A Pilot Study to Determine if Raltegravir Eradicates HIV From Peripheral Blood Mononuclear Cells
NCT01173510 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2017-06-14
Summary
Human Immunodeficiency Virus (HIV) infection is permanently established by integrating a deoxyribonucleic acid (DNA) copy into the human chromosome, a step also necessary to complete the Human Immunodeficiency Virus (HIV)replication cycle. Standard treatment of HIV infection suppresses Human Immunodeficiency Virus (HIV)replication and has not been able to eliminate Human Immunodeficiency Virus (HIV)from an infected person because of the integrated Human Immunodeficiency Virus (HIV). Raltegravir (RAL), the first approved antiretroviral (ARV) in a new class called integrase inhibitors, works by preventing integration of Human Immunodeficiency Virus (HIV). For participants with Human Immunodeficiency Virus (HIV)who have never taken antiretroviral medications, this research study will test whether Raltegravir (RAL), a recommended first-line ARV, can eliminate Human Immunodeficiency Virus (HIV)from key immune system cells.
Conditions
- HIV Infections
- Acquired Immune Deficiency Syndrome
Interventions
- DRUG
-
Raltegravir plus Truvada
Raltegravir 400 mg twice daily plus tenofovir/emtricitabine (Truvada) one tablet once daily
- DRUG
-
Atripla
Efavirenz/Emtricitabine/Tenofovir DF one tablet once daily
Sponsors & Collaborators
- collaborator INDUSTRY
-
Community Research Initiative of New England
lead OTHER
Principal Investigators
-
Clyde S Crumpacker, MD · Beth Israel Deaconess Medical Center - Division of Infectious Disease
-
Calvin J Cohen, MD · Community Research Initiative of New England
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-08-23
- Primary Completion
- 2012-10-19
- Completion
- 2012-10-19
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