Effect of a Change in HIV Therapy on Liver Steatosis, Inflammation, and Fibrosis
NCT00023218 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2015-03-09
Summary
The purpose of this study is to look at how 2 different anti-HIV drug treatments affect the liver.
The use of anti-HIV drugs like the nucleoside reverse transcriptase inhibitors (NRTIs) may be linked to liver problems like fatty changes, scarring, abnormal liver function tests (LFTs), and lactic acidemia (an increase in lactic acid in the blood). Increased liver enzymes may mean liver damage. The way that the liver changes in people with abnormal LFTs and lactic acidemia is not completely understood.
Conditions
- HIV Infections
- Hepatitis C
Interventions
- DRUG
-
Lopinavir/Ritonavir
- DRUG
-
Efavirenz
Sponsors & Collaborators
-
National Institute of Allergy and Infectious Diseases (NIAID)
lead NIH
Principal Investigators
-
Cecilia Shikuma
Study Design
- Purpose
- TREATMENT
Eligibility
- Min Age
- 13 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
Study Locations
More Related Trials
-
Study of HIV Patients With Undetectable Viral Load and Abnormal Lipids Switching to Atazanavir/Ritonavir
NCT00120393 ·Status: COMPLETED ·Phase: PHASE3
-
ABT-378/Ritonavir and Efavirenz in HIV-Infected Patients Who Have Taken More Than One Protease Inhibitor in the Past
NCT00004582 ·Status: COMPLETED ·Phase: PHASE2
-
Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success With Protease Inhibitor-Containing HAART Regimen(s)
NCT00028301 ·Status: COMPLETED ·Phase: PHASE3
-
Immune Reconstitution as a Determinant of Adverse Effects to New Antiretroviral Therapy in Persons With Advanced HIV Infection
NCT00885664 ·Status: COMPLETED ·Phase: PHASE4
-
Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients With Drug-resistant HIV
NCT00027339 ·Status: COMPLETED ·Phase: PHASE2
-
Dose Finding Confirmation of Atazanavir With Ritonavir and Efavirenz (ATV/RTV + EFV) in Healthy Subjects
NCT00357188 ·Status: COMPLETED ·Phase: PHASE1
-
Exploratory Study of Tipranavir and Ritonavir in Multiple Protease Inhibitor-experienced HIV Patients
NCT02238314 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacokinetics of Lopinavir/Ritonavir at Three Different Doses.
NCT00985543 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of the HIV Protease Inhibitors Atazanavir and Lopinavir/Ritonavir on Cardiovascular Disease Risk Factors
NCT00720590 ·Status: COMPLETED ·Phase: NA
-
Study of Lopinavir/Ritonavir Tablets Comparing Once-Daily Versus Twice-Daily Administration When Coadministered With Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-Experienced Human Immunodeficiency Virus Type 1 Infected Subjects
NCT00358917 ·Status: COMPLETED ·Phase: PHASE3
-
Lopinavir/Ritonavir in Combination With Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-Infected Subjects
NCT00043953 ·Status: COMPLETED ·Phase: PHASE2
-
Changes in Triglyceride and Other Lipids (Levels of Fats Found in Blood) When Taking Darunavir Compared to Atazanavir in HIV-infected Patients That Have Never Received Treatment
NCT00757783 ·Status: COMPLETED ·Phase: PHASE4
-
Effectiveness of ABT-378/Ritonavir Plus Lamivudine Plus Efavirenz Plus Tenofovir DF in HIV-Infected Patients
NCT00038220 ·Status: COMPLETED ·Phase: PHASE2
-
A Study Exploring an Induction-Maintenance Kaletra-Based Therapy Versus a Sustiva-Based Regimen in Previously Non-Treated, HIV-1/HCV Co-Infected Subjects
NCT00121017 ·Status: WITHDRAWN ·Phase: PHASE2
-
HIV Antiretroviral Drugs and Metabolism
NCT00525239 ·Status: UNKNOWN ·Phase: NA
-
Safety Study of Raltegravir in HIV/HCV Co-infected Patients
NCT01225705 ·Status: WITHDRAWN ·Phase: PHASE4
-
Lopinavir/r or Fosamprenavir/r Switch to Atazanavir/r or Darunavir/r
NCT00756730 ·Status: COMPLETED ·Phase: PHASE4
-
Effects of Tipranavir/Ritonavir on the Pharmacokinetic Characteristics of Triple Drug Nucleoside and Non-nucleoside Reverse Transcriptase Inhibitor Therapy in HIV-1-infected Subjects
NCT02251223 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety and Effectiveness of Lopinavir/Ritonavir in Individuals Who Have Failed Prior HIV Therapy
NCT00357552 ·Status: COMPLETED ·Phase: NA
-
PK of Efavirenz & Lopinavir Nano-formulations in Healthy Volunteers
NCT02631473 ·Status: SUSPENDED ·Phase: PHASE1
-
Tipranavir and Ritonavir vs. Saquinavir and Ritonavir Used With Two Nucleoside Reverse Transcriptase Inhibitors in Single Protease Inhibitor-experienced HIV-1 Patients
NCT02239835 ·Status: TERMINATED ·Phase: PHASE2
-
Trial About Hepatic Security of Antiretroviral Treatment Based on Kaletra Versus Nevirapine in Co-infected HIV/HCV Patients
NCT00661349 ·Status: TERMINATED ·Phase: PHASE4
-
The Pharmacokinetics of Double Boosted Protease Inhibitors in Antiretroviral-naive HIV-1 Infected Patients
NCT00400738 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy Study of Substitution of Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors
NCT00543101 ·Status: COMPLETED ·Phase: PHASE4
-
The Raltegravir and Ribavirin Pharmacokinetics (PK) Study
NCT00982553 ·Status: COMPLETED ·Phase: PHASE1