HIV Infection Clinical Trial
Official title:
Phase II Clinical Trial to Evaluate the Antiviral Activity of Pegylated Interferon Plus Ribavirin Plus Nitazoxanide in Individuals With Chronic Hepatitis Due to HCV Genotype 4 and Coinfected by HIV
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.
Main Objective To evaluate the SVR rate of treatment with Peg-IFN alfa-2b plus RBV and NTZ
in patients coinfected with HIV and HCV genotype 4, both never exposed to therapy against
HCV or who failed a previous treatment with Peg-IFN plus RBV, and to compare with the SVR
rate obtained in patients with Peg-IFN plus RBV in a historical cohort.
Secondary objectives: In naive, as well as in experienced patients:
1. 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.
2. To analyze the safety of Peg-IFN plus RBV plus NTZ in HIV/HCV-4-coinfected patients.
Design Single arm pilot clinical trial to evaluate safety and efficacy (phase II).
Disease or disorder under study Coinfection with HIV and HCV genotype 4.
Drugs under study Nitazoxanide 500 mg every 12 hours for 4 weeks followed by nitazoxanide
500 mg every 12 hours plus pegylated interferon alfa-2b 1.5 mcg/kg/week and weight-adjusted
ribavirin for 48 weeks.
Study Population and total number of subjects Patients infected with HIV-1 with chronic HCV
genotype 4 who meet the selection criteria.
Number of patients included in the study: 45.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02135419 -
Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions
|
Phase 3 | |
Active, not recruiting |
NCT02663856 -
My Smart Age With HIV: Smartphone Self-assessment of Frailty
|
||
Completed |
NCT02663869 -
Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles
|
||
Terminated |
NCT02743598 -
Liraglutide for HIV-associated Neurocognitive Disorder
|
Phase 4 | |
Completed |
NCT02659306 -
Metformin Immunotherapy in HIV Infection
|
Phase 1 | |
Completed |
NCT02921516 -
Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings
|
N/A | |
Completed |
NCT02846402 -
Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda
|
N/A | |
Completed |
NCT02564341 -
Targeting Effective Analgesia in Clinics for HIV - Intervention
|
N/A | |
Active, not recruiting |
NCT02302950 -
A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas
|
N/A | |
Terminated |
NCT02109224 -
Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection
|
Phase 1 | |
Terminated |
NCT01902186 -
Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir
|
Phase 4 | |
Completed |
NCT02269605 -
Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment
|
Phase 1 | |
Completed |
NCT01852942 -
Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV
|
Phase 2 | |
Completed |
NCT01830595 -
Lactoferrin Treatment in HIV Patients
|
Phase 2 | |
Completed |
NCT02118168 -
Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002
|
N/A | |
Completed |
NCT02525146 -
Birmingham Access to Care Study
|
N/A | |
Completed |
NCT01946217 -
Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials
|
N/A | |
Completed |
NCT02527135 -
Text Messaging to Improve HIV Testing Among Young Women in Kenya
|
N/A | |
Active, not recruiting |
NCT02602418 -
Neural Correlates of Working Memory Training for HIV Patients
|
N/A | |
Completed |
NCT01680094 -
Safety and Effect of The HDAC Inhibitor Panobinostat on HIV-1 Expression in Patients on Suppressive HAART
|
Phase 1/Phase 2 |