HCV-HIV Co-infected Patient Cohort in Thailand
Palabras clave
Abstracto
Descripción
Study Population Screening: HIV infected patients with a positive anti-HCV test will be approached for screening if they are at least 18 years old, participate in the PHPT cohort study, have evidence of control of HIV replication and have a CD4 cell count ≥200 cells/mm3 if currently receiving antiretroviral HIV treatment (on the same anti-HIV regimen for at least 12 weeks); or HIV RNA load ≤5000 copies/ml CD4 cells ≥500 cells/mm3if not receiving antiretroviral treatment.
Inclusion Criteria
- Evidence of chronic HCV infection for at least 6 months before study entry (at least one detectable HCV viral load, i.e. ≥17 IU/mL, with an antibody test positive at least 6 months before the HCV RNA load result)
- Fibrosis Stage F2-3-4 determined by transient elastography (Fibroscan or other similar equipment). During the first part of the study, priority will be given to patients with Fibrosis Stage F2-3.
- Negative pregnancy test (on the day of inclusion). Main exclusion criteria
- Anemia and thrombocytopenia
- Severe liver damage, advanced stage cirrhosis or cancer
- Uncontrolled diabetes, Uncontrolled thyroid dysfunction
- Retinopathy
- Creatinine clearance <50 mL/min (Cockcroft)
- Disease associated with the immune system
- Significant heart problems
- Severe neuropsychiatric conditions
- Contra-indication to study treatment (including pregnancy or lack of effective contraception in the participant or female partner)
- Other exclusion criteria related to the use of ribavirin and peg-interferon
- Any conditions that, in the investigator's judgment, may compromise the follow up.
Follow up After HCV treatment initiation, patients will be monitored for safety and antiviral efficacy at 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 weeks (end of treatment) and 6 months after treatment discontinuation.
Treatment will be discontinued earlier in patients who do not achieve early viral response, i.e. a decrease of at least 2 log10 HCV RNA IU/mL after the first 12 weeks of HCV therapy.
fechas
| Verificado por última vez: | 01/31/2019 |
| Primero enviado: | 09/08/2014 |
| Inscripción estimada enviada: | 09/18/2014 |
| Publicado por primera vez: | 09/24/2014 |
| Última actualización enviada: | 02/21/2019 |
| Última actualización publicada: | 06/02/2019 |
| Fecha de los primeros resultados enviados: | 03/15/2018 |
| Fecha de los primeros resultados de CC enviados: | 02/21/2019 |
| Fecha de los primeros resultados publicados: | 06/02/2019 |
| Fecha de inicio real del estudio: | 07/31/2014 |
| Fecha estimada de finalización primaria: | 04/30/2017 |
| Fecha estimada de finalización del estudio: | 12/31/2017 |
Condición o enfermedad
Intervención / tratamiento
Drug: PegINF-ribavirin
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Experimental: PegINF-ribavirin Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week
Ribavirin initial dosing in the morning and in the evening:
For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).
For genotypes 1, 4, 5 and 6:
800 mg/day, if bodyweight <65 kg,
1000 mg/day, if bodyweight between 66-80 kg,
1200 mg/day, if bodyweight between 81-105 kg,
1400 mg/day, if bodyweight >105 kg.
Duration: 48 weeks | Drug: PegINF-ribavirin Peg-interferon + ribavirin under HIV physician supervision |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - Evidence of chronic HCV infection for at least 6 months before study entry (at least one detectable HCV viral load, i.e. ≥17 IU/mL, with an antibody test positive at least 6 months before the HCV RNA load result) - Fibrosis Stage F2-3-4 determined by transient elastography (Fibroscan or other similar equipment). During the first part of the study, priority will be given to patients with Fibrosis Stage F2-3. - Negative pregnancy test (on the day of inclusion). Exclusion Criteria: - Anemia and thrombocytopenia - Severe liver damage, advanced stage cirrhosis or cancer - Uncontrolled diabetes, Uncontrolled thyroid dysfunction - Retinopathy - Creatinine clearance <50 mL/min (Cockcroft) - Disease associated with the immune system - Significant heart problems - Severe neuropsychiatric conditions Contra-indication to study treatment (including pregnancy or lack of effective contraception in the participant or female partner) - Other exclusion criteria related to the use of ribavirin and peg-interferon - Any conditions that, in the investigator's judgment, may compromise the follow up. |
Salir
Medidas de resultado primarias
1. Number of Participants With Sustained Virological Response 6 Months After Treatment Discontinuation [6 months after end of treatment, i.e. 1.5 years after treatment initiation]
Medidas de resultado secundarias
1. Number of Participants With at Least a Serious Adverse Events Associated With Study Treatment (Peg-interferon and Ribavirin) [From initiation of treatment to 6 months after treatment discontinuation]
2. Number of Participants Grouped by HIV-1 RNA Concentrations [At time of treatment discontinuation (whatever its date) and 6 months thereafter]
Otras medidas de resultado
1. Number of Participants Completed the First 24 and 48 Weeks of Treatment [From initiation of treatment to the first 48 weeks of treatment]
2. Number of Adverse Events by Severity Grade [From initiation of treatment to 6 months after treatment discontinuation]
3. Number of Participants Able to Perform Self-injections of Peg-interferon [From initiation of treatment to the first 48 weeks of treatment]
4. Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80% [From initiation of treatment to the first 48 weeks of treatment]
