Efficacy and Safety of TDF+3TC+EFV in Adults With HIV/HBV Coinfection
NCT01751555 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2013-06-28
Summary
This is a Phase 4 single-arm, post-marketing clinical trial evaluating the efficacy and safety of tenofovir disoproxil fumarate, lamivudine and efavirenz in adults with human immunodeficiency virus-1 and hepatitis B virus coinfection.
Conditions
Interventions
- DRUG
-
Regimen:TDF+3TC+EFV
TDF+3TC+EFV for HIV/HBV co-infection
Sponsors & Collaborators
- collaborator INDUSTRY
-
National Center for AIDS/STD Control and Prevention, China CDC
lead OTHER_GOV
Principal Investigators
-
Fujie ZHANG, MD · National Center for AIDS/STD Control and Prevention, China CDC
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-02-28
- Primary Completion
- 2013-06-30
- Completion
- 2013-06-30
Countries
- China
Study Locations
More Related Trials
-
TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.
NCT00540449 ·Status: COMPLETED ·Phase: PHASE3
-
A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects.
NCT01737359 ·Status: TERMINATED ·Phase: PHASE2
-
Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults
NCT03547908 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants
NCT01815736 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Safety and Efficacy of E/C/F/TAF Versus E/C/F/TDF in HIV-1 Positive, Antiretroviral Treatment-Naive Adults
NCT01797445 ·Status: COMPLETED ·Phase: PHASE3
-
TMC278-TiDP6-C215: A Clinical Trial in Treatment Naive HIV-subjects Patients Comparing TMC278 to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors
NCT00543725 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Efavirenz 400mg vs. 600mg Combined With Lamivudine and Tenofovir in Treatment Naive HIV Infection
NCT04463784 ·Status: UNKNOWN ·Phase: NA
-
Therapeutic Drug Monitoring (TDM) in Generic Tenofovir/Lamivudine/Efavirenz
NCT01160120 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients
NCT00002450 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Tenofovir and Emtricitabine in ARV-naive Patients With HIV/HBV Co-infection
NCT00476463 ·Status: COMPLETED ·Phase: PHASE2
-
Dose Optimisation of Stavudine for the Treatment of HIV Infection
NCT02670772 ·Status: COMPLETED ·Phase: PHASE3
-
Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects
NCT00112047 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Adults
NCT02345226 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Adolescents
NCT02276612 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy
NCT00053638 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Durability ofTenofovir and a Cell Cycle Agent for Viral Suppression
NCT00344981 ·Status: COMPLETED ·Phase: NA
-
Safety and Efficacy of Tenofovir DF in HIV-1 Infected Adolescents Failing Their Current Antiretroviral Therapy
NCT00352053 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children
NCT01854775 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy
NCT05979311 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients.
NCT01565889 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Effects of Ledipasvir/Sofosbuvir on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide (TAF)
NCT03126370 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
NCT01309243 ·Status: COMPLETED ·Phase: PHASE3
-
Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men
NCT00131677 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
NCT02607956 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of TMC278 in Human Immunodeficiency Virus Type 1 Infected Patients, Who Are Not Treated With Antiretroviral Medicines
NCT00110305 ·Status: COMPLETED ·Phase: PHASE2