the combination of Peg-IFN plus RBV plus NTZ in HIV/HCV-4-coinfected patients. b) To analyze the safety of Peg-IFN plus RBV plus NTZ in HIV/HCV-4-coinfected patients. Design: Pilot clinical trial without control to evaluate efficacy and safety (phase II). Patients: Individuals with HIV infection and with confirmed chronic HCV infection. Treatment: NTZ 500 mg every 12 hours during 4 weeks, followed by NTZ 500 mg every 12 hours plus Peg-IFN plus weigh-adjusted RBV for 48 weeks. Total duration of therapy: 52 weeks. Primary variable: The proportion of patients with HCV RNA ≤10 IU/ml 24 weeks after finishing the programmed length of treatment. Secondary variables: 1. The frequency of individuals with HCV RNA ≤10 IU/ml 12 weeks after finishing the programmed length of treatment. 2. The proportion of patients with HCV RNA ≤10 IU/ml at 4 and 12 weeks after adding PegIFN plus RBV to NTZ. 3. The frequency of severe adverse events.

Conditions

HCV Coinfection; HIV Infection

Keywords

HIV; genotype 4 HCV; pegylated interferon; ribavirin; nitazoxanide

Outcome Measures

Primary Outcomes (1)

• Sustained virological response

  The proportion of patients with HCV RNA ≤10 IU/ml 24 weeks after finishing the programmed length of treatment (52 weeks).

  24 weeks after finishing the scheduled treatment

Secondary Outcomes (1)

• Safety of Peg-interferon plus ribavirin plus nitazoxanide

  Every 4 weeks until 28 weeks of treatment, then every 8 weeks until the end of treatment (52 weeks)

Study Arms (1)

Nitazoxanide

EXPERIMENTAL

Drug: Nitazoxanide

Interventions

Nitazoxanide DRUG

Nitazoxanide 500 mg bid po for 4 weeks, followed by nitazoxanide 500 mg bid plus pegylated interferon alpha 2b 1.5 mg/kg/week sc plus weight-adjusted ribavirin po for 48 weeks.

Also known as: Alinia, Annita, Daxon, Dexidex, Kidonax, Mitafar, Pacovanton, Paramix, Nitax, Zox, Nitazox, Niazid, Toza

Nitazoxanide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV infection.
• Infection with HCV genotype 4.
• No prior treatment with any interferon or no response to a previous treatment with Peg-IFN plus RBV. The lack of response will include both nonresponders, and those who showed relapse.
• Stable antiretroviral therapy 24 weeks before starting the study drugs, with undetectable plasma HIV RNA during that period of time.
• Commitment to use two non-hormonal contraception during the study and up to 24 weeks after treatment.
• Acceptance to give written informed consent to participate in the trial.

You may not qualify if:

• Antiretroviral therapy including didanosine, stavudine, zidovudine and abacavir.
• Decompensated cirrhosis.
• Presence of other significant liver diseases, including chronic hepatitis or acute hepatitis B, acute hepatitis hepatitis A, hemochromatosis or deficiency of alpha-1 antitrypsin.
• Pregnancy and lactation.
• Men planning pregnancy with their partners during the study and up to 24 weeks after treatment.
• Active or uncontrolled depression, other psychiatric illness, or disease during the previous year which may, in the investigator's opinion, prevent participation in the study.
• Previous suicide attempt.
• Active thyroid disease or poorly controlled with treatment.
• Previous autoimmune diseases such as inflammatory bowel disease, psoriasis serious, or rheumatoid arthritis, which may be exacerbated by interferon.
• Chemotherapy or immunomodulatory 24 weeks before starting the study.
• Serious illness, including cancer or unstable coronary disease, 24 weeks before starting the study.
• Any chronic disease which, in the opinion of the investigator, may prevent complete the study.
• Presence of acute or active opportunistic infections 48 weeks before starting the study.
• Evidence of hepatocellular carcinoma or alpha-fetoprotein levels ≥ 50 ng / ml, unless an imaging technique shows no evidence of liver tumor, all obtained 24 weeks before starting the study.
• Hemoglobinopathy or other conditions that may facilitate hemolysis.

Sponsors & Collaborators

• Juan Macías: lead
• Spanish National Health System: collaborator

Study Sites (1)

H.U. Valme

Seville, Seville, 41014, Spain

Location

Related Publications (1)

• Macias J, Lopez-Cortes LF, Tellez F, Recio E, Ojeda-Burgos G, Rios MJ, Rivero-Juarez A, Delgado M, Rivas-Jeremias, Pineda JA. Low Efficacy of Pegylated Interferon plus Ribavirin plus Nitazoxanide for HCV Genotype 4 and HIV Coinfection. PLoS One. 2015 Dec 7;10(12):e0143492. doi: 10.1371/journal.pone.0143492. eCollection 2015.

  PMID: 26640956 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

nitazoxanide

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Juan Macías, MD, PhD

  Infectious Diseases and Microbiology Unit. Hospital Universitario de Valme. Servicio Andaluz de Salud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 5, 2012
• First Posted: February 8, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

ES (1)