At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 333 enrolled
Drug / intervention
Peginterferon alfa-2a +1 moredrug
Likely dose
Peginterferon alfa-2a 180 mcg subcutaneously plus ribavirin 200 mg oral tablets/capsulesAI-extracted
Key inclusion· 6
- ✓HIV-infected with stable antiretroviral therapy for ≥8 weeks OR antiretroviral-naive for ≥4 weeks prior to entry
- ✓HIV viral load <50,000 copies/ml within 6 weeks prior to study entry
- ✓CD4 count >200 cells/mm³ within 6 weeks prior to study entry
- ✓HCV-infected, either treatment-naive or previously treated with interferon-based therapy for ≥12 weeks with detectable HCV RNA after treatment
Key exclusion· 18
- ✕HCV treatment within 4 weeks of study entry
- ✕Inability to tolerate peginterferon alfa-2a (≥3 consecutive missed doses in first 12 weeks or ≥5 total missed doses prior to Step 3)
- ✕Use of G-CSF or GM-CSF within 14 days prior to study entry
- ✕Alpha-fetoprotein ≥400 ng/ml within 24 weeks prior to entry, or 50-400 ng/ml without imaging excluding hepatic tumor
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Suppressive Long-Term Antiviral Management of Hepatitis C Virus (HCV) and HIV-1 Coinfected Subjects (SLAM-C)
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Feb 25, 2004·Updated Nov 8, 2021
In Brief
A Phase 2 clinical trial evaluating Peginterferon alfa-2a and Ribavirin for HIV Infections and 2 related conditions. Completed, enrolled 333 participants across 37 sites in 2 countries.
Detailed Summary
Infection with both HIV and hepatitis C virus (HCV) may result in serious and sometimes fatal liver disease. The purpose of this study was to test the effectiveness of long-term pegylated interferon alfa-2a (PEG-IFN) and ribavirin treatment in slowing liver disease progression in people infected with both HIV and HCV.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, Hepatitis C, Liver Disease
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2004
Enrollment StartJul 2004
Primary CompletionMay 2007
Study CompletionFeb 2009
TodayJul 2026
First PostedFeb 25, 2004
Enrollment StartJul 1, 2004
Primary CompletionMay 1, 2007
Study CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 22.4 years ago
Interventions
Peginterferon alfa-2adrug
180 mcg PEG-IFN subcutaneously
Ribavirindrug
One tablet or capsule containing ribavirin 200 mg