Raltegravir And Darunavir Antiretroviral in Antiretroviral Naive Patients
NCT00677300 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 85
Last updated 2014-09-08
Summary
The purpose of this study is to determine whether a combination of raltegravir and darunavir is as effective as standard regimens in the treatment of HIV-infected patients who have not previously used antiretroviral drug (treatment naive)
Conditions
- HIV Infections
Interventions
- DRUG
-
Raltegravir
400mg P.O. (orally) twice daily for 48 weeks
- DRUG
-
Darunavir
800 mg P.O. (orally) once daily
- DRUG
-
Ritonavir
100mg once daily
- DRUG
-
Tenofovir/Emtricitabine
300 mg/200 mg P.O. (orally) once daily
Sponsors & Collaborators
- collaborator INDUSTRY
-
Tibotec Pharmaceutical Limited
collaborator INDUSTRY -
Dallas VA Medical Center
lead FED
Principal Investigators
-
Roger Bedimo, M.D. · Dallas VA Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-01-31
- Primary Completion
- 2012-10-31
- Completion
- 2012-12-31
Countries
- United States
Study Locations
More Related Trials
-
Pilot Study of a Raltegravir Based NRTI Sparing Regimen
NCT00814879 ·Status: COMPLETED ·Phase: NA
-
Comparative Efficacy and Safety Study of Dolutegravir and Lopinavir/Ritonavir in Second-line Treatment
NCT02227238 ·Status: COMPLETED ·Phase: PHASE3
-
Clinical Trial to Assess the Efficacy of Darunavir/Ritonavir (DRV/r), Etravirine (ETV) and Raltegravir (MK-0518) in HIV Patients With Resistant Viruses
NCT00460382 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients
NCT01199939 ·Status: COMPLETED ·Phase: PHASE2
-
Capacity of the Dual Combination Raltegravir/Etravirine to Maintain Virological Success in HIV-1 Infected Patients of at Least 45 Years of Age- ANRS 163 ETRAL
NCT02212379 ·Status: COMPLETED ·Phase: PHASE2
-
A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily
NCT01227824 ·Status: COMPLETED ·Phase: PHASE3
-
Raltegravir + Lopinavir/Ritonavir Versus Efavirenz + Tenofovir + Emtricitabine in Treatment Naive Patients
NCT00752856 ·Status: COMPLETED ·Phase: PHASE2
-
Raltegravir and Atazanavir Dosing Strategy Study
NCT00874523 ·Status: COMPLETED ·Phase: PHASE3
-
Raltegravir + Lopinavir/Ritonavir or Emtricitabine/Tenofovir for HIV Treatment Naive Subjects
NCT00654147 ·Status: COMPLETED ·Phase: PHASE2
-
Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients
NCT01332227 ·Status: COMPLETED ·Phase: PHASE4
-
Safety Study of Lopinavir/Ritonavir With Raltegravir in HIV-infected Patients
NCT00752037 ·Status: COMPLETED ·Phase: PHASE4
-
Early Access to Low-dose Ritonavir (TMC114/r) and Other Antiretrovirals (ARVs) for Treatment-naive or Early Treatment Experienced in HIV-1 Patients
NCT01702090 ·Status: COMPLETED ·Phase: PHASE4
-
Impact of Antiretroviral Therapy on Metabolic, Skeletal, and Cardiovascular Parameters
NCT00851799 ·Status: COMPLETED
-
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
-
Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL)
NCT00711009 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacokinetics (PK) Study of Once Daily Darunavir/Ritonavir and Twice and Once Daily Raltegravir in HIV-infected Subjects
NCT01047995 ·Status: COMPLETED ·Phase: PHASE1
-
Sustained Virological Suppression and Improvement of Adverse Events of Switching to Raltegravir Study
NCT01679964 ·Status: COMPLETED ·Phase: PHASE4
-
A Drug Interaction Study Evaluating GSK2248761 and Raltegravir Pharmacokinetics in Healthy Adult Subjects
NCT01101893 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics, Pharmacodynamics and Cervicovaginal Lavage of Combined Oral Contraceptives and Raltegravir
NCT01597180 ·Status: WITHDRAWN
-
Second-line Treatment of HIV-1 With Ritonavir Boosted Atazanavir or Darunavir With an Optimized NRTI Backbone
NCT01605084 ·Status: WITHDRAWN ·Phase: PHASE3
-
A Study of Drug-Drug Interaction Between Danoprevir/Low-Dose Ritonavir and Raltegravir in Healthy Volunteers
NCT01531647 ·Status: COMPLETED ·Phase: PHASE1
-
A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir
NCT03198884 ·Status: COMPLETED
-
Safety and Efficacy Study Comparing Raltegravir to a Protease Inhibitor in Treatment-naïve, HIV/Hepatitis C Drug Users
NCT01105611 ·Status: UNKNOWN ·Phase: PHASE4
-
TMC114-C202: A Study of Safety, Efficacy, and Tolerability of TMC114 and Low Dose Ritonavir in HIV-1 Infected Patients
NCT00071097 ·Status: COMPLETED ·Phase: PHASE2
-
TMC278-TiDP6-C153 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC278 and Raltegravir
NCT01288755 ·Status: COMPLETED ·Phase: PHASE1