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Clinical Trial Details

Trial ID: L7308
Source ID: NCT00665353
Associated Drug: Pioglitazone
Title: Pioglitazone Before Peginterferon and Ribavirin for Hepatitis C Infection in HIV/HCV-Coinfected Patients With Insulin Resistance
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00665353/results
Conditions: HIV-1 and Hepatitis C Co-Infection
Interventions: DRUG: pioglitazone|DRUG: peginterferon|DRUG: ribavirin
Outcome Measures: Primary: The Proportion of All Subjects With HCV Viral Load < 60 IU/mL at Week 24 of Step 2., Week 24 of Step 2 | Secondary: Safety and Tolerability, Summary of the number of subjects with at least one grade 3 or higher sign/symptom or laboratory abnormality., Step 1 (Up to 24 to 28 weeks)|Safety and Tolerability, Summary of the number of subjects with at least one grade 3 or higher sign/symptom or laboratory abnormality., Step 2 (Up to 72 weeks)|The Proportion of All Subjects With HCV Viral Load < 60 IU/mL at Week 72of Step 2., Week 72 of Step 2|Absolute Change From Entry to Week 24 of Step 1 in AST and ALT., From Entry to Week 24 of Step 1|Absolute Change From Entry to Week 24 of Step 1 in Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR), From Entry to Week 24 of Step 1|Absolute Change From Entry to Week 24 of Step 1 in Fasting Total Cholesterol and Triglycerides., From Entry to Week 24 of Step 1
Sponsor/Collaborators: Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 19
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2009-03
Completion Date: 2011-12
Results First Posted: 2012-09-13
Last Update Posted: 2018-10-12
Locations: Ucsf Aids Crs (801), San Francisco, California, 94110, United States|Northwestern University CRS (2701), Chicago, Illinois, 60611, United States|New Jersey Medical School-Adult Clinical Research Ctr. CRS (31477), Newark, New Jersey, 07103, United States|Cornell CRS (7804), New York, New York, 10011, United States|NY Univ. HIV/AIDS CRS (401), New York, New York, 10016, United States|AIDS Care CRS (1108), Rochester, New York, 14642, United States|Metro Health CRS (2503), Cleveland, Ohio, 44109, United States|Virginia Commonwealth Univ. Medical Ctr. CRS (31475), Richmond, Virginia, 23219, United States
URL: https://clinicaltrials.gov/show/NCT00665353

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D336 Pioglitazone small molecule DB01132 Details
D230 Ribavirin small molecule DB00811 Details